Help Needed
CHAPTER FOUR Psychological, Social, and Cultural Issues in Psychopharmacology
This chapter is divided into four sections. Section One provides an overview of issues surrounding adherence and compliance with medication prescriptions. Section Two addresses how to speak with clients about medications. Section Three covers the new subdiscipline of ethnopharmacotherapy and Section Four provides an overview of how institutions like pharmaceutical companies are impacting mental health practice.
SECTION ONE: ADHERENCE AND COMPLIANCE WITH MEDICATION REGIMENS
Learning Objectives
• Understand the difference between compliance and adherence.
• Be able to discuss the different ways clients conceptualize their symptoms.
• Be able to discuss common reasons people do not comply with medication regimens.
• Know the predictors of noncompliance and therapeutic ways to work through them with clients.
Many psychological issues that clients have related to psychotropic medications are illustrated in discussing compliance with medication. Even when a person suffers from terrible ego-dystonic symptoms , if taking medication is incongruent with the person's self-image, noncompliance or nonadherence may be an issue. Compliance is the overall extent to which a client takes medication as prescribed. Adherence is more specific, referring to the extent that the client takes the prescribed medication at the exact time and in the correct dose (Demyttenaere, 2001). We include adherence in our general discussion of compliance.
We recall one client (Agnes) who interpreted taking a medication as a sign of weakness that she avoided thinking about. Agnes had lost her husband one month before she consulted a physician for her “nerves.” Her physician was torn as to the best course of action. Under earlier diagnostic manuals (e.g., DSM-IV-TR, APA, 2000), she was experiencing uncomplicated bereavement, which is a developmentally normal event following loss of a loved one. However, she was not eating or sleeping, and met the DSM-5 (American Psychiatric Association [APA], 2013) criteria for a Major Depressive Episode. DSM-5 omitted the exclusion not to diagnose someone with depression if they had just lost a loved one [a move many in the field are critical of (Frances, 2013)].
Agnes asked if there were medication to “calm her nerves” but then became agitated stating that taking the medication would be a sign of weakness. The doctor wisely refrained from prescribing and connected Agnes with grief counseling. In the counseling sessions, Agnes revealed that the bottom line was “anyone who would take a pill for their mind is crazy.” Her response was clearly related to her own perceptions of psychotropic medication, which reflected the cultural stigma attached to mental/emotional disorders, particularly for a woman in her 70s.
Understanding such stigma is an important variable in understanding clients who may resist or feel conflicted about taking medication (Knudsen, Hansen, Traulsen, & Eskildsen, 2002), but the stigma seems to vary from generation to generation; from culture to culture (Britten, 1998; Priest, Vize, Roberts, & Tylee, 1996). Mental health professionals must be willing to commit the time with clients to explore issues such as stigma. For Agnes, cognitive techniques helped her reframe and metabolize her grief but ultimately her mind was made up about psychotropic medication and, right or wrong, it was not of therapeutic value to challenge it.
CLIENT REACTIONS TO THE MEDICAL MODEL OF MENTAL ILLNESS
Some qualitative studies examine the way clients perceive the medical model description of their symptoms. In one study of women suffering from symptoms of schizophrenia (Sayre, 2000), most of the sample seemed to have been given a medical model explanation of their symptoms (e.g., “Schizophrenia is a brain disorder”). Client responses fell into six general categories. The members of one group more or less accepted the disease explanation and viewed their problems as related to some externally caused illness that could be treated with medication. The members of another group (labeled the “problem group”) saw their symptoms as arising from personal qualities and behaviors that were the root causes. The members of a third group (the “crisis group”) viewed their symptoms as a response to some crisis or other recent stressor. In a fourth group (the “ordination group”), the members saw their symptoms as a sign of special powers or responsibilities. Although this explanation is similar to tales of initiation told in shamanic traditions of many indigenous people, in this case the explanations were more consonant with the symptom profile than any spiritual crisis. In the fifth group (the “punishment group”), members saw their symptoms as punishment for past actions. In the final group (the “violation group”), members viewed their hospitalization as an attack on them by hospital staff and the idea that they had an illness an excuse for detaining them. In the case of schizophrenia, although there is strong support for a theory of biological etiology, the symptom presentation is still heterogeneous.
Even if a clinician believes the etiology of a disorder is more physical than mental (e.g., more brain than mind), it is important for the therapeutic relationship to consider the way a client makes meaning of his or her symptoms. Clearly, some perceptions of illness recorded in the Sayre (2000) study may reflect the illness more than they represent any personal or cultural aspects of the client. For example, illusions or hallucinations may be perceived as a sign of special powers (as in shamanic initiation) but also may reflect megalomania , which manifests in many people suffering from severe disorders such as schizophrenia or Bipolar I Disorder.
It is important to remember that some clients prefer to use the medical model perspective to explain their symptoms. In such cases, a psychological perspective can help counselors understand why some clients have this preference. Although ideally clients will become able to face all the variables related to their symptoms, this may take time. In some cases of depression, the medical model may provide a good explanation; however, where the depression is overdetermined , the medical model may serve as what Yalom (1995) called an “explanatory fiction”—an explanation that is more allegory than fact corresponding to some external truth. One client (let's call him James) had low self-efficacy and was actively suicidal. This followed a series of difficult life events, including the loss of a job, being dumped by a longtime girlfriend, and the death of his mother from pancreatic cancer. Clearly, these life experiences were strongly related to his depression but for James, the explanatory fiction of his depression as a medical illness made it easier to accept help in the form of counseling and antidepressant medication. James took the antidepressants for eight months while also engaging in counseling. After eight months, his doctor titrated him off the medication. James terminated the counseling relationship after one year, at which time he was functioning much better.
The medical model as explanatory fiction or useful metaphor is illustrated in the notion that alcoholism (or any substance dependence) is a “disease” with a biological etiology. This notion is not supported by science or logic (Ross & Pam, 1995), but rather on the agenda of the group defining it. The Veterans’ Administration does not refer to alcohol dependence as a disease while the American Medical Association does. Defining alcohol-related problems as a “disease” can also steer us away from research supporting moderation management in some drinkers [e.g., some people can have an alcohol problem at one point in their life then return to moderate drinking (Hester, Delaney, & Campbell, 2011)]. On the constructive side, the metaphor of alcohol dependence as a disease has helped some clients avoid becoming crippled by guilt and self-recrimination so they can more fruitfully engage in treatment. Certainly the reverse holds true as well—some clients use the metaphor of alcoholism as a disease to avoid taking any responsibility for their drinking (“I can't help it—I have a disease”). Ethically, the clinician needs to know when the medical model perspective seems to be the best explanation for symptoms and when it seems the best metaphor to help the client engage in treatment. When metaphors are mistaken for facts, however, the potential exists for damaging word magic. One example is that in many polls, Americans believe that people who once have a problem with alcohol must abstain totally for the rest of their lives (Lillenfeld, Lynn, Ruscio, & Beyerstein, 2010) while more and more research supports that some (but not all) people can learn moderation management (Hester, Delaney, & Campbell, 2011).
Another example of metaphor gone wrong was a case of a fifth-grade student that I (Ingersoll) consulted on. The student was diagnosed with attentiondeficit-hyperactivity disorder (ADHD), with an inattentive specifier (in DSM-5 criteria). The school counselor and I learned that the diagnosis had been made in a physician's office without an assessment of the child's behavior across several settings. The child appeared inattentive because in school she would unpredictably stare off into space or get up and meander around the classroom. The physician told the parents that their child had a “chemical imbalance.” They took this to mean that the medication (a stimulant in this case) would correct the problem. Although the medication seemed to help the daydreaming, it also seemed to exacerbate the behavior of getting out of her chair and wandering around the room. The school counselor and I referred the child to a specialist who helped children with mild to moderate symptoms of ADHD. The parents agreed, and the counselor worked with the student on learning how to concentrate and helped the parents and teacher at the school cue and reinforce appropriate behavior in the student. After six months, the child was able to be titrated off the medication. Had the parents continued under the assumption that their child had “a chemical imbalance,” the child might not have received the help she needed or would have received it later than she did.
Even though a client may prefer a medical model explanation of symptoms because it is less threatening to his or her sense of self, mental health professionals must resist being caught up in the word magic of the medical model. We recall attending a presentation at a professional conference where the presenter lectured for three hours on the biological bases for mental disorders, without producing one reference or fact to support his thesis. He seemed far too mesmerized by the medical model to bother to provide factual support for his claims. Even though he was trained in psychosocial interventions, he did not mention the ones we know are effective for many of the disorders he covered (such as ADHD). In addition, this psychologist supported the movement to give psychologists the legal power to write prescriptions for psychotropic medications. As such, he was clearly biased. A better approach would have been to set his presentation in the context of his position that psychologists should be allowed to prescribe psychotropic medications.
A study of adolescents with mental/emotional disorders summarized their perceptions of treatment. These teenagers shared the common negative perception that staff relied too much on the medical model to explain depression. They reported that the staff seemed to just want to give them medication and to not talk to them about what was really bothering them (Buston, 2002). What was “really bothering them” in this case were psychological and cultural variables that they saw as related to their depression. These adolescents wanted to discuss their psychological perspectives with clinicians rather than just have their symptoms described as a disease process treatable with pills. More recent studies confirm that children and adolescents will often resist taking medication (Worley & McGuinness, 2010) many times for reasons that can be addressed in counseling like fearing personality changes, social stigma, and concerns about addiction (Hamlin, McCarthy, & Tyson, 2010).
Perhaps the best way to begin this section is to ask the reader a simple question. Have you ever (1) not taken a medication as directed, (2) taken more of a medication than prescribed, (3) taken less of a medication than prescribed, (4) stopped taking a medication before your doctor recommended it, (5) resumed taking a medication left over from an earlier prescription without checking with your doctor for the new episode? If you have done any of these, you have not followed—technically, you have been noncompliant with—a medication plan. (When we ask this question in class, 80 to 90% of our students raise their hands; we do, too.) Researchers estimate that only 50% of people on any prescription medication always take it as prescribed (Patterson, 1996).
Although there is no absolute way to predict which clients will be most compliant with medication regimens, some characteristics can be assessed. We have long known that adherence rates vary across racial/ethnic demographics (Cuffs et al., 2013; Diaz, Wood, & Rosenheck, 2005) with people of color reporting adherence rates between 66 and 77% while Caucasians report adherence rates around 90%. We also know that the younger the person taking the medication, the less adherence they exhibit (Worley & McGuinness, 2010). In general, people who follow medication plans are usually emotionally mature, in stable family situations, employed, and pay for their own or part of their treatment. This profile implies that the further along a client is developmentally, the more likely he or she is to follow a medication plan. Although there are dozens of lines of development, some key lines such as cognitive, emotional, and ego development seem particularly germane here. When you talk to a client about medication, you must consider his or her developmental level as well as lifestyle to get a sense of how compliant that person is likely to be. Predictors of noncompliance include being male, being young, and experiencing severe side effects (Demyttenaere, 2001).
It is also important to examine the clinician's attitude toward compliance. Many interns go into a mental health field with the misconception that part of their job is to make sure the client stays on prescribed psychotropic medications. This is untrue and may reflect anything from unresolved power issues, to poor training, to the unresolved power issues of their supervisors in the field. It is not the job of a mental health professional to make sure clients stay on their medications. It is the job of a mental health professional to help clients weigh the benefits and risks of taking medications, to help clients process conscious and unconscious resistance to medication, and to work with any number of theories to explore the risks and benefits of medications and how the medications relate to the goals a client has set in counseling. In the end, it is always the client's choice whether or not to take medications, even when not doing so will likely result in incarceration or confinement in a more restrictive treatment setting.
REASONS THAT CLIENTS MAY NOT COMPLY
When the noncompliance issue arises, mental health professionals must explore it with clients. Noncompliance can be caused by many things, including cost of the treatment, forgetfulness, and client values and beliefs (Demyttenaere et al., 2001). Beck, Rush, Shaw, and Emery (1979), who initiated research on irrational beliefs that contributed to noncompliance, concluded that clients on antidepressants were often noncompliant because of irrational thoughts about their medications. These researchers found the following three irrational thoughts among the primary ones associated with medication noncompliance: “The medication won't work,” “I should feel good right away,” and “My depression is incurable.”
Sometimes the client just thinks the drug will not work, without any evidence to support that notion. You may find the client has a pessimistic worldview— part of what Beck et al. (1979) called the cognitive triad of depression. Another possibility is that perhaps the client is involved in what is called a negative feedback loop. In a negative feedback loop , the client for some reason stopped getting reinforcers that up to a point were satisfying. An example is when a client suffers the breakup of a romantic relationship that he or she experienced as reinforcing. The result of losing these reinforcers was depression, but the depressive symptoms then began prompting reactions in other people, reactions that became reinforcing. In the latter example, assume the client then started getting more calls from friends who were concerned about him or her. Those calls then become reinforcing and, rather than seeking out another relationship, the client may come to rely on those calls. This pattern is colloquially referred to as “getting some secondary gain from the symptoms.” In such cases, clients prefer to believe no drug will work for their symptoms, because if they lose the symptoms they lose the secondary gains.
It would be ideal if all medications worked immediately. But that simply is not the case with most psychotropic medications, particularly antidepressants, that may take anywhere from two to six weeks for the full therapeutic effects to manifest (when they do work). Counselors and other therapists must help clients deal with the early onset of side effects and later onset of therapeutic effects. It is wise to let the client describe how he or she is feeling before the counselor asks direct questions about non-life-threatening side effects. In some instances (outlined by Greenberg & Fisher, 1997), side effects actually have some placebo value in that the client may interpret them as the medication “working.”
If a client seems to feel his or her depression is incurable, here again counselors should investigate what possible secondary gains the person may be getting from the symptoms (the negative feedback loop may be operating). This belief may also be a manifestation of one aspect of the cognitive triad of depression . Readers may recall that Aaron Beck stated that the cognitive triad of depression was comprised of negative feelings about self, the world, and the future. A third possibility is that the client actually has a subtle death wish and is mentally prepared to decompensate (decline in functioning) to the point where he or she may have the nerve to attempt suicide. A final possibility is that the client has engaged in several unsuccessful treatments and has come to believe there is no treatment for his or her condition. Taking a thorough treatment history is invaluable in identifying this last dynamic.
Patterson (1996) added that clients may not comply with their medication plan because of trouble with routines, or inconvenience; medication as evidence of an undesirable self; misinformation; and other issues.
Trouble with Routines, or Inconvenience
Trouble with routines, or inconvenience, is often a problem for clients with impaired cognitive functioning. The client may forget or become confused about the medication regimen, grow tired of taking the medication, or may not be able to afford the medication (or believes she or he can't afford it). Clients who do shift work, for example, may have changes in routine that hinder remembering when to take medication. This is one reason pharmaceutical companies try to develop medication formulations that allow once-daily doses or even intramuscular injections that let a client get the medications injected once a month.
Problems of inconvenience often relate to side effects. One client we treated felt lethargic and sedated when taking her medication. She worked in a university setting as a recruitment coordinator. Her job required enthusiastic presentations and campus tours throughout the day. This particular client felt the side effects made her job much more difficult. The extra effort to get through the workday was so inconvenient that she responded by stopping her medication.
Medication as Evidence of an Undesirable Self
The notion that taking medication shows undesirable personal traits is particularly important when considering the client's psychological perspective. Such a client may believe that requiring medication is a sign of weakness or indicates some flaw or stigma related to mental illness. The client may be embarrassed at the prospect of other people finding out about her or his taking medication. Other clients may say they feel they are not their “real selves” while on medication. Although this may in fact be true, it is also possible that the client has been experiencing symptoms for so long (as in Persistent Depressive Disorder [previously called Dysthymia ] in DSM-IV) that he or she has included the symptoms in his or her definition of “real self.” Generally speaking, clients who negatively interpret taking medication are concerned about losing control over their lives. They may feel their symptoms have taken control of their lives to some extent and that the medications further decrease their control. This resistance can be complicated by paranoia that is part of the client's symptom profile or that arises when the client (sometimes for good reasons) does not trust the therapist or prescribing physician.
In such cases, one excellent strategy is based on Rogers's (1957) six core conditions of constructive personality change. First, make sure the client is capable of making psychological contact. Clients with psychotic or manic symptoms may not be able or willing to make psychological contact. Second, if the client is able/willing to make psychological contact, Rogers's conditions posit that he or she is in a state of incongruence between ideal self and what he or she currently perceives as the self. In this situation, we assume that the lack of congruence is related to mental/emotional symptoms and the prospect of taking medication for those symptoms. Third, Rogers stipulates a therapist who is congruent, meaning that he or she is aware of both the client's ideal and current sense of self, how they overlap and where they may not. Fourth, the counselor experiences unconditional positive regard for the client. In this case, unconditional positive regard includes a nonjudgmental acceptance of the client's conflicts about taking the medication, including an acceptance of extreme feelings (e.g., some clients say they would rather die than take medication). Fifth, the counselor experiences an empathic understanding of the client's perspective, and sixth, when the counselor experiences this empathic understanding of the client he or she conveys it to the client. When these conditions are met the stage is set, according to Rogers, for constructive personality change—in this case, dealing with medication issues. If you are using another model of counseling, remember that it is most helpful to clients to work with a counselor who is empathic and willing to talk with them about their fears related to psychotropic medications.
Misinformation can be an easily remedied reason for noncompliance. In some cases, fixing misinformation simply requires referring the client to a credible source of information or sharing that information in the counseling session. One problem is related to the labels categories of the medications have. One client, who was taking olanzapine (Zyprexa) to control his symptoms of Bipolar I Disorder, heard that the medication was an “antipsychotic” and promptly replied, “Well, I'm not psychotic, so that must be the wrong medicine.” A good part of an entire session was spent discussing how such medicine categories are labeled and how they really do not relate well to different uses with different clients. To the notion of misinformation we add the idea of disinformation contamination. Disinformation is the intentional spreading of information that is patently untrue, for political or other purposes. When disinformation concerning drugs (such as “All drugs cause addiction”) contaminates a client's consciousness, it is possible that person may then assume any drug, even one that could help, is more dangerous than it actually is. The U.S. government's “war on drugs” has been built on disinformation for political purposes, such as labeling marijuana and heroin “narcotics,” which gives the impression that they are similar substances (they are not). Another example is when the government sponsored researchers who claimed their studies showed that the drug 3,4-methylenedioxy-N-methylamphetamine (MDMA) caused literal holes in the brain (Ricaurte, Yuan, Hatzidimitriou, Cord, & McCann, 2002). When his conclusions could not be replicated and were challenged Ricaurte claimed that the facility that dispensed the drug for his study gave him methamphetamine instead of MDMA (a labeling error he claimed). He later retracted the paper (Ricaurte, 2003). Disinformation like this only makes citizens more mistrustful of government spokes-people. Until the government accepts a reasonable policy on drug use and tells the truth about what we do know, disinformation will continue to contaminate the thoughts of the public regarding all medications.
Sometimes, when symptoms are controlled, a client believes she or he is cured (as with an antibiotic) and stops taking the medication. This is another illustration of how different psychiatry is from other branches of medicine. In the allopathic treatment model , symptom cessation often means the condition has in fact been cured. This is not necessarily so with the many mental/emotional disorders where “cure” is not possible yet or not necessarily due to medications. Clients suffering from depression that appears psychological in origin may take medications such as antidepressants for six months and engage in counseling at the same time. For many such clients, the medication provides a chemical window of opportunity wherein they get the energy to deal with the psychological issues related to the depression. Once they have resolved some of the psychological issues, their doctors can titrate them off the medicine. Other clients may suffer from psychological symptoms that seem to have a strong biological component (such as symptoms of Bipolar I Disorder). These clients may be facing years or a lifetime of some medication regimen and face different issues from those who need medication for only a short period.
At the other end of the spectrum is the client who stops taking the medication after a short period because she or he does not notice any effect. As we emphasize throughout this book, many of these medications may take weeks before their therapeutic effects begin. In addition, some clients who discontinue their medication do so because they do not like the side effects. Our experience is that such clients would do better to contact their prescribing professional to see if there is a different medication they may be better able to tolerate. Although mental health clinicians cannot make specific recommendations about medications, they can refer clients back to their doctors when necessary.
Patterson (1996) also noted that some clients believe their medications are not working because they have unrealistic expectations for the medication. One client we recall who was taking an anti-depressant was astonished at how sad she became at the funeral of a beloved aunt. She had a history of being overwhelmed by powerful depressive episodes and had developed a defense of warding off strong feelings, assuming that if she could do that, she could maintain emotional control. She said she sobbed throughout the funeral as if she hadn't cried for years (and in fact she hadn't). This client had an unrealistic expectation that the medications were akin to a vaccine against sadness. With her counselor, the client came to see her emotional expression at the funeral as a personal victory in that she expressed her true feelings and was able to grieve with loved ones but wasn't overwhelmed by the grief. Whether this victory was the result of the therapy, the antidepressant, or both could not be differentiated, but it was one of the first signs of improvement in quality of life for this client.
Another problem (although not as common as supposed) is clients who abuse their prescription medication because they like the effects or get a “high” from the medication. Of greatest concern among the psychotropic medications are the benzodiazepines and amphetamines, which can be abused to induce an altered state of consciousness and can potentially induce dependence. Although this is a concern for a minority of clients, most clients on these medications do not abuse them and once government disinformation is sifted out, the risk is relatively minor.
Perhaps the most problematic situation is when the medication seems to work for the client but it is precisely these therapeutic effects that the client does not want. This may be the case particularly when the symptoms are pleasant or somehow reinforcing for the client. We recall one client (Jacob) who suffered from Bipolar I Disorder and who really missed the manic “highs.” When Jacob suffered from mania his “highs” eventually became incapacitating, leading him to high-risk behaviors that twice ended with his incarceration. He said that although the medication seemed to preclude the mania, it made him feel “normal.” For Jacob, “normal” was not as good as he felt in a manic phase. The client tried three times to titrate off his medication over a period of five years. Each time he relapsed within eight months. This was truly frustrating for him, because his manic episodes always ended with him incarcerated or in an inpatient treatment facility. In cases such as Jacob's, an existential counseling approach is very helpful. Such approaches help clients develop a sense of meaning in the middle of difficult or even unacceptable existential givens (such as illness, infirmity, and mortality). John Brent's (1998) article on time-sensitive existential treatment is an excellent synopsis of an approach that can be used with clients such as Jacob. In Jacob's case, he had to work through the difficult reality that every time his doctor titrated him off his medication, he relapsed within one year. The existential givens for Jacob included a nervous system that seemed to require medical intervention for Jacob to be able to function in Western society.
Review Questions
• What is the difference between compliance and adherence?
• What are four different ways clients may conceptualize their symptoms?
• What are common reasons clients do not comply with medication regimens?
• What are predictors on noncompliance? What are some therapeutic ways to work through them with clients?
SECTION TWO: TALKING TO CLIENTS ABOUT MEDICATIONS: KNOW AND EDUCATE THYSELF
Learning Objectives
• Be willing to examine your own personal and countertransference issues regarding medication.
• Be able to discuss supervision issues that arise in assessing and monitoring clients taking psychotropic medications.
• Understand the important advocacy role mental health professionals play.
• Assess your own willingness to be an advocate for your client.
The variation on the Delphic motto (“Know thyself”) in the subheading for this section is another good mantra for any mental health professional in training. Your own attitudes about and past experiences with psychotropic medication can seriously affect your work with clients. It is of the utmost importance that all mental health counselors be aware of their own psychological issues with medication to preclude countertransference reactions. Recall that countertransference occurs when a client's issue triggers unresolved issues in the therapist, which the therapist may not be aware of. If left unaddressed, these can then render the therapist less effective with the client.
One counseling student we worked with had been an excellent student and had done equally well in her internship until she got her first client being treated with mood-stabilizing medication (lithium). She felt the client should stop taking the medication because of the severe side effects and almost went so far as to say that in a session with the client. This intern, who was normally open, interested, and very present in counseling and supervision sessions, became emotionally “closed off.” In supervision, it turned out she had had a sister who suffered from schizophrenia and had committed suicide. The intern had experienced a great deal of anguish in watching the effects of the medication on her older sister and to some extent blamed the low quality of her sister's life—and her eventual suicide—on the medication. Although the counselor's sister had been on a different medication (haloperidol/Haldol), the issues the counselor's client was dealing with were similar enough to trigger the counselor's own unresolved issues related to psychotropic medication.
If your client is on medication, take a minute to check in each session with the client about therapeutic effects, side effects, and compliance. If there seem to be problems with compliance, shift the focus of the session to that. Remember, however, that the aim of counseling or psychotherapy is not to make sure your client stays on his or her medication. Clients have a legal right to refuse medication and some studies suggest counseling is the most common response to medication refusal even in inpatient settings (Carey, Jones, & O'toole, 2013). Your client is another human being who has a right to make choices about her or his life and the treatment of his or her symptoms. Many beginning therapists are so consumed with worry over their client's compliance with a medication regimen that they cannot be present—attentive—for the client in the session. Some researchers have found that even clients with severe mental disorders can learn to assume responsibility for their medication management (Dubyna & Quinn, 1996; Mitchell, 2007).We will discuss adherence issues when children and adolescents are taking psychotropic medications in the chapter devoted to children and adolescent issues. The issues related to adherence are even more complex where children and adolescents are involved party because most psychotropic medications do not have on-label approval for pediatric use (Dean, Witham, & McGuire, 2009).
When mental health therapists are talking to clients about medication education is a critical component (American Academy of Child & Adolescent Psychiatry, 2009; Patterson, 1996). As indicated by many of the irrational thoughts about psychotropic medication just described, most people are not aware of what such medications can and cannot do for them. Patterson points out that the therapist must emphasize that these medications are treatments, not cures, and that the client ultimately must manage his or her own life. Understanding the main effects, the side effects, and how the medication is supposed to alleviate the symptoms is important knowledge for the client. Patterson also recommends, when talking to clients, using the word medications rather than drugs, because the latter term may be confused with drugs of abuse—about which very few people actually have good information, as we noted earlier in the chapter.
Ingersoll (2001) noted that the mental health clinician is in the role of “information broker,” which requires some real work. To be a good information broker, you must first be able to differentiate good information from bad information. For our purposes, good information draws from clinical case summaries, peer-reviewed literature, and one's own clinical observations. The biggest problem with peer-reviewed literature is that it may be biased toward the medical model, for reasons we discuss later in the book such as being funded by the pharmaceutical company making the drug. Because of this bias, peer-reviewed literature should also be complemented with clinical case observations published in medical journals and newsletters on psychopharmacology. In addition, it is always important to read the sections of peer-reviewed articles that describe who funded the research. Research funded by a pharmaceutical company may be biased toward that company's products. Obviously, to be a good information broker, you also need at least an adequate understanding of research design. This enables you to see the difference between a study that truly supports the efficacy of a drug and a study design that merely supports a particular view of a drug.
The student intern case discussed in the last section gives one example of how supervision plays an important role in dealing with clients who take psychotropic medication. In all supervision, the key is assuring quality treatment for clients. For clinicians in nonmedical fields such as counseling and psychology, supervisors are there to monitor client welfare by assuring that clinicians comply with legal and ethical standards as well as standards of good practice. An important component of supervising mental health clinicians is discussing medications that clients are taking and how the clinician is talking about these with clients. As stated earlier, there are no clear prohibitions against nonmedical mental health professionals discussing psychotropic medications with clients, and codes of ethics and standards in counseling, psychology and school psychology state that clinicians should be competent including knowledgeable about treatment options that clients may encounter. Buelow, Herbert, and Buelow (2000) note, legal problems are currently more likely to arise from mental health clinicians not learning about psychotropic medications than from discussing them. The types of supervision issues will vary depending on the mental health professional and the setting. Of the non-medical mental health professionals, psychologists have the broadest practice guidelines (depending on training) and thus will have more complex supervision issues. The American Psychological Association [APA] (2011) set forth guidelines for psychologists practicing at three points on a continuum regarding psychotropic medication. The first point is for those rare psychologists who have prescribing privileges. The second is for psychologists actively collaborating in medication decisions. The third and most common is when psychologists provide information that may be relevant to prescribing professionals. That is the practice point we focus on here as it is most common for psychologists and social workers, school psychologists, counselors, and other nonmedical mental health professionals.
What are some of the important supervision issues relevant to psychopharmacology? Berardinelli and Mostade (2003) have listed the following categories of responsibilities, which include activities for supervisors and supervisees: assessment, monitoring, and advocacy.
In the assessment phase of a counseling relationship, the mental health clinician needs to learn what current medications clients are taking, including dosage, frequency, and formulation. In addition, clinicians need to assess the client's use of other licit or illicit recreational drugs. Fulfilling this responsibility assumes some knowledge of the categories, effects, and side effects of psychotropic medications on the part of the supervisor and the supervisee. As Ingersoll (2001) notes, this is where training in psychopharmacology becomes important, particularly for supervisors. The APA has created curricula for three levels of training in psychopharmacology, and the first level (or its curricular equivalent) (APA, 1995) should be required for supervisors of mental health professionals.
The assessment phase should include getting a signed release from the client to view copies of the file on the client kept by the prescribing professional. Many large providers like hospitals are using electronic note systems like Epic and Avatar. Each of the charts in these systems have sections on client medication but sometimes they are broken into current medications and all previous medications. Obviously it is important to know when clients started and stopped medications so you can understand what has worked and what has not for each client. Assessment may also include (with client permission) contacting the prescribing professional for consultation and to let her or him know (again, only with the client's release) what you are treating the client for, and ask about the professional's sense of how the medication is working for the client (along with any other questions you may have). This is an opportunity to at least establish a connection with the prescribing professional, learn about his or her prescribing style, and make a good first impression. With that in mind, you should know what symptoms the prescribing professional has prescribed the psychotropic medications to treat and be familiar with the medications prescribed. While prescribers may speak in terms of diagnoses, always try to get them to specify particular symptoms because clients with the same diagnosis can present quite differently. Supervisors will want to make sure the supervisee is following these guidelines and adequately understands the topics relevant to his or her clients at each stage of assessment.
Berardinelli and Mostade (2003) also noted that supervisors should monitor exactly how supervisees are discussing medication side effects with clients. Although it is important to make sure the client is aware of potential side effects, we must avoid leading questions that elicit complaints of side effects (e.g., “are you having headaches with this medication?”). There is clearly more art than science to this. The initial topic can be discussed with open-ended questions about how the client is feeling, whether he or she has followed the medication prescription, and how he or she thinks the medication is working. Depending on the client, opening a session with specific questions that list side effects such as “Are you experiencing any sexual side effects, headaches, dizziness, or nausea?” may not be the best strategy unless there are compelling reasons to take this approach. Some clinical judgment is necessary here. Clients who are more prone to obsessively worrying about side effects may respond to such concrete questions as a list of things they then imagine they are experiencing. However, clients who are functioning at a concrete intellectual level may need direct questions to share side effects that are occurring. Unless you feel direct questions are necessary (as in the case of clients who are concrete thinkers), you can begin asking open-ended questions to elicit the client's thoughts about how the medication seems to be working.
Monitoring is an important component of the therapeutic relationship and supervision. Supervisors should make sure supervisees are checking in with clients at each session about medication, updating medication information as it changes, and keeping records of medication compliance as well as the client's response to medications. The last item is particularly important, especially for clients who do not see the same prescribing professional on a regular basis or for clients who have not given the clinician permission to contact their prescribing professional. The record of client responses to medication is also important in relation to the record of what is happening with the client psychologically.
For example, in one case we treated, the client suffered from Bipolar I Disorder and seemed to show subtle signs of improvement just before the onset of manic symptoms. This happened twice, with two different medications the client was on. The first time the therapist took the shift as a signal of improvement in mood, but the second time the therapist saw it as the first sign of approaching manic symptoms. The client learned in this case the difference between mood stabilization and the onset of manic symptoms. Genuine improvement in this client appeared similar but was followed by increasing insight and unimpaired reality testing.
In another case, the client's perceptions of how helpful the medication was correlated with how events were unfolding in her personal life. When her personal life was going the way she wanted, she felt the medication (in this case an antianxiety medication) was helping. When events in her personal life were not going well, she complained that all she got from the medication were side effects. In tracking this relationship, the issue of locus of control emerged as important in counseling. The client came to realize that she had, over a period of years, established the medication as an external locus of control and that the medication now provided a convenient target when things weren't going well. After six months of work on this locus-of-control issue, this particular client asked her doctor to titrate her off the medication. After a year she was still functioning well without it.
Advocacy is actively supporting the client to make sure she or he is getting the best service possible. Where medication is concerned, supervisors must make sure their supervisees’ efforts at advocacy do not cross the line between support and actually recommending medication. Although mental health professionals do not recommend medications, they can ask prescribing professionals questions on the client's behalf (e.g., “My client is taking an older antipsychotic with severe side effects. Do you think she would benefit from one of the newer antipsychotic medications?”) According to Berardinelli and Mostade (2003), advocacy issues include recognizing client needs and the particular needs of certain client populations, integrating medication issues into counseling, and knowing when to refer clients for case management and other services. Advocacy in this sense requires that supervisors and supervisees be familiar with community resources, including medication programs and trials, and programs that help clients pay the cost of medications and provide education to significant others and employers when necessary and when desired by the client.
An interesting question is whether mental health professionals should suggest to prescribing professionals that a particular client may benefit from a particular medication. The short answer is no. In the most conservative sense, in this situation the mental health clinician is assuming he or she has the same level of knowledge of psychotropic medications as the prescribing professional. Although this is possible, the most conservative interpretation of such action could be that the mental health professional is practicing medicine without a license. Obviously, cases in which mental health professionals have the proper training and legal mandate to prescribe (as in certain states and territories where psychologists have the right to prescribe psychotropic medications) do not apply here. The long answer is that because reality is complex we must look at the context of the situation and how the clinician approaches the prescribing professional. Ingersoll (2001) noted that much can be accomplished by assuming the “one down” position and approaching the prescribing professional with the attitude of requesting education. For example, if a client is prescribed carbamazepine/Tegretol for Bipolar I Disorder and still relapsing, the mental health clinician may wonder if new antipsychotics have been tried for the manic symptoms. Certainly carbamazepine/Tegretol has efficacy for some clients but if the client is relapsing the question may be worth asking. In this example the clinician may ask, “I've heard that some clients with this disorder take atypicals in addition to other mood stabilizing agents. How do you feel this client would respond to such a combination in treating Bipolar I symptoms?” If a clinician seriously questions the work of a medical professional, there are several possible approaches. If the work of the clinician appears to constitute malpractice, a report to the prescribing professional's licensing board is in order. If the questions simply revolve around whether the best medication was selected for the client, the clinician can reinforce the client's right to ask the prescribing professional questions or seek a second opinion if that is an option. We emphasize that this advocacy issue is grey and clinicians would do best to exercise conservative judgment here.
Review Questions
• What personal beliefs do you bring to the profession about psychotropic medications?
• What are key issues in assessment and monitoring for supervisors of mental health professionals who treat clients taking psychotropic medications?
• Discuss the extent to which you feel comfortable advocating for a client. If a senior clinician told a client incorrect information about a medication what would you do?
Many psychological issues arise in our clients when either psychotropic medication is recommended or taken. Clients use several strategies to avoid medication, including irrational beliefs about medications, secondary gains from symptoms, and difficulty with routines.
Multiple truths and realities govern the way clients respond to a course of psychotropic medication. Therapists need to recognize how clients accept psychotropic medications into their intrapsychic and unconscious worlds. It is helpful to talk to our clients about the strengths and limitations of both medications and conventional therapy. In addition, mental health clinicians need to know how to collaborate with medical professionals as well as how to review medication issues in supervision sessions.
SECTION THREE: ETHNO-PSYCHOPHARMACOLOGY: GROUP DIFFERENCES IN RESPONSE TO PSYCHOTROPIC AGENTS
Learning Objectives
• Be able to give a general definition of ethnopharmacotherapy and its main concerns.
• Discuss the role of sex and race in how pharmaceuticals affect people.
• Understand the effects of discrimination and oppression on people's view of prescription drugs.
• Be able to articulate ethical concerns that arise when dealing with prescribing professionals.
Ethno-psychopharmacology, a relatively new subdiscipline of psychopharmacology, explores ethnic and racial differences in response to medications, differences that appear to be physiologically based (Ng, Lin, Singh, & Chiu, 2008). Scientists have known for years that people of different racial and ethnic backgrounds may have genuine physical differences that make them more or less sensitive to certain drugs or medications. Alcohol has always been a quintessential case in point (Westermeyer, 1989). People of Asian descent and women have less of the enzyme that breaks down alcohol (alcohol dehydrogenase). This makes these groups more susceptible to the effects of alcohol (Gordis, 2000; Julien, Advocate, & Comady, 2011). This does not mean they are more likely to develop patterns of abuse or dependence, just that they are more sensitive to the effects. If such differences exist across groups regarding alcohol, many researchers began wondering whether such differences also exist for psychotropic medication, and in fact they do. These physiological differences can also be further accentuated by cultural differences in diet; use of substances such as herbs, alcohol, and caffeine; and the extent of environmental pollutants (Bhugra & Bhui, 2001; Malik, Lake, Lawson, & Joshi, 2010). Ethno-psychopharmacology is now being viewed through the discipline of pharmacogenetics. As genomic sequencing becomes more accessible some researchers like Ng and Castle (2010) believe we will be able to link racial and ethnic genetic differences to differential responses to medications. While this is still in the future, the possibility is intriguing (Jones & Perlis, 2006).
After some stark initial findings, scientists now agree that extensive work is needed to explore sex differences in response to psychotropic medication (Jensvold, Halbreich, & Hamilton, 1996; Marazziti et al., 2013). Strong evidence shows that males and females respond differently to medication, but little research is devoted to understanding this difference. Robinson (2002) has documented that although women are the primary consumers of most types of psychotropic medication, and although sex differences appear in the absorption, metabolism, and excretion of many medications, little attention has been paid to these differences in research. This gap implies an ethical imperative for pharmaceutical companies. If they target women in direct-to-consumer advertising (Petersen, 2009), then they must conduct research supporting the safety and efficacy of these medications for women. Until such a research database is built, clinicians must advocate for clients by keeping up-to-date on the research that exists on psychotropic medications and responses of females. In addition, there are sex differences in symptom profiles. For example, women are more likely to have atypical symptoms of depression, comorbid anxiety and attempt suicide (Gorman, 2006).
Differences in absorption exist between premenopausal women and men, with premenopausal women moving material more slowly through their digestive tract. This delays peak levels and lowers blood concentrations of medications. Women also typically weigh less than men, have less total blood volume than men, and carry a higher percentage of body fat than men. For example, women may initially have low blood levels of a compound, but if the compound is stored in fat cells then levels may rise overall, eventually providing women with higher levels of the compound than men would have. The fact that women clear drugs more slowly than men means that optimal doses for males may be too high for females. Robinson (2002) notes that this may be why women experience side effects from psychotropic compounds about twice as often as men. Along these lines, Hamilton (1986) found that women taking older antipsychotic medications have higher rates of tardive dyskinesia (a disorder of abnormal, late-appearing, involuntary movement) than do men taking the same medications. In addition to these differences, women's physiology changes through the menstrual cycle. Premenstrual changes include a slowed rate of gastric emptying and decreased gastric acid secretion. Both these changes tend to raise blood serum levels of psychotropic medication before menstruation.
It is important to know that many psychotropic medications appear to interfere with fertility. Psychotropic medications (and particularly mood stabilizers and antipsychotics) have been shown to have adverse reproductive and gynecologic effects (Talib & Alderman, 2013). If a client on psychotropic medications is trying to become pregnant, she should discuss this decision with her physician, who can help her weigh the risks. This is an area where female clients may need the support and advocacy of mental health professionals. Many clients still believe they cannot question their doctors and cannot participate in treatment decisions.
Several psychotropic medications have also been linked to teratogenesis (the development of birth defects). Obviously, if a woman is pregnant, she should, if possible, refrain from taking any psychotropic medications. Although this is not always possible, the risks to the unborn child must be weighed against potential risks to the mother should she stop taking a particular medication. In other cases medications have documented dangers to the neurodevelopmental health of the fetus (Galbally et al., 2010; Gentile, 2010). Such decisions are typically difficult. One client whom I (Ingersoll) treated in the late 1980s was taking mood-stabilizing medications that had been shown to put the fetus at risk (lithium/Lithobid, which causes a heart valve defect called Epstein's Anomaly). She chose to go off the medication during her pregnancy, which resulted in her decompensation and the need for a more restrictive treatment setting (an inpatient facility, in this case). Although we may never know the impact of her emotional suffering (as a result of relapse related to going off medication) on her child, we do know that going off the medication decreased the child's risk of heart malformation associated with the medication the mother was taking.
The Food and Drug Administration (FDA) requires that prescription medications that may cause harm to the developing fetus be classified according to one of five categories (A, B, C, D, X). Category A includes medications for which controlled studies in women fail to show risks to the fetus in the first trimester and the risk of harm appears low. Category B includes medications for which animal studies have not shown fetal risk but there are no controlled studies in pregnant women or for which a risk shown in animal studies was confirmed in studies with women. Category C includes medications for which either studies with animals have shown teratogenic effects or there are simply no animal or women's studies. Category D includes medications for which there is positive evidence of human fetal risk. Such medications have warning sections in their labeling. Category D medications may still be used if the risk–benefit analysis shows that more harm may come to the mother if the medication is not used. Category X includes medications for which studies in animals or humans clearly link the medication to fetal abnormalities and the use is unacceptable (e.g., all formulations of lithium has a rating of “X”). This information is listed in the contraindications section of the label.
Robinson (2002) has summarized some of the literature on teratogenic effects (causing malformations) of particular medications. Most of these effects are due to antimanic drugs and are risks primarily in the first trimester. These are summarized in Table 4.1. Please note that this is not an exhaustive list. Although many medications have teratogenic properties, scientists are not sure about many other medications yet. One good source of information is the Pregnancy Teratogens Healthline at http://www.healthline.com/health/pregnancy/teratogens.
TABLE 4.1 Examples of Antimanic Medications and Teratogenic Risks
|
Medication |
Risk |
Citation |
|
Lithium |
Ebstein's anomaly |
Altshuler, Burt, McMullen, & Hendrick, 1995 |
|
Carbamazepine |
Craniofacial defects Neural tube defects |
Jones, Lacro, Johnson, & Adams, 1989; Rosa, 1991 |
|
Valproic acid |
Neural tube defects |
Koren & Kennedy, 1995 |
|
Antidepressants |
Neonate CNS depression and urinary retention |
Preston, O'Neal, & Talaga, 2002 |
© Cengage Learning®
Many states have set up their own websites dealing with teratogenic information. For example, the FDA has an informational PDF at http://depts.washington.edu/druginfo/Formulary/Pregnancy.pdf. Discussing the prospect of psychotropic medication for pregnant women, Preston, O'Neal, and Talaga (2002) comment, “It is important to remember that absolute data in this area is disturbingly incomplete” (p. 229). As noted in Chapter Three the same holds true for breast-feeding on psychotropic medication (Fortinguerra, Clavenna, & Bonati, 2009). Therefore, the mental health professional concerned with client advocacy must keep up with the literature in the area and be willing to help the client (and/or guardians) weigh the risks of particular medications.
In addition to teratogenesis (malformation of the fetus), psychotropic medications may affect the developing fetus, the newborn, the actual process of birth, and breast-fed infants. Psychotropic medications may result in behavioral problems in the child who is exposed to these drugs in utero. Finally, because pregnancy induces so many changes in a woman's body, these changes can radically alter the action of psychotropic medications (Preston, O'Neal, & Talaga, 2002).
In addition to cultural differences in attitudes and trust toward psychotropic medication and the doctors who prescribe them, scientists are now learning that psychotropic medications affect people with different racial backgrounds in significantly different objective ways. Here is a summary of a few of the racial differences that researchers have found in physiological responses to psychotropic medications:
• Some studies have found that African Americans taking older antipsychotic medications are more likely to develop tardive dyskinesia than Caucasians taking the same medications (Glazer, Morgenstern, & Doucette, 1994; Morgenstern & Glazer, 1993). This may also be related to the fact that many studies have consistently found that African Americans are more likely to be diagnosed with severe mental disorders and receive higher doses of the medications to treat them (Netjek, 2012; Strickland, Lin, Fu, Anderson, & Zheng, 1995) or to reasons that may be related to racism. In a recent study reviewing prescription trends by racial group, Daumit and colleagues (2003) found that African Americans were still more likely to receive older antipsychotics as opposed to the newer, supposedly more effective, atypical antipsychotics . Also, African Americans are more likely to be treated with polypharmacy strategies than Caucasians (Garver et al., 2006).
• Compared with Caucasians, nearly all minority groups have lower odds of adequate antidepressant use (Quinones et al., 2014). African Americans are also far less likely to adhere to antidepressant treatment later in life than Caucasians (Kales et al., 2013). Some of this seems to be an effect of systematic oppression leading to a mistrust of mainstream medicine.
• Asians and Asian Americans report more adverse effects from antipsychotic and tricyclic medications than do Caucasians. They also show higher plasma levels than do Caucasians at the same dosage (Bond, 1990; Bowden, 1995; Pi, Gutierrez, & Gray, 1993). This evidence tends to point toward the need for lower doses for these clients.
• African Americans appear to be more sensitive to tricyclic medications than are Caucasians in terms of both therapeutic and side effects (Lin & Poland, 1995).
• There are disparities on Medicaid expenditures on psychotropic medications for maltreated children. In a sample of over 4000 children, children of color received substantially less Medicaid support for psychotropic medications (Raghavan et al., 2014). African American children received $292 less on average per year than Caucasian children and Hispanic children received $144 less per year. These findings demonstrate that policy makers need to pay more attention to the needs of children of color.
• There are also racial disparities in the monitoring of patients on chronic opioid therapy. There are disparities in prescribing habits (Tait & Chibnall, 2014) as well as in monitoring patients with African Americans being less likely to be prescribed opioid pain medication and more likely to be subjected to more drug tests than Caucasian peers. Compared to Caucasian patients, African American patients are more likely to be referred to a substance abuse specialist than a pain specialist (Hausmann, Gao, Lee, & Kwoh, 2013).
• Also, African Americans seem to have a host of different influences affecting their rates and expression of depression, compared to other racial groups in the United States (Meyers, 1993) though they are less likely to take antidepressants (Paulose-Ram, Safran, Jonas, Gu, & Orwig, 2007).
• Recall that the cytochrome P450 enzyme system governs metabolism of, among other things, psychotropic medication. The differences outlined in the following studies seem to be based on racial differences in this important enzyme system (Lawson, 1999; Lin, Poland, & Anderson, 1995; McGraw, 2012; Wood, 2001). These differences may vary for genetic and environmental reasons. Various enzymes vary dramatically across different racial groups (Lin, Poland, & Nakasaki, 1993). This same mechanism may also partly cause the increased risk of hypertension in African Americans (Strickland et al., 1995).
In comparing data from across different societies, one confounding factor is that average daily dose of medication or minimum effective dose frequently varies from one society to the next. For example, minimum effective dosage of a medication is often higher in the United States than in other countries (Bhugra & Bhui, 2001). Also note that much research on racial group differences in adverse effects focuses on older medications (tricyclic anti-depressants, older antipsychotics) that are slowly being phased out with the arrival of newer agents with better side effect profiles. Even though newer medications ostensibly have fewer side effects, the data on older medications point to differences between groups that will likely also have implications for newer compounds. In addition, because many minorities live in lower socioeconomic brackets, they may be prescribed older psychotropic medication that is available in less expensive, generic form because the patent has expired.
What should the nonmedical mental health therapist do with this information? First, we hope this information makes clinicians better information brokers, as we mentioned earlier. For better or worse, prescribing professionals may fail to take racial/ethnic differences into account and mental health clinicians need to raise these relevant points for the well-being of the client. This is particularly true in clinic settings where prescribing professionals (doctors and psychiatrists) are so overwhelmed with work that they may only get 10 or 15 minutes with clients. Doctors report racial and ethnic differences in comfort discussing things like medication cost with the prescriber and the time limitations only exacerbate such problems (Dalawari et al., 2013). In situations like these, clinicians must be willing to advocate for their clients. Later in this chapter, we offer one model on how to collaborate with prescribing professionals. In monitoring the therapeutic and side effects of medications on their clients, therapists need to be alert to the differences we have discussed. As a starting point, Bhugra and Bhui (2001) recommend screening the items in Table 4.2 for clients receiving psychotropic medication.
TABLE 4.2 Important Cultural Dimensions Related to Psychotropic Medications
|
The client's diet |
|
Any dietary restrictions |
|
Relevant religious taboos |
|
Alcohol, caffeine, and nicotine intake |
© Cengage Learning®
As noted, there has been little research on ethnopharmacotherapy. Although a small number of committed researchers are making important contributions in this area, the nonmedical mental health clinician must regularly review the literature, because these studies are frequently not included in books on psychotropic medications.
A FOCUS ON THE CULTURAL PERSPECTIVE
Recall that what we call the cultural perspective describes subjective, shared experience and beliefs. It is the dimension that describes phenomenological aspects of groups. In this sense, culture can refer to shared worldviews and beliefs clustering around race, ethnicity, socioeconomic status, sexual orientation, spiritual tradition, sex, gender, ability/disability, or age. Culture can also refer to shared worldviews and beliefs clustering around one's professional identification. Thus one can speak of the culture of the pharmaceutical industry, the culture of the counseling profession, and the culture of the psychiatric profession.
Because a mental health professional's main tool is the therapeutic encounter, the impact of culture on that encounter must be figured in. The therapeutic encounter is supposed to improve the interpersonal functioning and the subjective comfort of the client. This necessarily implies defining “normal” and “abnormal” behavior, and cultural milieu determines to a large extent whether a person's behavior or emotional state is considered “normal” or “abnormal.” Students in the mental health professions have increasingly addressed cultural variables with regard to mental health diagnosis and treatment (Labruzza, 1997; Malik et al., 2010), but how does culture relate to psychopharmacology? There are two dimensions to this relationship: the shared beliefs of cultural groups, and group differences in response to medications. We already explored the latter through the social perspective. We now address what scientists know about those factors relating to the shared worldviews and beliefs of groups. As Lin (1996) noted, psychopharmacologists simply do not know much about how cultural or ethnic factors affect whether or not a particular medication will be helpful for a particular condition.
Shared Belief Systems Regarding Psychopharmacology: Multicultural Variables
Human beings in the 21st century are still grappling with the challenges presented by diversity in the species. For example just think of how human universals vary culture to culture. Although the human body generally has a universal structure, it is adorned and altered differently across cultures and even subcultures (witness the current increase in tattooing in U.S. culture). Although many personal developmental sequences occur across cultures, cultures label and facilitate them differently (Gardiner & Kosmitzki, 2001).
Many aspects of culture may make Western forms of mental health work challenging. Consider, for example, an Arabic student who is suffering from symptoms of depression and who comes to a college counseling center at the urging of his roommate. Also consider that for this client, sharing intimate personal information outside the family may be anathema. Further, consider that this client also may view taking psychotropic medication as a sign of weakness. True, this client shares the structures of a triune brain and the accompanying nervous system however, without understanding and attempting to accommodate this client's cultural background, a therapist is unlikely to succeed in treatment.
The cultural perspective also provides a vehicle to explore shared worldviews that stem from a history of discrimination and oppression. Many African American clients with whom we have worked approach counseling and psychotherapy with a great deal of suspicion. Without understanding the shared worldview that underlies this suspicion, mental health professionals may misinterpret it as paranoia or resistance. There is ample justification for African Americans to mistrust mental health treatment systems. Flaherty and Meagher (1980) documented that in mental health systems, African Americans tend to receive less desirable treatments (Puyat et al., 2013). In addition, many researchers have noted that African Americans have been more likely to be hospitalized (Lawson, Hepler, Holladay, & Cuffel, 1994), involuntarily committed, and placed in restraints than members of other ethnic groups (Lawson, 1999). In addition, as Lawson (1999) explained, mental health providers are often not African American and may have views of treatment very different from the views of African Americans.
Many clients of African American and Hispanic background may share a suspicion of mental health counseling and psychotropic medication, believing that basically these interventions are tools of oppression and to be avoided. Moreover, until very recently psychotropic medication trials were conducted largely with Caucasian, male samples and then assumed to generalize to other cultural groups. Again, to interpret this as symptomatically significant paranoia only exacerbates the misunderstanding. African American resistance to participation in the mental health treatment system occurs in light of the Tuskegee study sponsored by the U.S. government in the 1930s. It is now widely known that in this study, treatment was withheld from African American men with syphilis. The study continued for some 40 years before it was ended by a newspaper exposé. The federal government finally acknowledged the study officially in the 1990s, under then-president Bill Clinton. I (Ingersoll) worked with a granddaughter of one man in the Tuskegee experiment, in a sociodramatic recreation of the devastation wrought by the study. This gave me a firsthand understanding of how “paranoia” regarding medical interventions was a healthy defense for members of this family.
A substantial body of literature supports the charge that minority clients with mental and emotional disorders have often been misdiagnosed, which has led to incorrect treatment (Lawson, 1999). Strickland et al. (1995) demonstrated that African Americans and Hispanics are overdiagnosed with schizophrenia and more likely to be given antipsychotics when such medications are not needed. Bell and Mehta (1980, 1981) made a strong case that African Americans suffering from Bipolar I Disorder (and showing excellent lithium response) were often initially diagnosed with schizophrenia and therefore given antipsychotic medication. Stratkowski, McElroy, Keck, and West (1996) have also demonstrated that African Americans with mood disorders are more likely to have psychotic symptoms associated with these disorders. Their conclusion was that this required more careful differential diagnosis so that African American males who were really suffering from Bipolar I Disorder were not mistakenly diagnosed with schizophrenia. As Lawson (1999) noted, this evidence is especially problematic because there is also evidence that African Americans are more likely to develop tardive dyskinesia in response to antipsychotic medications.
Ideally, in the first encounter with culturally different clients the counselor or prescribing professional will be aware of these issues and (if psychological contact permits) will explore them with clients who appear highly guarded or suspicious. In many cases, frank discussion of the issues is the best approach. Generally speaking, the professional should also note that stress plays an important role in shaping compliance with a medication regimen and in the patient's response to the medication. Many culturally different people are under enormous amounts of stress including financial stress, stress related to relocation, and stress resulting from isolation when they move to a new country and leave family and community supports. Prescribing professionals need to consider the possibility of these stressors for such clients (Bhugra & Bhui, 2001).
CASE STUDY: THE CASE OF RAFAEL
Rafael, a 57-year-old married Mexican man, came to counseling at a mental health center because he complained of hearing many voices. He visited his priest, who was unable to assist him and who referred him to the mental health center. The staff psychiatrist evaluated Rafael and prescribed Loxitane (loxapine), an antipsychotic for his hallucinations and disorganized thinking. He told Rafael to take his medication daily and assigned him to an agency counselor.
Each week Rafael reported to his counselor that he took his medication, but this puzzled her, because he seemed ever more psychotic and disorganized. However, he reported compliance. Rafael became so confused and impaired that he could no longer drive to his appointments, so his wife brought him. After one very perplexing session, the counselor asked his wife if Rafael was taking his medications. She looked away and said quietly, “Only on the days he comes to see you. On all the other days he prays to the Blessed Virgin for his health with his men friends.” The counselor learned that Rafael encountered great resistance about medications from his cohort of friends, who urged him not to take his medication but to pray for sanity and health to the Blessed Virgin. So the only times he took Loxitane were on the days he had an appointment with his counselor. Fortunately his counselor was able to seek the assistance of the Latina counselor on staff and Rafael's priest to intervene with Rafael and his wife and prevent further decompensation and possible hospitalization.
Obviously, it is an error to prescribe psychotropic medications with the assumption that all people from all cultures will receive support and understanding of the process in their homes. People from many cultures have various rules, rituals, and ideas about the danger of “pills for the mind,” and the levels of resistance are legion.
The astute reader may have a question at this point that goes something like this: “So in reality, all Rafael's prayer did not cure his psychosis, but the Loxitane seemed to help. Doesn't this validate the importance of the medical model intervention (medication) over the prescribed cultural cure (prayer)?” Certainly Rafael's symptoms seemed to benefit from the medication, but that intervention needed to be complemented with the support from his prayer time with friends. Without seeing a way to integrate these two things, Rafael simply stopped taking the medication. In this case, the counselor also consulted with Rafael's priest, who met with Rafael to discuss the difference between praying for healing and praying for a cure. When Rafael was able to engage in this dialogue, he came to understand that although his prayers to the Blessed Virgin did not produce a “cure” per se, he did receive “healing” of sorts in the form of comfort and the strength to eventually go on the medication despite the opinions of his friends. Here, the prayer and the medication served as different tools that brought about different types of healing.
Mr. Liao is 75-year-old citizen who came to the United States 50 years ago from mainland China. Currently he suffers from a very rare autoimmune disorder of the liver that is not stable with medication. He is also seriously depressed. His life partner of 40 years is trying desperately to take him to a psychiatrist for an evaluation. Mr. Liao knows that if his partner is successful it will confirm the Chinese communities’ suspicions that they are gay and they will be ostracized from their cultural group. He insists that acupuncture and Chinese herbal medicine will help him more than western antidepressants. His partner insists that he is wrong and hires a private ambulance to take Mr. Liao to the community psychiatrist. The psychiatrist evaluates him puts him on a course of citalopram and buspirone and refers him to the culturally sensitive counselor at the agency. He also refers Mr. Liao's partner.
Questions About the Case
1. What are the salient cultural concerns in this case?
2. Speak to the potential conflict between western and eastern approaches to medicine.
3. Discuss what happens to people in cultures where the gay and lesbian lifestyle is either forbidden by religious practice or rejected by cultural norms.
4. How did the psychiatrist respond to Mr. Liao's concerns?
A MEETING OF SUBCULTURES: COLLABORATION WITH PRESCRIBING PROFESSIONALS
Cultural variables can also be interactions between professional subcultures such as counseling and psychiatry or, more generally, between prescribing professionals and nonmedical mental health therapists. Western culture shares a belief in a hierarchy among health professionals, with doctors at the top. The mental health hierarchy has psychiatrists at the top. Neal and Calarco (1999) noted that in the past medical training always emphasized that the doctor is in charge in any team approach to treatment and that some doctors, having internalized this belief, can be quite authoritarian even when they have not studied and do not understand psychotherapeutic approaches. Although one can certainly deconstruct this, place it in nested contexts, or argue that it is a “patriarchal hangover,” it still exists as a shared belief with which nonmedical mental health clinicians must deal.
Ingersoll (2001) noted that the nonmedical therapist's approach depends on the attitude of the prescribing professional toward psychotherapy. If a psychiatrist does not value psychotherapeutic approaches, the mental health professional may find a “one down” approach helpful. In this approach the nonmedical therapist presents him- or herself as willing to learn about medications from the prescribing professional. This approach can begin the alliance-building process between the medical and nonmedical members of a treatment team and can give the mental health professional an opportunity to practice equanimity.
At the time of this writing, there are some problematic trends that could create a larger divide between medical and nonmedical mental health professionals. First more and more people with mental health problems are going to their general practitioners rather than a psychiatrist (Olfson, Kroenke, Wang, & Blanco, 2014). Although nonmedical mental health professionals can certainly collaborate with general practitioners, they often do not have extensive training in mental health issues. They do their best to help clients alleviate symptoms with medications but may not be aware of the overdetermined nature of some disorders. Another reason for this shift may be that increasingly fewer psychiatrists are accepting new patients with noncapitated insurance, Medicaid and Medicare compared to physicians in other specializations and in general practice. Acceptance rates for all types of insurance were significantly lower for psychiatrists than physicians in other specialties and this may pose barriers to mental health service (Bishop, Keyhani, & Pincus, 2014).
In collaborating with prescribing professionals, mental health clinicians can benefit from a judicious combination of equanimity and what we would colloquially call “people skills.” Centuries ago, Buddhism introduced equanimity as one of the four sublime states (the other three being love, compassion, and sympathetic joy). Equanimity is the practice of approaching an interaction with respect and caring while remaining unattached to how the interaction unfolds and how you are treated (Gunaratana, 2002). Although this approach can be challenging, it is possible. Reflecting on the good that could come to the client you share with the prescribing professional can be enough to foster the equanimity you need. Also, if a particular prescribing professional thinks poorly of mental health professionals in general, you are not likely to change his or her mind in one interaction.
Next, use good interpersonal skills. This is obvious, but worth noting because people can forget these skills in the press of a crisis or busy day. Most prescribing professionals are equally busy and well intentioned. Reminding ourselves of this can serve as a cue to enter the interaction in a courteous manner regardless of how frantic the setting or your mind-set may be. Ideally both professionals approach the relationship with some mutual respect, because this inevitably helps the client, who would likely be disadvantaged by friction between providers. As Balon (1999) points out, good collaboration is important because the team approach is an economic necessity and likely to remain so.
How the collaboration is set up is important. In agency work, therapists do not have much choice about which doctors they are going to work with. In private practice there is more choice, depending on which practitioner can be persuaded to collaborate. Evidence is growing that a good therapist–prescriber relationship is correlated with more positive client outcomes (Neal & Calarco, 1999). Next we discuss some important elements of collaboration.
Conditions of the Relationship
Each professional should know the credentials of all other collaborating professionals as well as the areas of specialization and populations each party has worked with. As noted, mental health professionals want to know the medical practitioner's attitude toward counseling and psychotherapy, because a negative attitude can diffuse the therapeutic alliance. Also, it is important to define the role (if any) the mental health clinician plays in giving feedback to the medical practitioner (and whether the professional will welcome or resist feedback).
Regardless of whom the client met first (doctor or mental health professional), the recommendation for either therapy or medication presupposes that the client's case will be fully disclosed to the prescriber and that appropriate documentation and releases must be obtained. This is even more important since the enactment of the Health Insurance Portability and Accountability Act of 1996 (HIPAA).
At times, clients either decompensate in reaction to a psychotropic medication or quickly develop adverse effects to the medications. The treating medical professional may be either oblivious to the changes or may insist that the medications are correct for this client. To prepare for such conditions, the mental health clinician must develop assertive and appropriate confrontation skills to advocate well for the client.
Transference and Countertransference Issues
Finally, transference and countertransference issues must be addressed when they arise, and a vehicle must be set in place for addressing them. To avoid triangulation, which will likely undermine the treatment plan, each professional must be aware of his or her transference and countertransference relationships with the client and with each other. Whenever a third party is brought to the relationship, the impact on the client must be assessed.
SECTION FOUR: SOCIAL INSTITUTIONS AND THEIR IMPACT ON PSYCHOTROPIC MEDICATIONS
Learning Objectives
• Be able to discuss the supposed risks and benefits of direct-to-consumer (DTC) advertising of psychotropic medications.
• Understand how financial conflicts of interest in pharmaceutical research can harm your clients.
• Understand the five schedules used for categorizing drugs by the Drug Enforcement Agency (DEA).
Although many social institutions could be examined here, we focus on the FDA and on pharmaceutical companies in general, because they have the most profound impact on psychotropic medications. It would be nice if mental health professionals could operate in a vacuum unaware of what the FDA and pharmaceutical companies were doing, but responsible advocacy requires at least a general understanding of these two forces.
The Food and Drug Administration
The FDA is the federal U.S. government agency charged with overseeing drug testing and development, approving new drugs and compounds, and monitoring approved drugs and compounds. Currently, the FDA has nine different centers or offices, performing a variety of functions. In the early 20th century, the FDA was part of the U.S. Department of Agriculture. As recently as 1929, consumers got all but 5% of their medications directly from pharmacists, with no prescription from doctors necessary (Temin, 1980). This changed with the passage of the 1938 Food, Drug, and Cosmetic Act, which was amended in 1962. The FDA has historically addressed three distinct (and at times antithetical) risks:
1. The risk of overpaying for a drug (because of diluted form or low quality)
2. The risk of an adverse drug reaction
3. The risk of failing to recover after taking a drug as prescribed
These risks receive different emphasis at different times in history, but the results have largely been of the “good news/bad news” type (Temin, 1980). The good news is that although regulation has not eradicated risk, it has decreased some risks by requiring standards of dosage, potency, and proof of efficacy. The bad news is that the result has been to further remove the power of choice from the consumer and from the prescribing professional. These results take on a surreal quality today, when, as psychologist Robert Anton Wilson (2002) noted, there is no “war on drugs,” only a war on some drugs. Although tens of thousands of citizens are denied access to medical marijuana because it is allegedly “addictive,” millions are prescribed legal antidepressants that are clearly “addictive” and that in many studies perform no better than placebo.
Review Questions
• What is ethnopharmacotherapy and what concerns does it try to address?
• What are some differences in response to medications that have been noted across the sexes and persons of different races?
• How can a history of discrimination and oppression affect peoples’ views of psychotropic medication?
• What is the best strategy for approaching prescribing professionals with questions?
• What confidentiality issues can arise when consulting with prescribing professionals?
Pharmacoeconomics is an interdisciplinary field where clinical outcomes overlap with health economics (Makhinova & Rascati, 2013). It began in the late 20th century as research on the economic evaluation of pharmaceutical products. Most importantly, it was to help clinicians make choices about new pharmaceutical products and helping clients get access to new medication (Schulman & Linas, 1997). Because of the economic pressure on health care systems worldwide this has developed into a thriving subdiscipline in schools of pharmacy that grant PhDs in Pharmacoeconomics (Slejko, Libby, Nair, Valuck, & Campbell, 2013). Ultimately we want to know if newer treatments that cost more are more effective. As in the case of antidepressants, it seems that they all have an efficacy hovering around 50% and newer ones do not noticeably outperform older ones. Another variable that Pharmacoeconomics must include is the power of pharmaceutical companies.
The Power of Pharmaceutical Companies
Drug companies have enormous power in all Western economies, and their power is also growing in Eastern economies. They were among the few companies to survive the Great Depression with little negative impact (Healy, 1997). Because they have enormous economic power, they also have important responsibilities once a given drug is released and important ethical considerations regarding their relationships with medical schools and other researchers (Schowalter, 2008). In many schools, Human Research Ethics Committees are reluctant to regulate potential conflicts of interest between researchers and pharmaceutical sponsors (Newcombe & Kerridge, 2007). In a survey of U.S. medical schools, only a minority of them had comprehensive conflict of interest policies (Chimos, Evarts, Littlehale, & Rothman, 2013; Chimos, Patterson, Raveis, & Rothman, 2011). The problem is not confined to the United States. In a Canadian study on conflict of interest parameters, researchers concluded only about 23% of schools polled had strong conflict of interest policies (Canadian Medical Association, 2013). Brubaker (2012) summarized conflicts of interest in three elements:
1. Main Interest: Promoting and protecting the integrity of research, patient safety and the quality of medical education.
2. Secondary Interests: Financial gain and desire for professional advancement.
3. The conflict itself wherein the main interests are sacrificed in pursuit of the secondary interests.
Brubaker (2012) suggests that all disclosures should be mandatory and should be labeled so that there is no doubt that they are mandatory. She feels that professional associations and licensure boards are well-suited to enforce such changes. Certainly changes in medical education can have an impact. Epstein, Busch, Busch, Asch, and Barry (2013) examined psychiatric residents’ prescribing of antidepressants before and after a mandatory conflict of interest training. The residents who had the training were significantly less likely to prescribe the most heavily promoted antidepressants. Reviewing similar studies, Korn and Carlat (2013) conclude that strongly enforced conflict of interest policies do affect prescribing behavior.
Pharmaceutical Company-Sponsored Research
A problem recently explored in medical journals concerns pharmaceutical companies contracting with medical colleges to conduct research on company compounds. Researchers have raised the problems of conflict of interest (Boyd & Bero, 2000), publication bias (Rivara & Cummings, 2002) and what appear to be influences in effect size (Djulbegovic et al., 2000). Djulbegovic and colleagues found that industry sponsored studies were far more statistically likely to have higher quality scores than government funded studies. Although these specific areas are indeed problematic, recently the focus has shifted to overall bias in industry-sponsored research. The bias includes the sponsor's role in the study design, investigators’ access to data, and control over publication (Schulman et al., 2002). The conflict-of-interest biases were addressed by the Association of American Medical Colleges guidelines on the management of financial interests related to biomedical research (Task Force on Financial Conflicts of Interest in Clinical Research, 2001). The International Committee of Medical Journal Editors (ICMJE) also revised guidelines requiring full disclosure of the sponsor's role in the research as well as requiring that investigators be independent of the sponsor, be fully accountable for the study design, have access to all study data, and have control of all editorial and publication decisions (International Committee of Medical Journal Editors [ICMJE], 2001). Recently, the ICMJE (which includes editors from the New England Journal of Medicine and JAMA, the Journal of the American Medical Association) adopted a policy that requires studies on medications be listed on a public registry before enrollment of human subjects. The committee felt this would give the public access to many of the studies with negative findings that pharmaceutical companies frequently keep private. This policy was adopted in the wake of unpublished data linking some antidepressants with suicidal behavior in children (Tanner, 2004).
Although these seem reasonable guidelines to safeguard the research process, the question remains, are the guidelines adhered to? In a national study of U.S. medical school agreements to conduct research for pharmaceutical companies, Schulman et al. (2002) found that the ICMJE guidelines were rarely followed. The authors gathered results from 108 of 122 medical colleges. The median number of site agreements per college per year was 103. The researchers found that agreements between pharmaceutical companies and medical colleges rarely required an independent committee or monitoring board as a condition of the agreement. Agreements rarely addressed collection or monitoring of data, or analysis and interpretation of results. Only in 17 cases of 108 did institutional review boards routinely review agreements. In addition, most colleges got low compliance scores for access to data and power over publishing results. The authors conclude, “A reevaluation of the process of contracting for clinical research is urgently needed” (p. 1340).
Nonmedical mental health clinicians may wonder what this has to do with them. The short answer is that an overview of the influence of pharmaceutical companies seems to call into question how much clinicians can rely on published research to give a sense of the efficacy and safety of psychotropic medications. It is also important for client advocates to think critically about prescription medications. Although pharmaceutical companies certainly have improved the quality of life for many, they are among the wealthiest companies in the United States and, as such, have enormous political influence. This requires oversight and monitoring by the government, consumer groups, and those who advocate for consumers—including mental health clinicians. Those who have power rarely give it up willingly, so it must be monitored by those under its influence. However, having too much government regulation may also block a person who wants/needs a particular compound from getting it.
Pharmaceutical Companies and Direct-to-Consumer Advertising
The economic power of the pharmaceutical industry is enhanced by its direct link to the consumer through advertising. Pharmaceutical companies are now allowed to advertise directly to consumers via print and media campaigns for medications. This is called direct-to-consumer (DTC) advertising or sometimes direct-to-consumer-pharmaceutical advertising (DTCPA). DTC advertising can be defined as efforts by pharmaceutical companies to promote prescription medication directly to consumers (patients) rather than doctors. DTC advertising is now the most prominent sort of health information that the public encounters (Ventola, 2011). It is only legal in the United States and New Zealand although Canada allows ads that mention either the product or its use but not both. Pharmaceutical companies have put a major effort into overturning DTC bans in Canada and the European Union (Ventola, 2011).
Before the ban on such advertising was lifted in the late 1980s, pharmaceutical companies spent approximately $12 million a year on drug advertisements, mostly aimed at prescribing professionals. Since DTC advertising has been allowed, companies spent $600 million on such advertising in 1996 and $900 million in 1998 (Hollon, 1999). Further loosening of restrictions in 1997 (especially regarding television ads) led to DTC advertising to be a multi-billion dollar industry with $4.51 billion being spent between 2008 and 2009 (Avery, Eisenberg, & Simon, 2012). Antidepressants are the second largest prescribed drug class in the United States and DTC ads have significant impact on the sales of antidepressants (Avery, Eisenberg, & Simon, 2012a). Companies are currently including psychotropic compounds for children in their marketing strategies for those few drugs (such as stimulants) that do carry FDA on-label approval.
Advocates of the DTC movement note that it can be an excellent way of providing educational information to the consumer including new drug treatments and awareness of symptoms (Hollon, 1999; Womack, 2013). Critics note the considerable profit margins correlated with advertising and suggest that, without medical oversight, whatever quality information is available will get lost in the race for profits (Hollon, 1999; Womack, 2013). In a recent analysis Avery, Eisenberg, and Simon (2012b) concluded that less attention in ads is given to risks of medications, ad content favors communication of benefits though they feel the balance is getting better.
Many advertisements for psychotropic medication make a point of stating that the psychological disorder (whichever is being targeted in the ad) is a “medical illness,” thus seeking to capitalize on the association with allopathic models for treating disease processes such as bacterial infections. Taken literally, this could severely affect mental health professionals. Imagine if the relevant regulatory bodies agreed that mental/emotional disorders were strictly “medical illnesses.” If this stricture were taken to the logical extreme, we could all be accused of practicing medicine without a license. DTC advertising is correlated with significantly larger profits. In the year 2000, the most advertised drugs saw increases in sales of 32% (Express Scripts, 2001). This trend, for better or worse, will certainly drive pharmaceutical companies to get FDA on-label approval for as-yet-untapped markets such as children and adolescents. As noted these take time. See the FDA approval process detailed in Table 4.3. While the debate on DTC advertising rages on (Ross & Kravitz, 2013), studies increasingly conclude it can lead to needless and potentially harmful overprescribing (Niederdeppe, Byrne, Avery, & Cantor, 2013).
The Subculture of the Pharmaceutical Industry
A culture is a group of people with a shared belief system or worldview, and each pharmaceutical company, as well as the industry as a whole, develops its own subculture. With the repeal of laws banning DTC advertising, pharmaceutical companies have more opportunities than ever to portray themselves to the public. In many commercials, pharmaceutical companies portray themselves in almost heroic fashion as being on the front lines of battle against some disease or on the brink of some discovery that will revolutionize medicine. At the same time, critics have had more opportunities than ever to point to the tactics underlying DTC advertising and to what they feel are misrepresentations of facts about medicine and medical science. As MacDonald (2001) pointed out, such ads are more designed to sell the medications in question than to inform the public. Although both perspectives may have merits, the truth probably lies somewhere in the middle. The culture of pharmaceutical companies exists in the semi-free-market economy (one dynamic that prevents a purely free-market system is the granting of huge government subsidies to large corporations), and the bottom line is that the companies must make profits. How much profit they should make has been a point of contention since Estes Kefauver opened his hearings on the drug industry in the late 1950s.
TABLE 4.3 Phases of the FDA Approval Process
|
Preclinical research and development using animal models (can last up to six years). |
|
Filing and approval of Investigational New Drug Application. |
|
After approval of Investigational New Drug Application, FDA has 30 days to decide if clinical trials will be allowed. |
|
Phase 1: If the drug is approved, clinical trials begin with a small number of healthy volunteers (lasts about 18 months). |
|
Phase 2: Phase 2 clinical trials include patients who might benefit from the drug (lasts about two years). |
|
Phase 3: Phase 3 clinical trials proceed with a large number of patients where the drug is tested against placebo. This phase must yield at least two “pivotal” trials with statistically significant results. Trials typically last 4 to 6 weeks (entire phase requires about 18 months). |
|
When Phase 3 is over, the company files a New Drug Application summarizing data. |
|
The FDA then has 24 months to approve or not. |
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If the New Drug Application summarizing data is approved, the FDA then must approve the label for the drug. |
|
Finally, after approval of label and after marketing begins, the drug must be monitored in the market for newly discovered problems. |
© Cengage Learning®
The culture of pharmaceutical companies cannot be divorced from the fact that they are among the wealthiest and most powerful industries in the world. Critics such as Ariana Huffington (2000) note that the prescription drug industry cloaks its “self-interest in language about pharmaceutical research and the public good” (p. 169). Huffington chronicled the efforts of several pharmaceutical companies to stop production of inexpensive AIDS drugs in South Africa. The companies wanted South Africans to pay U.S. prices for the drugs, but the U.S. price of $500 a week equaled the annual per capita income of sub Saharan Africa. Three companies sued South Africa to keep the South African law allowing access to these medications from taking effect. The companies also lobbied for severe trade sanctions against South Africa. Huffington raises serious questions about the ethics of an industry that makes among the largest profits in the world, neglecting research on lethal diseases in favor of developing yet more antidepressant medications or pharmaceuticals for pets (pet pharmaceuticals gross about $1 billion annually in the United States).
On the other side of the argument, commentator Thomas Sowell (2002) notes that the costs of medications reflect years of research and development, as we have seen in reviewing the FDA process. He also notes that although other countries have scientists and facilities capable of developing new medicines, economic and political situations in those countries discourage companies from investing as hugely as U.S. pharmaceutical companies do in developing new products. Sowell makes the case that the U.S. patent laws allow the company to recoup its investment and make a profit. Other countries often ignore or evade U.S. patent laws to get medications more cheaply. He also adds that the United States produces a disproportionate share of the life-saving drugs in the world.
When we ask doctors what they feel the main impact of DTC advertising is, they say it increases the numbers of patients who come in asking for some medication they saw advertised. These doctors also add that rarely do the clients fully understand what the medication can actually do for them and what the possible adverse effects are. Mental health clinicians therefore need to be aware of the connection between the way pharmaceutical companies portray themselves and those companies’ economic interests, because clinicians must bridge the information gap for their clients. Students in mental health areas may feel it is hard enough keeping track of all the new medications, let alone understanding other integrative variables such as the FDA and the culture of the pharmaceutical companies. But education that is only utilitarian in nature is incomplete and potentially dangerous. The clients whom mental health professionals are pledged to serve deserve clinicians who can help them navigate complex reality by weighing the claims made for any medication in the given social and cultural environment.
The federal Drug Enforcement Agency (DEA) is another agency that has enormous power in the United States. Reports conflict regarding the extent to which the DEA uses this power wisely, the extent to which it abuses this power (see, e.g., Szasz, 1992), and the extent to which it actually violates civil rights (Wilson, 2002). The DEA is in charge of defining and enforcing the federal drug schedules, Schedule I through Schedule V. We discuss these categories because it is important to understand that these drug categories are set up for law enforcement purposes rather than pharmacological clarity. The closer to Schedule I, the more closely monitored the drug. In many instances, the DEA guidelines refer to substances by names that are pharmacologically incorrect (e.g., calling marijuana or LSD “narcotics”). In addition, Schedule I drugs supposedly have no medical benefit, but this is often debated, as in the case of medical marijuana.
TABLE 4.4 Summary of Drug Enforcement Agency Drug Schedules
|
Schedule |
Drugs Defined as Having … |
Examples |
|
I |
A high potential for abuse and no accepted medical use |
Marijuana, heroin, mescaline |
|
II |
High abuse potential and liability for dependence. Prescriptions cannot be phoned in or renewed |
Morphine, amphetamine |
|
III |
Some potential for abuse but less than drugs in the first two categories |
Some stimulants and CNS depressants; lower-dose opioids |
|
IV |
Lower potential for abuse than those in Schedules I to III |
Valium, antidepressants |
|
V |
The lowest potential for abuse |
Drugs that contain small amounts of narcotics for antidiarrheal purposes |
© Cengage Learning®
Table 4.4 summarizes the five drug schedules. Although very few psychotropic medications described here are in the first two schedules, a few, such as methylphenidate (Ritalin), are on Schedule II. Readers can review the relevant laws and drug schedules on the DEA website at www.usdoj.gov/dea/.
In this chapter we discuss what we call herbaceuticals, that is, plants or herbs that have or are thought to have value in affecting psychological symptoms. This chapter is structured into six sections. Section One deals with psychological issues surrounding herbaceutical use. The second deals with cultural issues, and the third with social issues. In Section Four, we examine the problems in assessing herbaceutical efficacy and use. Section Five covers the most commonly used herbaceuticals and Section Six provides an overview of the issue of legalizing cannabis for medicinal and recreational use.
Learning Objectives
• Understand why people use herbaceuticals and some of the problems with understanding their mechanisms of action.
• Know the herbs most commonly used in treating psychological symptoms, their mechanisms of action (if any), and side effects.
• Understand the debate over medical and recreational marijuana use.
The topic of herbaceuticals strikes at the heart of many issues already raised in this text. In the case of herbaceuticals, questions of efficacy, availability, potency, and responsibility are for the most part unanswered. We use the term herbaceuticals for herbal compounds used for medicinal purposes related to mental or physical well-being. It seems the most appropriate term, because to call these compounds “herbal drugs” implies some connection with synthesized drugs sold as pharmaceuticals or street drugs used recreationally, neither of which is true. To call these compounds “medications” also misrepresents them, because they are treated differently from medications, as we will describe. We also briefly discuss the role of herbaceuticals as entheogens (from the Greek, meaning a way to realize the divine within oneself) but that will be the focus of Chapter Twelve (Ott, 1993). Ironically, the licit herbaceuticals we discuss here cannot, by law, advertise themselves as anything other than “dietary supplements.” We address why later, in discussing social issues and perspectives. The use of herbaceuticals (called phytotherapy, from the Greek, meaning “plant therapy”) is ancient, and many of these plants have been used for thousands of years, for a range of purposes, including mental, physical, and spiritual healing.
We have structured this chapter a bit differently from other chapters in the book. We begin by introducing general herbaceutical issues from the four integrative perspectives. Next we review what is known (and speculated) about a variety of herbal supplements, and then revisit the perspectives of the integrative model to examine specific issues. Finally, we use the perspectives of the integrative model review cannabis. There are no cases in this chapter, because the scope of our practices does not include consultation on herbaceuticals. For reasons we discuss, mental health clinicians who recommend herbal remedies do so at great risk for committing malpractice. Please note that we cite as much literature as possible in this chapter, because our knowledge regarding herbaceuticals is incomplete and the best we can do is keep up with and report to readers the literature that exists.
THE BEHAVIOR OF HERBACEUTICAL USE
What do we know about people's behavior regarding the use of herbaceuticals? Worldwide, it is estimated that up to 80% of all people have tried complementary and alternative medicine, including herbaceuticals (LaFrance et al., 2000). In a study of over 21,000 people in England (Harrison, Holt, Pattison, & Elton, 2004), more than 1 in 10 adults were taking herbal supplements regularly. Many people using herbal supplements do so because they cannot afford allopathic medicines (Mosihuzzaman, 2012). Alternative medicine is becoming more mainstream. In Cleveland, Ohio, where we work, the Cleveland Clinic recently added an institute for integrative medicine that includes Chinese herbal therapies (see http://my.clevelandclinic.org/wellness/integrative-medicine/treatments-services/default.aspx). From an integrative perspective, it is important to note that the widespread use of herbaceuticals worldwide is likely in part because many people do not have access to other medications for cost or distribution reasons. Herbaceutical approaches are firmly integrated into the medical systems in China, North and South Korea, as well as Vietnam (Northridge & Mack, 2002). Also, in many cultures people use herbaceuticals specifically to enhance well-being (Cocks & Moller, 2002; Perry, 2002). In Germany, herb use is more common than in the United States, and depression is treated with St. John's wort (Hypericum perforatum) four times as often as with fluoxetine (Gray, 1999). Herbaceutical use is also said to be increasing in England (Redvers, Laugharne, Kanagaratnam, & Srinivasan, 2001). We also know that more and more people with mental disorders are turning to herbaceuticals and dietary supplements. Users of these are more likely to view themselves as having mental health needs, to have received mental health care and to be dissatisfied with their overall healthcare (Niv et al., 2010).
Researchers indicate herbaceutical use is increasing worldwide (Boniel & Dannon, 2001). What are the estimates in the United States? Researchers estimate that 40% of Americans have tried “alterna-tive therapies,” with herbal therapies being the most common (Gray, 1999). The most rapidly growing herbal market in the United States is for products with supposed efficacy in treating symptoms of mental and emotional disorders (Beaubrun & Gray, 2000). An ongoing problem with herbaceutical use is that, as researchers estimate, 40 to 60% of those using herbal remedies do so without telling their physician (Gutherie, 1999). As you can see in examining various herbal preparations, all have potential for interactions with other drugs as well as for their own adverse effects. Most users in the United States are middle/upper-middle-class Caucasian women paying out-of-pocket (Klesper et al., 2000). In addition, older Mexican Americans suffering from poor health and depressive symptoms are more likely to use herbal supplements than is the general population (Loera, Black, Markides, Espino, & Goodwin, 2001). Increased use among Americans can be directly linked to a 1994 law that allowed herbal preparations to be sold unregulated as dietary supplements.
Do psychiatrists prescribe or recommend herbaceuticals to their patients? Interestingly, there are few data on this question, but a review of the literature seems to indicate significant differences depending on where the psychiatrists reside and practice. American medical practitioners are really not in a position to prescribe or recommend herbaceuticals, because the FDA does not regulate them, so in most cases the prescriber and the consumer have no idea what is actually in the product. Not many more data are available on physicians’ attitudes toward herbaceuticals. One study, done with the faculty and students at the State University of New York Science Center, indicated that although most physicians do ask their patients about the use of herbaceuticals, most never research the herbaceuticals that patients report taking. These researchers did note that the younger the doctor, the more likely the doctor was to be aware of herbaceuticals (Silverstein & Spiegel, 2001).
It is interesting that American researchers raise questions about studies examining herbaceuticals that researchers rarely raise (but could raise) in regard to studies of drugs. Some researchers have noted that the medical community seems particularly critical of trials of herbaceuticals and applies to them more conservative standards than to drug compounds (Even, Friedman, & Dardennes, 2001). One problem that has arisen in the United States with regard to herbaceuticals is the “Don't ask, don't tell” syndrome (Boniel & Dannon, 2001). Basically, patients are reluctant to report their use of herbaceuticals with their doctor because they think the doctor would not approve. Similarly, most doctors don't ask patients if they are using herbaceuticals. This “silence” regarding herbaceuticals can be problematic, because they can interact badly with regular pharmaceuticals (Cupp, 1999; Gold, Laxer, Dergal, Lanctot, & Rochon, 2001).
A study of psychiatrists in Australia and New Zealand found that psychiatrists there were far more positive toward herbaceuticals, with 80% of respondents having used St. John's wort (Walter, Rey, & Harding, 2000). In European countries, where herbs such as St. John's wort are regularly prescribed (for example, Germany), psychiatrists have more positive attitudes about herbaceuticals. A crucial difference to consider is that the German government regulates the dosage and potency of herbaceuticals and promotes research and public education on them, so psychiatrists know exactly how much of the compound patients are being prescribed (Preston, O'Neal, & Talaga, 2002). Several studies from Germany indicate efficacy for St. John's wort (Kasper & Dienel, 2002).
SECTION ONE: PSYCHOLOGICAL ISSUES
Why Do People Take Herbaceuticals?
People report many reasons for turning to herbaceuticals. Table 10.1 summarizes some of the more common reasons given.
TABLE 10.1 Reasons People Report for Taking Herbaceuticals
|
Mistrusting traditional Western medicine |
|
Believing that “natural” products are safer, less toxic than drugs |
|
Sensing that herbaceuticals are more consistent with patient values or philosophy of health |
|
Accepting anecdotal testimony about efficacy |
|
Not needing a prescription |
© Cengage Learning®
Mistrust of Traditional Western Medicine
Gutherie (1999) and Vermani, Milosevic, Smith, and Katzman (2005) noted mistrust of traditional Western medicine as one reason that patients seek alternative and complementary therapies. Many clients and members of the general public are becoming more aware of the adverse effects of medications as well as of questionable practices by pharmaceutical companies. This mistrust may be more pronounced regarding the medical subspecialty of psychiatry—particularly its diagnostic categories. Critics such as Colbert (2002), Breggin (1997), Healy (2002) and Ingersoll and Marquis (2014) all raise substantial questions regarding the accuracy of the DSM diagnoses, the degree to which the disorders have biological etiologies, and the extent to which they should be treated with traditional Western medicine. It is interesting too that people who take herbal medicines in some studies have a stronger internal locus of control (Sasagawa, Martzen, Kelleher, & Wenner, 2008).
The state of managed health care in the United States has also decreased consumer confidence in traditional Western medicine. Clients frequently report to us that their health maintenance organization (HMO) will not fill a prescription their doctor has given them, and offers them a different medication. They are usually aware that HMOs routinely make deals with pharmaceutical companies to carry particular drugs and not competing drugs that may have more efficacy in treating the same disorder.
In a nationwide survey, Astin (1998) also explored whether mistrust of traditional medicine was the reason people used herbaceuticals but found in his sample that the primary reasons people sought out alternative therapies were because such approaches were more congruent with their own beliefs, values, and philosophic orientations toward health and life. Rather than framing his participants’ preference for herbaceuticals as a reaction to mistrust of traditional Western approaches, Astin sees it as proactive choice based on consciously chosen values. This is certainly the case for many whose spiritual or religious paths have a history of using herbaceuticals both medicinally and ritually. Religions like Wicca and Santeria are examples of spiritual paths with rich heritages of herbaceutical use (Hutton, 1999).
Belief That Natural Products Are Safer Than Drugs
Although people taking herbaceuticals often say they believe that natural products are safer than drugs (Gutherie, 1999; Walter & Rey, 1999), many hazards are actually associated with taking herbaceuticals (Mosihuzzaman, 2012). You do not have to look very far to find toxic compounds in nature. For example, belladonna, sassafras, licorice, and ephedra are all toxic in large enough amounts. In addition, because herbaceuticals are not regulated in most countries (including the United States), consumers really have no way of knowing exactly what they are taking in terms of contents, dosage, and potency of contents. Later in the chapter, we review the growing body of literature that reports on the interactions herbaceuticals can have with medications. Given that a significant percentage of clients taking herbaceuticals do not tell their doctors, these risks for problematic interactions increase (Izzo & Ernst, 2001).
Acceptance of Anecdotal Testimony About Efficacy
Both of us have treated clients who asked us about herbal supplements to treat symptoms of anxiety and depression. When we ask clients how they heard about these, they frequently say they know people who claim to have had success using herbal supplements to treat one or another symptom. It is possible that belief in anecdotal testimony facilitates some placebo effect. We caution readers that although anecdotal evidence may be a good starting point for research questions, it is not a good source for drawing conclusions. Case histories and individual clients’ responses to different treatments help us refine how to research and evaluate those treatments. However, conclusions should not be overgeneralized based on one or two cases.
SECTION TWO: ISSUES OF CULTURE
Issues of culture related to herbaceuticals can be placed in two categories. The first is herbaceutical practices that derive from indigenous cultures and have been handed down to the present day. Examples include older Mexican Americans’ reliance on herbaceuticals (Loera et al., 2001) and those cultures where herbaceuticals are an integrative part of medicine and wellness. Here, herbaceuticals could logically be extended to include entheogens , meaning “God-manifesting” agents. Despite the current prohibition in the United States, entheogens have been used (and continue to be used) here and in traditional societies as ways to facilitate the mystical vision (Smith, 2000). Despite the over-generalizing rhetoric in the United States about the evils of mind-altering substances, ample evidence shows that in many cultures the moderate use of mind-altering plants is part of human evolutionary legacy as well as a strategy that can enhance well-being (Roberts & Winkelman, 2007; Siegel, 1989; Sullivan & Hagen, 2002).
The second category concerns the subcultures fighting over whether herbaceuticals can be a standard part of medical practice in the United States. This power issue interests not just medical practitioners but also pharmaceutical companies. Imagine what might happen if a plant such as St. John's wort caught on as an effective treatment for depression. Would the FDA seek to regulate its production and distribution? Would it become illegal to grow, as marijuana currently is? If not, would consumers with any gardening savvy pay for an antidepressant, when they could grow St. John's wort in a backyard at a fraction of the cost? In addition, would the medical lobby seek to restrict St. John's wort to prescription-only access? Although many believe there should be an over-the-counter anti-depressant (Volz & Laux, 2000), many others contest that possibility. From an integrative perspective, all these are important questions.
Another question implied in the power issue is, “How much protection can and should the government give its citizens?” People have come to expect regulation in how drugs are accessed as well as what is allowed in terms of advertising. The United States in particular has not defined the extent to which drugs should be regulated by prescription. Some researchers have suggested that compounds such as antidepressants could all be sold over the counter, because they are no more dangerous than many other over-the-counter substances (Healy, 1997). The prescription issue has particular relevance when considering such issues as marijuana used for medical purposes. Should citizens have the right to grow plants with psychotropic properties for their own use? Is government's role to protect people from themselves even when they don't want such protection?
SECTION THREE: ISSUES FROM THE SOCIAL PERSPECTIVE
In pondering some of the questions ending the last section, you are likely aware that herbaceuticals use has legal aspects. Many people wonder why herbaceuticals sales picked up so much in the last 10 years. One answer is a 1994 law called the Dietary Supplement Health Education Act. The law, for which the supplements industry lobbied heavily, restricted the FDA's ability to control herbal products. Passage of that law allowed any product to be labeled a supplement as long as no claims were made that the product affected a disease. Whereas a manufacturer cannot claim something such as St. John's wort “alleviates depression,” it can legally claim that a substance “helps facilitate emotional balance.” As the Consumer's Union (1999) points out, the current law allows such products to be marketed with absolutely no demonstrations of safety or efficacy. On the one hand, critics such as Pies (2000) believe that because herbal products can create adverse reactions in users, consumers need stricter FDA regulation of these products. On the other hand, advocates of access to herbaceuticals fear that regulation will turn into unnecessarily harsh, even draconian, restrictions, as happened with marijuana prohibition.
Another important legal issue concerns the types of liability U.S. physicians and mental health care providers may incur if they discuss unregulated compounds with clients. The cost of malpractice insurance in the United States has skyrocketed out of control (Vasankathumar, 2001), and attorneys and a public that seem eager to resort to litigation routinely scrutinize physicians. In such a climate, is it any wonder physicians are unlikely to recommend untested and unregulated herbaceuticals? Again, from an integrative perspective, it is unfair to blame physicians for what actually is an effort to achieve a “best practices” standard.
The legal and ethical issues become more complex for nonmedical mental health clinicians. We have already said clinicians are likely to be practicing ethically when discussing basic information about medication, helping the client work through issues related to medication, or acting as an information broker in helping the client get quality information about a medication. Although clinicians should try to answer clients’ questions about herbaceuticals, clinicians should restrict themselves to the conclusions in peerreviewed literature and should recommend that clients check with the doctor before starting any herbaceuticals compound. This conservative approach is important until more data on herbaceuticals are amassed and more standardization is achieved. As Rivas-Vasquez (2001) has pointed out, this is a high-risk area, and clinicians should tread carefully.
SECTION FOUR: PROBLEMS IN STUDYING MEDICINAL PLANTS
An important social issue we must also comment on is research practice related to herbaceuticals. Although approximately 5000 medicinal plants are known, there are only current studies and published papers on about 100 (Northridge & Mack, 2002). Why the dearth of information? Clearly some of this lack is related to difficulties in studying plants that may have hundreds of active compounds and trying to decide which compounds produce the therapeutic effects. Table 10.2 lists some challenges in studying medicinal plants that may contribute to the dearth of literature. A brief discussion follows.
TABLE 10.2 Problems in Studying Medicinal Plants
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Isolating compounds |
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Identifying species |
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Variations in composition |
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Variations in preparation |
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Adulteration and substitution |
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Chemical complexity |
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Problematic study designs |
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Language barriers |
© Cengage Learning®
Isolating naturally occurring compounds is currently not a frontline research strategy in pharmaceuticals. The most popular research now focuses on drug-receptor interactions as well as on intracell changes. Further, isolating active compounds that produce a supposed therapeutic effect is very difficult and time consuming. In Chapter Seven, writing about the new antipsychotics, we noted an important question: How much dopamine antagonism versus serotonin antagonism is necessary for optimal antipsychotic effects? This is a difficult problem to solve even when there are only two primary variables. In plants with hundreds of active compounds, the variables multiply exponentially, and it is hard to know where to begin. Here, the chemical complexity of medicinal plants continues to be a problem. Plants contain thousands of chemicals. This complexity means each herbal preparation may have a variety of pharmacologic effects. For example, at least 40 chemical compounds contribute to producing the aroma of coffee. That is 40 chemical compounds just for aroma alone, without even considering the pharmacologically active chemicals.
Medicinal plant species also vary, as do individual plants within a species, with each variation having its own combination and concentration of active elements. Inaccurate identification of species thus poses a potential problem for systematic study of medicinal plants. For example, the 250 varieties of the herb valerian vary in concentration of active compounds. Researchers would first have to determine which varieties had the most therapeutic effect and then isolate the active compounds to determine those that produce the effect.
Even if a researcher identifies the correct plants and can isolate the active elements, variations in composition result from genetic factors, climate, growing season, soil quality, rainfall, and postharvest storage conditions. Any of these can affect the composition of the plant. So researchers would also have to find ways to exercise control over as many of these variables as possible.
Once an herb is harvested, it can be prepared in many different formulations. For example, herbs can be dried and made into tea or concentrated and used as extract. In addition, extracts may be created with various solvents, including alcohol, oils, or water. Amount of active ingredients varies with preparation method.
Even for herbs harvested and prepared in a uniform manner, lack of standardization can affect the end product. Standardization depends on the integrity of the company selling and distributing the herb. Suppliers often adulterate and substitute other plant materials when the target plant is expensive. Tyler (1994) found that many preparations of ginseng have no ginseng but are filled with numerous other substances.
For the hardy researcher ready to tackle these challenges, there are more, including study design and access to current data. As with lithium, no one can patent a naturally occurring element, and this precludes making a lot of money on herbaceuticals. Thus, most herbaceuticals have few adequate studies to test their efficacy. Another problem is likely more pronounced for U.S. researchers, who are more likely than researchers in other countries to speak only one language. There are data on many herbaceuticals, but the data are in languages other than English. Although many noteworthy works on phytotherapy are now beginning to be translated into English (Blumenthal, 1998), the process is slow.
DIFFERENCES BETWEEN HERBS AND DRUGS
All the latter research problems point to some of the essential differences between herbal preparations and drugs. Although some may seem to be commonsense distinctions, they bear emphasizing, particularly in a society where people are so confused over what constitutes a “drug.” Many critics of the current U.S. practice of labeling herbs such as St. John's wort as “dietary supplements” note that if such herbs may negatively interact with medicines, public safety is best served by regulating them as drugs (Stein, 2002). Table 10.3 summarizes important differences between herbs and drugs. This table is also followed by commentary.
As noted earlier, dosage of an herbal product is very difficult to determine, because there are few efficacy studies on varying dosages to determine the optimal dosage range. In addition, lack of standardization in preparing many herbal supplements makes it next to impossible to know the potency of the compound making up each dosage. Drugs are required to have efficacy studies as well as uniformity in dosage and potency. Under U.S. law, herbaceuticals do not. In addition, as noted, drugs must be regulated by the FDA, whereas herbaceuticals need not be. Drugs are usually monosubstances, whereas herbaceuticals may have many active elements. Finally, when a pharmaceutical company synthesizes a drug, it can get a patent on the compound, which lets the company monopolize the substance for a period of time (usually 17 years) in which to earn back the money it took to research the compound (plus, one assumes, profits).
TABLE 10.3 Important Differences Between Herbs and Drugs
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Dosage |
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Efficacy |
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Complexity of the compound |
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FDA role |
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Role of patents |
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Role of potency standards |
© Cengage Learning®
These differences contribute to many problems with herbaceuticals, including lack of purity. Slifman et al. (1998) did a study of chemical analy-ses for many popular herbal compounds to see what was actually in them, and logged some disturbing results. The herbs studied had many contaminants. In some of the Chinese patent medicines studied, the researchers found mercury, arsenic, aspirin, and phenobarbital. In some of the medicines from India, the researchers found carbamazepine/Tegretol and diazepam/Valium!
Another related problem concerns unethical marketing. Bear in mind that under the 1994 Dietary Supplement Health Education Act, advertising can be legal without being ethical. One product marketed as an antitension supplement claimed to contain St. John's wort, 10 complementary herbs, and calcium. The product claimed these ingredients worked together for a synergistic effect. The product listed the following ingredients in each tablet:
300 mg St. John's wort
90 mg passion flower
70 mg hops
30 mg skullcap
40 mg black cohosh
30 mg wood betony
30 mg chamomile
15 mg lady's slipper
10 mg cayenne
5 mg chlorophyll
40 mg elemental calcium
10 mg elemental magnesium
Clearly, there is no way the company could have “known” the combination would have a calming effect, because most of the herbs listed had not been studied for any “calming” effect. Further, there would be no way of knowing what the effects of all these ingredients would be on the person taking the supplement. Should laws prohibit such advertising? It stands to reason that because the claims cannot be backed up by research, such claims should not be made to consumers.
SECTION FIVE: EXAMINING BETTER KNOWN HERBACEUTICALS WITH APPLICATION FOR PSYCHIATRIC PROBLEMS
In this section of the chapter, we share what we know about some of the more popular herbaceuticals thought to have uses for mental/emotional symptoms. Note that although some herbs have a good deal of research behind them at this point (such as St. John's wort), others have very little, and in some cases the jury is still out regarding efficacy. For each herb, we note the side effects we are aware of. Table 10.4 summarizes the herbs we cover in this section.
TABLE 10.4 Herbaceuticals Thought to Have Use in Mental/Emotional Disorders
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Herb |
Supposed Therapeutic Property |
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St. John's wort |
Antidepressant |
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Kava |
Anxiolytic |
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Valerian root |
Anxiolytic |
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Passion flower |
Anxiolytic/hypnotic |
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Hops |
Anxiolytic/hypnotic |
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Melatonin |
Hypnotic |
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Ginkgo |
Cognitive enhancer |
|
Ephedra |
Stimulant |
© Cengage Learning®
St. John's wort (Hypericum perforatum) is an aromatic perennial that is native to Europe and grows wild in Asia, North America, and South America. It has bright yellow flowers with red spots and is abundant in June. The red spots are supposed to symbolize the blood of John the Baptist, a Christian figure who was beheaded at the time of year the spots appear (early summer). Perforatum refers to the tiny perforation in each leaf of that subspecies; the leaves seen from directly overhead are positioned like a cross, in four directions on the stem; German ethno-botanist Bernhard Becker of Beendorf told the tale that St. John looked down and the devil was hiding beneath the plant; the plant opened up tiny holes to reveal the devil; a version from a less Druidic past says God's all-seeing eye bored the tiny holes. Other legends hold that June (when the plant flowers) is also the birthday of John the Baptist (the word “wort” is derived from the Old English wyrt and means “plant” or “vegetable”). St. John's wort has been used medicinally for over 2000 years. Paracelsus called it “arnica of the nerves” (“arnica” referring to perennial herbs) because of its soothing effects on nervous disorders (Bilia, Gallori, & Vincieri, 2002). Its use in treating mood disorders was pioneered by a German physician in 1939. Although traditionally prepared as tea, currently it is also prepared in ethanol and methanol extracts. The methanol extract is the extract used in the most systematic research on the herb and is prepared by a firm in Germany. Any research on St. John's wort in Germany uses this compound (labeled LI 160), as reflected in the literature. St. John's wort is hypothesized to have efficacy in treating depression. We review the studies supporting this hypothesis later; for now it's enough to say that a great deal of research supports the efficacy of St. John's wort in mild to moderate depression.
St. John's wort has many elements that are biologically active, including naphthodianthrones, flavonoids, and xanthones. The two active ingredients, presumed to be naphthodianthrones, are hypericin and hyperforin. The word hypericin is a Greek word meaning “overcoming an apparition,” and medical historians think the ancients believed the plant had the ability to ward off evil spirits. Modern researchers initially thought hypericin disabled MAO (like an MAO inhibitor), but now they think hypericin is more of a reuptake inhibitor of serotonin, dopamine, and norepinephrine (Wong, Smith, & Boon, 1998). In addition, hypericin seems to bind to GABA receptors, benzodiazepines receptors, and glutaminergic receptors. Hyperforin is also hypothesized to play a key role in the antidepressant activity of St. John's wort (Cervo et al., 2002); however, it is not known what its primary mechanism of action is at the time of this writing.
The consensus of opinion currently seems to be that St. John's wort has efficacy over placebo in treating mild to moderate depression (Sarris, Fava, Schweitzer, & Mischoulon, 2012). Several meta-analyses support this conclusion, including Gaster and Holroyd (2000); Kasper and Dienel (2002); Kim, Streltzer, and Goebert (1999); Laakmann, Jahn, and Schuele (2002); Linde et al. (1996); Linde and Mulrow (2000); and Whiskey, Werneke, and Taylor (2001). In addition, clinical trials have also supported the use of St. John's wort in mild to moderate depression (see Benner, Bjerkenstedt, & Edman, 2002; Ernst, 2002; Friede, Henneicke von Zepelin, & Freudenstein, 2001; Holsboer-Trachsler & Vanoni, 1999; Kelly, 2001; Lecrubier, Clerc, Didi, & Keiser, 2002; Volz, Murck, Kasper, & Moeller, 2002). The extract of St. John's wort used in most studies is labeled LI 160 and is the commonly prescribed compound for depression in Germany. LI 160 is distributed and regulated in Germany with regard to the potency and dosage of the compound. The recommended dosage is at least 900 mg per day. Of the trials that did not support efficacy, one of the more controversial was that by the Hypericum Depression Trial Study Group (2002), which found no differences among sertraline, St. John's wort, and placebo. This study was followed by no fewer than six commentaries (Cott & Wisner, 2002; Klaus, Mechart, Mulrow, & Berner, 2002; Kupfer & Frank, 2002; Spielmans, 2002; Volp, 2002; Wheatley, 2002), indicating a number of questions regarding the findings. Another trial (large-scale, multisite, placebo-controlled) also did not find St. John's wort significantly different from placebo (Shelton et al., 2001). All the studies showing significance for St. John's wort did so only with mild to moderate depression. These studies used participants whose depression was in the moderate to severe range, as measured by the Hamilton Depression Rating Scale. This discrepancy alone could account for the differences in findings.
With regard to studies comparing St. John's wort with standard antidepressants, four studies have compared St. John's wort to maprotiline/Ludiomil (a tricyclic derivative), imipramine/Tofranil and amitriptyline/Elavil. No significant differences were found in responses to the St. John's wort and these agents. One severe limitation in these studies was that the antidepressant doses were lower than would be normal in clinical practice (Wheatley, 1997). Another study (Friede et al., 2001) found St. John's wort at 500 mg per day as effective as fluoxetine/Prozac at 20 mg per day (the minimum therapeutic dosage in the United States) in treating mild to moderate depression. It is hoped that researchers will replicate this latter study.
In addition to treating mild to moderate depression, studies have suggested efficacy for St. John's wort in treating menopausal symptoms (Grube, Walper, & Wheatley, 1999) and Seasonal Affective Disorder (Wheatley, 1999). There is still debate about the efficacy of St. John's wort. Sarris (2013) and Sarris and Kavanaugh (2009) like most researchers found it had efficacy for mild to moderate depression. Grobler, Matthews, and Molenberghs (2013) claim that in many studies that show efficacy, there were missing data that when added and reanalyzed show St. John's wort performing no better than placebo. Obviously, the debate over this herbaceutical goes on.
Side and Interaction Effects of St. John's Wort
Although there is no systematic study of the side effects of St. John's wort, some reported side effects in studies can be shared here. Many researchers report that side effects are minimal (Gaster & Holroyd, 2000) and others that St. John's wort is well tolerated (Volz et al., 2002). Parker, Wong, Boon, and Seeman (2001) and Dannawi (2002) found that in sensitive patients, St. John's wort is associated with serotonin syndrome. This is a potentially life-threatening syndrome caused by increased accumulation of serotonin in the central nervous system. The symptoms of serotonin syndrome include disorientation, confusion, agitation, restlessness, fever, chills, diarrhea, hypertension, and sweating.
Far more likely than developing serotonin syndrome just from St. John's wort is that clients could develop the syndrome from combining St. John's wort with another serotonergic drug, as was the case in the Dannawi (2002) study. Parker and colleagues (2001) identified cases where the syndrome was associated only with St. John's wort. These researchers also found a case where St. John's wort was associated with hair loss. This is reminiscent of the case we shared in Chapter Five where the hair loss seemed caused by sertraline/Zoloft. In another study (Holsboer-Trachsler & Vanoni, 1999), gastrointestinal upset was one of the most frequently reported side effects, but in most cases it was rated as mild to moderate. Finally, one researcher noted that sexual dysfunction was a side effect of St. John's wort and could be treated with sildenafil (Viagra) (Asslian, 2000).
Although side effects are always a concern with a substance, they are eclipsed in importance by adverse interactions with other substances. All herbaceuticals exerting a psychotropic effect can have adverse interactions with other herbaceuticals or with other drugs the client may be taking. In one study, 19% of the people who reported taking herbaceuticals also reported an adverse reaction to them (Hailemaskel, Dutta, & Wutoh, 2001). Concern over adverse interactions between herbaceuticals and drugs have been voiced by researchers in Europe (Izzo & Ernst, 2001; Kistorp & Laursen, 2002), the United States (Keller & Lemberg, 2001; Pies, 2000), Canada (Asslian, 2000; Gold, Tullis, & Frost-Pineda, 2001), Israel (Boniel & Dannon, 2001), and Lebanon (Dannawi, 2002). Note that the presence of interaction effects implies pharmacodynamic activity in St. John's wort.
Drug interactions peculiar to St. John's wort include lowering blood concentrations of other drugs (particularly anticoagulants and anti-inflammatory drugs for arthritis). St. John's wort combined with certain oral contraceptives (ethiny-lestradiol/desogestrel) has been correlated with intermenstrual bleeding (Izzo & Ernst, 2001). These interactions seem related to the effects St. John's wort has on the cytochrome P-450 enzyme system, the liver enzyme system responsible for metabolizing most drugs. St. John's wort, like many FDA-approved pharmaceuticals, appears to elevate these enzymes, making them more efficient at metabolizing other drugs (Bilia et al., 2002).
The kava, or kava kava, shrub (Piper methysticum) is native to Polynesia and the Pacific Islands. It has been used there for millennia, primarily in liquid form made by grinding the dried rhizome (underground stem) and mixing with water and coconut milk. Captain James Cook and other European explorers in the 18th century described kava as having a calming effect. The crude drug can be derived from the rhizome, but now most formulations are made as ethanol—water or acetone extracts. Traditionally, kava is used socially similar to the way we use alcohol. At high doses kava, like alcohol, can cause intoxication.
Kava is one of the few herbal treatments where the active ingredient is known. Meyer (1967) proved that the effects of kava were due to kavapyrones. These act as muscle relaxants and anticonvulsants, and they reduce excitability in the limbic system. They do so by inhibiting voltage-dependent sodium channels, increasing the number of GABA-A receptors, blocking NE reuptake, and suppressing release of glutamate (which metabolizes into glutamic acid, which, recall from Chapter Two, serves an excitatory function).
Efficacy of Kava as an Anxiolytic
Several double-blind, placebo-controlled studies support the use of kava as an anxiolytic (Kinzler, Kroner, & Helman, 1991; Volz, 1997; Warnecke, 1991). The only problem with these studies is that the patient population was not clearly defined by diagnosis. Two studies exist researching the effects of kava on symptoms of Generalized Anxiety Disorder (GAD). The first study (Wheatley, 2001) compared two doses of kava in patients suffering from GAD. Both dose schedules (120 mg once daily and 45 mg three times daily) were found effective. In the second, although overall differences from placebo were not significant, the authors felt the improvement warranted further investigation (Connor & Davidson, 2002). Rex, Morgenstern, and Fink (2002) compared kava with diazepam/Valium used on rats using a maze test. These authors concluded that the kava exerted an anxiolytic response in the rats similar to that induced by diazepam. They felt the study supported the use of kava as an anxiolytic. Sarris et al. (2013) found kava was well-tolerated and may be a moderately effective short-term option for the treatment of Generalized Anxiety Disorder. Finally, one meta-analysis (Witte, Loew, & Gaus, 2005) also found kava extract to have efficacy in nonpsychotic anxiety disorders.
Side Effects and Adverse Reactions
Although the few studies that exist note minimal side effects, there are some reports of rash, tiredness (Leak, 1999), and a rare occurrence of nausea (Wheatley, 1997). Although initial studies (few in number) seem to indicate kava is well tolerated, more research is needed to draw conclusions. The risk of adverse reactions for kava includes the possibility that it induces tolerance and dependence (Mischoulon, 2002), and there has been at least one report of acute liver failure tied to kava use (Brauer, Stangl, Siewert, Pfab, & Becker, 2003). Clearly, kava should not be mixed with other CNS depressants.
The Ginkgo biloba tree is native to East Asia. Gingkos were first imported to Europe from Japan during the 18th century and now are common ornamental trees throughout Europe and North America. According to Wong et al. (1998), they are among the oldest species of deciduous trees on the planet. Ginkgo fruit and seeds have been used in China for medicinal purposes for millennia. Ginkgo has been used to treat people with asthma, and leaves are used to dress wounds. Currently, most ginkgo products are derived from the dried leaves (the therapeutic extracts are labeled Egb 761 and LI 1370).
Gingko, like other herbs, contains a large number of substances that have been demonstrated to have a wide variety of pharmacologic properties. As with most herbs discussed so far, ginkgo has a wide variety of active ingredients we are only just learning about. A primary active ingredient seems to be flavonoids. Flavonoids are compounds found in numerous plants, and ingesting them is associated with decreased risk of several chronic diseases (Knekt et al., 2002). Flavonoids are effective anti-oxidants that decrease free radicals in the body. Free radicals are reactive chemicals that attack molecules by capturing electrons from the molecules and then modifying their chemical structure. Free radicals are believed to be one cause of Alzheimer's-type dementia. This connection provides a rationale for testing ginkgo on people suffering from Alzheimer's disease. If ginkgo has flavonoids that decrease the free radicals causing the damage to neurons, researchers hope their administration may slow the disease. Ginkgo leaves are harvested in May when the flavonoid content is highest.
Compounds called ginkgolides are another active ingredient in ginkgo. Researchers think ginkgolides inhibit platelet-activating factor. This effect may play a role in patients with vascular dementias, using the same mechanism as aspirin in forestalling additional strokes. It is also related to some of the adverse effects of ginkgo such as prolonged bleeding after chronic administration.
So how well does ginkgo work with people suffering from Alzheimer's-type dementia? After several false starts and years of studies, it appears ginkgo does not have efficacy for treating this disorder, as once believed. More than 40 controlled studies were initially conducted in Europe testing ginkgo efficacy for treating dementia. Although these studies seemed to show positive effects, the patient populations were poorly defined, the numbers were small, the randomization poorly done, and the outcome measures were not standard (Kleijnen & Knipschild, 1992).
The LeBars study in 1997 corrected many of these shortcomings. This 52-week, randomized, double-blind, placebo-controlled study was done with 202 patients, who were diagnosed with either Alzheimer's disease (129) or vascular dementia (73). The patients were 45 to 90 years of age. Outcome measures included the Alzheimer's Disease Assessment Scale, Cognitive subscale (ADAS-Cog); the Geriatric Evaluation by Relatives Rating Instrument (GERRI); and the Clinical Global Impression of Change (CGIC).
On average, the ADAS-Cog and the GERRI showed significantly less decline in the ginkgo extract group than in the placebo. This difference was equivalent to a 6-month delay in progression of the disease. The results were comparable to the effects of 80 to 120 mg of tacrine/Cognex, a drug used to delay progression of Alzheimer's Disease. Although statistically significant, the results of the LeBars study were actually modest. In a later paper, LeBars and Kastelan (2000) noted that ginkgo is more likely to appear efficacious on broad dependent measures as opposed to more narrow cognitive assessments. Other studies using such narrow assessments do not find any significant differences between patients on ginkgo and those on placebo (Soloman, Adams, Silver, Zimmer, & DeVeaux, 2002). The evidence to date seems to show that the effects of ginkgo on cognition are minimal (Sommer & Schatzberg, 2002).
Valerian root is another herb commonly prescribed in Europe. Valerian is a flowering perennial plant that grows in temperate climates worldwide. The root is believed to be a mild sedative/anxiolytic, although results of research have been conflicting. Valerian is on Germany's list of approved herbs, and supplements can be purchased in various formulations. For thousands of years the Greeks, Chinese, and the people of India used valerian as a mild sedative, and it is still used to flavor foods and beverages such as root beer. The rhizome and roots are harvested, dried, and served as tea or used to make an extract.
Valerian extract contains over 100 different constituents. Researchers do not know which of these is or are responsible for its effects, although some believe valerian may have an effect on GABA receptors and act like a mild benzodiazepine. Others have hypothesized that valerian inhibits the enzymatic breakdown of GABA, thus producing its tranquilizing effects (Houghton, 1999).
In studies, 400 to 900 mg of valerian extract decreased sleep latency and nocturnal awakenings and improved subjective sleep quality. In some cases, the beneficial effects were seen only after two to four weeks of therapy (Balderer & Bobely, 1985; Leathwood & Chauffard, 1982; Leathwood, Chauffard, Heck, & Munoz-Box, 1982). It appears valerian can produce an anxiolytic effect, although the degree of that effect relative to the dose is still debated (Leak, 1999).
The side effects of valerian have been reported to be headache, agitation, uneasiness, and possible liver toxicity (Yager, Siegfried, & DiMatteo, 1999). Julien noted the possibility that valerian could interact with SSRI antidepressants and cause serotonin syndrome. Studies on reaction time, alertness, and concentration indicate that the effects of valerian do not impair these functions on the morning after taking a dose (Kuhlmann, Berger, Podzuweit, & Schmidt, 1999). More research is obviously needed, but at this point valerian may prove promising as a mild anxiolytic.
Ephedrine is a sympathomimetic alkaloid derived from any of several species of ephedra. The Asian species Ephedrasinica typically has the highest concentration of ephedrine. Perhaps more than any other herbaceutical, ephedrine illustrates the dangers inherent in unregulated products that have powerful mechanisms of action. On February 17, 2003, major league baseball player Steve Bechler, 23, collapsed and died from heatstroke during spring training. The coroner in Broward County, Florida, believed that Bechler's use of an ephedrine-containing weight loss product contributed to his death. This tragedy reignited the debate over whether products containing ephedrine should be sold as over-the-counter supplements (Fox, 2003). In 2004, the FDA banned the sale in the United States of products containing ephedrine (Parry, 2004).
You may recall from Chapter Nine that ephedrine is an alkaloid (organic, nitrogen-containing compounds) found in the ma huang plant (Ephedra sinica), which has been used in Chinese medicine for thousands of years. The primary active constituent of ephedra is ephedrine, which served as the organic model for the first synthesized amphetamine. Ephedrine gained widespread medical use in the United States in the 1920s as a nasal decongestant, CNS stimulant, and asthma treatment, but its use decreased because of safety concerns. Ephedrine reappeared as a dietary supplement to weight loss products sold as herbal supplements. Although ephedrine-containing products account for less than 1% of herbaceuticals purchased, they are responsible for 64% of the adverse effects reported (Bent, Tiedt, Odden, & Shlipak, 2003).
Ephedrine is a psychostimulant that exerts its effects by releasing epinephrine, norepinephrine, and dopamine. It resembles amphetamine, although it has a much shorter half-life. Ephedrine has been shown to have pharmacodynamics similar to those of amphetamine (Angrist, Rotrosen, Kleinberg, Merriam, & Gershon, 1977; Ercil & France, 2003; Glennon & Young, 2000). Ephedrine is categorized as a sympathicomimetic agent, because it mimics the sympathetic nervous system. Recall from Chapter Two that the sympathetic nervous system prepares the body's fight–flight-freeze response. Ephedrine stimulates the cardiovascular system and dilates the bronchial tubes (hence its use in treating asthma attacks) (Van der Hooft & Stricher, 2002; Wooltorton & Sibbald, 2002). These effects also seem to be responsible for its appetite-suppressing qualities.
The primary adverse effects include stroke, heart attacks, cardiac arrhythmias, and seizures—all potential adverse effects seen in amphetamines as well (Geiger, 2002; Kaberi-Otarod, Conetta, Kundo, & Farkash, 2002; Van der Hooft & Stricher, 2002; Wooltorton & Sibbald, 2002). In addition to these adverse effects, there have also been reports of ephedrine-induced mania (Capwell, 1995), psychosis (Jacobs & Hirsch, 2000), and dependence (Gruber & Pope, 1998).
In the wake of the deaths from adverse effects, the FDA treated ephedrine as a potent psychostimulant to be regulated. Although the Dietary Supplements Health and Education Act of 1994 prohibits regulation of dietary supplements, the FDA may regulate if a supplement poses a significant or unreasonable risk of injury or illness. Given this authority, the FDA called for stricter regulations in 1997 (Maradino, 1997) and then banned ephedrine in 2003. A federal court upheld this decision in 2004 (Parry, 2004).
From an integrative perspective, regulation promises only a partial solution. Far less socially and individually dangerous drugs (such as cannabis) are completely prohibited in the United States, but people who want them find a way to get them. Thus, regulation may not solve the problem and may in fact increase the problem, adding immeasurably to the social damage surrounding its use. Many users of ephedrine-containing products seem to be athletes, and many are adolescents. From the intrapsychic perspective of the Integrative Model, these users report feeling that using the supplement gives them a “competitive edge” or brings them closer to an internalized ideal of thinness. Further, from the cultural perspective, subcultures can easily develop in groups of adolescent athletes where taking supplements becomes a norm, and this norm in turn increases use of supplements and the attendant risks. In one large-scale study, researchers found that trainers had a significant influence on the attitudes and subjective norms of adolescent athletes and the researchers proposed ways to encourage attitudes that discouraged supplement use (Dunn et al., 2001).
Both passion flower and hops are purported to have sedative/anxiolytic properties, but there are little scientific data on either. Passion flower is a climbing vine native to North America. It has fallen into disuse in this country but is still one of the most common herbal hypnotics in Great Britain. Components of its extract appear to bind to GABA receptors.
Hops are the fruit of the hop plant, a vine native to Europe. Although used primarily for making beer, hops have been used as a tonic for over 1000 years. Their use as a sleeping aid resulted from the observation that hop pickers tired easily, possibly due to the transfer of hop resin from hands to mouth. Studies have not confirmed that hop resin, hop extract, or lipophilic hop concentrates have a sedative effect. There do not appear to be sufficient data to support its use as a sleep aid.
Melatonin is a hormone produced by the pineal gland. It binds to the suprachiasmic nucleus (SCN), which is the body's circadian pace maker or internal clock. The SCN normally produces an alerting signal that researchers think is blunted by melatonin. Melatonin is useful in initiating sleep but can cause a rebound in the SCN, causing wakefulness three to four hours after taking the melatonin. Various doses are used (1 to 100 mg), and anything over 5 mg raises the melatonin in the blood to levels higher than normal. The melatonin in health food stores is labeled to range between 1 and 5 mg, but the actual range is much more variable. Recent research has supported the use of melatonin as a safer alternative to hypnotics for adolescents (Eckerberg, Lowden, Nagai, & Akerstedt, 2012) and a recent meta-analysis supported the use of melatonin for primary sleep disorders (Ferracioli-Oda, Qawasmi, & Bloch, 2013).
SECTION SIX: AN INTEGRATIVE VIEW OF MARIJUANA
Although marijuana is not a licit herbaceutical in the United States, many people around the world still use it for everything from medical purposes, to enhancing sexual experience and well-being, to “finding God”—that is, as an entheogen. We have included this section for two reasons. First, I (Ingersoll) have taught dozens of courses and seminars on psychopharmacology, and in most of them students have questions about marijuana, its efficacy for medical use, and its actual dangers. Although it is not popular to say, many of these students are skeptical about the government media campaign against marijuana use and want to know where to find reliable information. The second reason we have included this section is because it illustrates the Integrative Model's capacity to capture the complexity of a topic, revealing the partial truths while also providing a critical view of the issues.
A Brief History of Marijuana Use
There is something profoundly frightening to the orthodoxies of higher civilization about the shamanistically originated vision quest with drugs. (Wilson, 1993, p. 164)
Marijuana is an ancient drug that apparently has been used since prehistoric times. It is a product of the hemp plant (Cannabis sativa, Latin for “planted hemp”), a species that provides a useful fiber, an edible seed, oil, and a medicine (Weil & Rosen, 1993). Until recent times, it has been an important cultivated crop. As recently as 1943, farmers were paid to grow hemp; “Hemp for victory” was one of the industrial catchphrases of World War II. This was industrial hemp, not cultivated for its psychoactive properties, but marijuana was being used recreationally in society at the time. The United States at the time of this writing is clearly becoming more accepting of marijuana use (Benac, 2013) with 21 states allowing the use of medical marijuana and two states allowing recreational use (http://medicalmarijuana.procon.org/view.resource.php?resourceID=000881). Despite fears that this would unleash an epidemic of marijuana use especially among teenagers that does not seem to be the case (Lynne-Landsman, Livingston, & Wagenaar, 2013).
Marijuana is derived from the flowers and the tops of the leaves from male and female plants. Cannabis will grow almost anywhere, given adequate water and drainage. Cannabis sativa produces a sticky, yellowish resin, which seems to have evolved as a defense mechanism to protect itself from harmful predators. This resin contains the primary psychoactive ingredients of marijuana.
Cannabis is one of the few plants that legend says was not discovered by animals. Typically, humans seem to have learned which plants were safe for ingestion by watching animals eat them (and not fall over dead!). According to an Arab legend, in 1155 C.E. Haydar, an ascetic monk who founded an order of Sufis, discovered the plant dancing in the heat of a summer day (Siegel, 1989). Haydar mixed the plant with wine and found the drink made him laugh—little wonder. Medieval Muslim society disapproved of Haydar's discovery, but alas, the proverbial “cat” was out of the bag. The Sufis became heretics in Arab society, but the world was introduced to one of the most versatile and hotly debated plants; after all, how many plants have “wars” declared on them? A great deal of emotionalism surrounds marijuana today. Most of the debate does not even ask the most important questions, which we explore through the different perspectives of the Integrative Model.
Although we will never know if humans discovered the Cannabis sativa plant first, we do know many birds love marijuana seeds, which are rich in protein. For hundreds of years bird breeders have referred to marijuana seeds as “pigeon candy” and noted that birds fed on these seeds border on erotomanic behavior. This is not entirely surprising, because the seeds, and other parts of the plant, have been considered aphrodisiac at least since ancient Roman and Greek times (Grinspoon & Bakalar, 1997; Siegel, 1989). B. F. Skinner's famous pigeons, which played such a pivotal role in putting operant conditioning on the map, were fed a mixture that contained 10% hemp seeds. As Siegel (1989) wrote, people may never know “to what extent the foundations of Skinnerian psychology were made under the influence” (p. 155).
A Medical Model Perspective on Marijuana
From the medical model perspective, what do scientists know about marijuana? We begin by reviewing the active ingredients and their mechanisms of action. Obviously, like other herbaceuticals discussed in this chapter, cannabis varies a great deal in potency depending on the conditions under which it is grown and on the sex of the plant (Schwartz, 1987).
The Cannabis sativa plant contains over 400 chemical agents, including over 60 cannabinoids. In 1964, researchers determined delta-9-tetrahydro-cannabinol (THC) to be the primary psychoactive ingredient in marijuana. It took another 20 years to determine that THC acted on a specific set of receptors in the brain called cannabinoid receptors. Two of these receptors have been discovered and are localized in the brain as well as throughout the body, particularly in the immune system (Herkenham et al., 1990; Matsuda, Lolait, Brownstein, Young, & Bonner, 1990). Cannabinoid receptors are located in the cortex, motorsystem, limbic system, and hippocampus. This appears to explain some of THC's effects on cognition, motor coordination, memory, and mood. Researchers have further determined that humans produce the equivalent of endogenous cannabinoids, which act on these receptors and appear to play a natural role in pain regulation, control of movement, cognition, memory (Watson, Benson, & Joy, 2000) and possibly as anti-inflammatory agents (Burstein & Zuerier, 2009).
Cannabinoid receptors exist primarily on presynaptic neurons and seem to inhibit the flow of calcium ions and facilitate the influx of potassium ions (Felder & Glass, 1998). With these mechanisms, cannabinoid receptors inhibit the release of other neurotransmitters from presynaptic neurons, and this inhibition likely causes THC's psychoactive effects. Some researchers hypothesize that cannabis is also related to dopamine release in the brain's pleasure centers (Voruganti, Slomka, Zabel, Mattar, & Awad, 2001). Watson et al. (2000) point out that scientists are just beginning to understand cannabinoid receptors and the different endogenous and exogenous cannabinoid compounds that may affect them. These authors point out that research on these compounds should not be restricted to THC proper, because a number of cannabinoids may have utility for a variety of uses.
Being highly fat soluble, THC quickly enters the central nervous system. Heart rate and blood pressure both increase, and skin temperature falls. The drug calms aggressive behavior in animals, and further research is needed to determine whether this effect is also consistent in humans. Although the subjective high (which we later discuss from the intrapsychic perspective) lasts up to 12 hours, THC is metabolized slowly and can persist in the body for up to two weeks. Although this slow metabolism can lead to a reverse tolerance syndrome when the user becomes more sensitive to the drug, it also minimizes physical tolerance and dependence on THC. The only studies suggesting that marijuana is highly “addictive” (De Fonseca, Carrera, Navarro, Koob, & Weiss, 1997; Gianluigi, Pontieri, & Chiara, 1997) had three serious flaws. First, they used animal models, and results from such studies do not necessarily generalize across species. Second, the researchers disabled this natural process for the slow metabolism of the THC, creating an artificial reaction in the bodies of the lab animals. And third, the researchers did not even use THC but a synthetic compound (HU-210) believed similar to THC. Even these researchers, who seemed biased toward equating marijuana with heroin, admitted that probably only 9% of marijuana users would meet the criteria for dependence. These data were first summarized by Warner, Kessler, Hughes, Anthony, and Nelson (1995), who noted that 9% of the people who ever tried marijuana would develop dependence on it. This question of the dependence-inducing potential of cannabis requires further comment.
The Issue of Cannabis Dependence and Withdrawal
Although it is fashionable to use the word addiction, we find the word emotionally loaded and poorly operationalized, and used more to generate emotionalism than to explore a phenomenon rationally. Generally, it is thought bad to be “addicted” to something. Although Webster's Unabridged Dictionary (1989) defines addiction as having yielded to something that is habit forming, such as narcotics, the colloquial understanding seems to be any compulsive need to take a substance or engage in a behavior. However, as pointed out in Chapter Five, if addiction is defined as (1) tolerance to repeated administrations of a drug and (2) withdrawal on discontinuation, then we must conclude that SSRI antidepressants as well as benzodiazepines cause “addiction.” These examples illustrate why we prefer to use words such as tolerance and dependence. Tolerance and dependence are more easily operationalized and explored using the scientific method. As in Chapter Five, dependence here is defined as a physical tolerance produced by repeated administration of a drug and a concomitant withdrawal syndrome (Stahl, 2000) or as a change in physiology or behavior after stopping a drug.
In surveys of which drugs are the most and least dependence inducing, marijuana is consistently found to be one of the least dependence inducing (Franklin, 1990). Although some marijuana users develop psychological dependence, most do not (Anthony, Warner, & Kessler, 1994; Watson et al., 2000). As noted earlier, the pharmacokinetics of cannabis cause it to be stored in the fat cells of the body and then slowly released over a relatively long period (long for a drug, that is). It is interesting that although advocates of marijuana prohibition downplay this mechanism, a similar mechanism in methylphenidate is described with enthusiasm as making it less likely that children on methylphenidate/Ritalin will become dependent on it (Volkow et al., 1995). Mechanisms that allow for slow metabolism seem to decrease the probability of physical dependence for compounds they operate in. Those rules apply regardless of whether the substance in question curries political favor. Heavy use of marijuana, like the heavy use of many substances, can, on stopping, result in mild withdrawal in symptoms such as sleeplessness and restlessness. One such study gave participants oral dosages of 180 to 210 mg of THC (the equivalent of THC that would be smoked in approximately four to eight marijuana cigarettes when less than one cigarette would be closer to what is generally used). Mild withdrawals followed discontinuation of these heavy doses (Jones, Benowitz & Bachman, 1976).
In a minority of chronic users (for example, those who smoked marijuana every day for years), withdrawal can include mental cloudiness, irritability, cramping, nausea, and aggression (Gold, Tullis, et al., 2001; Watson et al., 2000). When these effects occur, they are said to be short-lived (Haney, Ward, Comer, Foltin, & Fischman, 1999). DSM-5 (APA, 2013) has added a section of Cannabis-Related Disorders including Cannabis Use Disorder, Cannabis Intoxication, and Cannabis Withdrawal. Cannabis withdrawal is cessation of cannabis use that has been heavy and prolonged (e.g. daily for at least a few months). The symptoms are not severe enough to require medical attention. How much of the withdrawal is psychological and how much is physical remains undetermined.
Even researchers who claim that there is physical dependence note that it is less severe than dependence on other drugs (Budney, Roffman, Stephens, & Walker, 2007). Psychological dependence is a state in which a person believes he or she cannot get through the day without a particular substance or activity. Researchers do know that, as with anti-depressants, chronic cannabis exposure causes downregulation of cannabinoid receptors (Abood & Martin, 1992), which can be thought of as a type of physical tolerance. Recent studies on dependence and withdrawal seem consistent with what we have reported here. In one review of the literature, Smith (2002) concluded that studies to date do not provide strong evidence for the existence of a cannabis withdrawal syndrome similar to that with other drugs of abuse such as opioids. Research should continue in this area, and researchers should take care to preclude contaminating studies with political agendas.
Note that other characteristics are found in chronic and/or heavy users of marijuana, characteristics not likely to be found in moderate users. This group of heavy users includes people with AntiSocial Personality Disorder and Conduct Disorder (Watson et al., 2000). Some studies indicate that these characteristics, and the sequence of drug use, are better predictors of who will become dependent on any given substance than is the use of the substance alone (Eldredge, 1998; Morral, McCaffrey, & Paddock, 2002).
Another interesting debate regarding cannabis is whether or not it is a gateway drug similar to alcohol and cigarettes. This gateway theory (also called the stepping-stone theory) has yet to be soundly supported (Watson et al., 2000). The theory basically is that using drugs such as alcohol, tobacco, and marijuana lead to the use of “harder” drugs such as cocaine and heroin. This notion mistakes correlation for causation. It is like noting that most people with pilot's licenses had driver's licenses first and then concluding that getting a driver's license somehow caused such people to get a pilot's license. In the same way, we could make the argument that diapers are “gateway pants.” When researchers have found marijuana use to be correlated with later illicit substance use, they note that the other substance use is much more correlated with employment status and is short-term, subsiding by age 21 (Van Gundy, 2010).
Proponents of the gateway theory resort to unconvincing logical maneuvers to make their case. While defending the gateway theory from this criticism, Clayton and Leukefeld (1992) wrote, “We often act or react in our professional and personal lives according to observed correlations without solid and irrefutable evidence that two phenomena are causally related … shouldn't we do the same with this information on smoking and other drug use?” Our short answer is no. If correlation is enough to pass as causation, then proponents of the gateway theory must account for other correlations. For example, why is it that where cannabis use carries no criminal penalties and is more available (such as in the Netherlands), there is a decreased tendency for people to use harder drugs (Korf, 2002; Model, 1993)? Further, proponents of the gateway theory would have to explain why Dutch studies note that the availability of cannabis has no relationship with heroin use or even with whether people continue to use cannabis (Sifaneck, 1995). The report on the gateway theory, by the think tank Rand Drug Policy Research Center (Morral et al., 2002), concludes there are other plausible explanations for hard drug use beside the gateway theory. For these researchers, it is not marijuana but individual propensities to use drugs that determine a person's risk of initiating hard drug use. Further, the researchers propose that the current prohibition policies that rely so heavily on the gateway theory are unnecessarily burdensome to society particularly in filling the courts and prisons with perpetrators of the victimless crime of marijuana possession.
It may be more helpful to examine patterns of drug use in heavy users, who are more at risk to develop dependence on marijuana or other drugs. One study that examined the sequence of drug use among serious users (Mackesy-Amiti, Fendrich, & Goldstein, 1997) found that progression of use in these users did not follow the standard gateway theory progression (alcohol, then marijuana, then harder illicit drugs). Rather, they found that many were more likely to use marijuana before alcohol and even harder drugs before marijuana. Their findings suggest that youths who are most at risk for serious drug use may be less likely to follow the sequence predicted by the gateway theory. Alcohol is still far more of a “gateway” drug than marijuana and some researchers promote the idea of focusing on preventing alcohol use in K-12 healthy-living programs (Kirby, 2012).
Proposed Medical Uses for Cannabis
Excellent reviews of the medicinal potential of cannabis are provided by Clark (2000); Gurley, Aranow, and Katz (1998); Mathre (1997); and Watson et al. (2000). Unless elsewhere noted, the following material is drawn from these sources. We noted earlier that cannabinoid receptors seem involved in analgesia (pain relief), and much evidence supports the use of cannabis for pain relief (Williamson & Evans, 2000). Evidence from studies on animals and humans indicates that cannabis can provide significant pain relief. On a related note, cannabinoids seem to treat migraine headaches as well, because they maintain vasoconstriction (constriction of blood vessels). Patients with chronic pain are much less likely to develop dependence on cannabis than on a regimen of opioids. Cannabis also has efficacy as an antiemetic (antinausea) drug for patients undergoing chemotherapy and for patients suffering from wasting syndrome associated with AIDS. Researchers have also found that oncologists’ attitudes toward medical marijuana are far more favorable than regulatory authorities have believed (Doblin & Kleinman, 1991). Although research in this area is relatively new, taking cannabis to reduce nausea and encourage appetite as well as to reduce pain are well-established uses. We discuss the subjective “high” produced by THC in discussing the intrapsychic perspective.
In addition to treating pain and nausea, medical marijuana may show efficacy in treating spasticity and movement disorders associated with spinal cord injuries, basal ganglia dysfunction, and multiple sclerosis. More data are needed to assess these claims however. Although many people have heard of medical marijuana in association with the treatment of glaucoma, it is not as efficacious as other therapies. Although cannabis does decrease intraocular pressure, the effects are short-lived and require high doses.
Finally, a line of research examines whether cannabinoids may act in the brain as neuroprotective agents. These agents would preclude or slow down a neurodegenerative disease such as Parkinson's disease or Alzheimer's disease. Hampson et al. (2000) examined this property of cannabinoids in rats and found that cannabidiol (a type of cannabinoid) was superior to other agents tested in preventing glutamate toxicity. In addition, both marijuana and synthesized cannabinoids have efficacy to protect the brain from neurotoxic responses after head injury or stroke (Nagayama et al., 1999). Again, regardless of what happens with marijuana as an herbaceutical, such lines of research hold promise for the development of neuroprotective pharmaceuticals.
What are the adverse effects of marijuana? First, it is not a drug that can be taken in lethal quantities, and no fatalities from marijuana are recorded. This is likely because there are no cannabinoid receptors in the brain stem or other parts of the brain controlling vital functions. There are adverse effects that should be considered; however, they are no more severe than any adverse effects for many of the prescription psychotropic medications we have discussed thus far if the drug is not taken by smoking. Table 10.5 summarizes categories of adverse effects of marijuana that we have evidence to support.
If marijuana is smoked, the user has an increased probability of respiratory problems associated with smoking. As noted earlier, the tar content of marijuana cigarettes is significantly higher than that of tobacco cigarettes. In addition to tar, smoke from the cigarette is likely to cause airway irritation and inflammation in users. The degree of the problem stems from the combination of the user's susceptibility, amount used, and frequency of use (Roth et al., 1998; Tashkin, 1999). These effects can be totally avoided by ingesting marijuana baked in foods, unless the person taking it is so nauseous that he or she cannot keep any food down at all. In that case, some of the substance can be smoked and then once nausea subsides, more can be ingested.
TABLE 10.5 Adverse Effects of Marijuana
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Respiratory problems related to smoking the drug |
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Cardiovascular side effects |
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Psychiatric side effects |
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Drug interactions |
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Infection from contaminated crop |
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Impairment of motor skills |
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Problems in pregnancy |
© Cengage Learning®
Marijuana is associated with a number of cardiovascular effects that can be significant (El-Mallakh, 1987; Hall & Degenhardt, 2014). Users can suffer from pronounced tachycardia, with an increase in heart rate of up to 50%. Users may also have transient hypertension. Although this hypertension is usually tolerated well in young users, it should be closely monitored in older users. One implication of this side effect is its propensity to lead the user to suffer panic and anxiety (Gurley et al., 1998). This is further discussed under psychiatric effects.
One of the most important factors in using psycho-active substances is referred to as “set and setting.” Set refers to the psychological makeup and mind set of the user, and setting to the environment in which the psychoactive substance is to be used (Smith, 2000). Set and the human response to setting are two things that make it difficult to generalize from animal to human models. Some individuals’ mind set and psychological makeup make them poor candidates for using particular psychoactive substances. These individuals are more prone to anxiety and panic under the influence of marijuana. Anxiety and panic can be a function of the setting as well.
Although cognitive effects are experienced during the high after smoking marijuana, studies thus far have found no long-term effects on intelligence (Fried, Watkinson, James, & Gray, 2002). There have been reports of marijuana triggering or exacerbating psychotic symptoms in people predisposed to such symptoms (Johns, 2001; Shufman & Witztum, 2000), but not in those who are at not at risk for developing psychotic symptoms.
Users of cannabis need to know it can have interactions with other drugs related to decreased intestinal motility (movement) and decreased stomach acid. Prescription use would need to take each of these effects into consideration. As with other herbaceuticals, to preclude any problematic interactions standard dosage and potency would have to be set.
Infection from Contaminated Crop
The adverse effect of infection from a contaminated crop is largely encouraged by the prohibition of marijuana and could be practically eliminated were the drug grown and processed under regulation. Marijuana can be contaminated with organisms, including fungal species found in the fecal matter of animals. Outbreaks of both hepatitis B and salmonella have been linked to contaminated marijuana (Gurley et al., 1998). Contaminated crop effects also include chemical contamination such as that from the U.S. government supporting the spraying of marijuana crops with dipyridylium (Paraquat), which is designed to sicken consumers and could be fatal depending on the amount ingested (Duke & Gross, 1993; Miron, 2004; Williamson, 1983).
Marijuana clearly impairs motor skills and reaction time (Ashton, 2001). The drug causes temporary impairment in perception, coordination, reaction time, and time perception (Sugrue et al., 1995). Users under the influence should not drive cars or operate other similarly dangerous machinery. Irresponsible behavior is a risk factor for automobile accidents and injuries.
Marijuana use in pregnancy has been correlated with impaired fetal growth and shortened gestation (Zuckerman et al., 1989). Researchers believe that pregnant women underreport marijuana use but that these same women are likely to be polysubstance users.
The notion of medical marijuana raises the same problems inherent in the use of any herb. Problems of dosage, potency, plant gender, type, and so forth all need to be subjected to regulatory scrutiny. As with many other compounds, perhaps the simplest solution is to synthesize the cannabinoid, as has been done with dronabinol (Marinol). The biggest problem with dronabinol for people with severe nausea has been its oral formulation. This problem is being addressed in the United Kingdom, where GW Pharmaceuticals has developed and is currently testing a cannabis spray that is showing efficacy for chronic pain (Hoge, 2002).
Marijuana from the Psychological Perspective
Examining the evidence from the medical model perspective does not really begin to capture the complexity of the experience of marijuana use. Clearly, people do not smoke marijuana to cause respiratory distress, increased heart rate, and temporarily impaired motor skills. Why do so many people around the world, some legally and others illegally, use marijuana? There is not as much research on this question as on the medical uses of marijuana, and the answer is usually a form of word magic referring to “addiction,” when in fact, as noted, only a minority of marijuana users develop any type of dependence on it. Many people smoke or ingest marijuana because they enjoy its euphorant effect. Some who use it for medical purposes also report this. Does this effect make marijuana an attractive drug of abuse? Yes, but several abusable, recreational drugs in our society are licit. Although prohibitionists argue that legalizing even medical marijuana will lead to more abuse of the drug, these fears have not been confirmed in societies more tolerant of cannabis use, and prohibitionist arguments in general have no support if their goal is to decrease drug consumption.
Many government officials would support medical use if the “high” could be taken out of it. This is a curious statement, given the drug's low potential for dependence—clearly much lower than legal drugs such as nicotine, caffeine, and alcohol. What is wrong with responsible enjoyment of the high that comes from smoking or ingesting marijuana? For that matter, anyone who has ever been on an oncology ward and listened to the suffering and retching of patients receiving chemotherapy would agree that if these people could enjoy a temporary drug-induced euphoria, why not let them? Certainly recreational use differs from medical marijuana use, although many see medical marijuana as the first step toward legalization (Crites-Leoni, 1998). However, the subjective reports of recreational users are an important component of an integrative analysis and is more important now that, since the first edition of this book, two states (Washington and Colorado) have legalized recrea-tional use of marijuana and the federal government in 2014 passed an act agreeing that there would be no federal interference with these state initiatives (see http://www.upi.com/Top_News/US/2014/05/30/House-stops-feds-from-executing-raids-in-medical-marijuana-states/8451401465100/).
Perhaps the most thorough research on this topic was done by psychologist Charles Tart (1971/2000). His psychological study of marijuana intoxication is perhaps the best available. Current legal restrictions on research have precluded psychological studies on the drug, and researchers today rarely ask the question of what people enjoy so much about marijuana. From an integrative perspective this is an important question, though. First, note that not everybody enjoys the experience of being under the influence of marijuana. This section merely raises the question, for those who do enjoy it, should the drug continue to be prohibited? Tart has noted that the effects of the drug are variable and can be divided into three types: pure, potential, and placebo. Pure effects are almost always manifested regardless of set and setting (for example, alertness produced by amphetamine). Potential effects do not manifest unless numerous nondrug variables are in place related to set and setting. Placebo effects are brought on almost entirely by nondrug effects. The interesting thing about an integrative view of marijuana is that the medical model perspective describes pure effects, whereas potential effects relate more to the intrapsychic perspective.
Although medical users of marijuana experience relief from troubling symptoms, they also experience many of the things reported by Tart's participants. Following are just some of the reinforcing experiences these users associated with marijuana.
Visually, users reported increased perceptual organization described as meaningful in terms of patterns, designs, and forms not perceived when not under the influence of marijuana. Users reported perceiving more subtle shades of colors and an enhanced visual depth. Commonly users report a sensual quality to vision while under the influence of marijuana. Although visual illusions or hallucinations are infrequent, they did occur occasionally.
In terms of auditory effects, several of Tart's participants reported subtle changes in sound as well as more acuity with regard to sounds. Other users report what would be akin to a three-dimensional sound space that for them took on a beautiful, indescribable quality. Other users reported synesthesias, “the experience of another sensory modality than the one actually stimulating the person” (Tart, 1971/2000, p. 74). An example of a synesthesia is “seeing sound” or “feeling a smell.”
Enhancement of the sense of touch seems to be related to marijuana's purported sexual enhancement effects (Lewis, 1973; McGlothlin & West, 1968; Wilson, 1993). As the author Norman Mailer is reputed to have said, “Sex with pot is better than sex without pot” (in Wilson, 1993). Although many users felt less sexual drive under the influence of marijuana, others reported more attunement to their own body and to the body of their partner. They also noted that orgasm had new pleasurable qualities. Many participants in Tart's study felt they were better lovers under the influence of marijuana because they were less inhibited and more arousable, gentler and more giving, experienced prolonged duration of lovemaking, (for males) had longer-lasting erections, and were more in the present moment with the other. This ability to be in the present moment was interpreted as a deepening of intimacy.
Finally, subjective entheogenic experiences are associated with marijuana. Recall that an entheogen is a substance that supposedly accelerates or in some cases initiates experiences described as mystical or divine. As Smith (2000) noted, true mystical experiences must be incorporated into daily living, including mundane, sober daily consciousness. Altered states must transform into altered traits. Although entheogens are not a substitute for a spiritual practice, they may enhance a spiritual practice. Although marijuana is not as powerful an entheogen as a substance such as psilocybin, some users report spiritual experiences while under the influence. In Tart's study, users reported feeling in touch with the divine or more in touch with a spiritual perspective. Several users felt they meditated more effectively under the influence, and 33% of participants felt they had powerful religious experiences under the influence of marijuana, experiences that had long-term effects on them.
Marijuana From the Cultural Perspective
Marijuana has enjoyed popularity with different groups at different times in different societies. Herer (1992) noted that from approximately the 27th to the 7th century B.C.E., cannabis was incorporated into most cultures of the Middle East, Asia Minor, India, China, Japan, and Europe for uses ranging from the utilitarian to the recreational. We have already mentioned its rejection in 12th-century Muslim society, with the exception of Sufis. It was popular in 19th-century Europe, where in Paris intellectuals would gather with French doctor Jacques Moreau, who was studying the subjective effects of THC. Siegel (1989) has noted that human beings seem to manifest a fourth drive (in addition to hunger, thirst, and sex), seeking mind-altering or intoxicating states. Culture plays a large role in how this drive is going to be channeled. In U.S. society, many people are moderate users of alcohol. Most alcohol users do not drive under the influence, and they do not drink more than is good for them or enough to interfere with their obligations. Although this majority is not studied extensively, what is so different about someone who uses marijuana moderately in the same manner? In tolerating cannabis use, Dutch society has had none of the problems feared by prohibitionists in the United States. Given the lack of evidence for the effectiveness of prohibition, an increasing number of U.S. states, the United Kingdom, and Canada are minimizing criminal penalties for possession and use of marijuana.
Wilson (1993) and Eldredge (1998) have pointed out that in the United States the “war on drugs” has racist overtones. Marijuana smoking was strongly associated with Mexican immigrants during World War I. It is from this group that the slang “Mary Jane” is derived, because this is the Mexican Spanish translation of marijuana. Drug laws in many cases are far harsher on users in lower socioeconomic income brackets, and the case could certainly be made that they become a useful measure of class control. For example, the penalties for possessing crack cocaine (derived from powder cocaine) are harsher than those for possessing powder cocaine (the parent compound of crack cocaine). Advocates of drug law reform note that users of powder cocaine are far more likely to be Caucasian and users of crack, to be African American. In addition, marijuana has been linked in the minds of many with countercultural movements that challenged authority during the Vietnam War era. The phrase “war on drugs” was coined by then-President Richard Nixon. The Carter administration was apparently considering legalization, but this was stopped by the Reagan administration, although prohibition has consistently been shown to be ineffective for both alcohol and marijuana. Some of the largest funders of the “war on drugs” are pharmaceutical companies. As commentator Ariana Huffington (2000) speculated, “It's not that they do not want us on drugs—they just want us on theirs” (p. 167). Pharmaceutical lobbies’ influence on laws related to access to medical marijuana needs to be monitored.
Clearly U.S. culture has many issues to consider in relation to medical marijuana, and this review is a rough outline of just a few. Again, for medical purposes many problems could be overcome by allowing the prescription of synthetic cannabinoid inhalers, which would be treated like any other pharmaceutical with abuse potential (such as morphine).
From the cultural perspective, also consider that people in many oppressed groups use drugs (including marijuana) as an escape from a life that, in their opinion, is not worth living. This is one of the secrets (and fears) of American society: that its citizens may not find life worth living. If a majority of a society comes to this conclusion, they may decide they want to change the way the society is structured and this is a constant threat to those in power. Like it or not, we all must acknowledge that currently not all U.S. citizens have equal access to resources and many have little hope of attaining a decent standard of living. On the other side of the coin, other people, despite having material abundance, feel their lives have a meaningless quality. The promises of consumer culture leave them feeling empty. The question remains: If a government criminalizes the things its citizens use to relieve the pain of their daily existence, does it thus incur any responsibility to helping its citizens pursue other avenues toward happiness to decrease that pain? This was of course one of the themes in Aldous Huxley's (1932) dystopian novel Brave New World where the drudgery of daily life is eased by a mythic substance called soma.
Social/Legal Perspectives on Marijuana
Perhaps the biggest social/legal issue is the current drug laws, which have been described as “draconian” in publications as diverse as libertarian treatises (McWilliams, 1993) to commentaries in medical journals (Kassirer, 1997). Table 10.6 lists the groups who have recommended decriminalization of marijuana for medicinal purposes.
The laws that exist to prosecute people involved in marijuana possession, cultivation, or trafficking include people who, under their own state laws, may be growing or distributing medical marijuana through state-approved medical marijuana clubs. The laws of 15 U.S. states require life sentences for certain nonviolent marijuana offenses. Under federal law the death penalty can be sought for growing or selling a large amount of marijuana, even for a first offense. The 1986 Drug Abuse Act increased penalties for federal drug offenses and established mandatory minimum sentences, a move opposed by the American Bar Association and federal judges. The federal government can seize the property of “suspected drug traffickers” without even filing charges against them. For example, an entire farm can be seized if one marijuana plant is found on its grounds. Perhaps even more disturbing is a little known clause in the laws that allow informers to receive up to 25% of the assets seized in return for their testimony (Schlosser, 1997). The average time served in prison for a nonviolent drug offense is five years. Compare these penalties to the average penalty for kidnapping (4.5 years), assault (2 years), and sexual abuse (2.5 years) (McWilliams, 1993). Reviewing these averages, it is hard to avoid feeling as if we all were living in a surrealist novel. The laws passed to prohibit marijuana use appear far more dangerous than the drug itself. Despite prohibitionist fears that decriminalizing marijuana for medical use would increase crime and marijuana use in general, initial studies do not support this (Harper, 2012; Morris, TenEyck, Barnes, & Kovandzic, 2014).
TABLE 10.6 Groups Supporting Medical Marijuana
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American Bar Association |
|
American Civil Liberties Union |
|
American Public Health Association |
|
National Nurses Society on Addiction |
|
Conference of Episcopal Bishops |
|
The People of the State of Alaska |
|
The People of the State of Arizona |
|
The People of the State of California |
|
The People of the State of Canada |
|
The People of the State of Colorado |
|
The People of the State of Connecticut |
|
The People of the State of Delaware |
|
The People of the State of Hawaii |
|
The People of the State of Illinois |
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The People of the State of Maine |
|
The People of the State of Maryland |
|
The People of the State of Massachusetts |
|
The People of the State of Michigan |
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The People of the State of Minnesota |
|
The People of the State of Montana |
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The People of the State of Nevada |
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The People of the State of New Hampshire |
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The People of the State of New Jersey |
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The People of the State of New Mexico |
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The People of the State of Oregon |
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The People of the State of Rhode Island |
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The People of the State of Washington, DC |
© Cengage Learning®
What does an integrative investigation of marijuana as an herbaceutical tell us? How do the partial truths revealed help us draw conclusions? First, the Integrative Model does illustrate the complexity of the situation far more effectively than parochial debates in disciplines that rarely converse with each other. It is imperative to discuss marijuana from the medical model, psychological cultural, and social perspectives. An integrative approach to an issue such as medical marijuana could inform politicians of problems with the federal laws as they are written, particularly if medical marijuana is to receive federal approval. The integrative approach to medical marijuana also demythologizes the subjective high experienced with marijuana use. The psychological perspective requires us to hear the testimony of not just those in the minority whose use has led to personal or legal troubles, but from those who have had positive experiences using marijuana. This is an important complement to the information from the medical model perspective that, although useful, is incomplete.
Herbaceuticals are not FDA-regulated substances in the United States and therefore, are not considered medicines proper. They are, however, increasingly used as an alternative and complementary approach to healing, even though federal laws prohibit their being advertised as a cure for any disorder. Mistrust of traditional medicine, cultural beliefs, increasing numbers of proactive consumers, and a belief in the safety of “natural” products all seem to be contributing to the increased use of these substances. Currently, research supports the efficacy of some compounds but not of others. It is important for mental health professionals to understand that just as they cannot make recommendations about psychotropic medications to clients, they should not recommend herbaceuticals either. They should, however, keep abreast of the literature on these substances, given their increasing use by consumers.
The herbaceutical with the best support for efficacy is St. John's wort, which is used to treat depression in Europe. Kava seems to be an effective anxiolytic as well. The literature on other substances such as ginkgo, valerian root, passion flower, hops, and melatonin is mixed but at this point does not seem to support their use as psychotropic agents. The most controversial substance in this chapter is marijuana. Although there appear to be some medical uses for it federal law still prohibits its use even if recommended by a physician. It is likely that the cultural and social issues (and the accompanying propaganda) will slow intelligent debate and discussion of both the proposed medical uses as well as the failure of prohibition.
CHAPTER ELEVEN Pharmacotherapy of Alcohol and Drug-Related Disorders By Logan Lamprecht
The pharmacotherapy of alcohol and drug dependence has dramatically changed over the past decade. Ongoing research concerning pharmacological options as a meaningful adjunct to the treatment experience of individuals attempting to rehabilitate from substance-related addictions and to maintain abstinence continues to demonstrate the efficacy of such therapeutic interventions when used appropriately and under the direction of medical professionals. In addition, the discovery of new medications along with combinations of pharmacotherapies to treat addiction from a multifaceted approach (management of physiological and psychological withdrawal symptoms, decreasing using behaviors, lowering craving urges, and maintenance of abstinence) have been shown to positively impact client treatment goals for abstinence and lifestyle change (Heilig & Egli, 2006; Karila et al., 2007; Williams, 2005).
This chapter is demarcated into five sections. Section One provides a brief overview concerning the development of pharmacological treatment options to supplement the therapy process for individuals struggling with alcohol and/or drug-related problems. Section Two presents statistical information regarding the prevalence of drug and alcohol-related problems over the past two decades and reports on current trends in treatment seeking behaviors. Section Three covers pharmacological information regarding the treatment of alcohol dependence. Section Four provides a detailed description of current pharmacotherapy treatments recommended for opioid dependence and presents a review of the research regarding the efficacy of these treatments in practice. Section Five briefly covers salient viewpoints concerning cultural considerations about the implementation of medications to support treatment outcomes for patients who experience drug and/or alcohol-related problems of living.
Learning Objectives
• Increased understanding about the development of pharmacological treatments for substance-abuse-related concerns.
• Know the approval process as well as approval dates for specific pharmacological medicines as determined by the Food and Drug Administration (FDA).
• Be able to conceptualize how pharmacological interventions were introduced as a pharmacological means for treating alcohol and/or drug addiction.
The historical context outlined in this section regarding the pharmacological treatment of substance-use disorders primarily focuses on alcohol and opioid-related dependence concerns and some of the historical antecedents and precursors that provided the foundation for research and evaluation of medications used for the primary purpose of promoting abstinence and decreasing the physiological and physical withdrawal symptoms from use.
PHARMACOLOGICAL TREATMENT OF ALCOHOLISM
Drugs approved for treating alcohol dependence are listed in Table 11.1. The first pharmacological drug used in the treatment of alcoholism was disulfiram, otherwise known as tetraethylthiuram disulfide (Antabuse) (Fuller et al., 1986; Williams, 2005). Disulfiram was used in the 1800s as a compounding chemical that aids in the creation of vulcanized rubber. Several alcohol-consumed laborers, upon being exposed to disulfiram experienced an immediate physiological reaction that included skin flushing, increased heart rate, and decreased blood pressure (Kurtzweil, 1996). The efficacy of disulfiram as a treatment option for alcoholism was later discovered by accident when a group of Danish researchers who were trying to determine the drug's potential to control for parasitic infestations in the body realized that sensitization to the adverse consequences of alcohol consumption could represent a potent treatment option for alcoholism. Disulfiram was federally approved in 1948 in the United States and became the first drug to be approved by the Food and Drug Administration for the treatment of alcohol-related disorders. Pharmacodynamically, disulfiram blocks an enzyme that is necessary for the metabolism of ethanol in the body, which then produces extremely unpleasant physical consequences, including nausea and vomiting, whenever alcohol is ingested in the body.
TABLE 11.1 FDA-Approved Pharmacotherapies for Alcohol-Use Disorders
|
Generic Name |
Brand Name |
Recommended Daily Dosage |
|
Naltrexone Hydrochloride |
ReVia (oral) |
50 mg/day to 100 mg/day |
|
|
Vivitrol (injection) |
Monthly dose of 380 mg |
|
Acamprosate |
Campral |
666 mg 3× daily or 2 g |
|
Disulfiram |
Antabuse |
250 mg per day |
|
Topiramate |
Topamax |
50 mg per day or up to 150 mg twice per day |
|
Baclofen |
Lioresal |
60 mg per day |
© 2015 Cengage Learning®
The second of three drugs approved by the FDA in the United States is naltrexone (ReVia). Naltrexone was originally approved by the FDA in 1984 as a treatment for opioid addiction and was administered under the brand name Trexan. The FDA approved naltrexone in 1994 as a treatment option for alcohol-use disorders (Litten & Allen, 1999). It is manufactured under the name ReVia with its generic equivalent, Depade. Naltrexone has also recently become available in an extended-release option that is administered monthly to patients (Vivitrol). The primary pharmacodynamic purpose of naltrexone is to inhibit opioid receptors in the brain and to help to alleviate the endorphin-mediated reinforcing consequences of alcohol consumption (Herz, 1997). Contemporarily, the combined effects of naltrexone when prescribed adjacent to acamprosate, have shown promising results in terms of an effective treatment option for alcoholism (Garbutt, West, Carey, Lohr, & Crews, 1999).
The third drug approved more recently (2004) by the FDA for the treatment of alcohol-related disorders is acamprosate (Campral). The effectiveness of acamprosate was first demonstrated in Europe and has been a form of treatment for several years in many countries outside the United States, including Australia. The primary function of acamprosate, pharmacologically, is to support abstinence from alcohol by alleviating the physical and psychological discomfort symptoms that accompany individuals once they stop drinking behaviors (Mann, Lehert, & Morgan, 2004).
An additional pharmacological alternative being used for treating individuals with alcohol-related disorders is nalmefene (Revex). Nalmefene is an opioid receptor antagonist that was developed in the late 1970s and used primarily for the treatment of patients attempting to maintain abstinence from alcohol use (Garbutt et al., 1999). Although there are some studies that demonstrate the effectiveness of this drug, pharmacologically, when used to target alcohol-using behaviors, these studies are primarily contained within Europe and the drug has not been available for legal consumption in the U.S. pharmaceutical market since 2008. The drug has not been approved by the FDA.
Contemporary research also demonstrates some efficacy with additional pharmacotherapies as a treatment adjunct to alcoholism, including gammahydroxybutyric acid (GHB), baclofen (Kemstro), topiramate (Topomax), and fluoxetine (Prozac). This chapter briefly highlights some areas of research that explore the effectiveness of these medications for addressing pharmacological aspects of craving treatment in alcohol addiction.
PHARMACOLOGICAL TREATMENT OF OPIOID DEPENDENCE
The onset of pharmacotherapeutic treatments to target opioid dependence was primarily the result of the dramatic increase in intravenous abuse of heroin after World War II, particularly in New York City (Courtwright, Joseph, & Des Jarlais, 1989). By the late 1950s and early 1960s, abuse of heroin had escalated to epidemic proportions. Methadone (Dolophine), a long-lasting agonist with a half-life of between 24 and 36 hours, was created in Germany for analgesia before World War II. Isbell and Vogel (1949) demonstrated that methadone was an extremely effective medication for heroin addicts experiencing acute withdrawal symptoms due to prolonged heroin abuse. At the time of their research, Isbell and Vogel (1949) contended that patients who were addicted to heroin at the onset of treatment be submitted to a process where doses of methadone were slightly reduced over a timespan of 10 days or more. However, the research at the time showed that patients that were discharged from treatment relapsed at extremely high rates. Due to the epidemic numbers of individuals that were addicted to heroin at the time, in 1958, the Joint Committee of the American Bar Association and the American Medical Association officially recommended the development of outpatient facilities to regulate the prescription of narcotics as a treatment modality on an experimental basis (Hunt & Odoroff, 1962).
Drugs used to treat opioid dependence are listed in Table 11.2. Methadone maintenance treatment (MMT) was initiated as a research endeavor at The Rockefeller University in 1964 and was funded by the Health Research Council of New York City in direct response to the alarming percentages of patients who were addicted to heroin post—World War II (Joseph, Stancliff, & Langrod, 2000; Payte, 2002). The research was headed by Dr. Dole, the chair of the Narcotics Committee Council located in New York, and Dr. Mary Kreek. They initially looked at the efficacy of daily administrations of morphine to patients experiencing heroin addiction. The research proved difficult due to the number of times morphine had to be injected into patients each day. After it was determined by the research that morphine was not a feasible treatment option, longer-lasting narcotics were introduced, including methadone. Instead of discontinuing methadone treatments as was previously noted in experimental research conducted at the U.S. Public Health Hospital in Lexington, Kentucky, the research team had the patients remain on methadone so that its effectiveness could be explored (Dole, 1988). The research noted that as patients remained on the medication, they developed tolerance to the drug and were no longer sedated by the influence of opioids. One consequence of this outcome was that behavioral change was also noted, and patients began to plan for a productive, drug-free future, including employment and education. The patients in this particular study were able to obtain employment while remaining on a daily dose of 100 to 180 mg (Dole, 1988). This study contributed significantly to future studies that explored an ongoing and stabilized treatment process that required individuals to be on a consistent dose of methadone as a means of promoting positive treatment outcomes. Over the next few decades, the population of patients receiving regulated MMT grew from 6 (1964) to 44,000 (1998) (American Methadone Treatment Association [AMTA], 1998).
TABLE 11.2 FDA-Approved Pharmacotherapies for Opioid Dependency
|
Generic Name |
Brand Name |
Recommended Daily Dosage |
|
Methadone |
Dolophine |
80 to 150 mg daily |
|
Levomethadyl acetate (LAAM) |
Orlaam |
40 to 140 mg daily |
|
Buprenorphine |
Butrans |
8 to 12 mg daily |
|
Buprenorphine/Naloxone |
Suboxone |
16 mg/4 mg daily |
|
Naltrexone |
Depade |
50 mg daily |
© 2015 Cengage Learning®
Several studies from 1965 through 1991 demonstrated a few central themes with respect to the treatment outcomes for opioid-dependent patients who submit to a regimented treatment program involving daily ingestion of methadone (Ball & Ross, 1991; Dole & Joseph, 1978; Gearing & Schweitzer, 1974). Some of these findings result in the following themes relative to patient outcomes post discharge from treatment:
• Significant improvements in productive behaviors, including employment and education seeking behaviors and a substantial decrease in number of arrests per 100 persons entering treatment (Gearing & Schweitzer, 1974)
• Death rates of patients terminating treatment is three times the amount of patients who are currently engaged in methadone treatment (Gearing & Schweitzer, 1974)
• A small number of patients (between 8 and 12%) were able to maintain successful treatment outcomes, including not relapsing and not being re-arrested (Dole & Joseph, 1978),
• A relatively high probability of relapse to heroin abuse (60% had relapsed within six months post-treatment discharge) (Dole & Joseph, 1978)
• Thirty-four percent of patients who were discharged from treatment in good standing were able to successfully maintain sobriety for between six months and one year (Dole & Joseph, 1978)
• After prolonged exposure to treatment (between 3 and 5 years), 92% of patients had successfully discontinued heroin use (Ball & Ross, 1991)
• Eighty-two percent of patients who had left short-term methadone treatment relapsed to heroin abuse within the first year (Ball & Ross, 1991)
It should be noted that according to the Bureau of Research and Evaluation at the University of Michigan, which surveyed 44 federally regulated methadone treatment programs, the primary determinants of successful outcomes (reduction of drug-using behaviors and/or abstinence) that were also consistent in each of the above studies were the dosage of methadone (amount consumed per day) and the amount of time the patient remained in treatment (Joseph et al., 2000).
As a result of significant research that examined the efficacy of methadone as a pharmacological treatment strategy for opioid dependence and opioid detoxification, methadone was approved by the FDA in 1972 as a primary means of treating opioid addiction.
Another primary psychopharmacological option used to reduce and treat opioid cravings and opioid-seeking behaviors is naltrexone (which has also been approved by the FDA for the treatment of alcohol dependence). Naltrexone was synthesized in 1965 and tested during the 1970s and 1980s for treating opioid dependence. The FDA approved the use of naltrexone for this purpose in 1984.
Dr. Abraham Wikler, a psychiatrist and neurologist, administrated the narcotic-withdrawal ward at the Lexington Narcotic Hospital for several years. While there, he hypothesized that opioid craving and sustained drug abuse could be reduced if specific reinforcing effects were somehow diverted or thwarted at critical points (Wikler, 1948). Pharmacodynamically, naltrexone can effectively inhibit the cyclical nature of drug reinforcement and dependency by stopping opioid receptors. The metaphorical equivalent might be a bicycle tire moving at speed when suddenly, a solid object becomes lodged within the spokes, causing the wheel to come to an immediate stop (and its rider flying dangerously forward). With dependency, the receptors that have become sensitized and habituated to the euphoria caused by opioid ingestion and its accompanying behaviors require interruption. Naltrexone can assist with interrupting the physiologically conditioned responses within the body (particularly, the brain) associated with craving urges. Research has consistently shown positive treatment outcomes when opioid-dependent patients receive naltrexone, pharmacologically, in concert with psychosocial supports (Gonzalez & Brogden, 1988; Washton, Gold, & Pottash, 1984).
Another pharmacological option for treating opioid dependence is the drug known as buprenorphine (Butrans). Buprenorphine-related products were approved by the FDA in 2002 as a medication assisted treatment for opioid addiction (it should be noted that a buprenorphine product known as Buprenex has not received FDA approval as of this time). It is primarily used to decrease withdrawal symptoms and inhibits euphoric responses, physiologically, when used by the opioid-dependent patient. Patients who use buprenorphine are not required to participate in a federally regulated program such as a methadone clinic. Recent research has also shown the efficacy of buprenorphine when used in concert with naloxone (an opioid antagonist) (Suboxone). Bup/Nx (buprenorphine and naloxone) decreases withdrawal symptoms from opioids and does not lead to euphoria in the opioid-addicted person, and it significantly reduces the effects of other potentially problematic opioids for up to one day (Donovan, Knox, Skytta, Blayney, & DiCenzo, 2013). Suboxone continues to be a well-researched and prescribed form of medication-assisted treatment for opioid-use disorders.
This section provided the reader with a brief overview of the historical context surrounding medication-assisted therapies for the treatment of alcohol and opioid-use disorders, including FDA approval for recommended use in the United States. The next section provides a detailed narrative of statistical information regarding drug and alcohol dependency—related problems over the past few decades and presents the reader with a conceptual understanding of dependency for operational purposes.
Review Questions
• What are some of the historical antecedents to the pharmacological treatment of substance-use disorders?
• What is the timeline for FDA approval for some of the more prominently used pharmacological drugs for treating substance-use disorders in the United States?
• Why was methadone used to treat opioid dependence in place of morphine?
• What are two significant factors for methadone maintenance treatment and positive client outcomes?
SECTION TWO: CURRENT STATISTICAL IMPACT OF DRUG AND ALCOHOL ABUSE/DEPENDENCY AND TERMINOLOGY
Learning Objectives
• Understand the statistical impact of alcohol and drug dependency in the United States.
• Be familiar with the statistics regarding treatment seeking behaviors, including pharmacological treatment for illicit drug and alcohol-use disorders.
• Develop a working definition of alcohol and opioid dependence that draws from diagnostic criteria from historical narratives as well as the recently published DSM-5.
According to the newly revised Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (2013a), the criteria for substance-use disorders has been changed to reflect the existence of a variety of behaviors associated with persistent use that interferes with daily activities of living. The DSM-5 integrates the two DSM-IV disorders, abuse and dependence, into a coherent, single disorder called substance-use disorder (SUD) with mild, moderate, and severe sub-categories or classifications. Depending on how many criteria are met would denote whether or not the individual can be diagnosed with a substance-use disorder, or more specifically an opioid-use disorder (OUD) or alcohol-use disorder (AUD). The number of criteria met by the individual would determine the severity of the concern and provide recommendations for treatment. Some of these diagnostic criteria include: (a) significant use of time expended to obtain and use drugs and/or alcohol; (b) persistent desire or unsuccessful effort to decrease or appropriately manage alcohol and/or drug use; (c) recurrent alcohol and/or drug use leads to significant impairment in other tasks of daily life, such as employment, interpersonal, and/or educational; and (d) tolerance levels are reached, which requires increasingly larger amounts of consumption. A new criteria added to the diagnostic language in DSM-5 is strong, craving urges for the individual to consume illicit drugs and/or alcohol.
The most recent statistic according to the National Survey on Drug Use and Health (2013) indicated that over 17.7 million Americans over the age of 12 (7.7% of the total population) were dependent on alcohol. In addition, it is estimated that nearly 20 million people needed some form of treatment for serious alcohol-related problems, but only 1.5 million of these individuals received treatment in the past year. For individuals who do enter treatment, it is estimated that between 40 and 70% of them experience relapse to drinking behaviors within one calendar year of terminating treatment (Finney, Hahn, & Moos, 1996).
Some additional statistics provided by the Substance Abuse and Mental Health Services Administration (SAMHSA) (2013) regarding alcohol use in the year 2012 in the United States include the following:
• Just over half of Americans aged 12 or older reported being current consumers of alcohol (135.5 million current drinkers)
• Nearly 25% of persons aged 12 or older reported binging on alcohol in the past 30 days
• In 2012, heavy drinking was reported by 6.5% of the population aged 12 or older (17 million people)—heavy drinking is defined as binge drinking on at least 5 days in the past 30 days
• In 2012, it was estimated that 14.9 million adults were alcohol dependent
• Cultural variables are significant factors for understanding alcohol-use disorders; gender and ethnicity play a significant role in deter-mining the composition of the percentage of the total population that experiences alcohol-related problems (i.e., Whites and biracial individuals are more likely to abuse alcohol than all other ethnicities)
• The numbers of individuals who are alcohol dependent have remained consistent over the past decade (between 20 and 22 million people annually)
Williams (2005) noted that only about 20% of individuals who receive treatment for alcohol-related problems receive pharmacotherapy as a treatment adjunct. At the conclusion of this section, additional statistics regarding individuals receiving treatment for alcohol and/or substance abuse-related concerns will be briefly presented in a summative overview format.
The National Survey on Drug Use and Health (NSDUH) (2013) reported that in the year 2012, 23.9 million Americans over the age of 12 had abused an illicit drug and/or a psychotherapeutic medication in the past month. Of these 23.9 million people, 7.7 million needed help for illicit drug use, but only 1.4 million received any form of treatment, including psychosocial and/or pharmacological.
SAMHSA's 2013 national survey on drug use provided the following statistics related to illegal consumption of illicit drugs:
• Rate of current drug use among persons 12 or older increased from 8.1% in 2008 to 9.2% in 2012
• Cannabis is the most commonly abused illicit drug, with 18.9 million people abusing cannabis in the past month
• 1.6 million adults who currently abuse cocaine
• Nearly 700,000 adults who abuse heroin chronically, an increase of nearly 300,000 since 2007
• 2.6% of the adult population abused prescription-type psychotherapeutic drugs for nonmedical purposes in the past month
• An estimated 69.5 million Americans aged 12 or older were current users of a tobacco product (26.7% of the total population)
• 2.9 million persons aged 12 or older used an illicit drug for the first time within the past one year
• An estimated 22.2 million people aged 12 or older were classified with substance dependence or abuse in the past year (of this total, 2.8% were classified as dependent with respect to illicit drug use)
• Cultural demographic factors are a significant variable for understanding illicit drug use (i.e., adult males are two times as likely to abuse drugs than adult females)
The SAMHSA (2013) survey defined treatment need as having substance dependence or abuse or receiving substance-use treatment at a special facility, including inpatient settings, drug or alcohol rehabilitation or mental health facility, within the past year. In 2008, nearly 20% of all substance abuse treatment admissions were for primary opioid abuse or dependence (SAMHSA, 2009). In 2012, 23.1 million people needed treatment for an illicit drug or alcohol problem (nearly 9% of the total population). The survey noted that over 20 million people needed treatment for a substance abuse—dependency problem but did not receive any treatment as a special facility in 2012. The primary reason noted by participants for not seeking treatment was due to financial burdens and/or poor or inadequate insurance.
It is estimated that nearly a quarter of a billion dollars is spent annually in the United States on medical expenses, lost work productivity, expenses connected to drug-related criminal activity and on other expenses related to drug and alcohol problems. Nearly 18 billion annually is spent on drug and alcohol problems, and the majority of this amount is funded by public money, including Medicaid, Medicare, and local state and county-sponsored government programs that allocate monies for the treatment of drug and alcohol-related concerns for individuals without insurance. In their 2005 report on U.S. spending for substance abuse–related concerns, Mark, Coffey, Vandivort-Warren, Harwood, and King (2005) estimated annual costs of nearly $185 billion for alcohol abuse and 143 billion for drug abuse. In addition, they estimated that approximately 21 billion was spent in 2003 on the treatment of substance-use disorders (1.3% of all health care spending). Positive trends continue to be reported with respect to motivated individuals who receive a multifaceted treatment approach to address substance-use disorders (SAMHSA, 2007).
This section presented the reader with a brief overview of the statistical significance of the pervasive nature of substance-use disorders in the lives of many adolescent and adult Americans, including their widespread use, treatment-seeking probability, and financial costs to the public sector. The next section will provide an overview of alcoholism and pharmacotherapy treatments for promoting abstinence while simultaneously treating acute withdrawal symptoms.
Review Questions
• How does the DSM-5 conceptualize substance-use disorders (as compared with the DSM-IV's conceptualization of abuse and dependence)?
• What are your thoughts or reactions to the statistical significance of the pervasive nature of drug and alcohol abuse in America? What might explain the continued increase in the numbers of adult Americans who abuse alcohol and drugs annually?
• What are some of the sociopolitical forces that practitioners must consider when thinking about factors that prevent clients who are addicted to illicit drugs and alcohol from seeking and receiving meaningful and comprehensive treatment resources?
SECTION THREE: PHARMACOLOGICAL TREATMENT OF INDIVIDUALS WITH ALCOHOL-USE DISORDERS
Learning Objectives
• Be able to operationalize alcohol-related disorders for the purpose of understanding pharmacological treatment options in a mental health delivery context.
• Understand approved pharmacotherapy treatments for treating alcohol dependence, with the goal to address the impact of acute withdrawal symptoms and to promote continued abstinence of drinking behaviors.
• Be familiar with the pharmacodynamics (what the drug does to the body) and the pharmacokinetics (what the body does to the drug) of the drug, the patient and treatment outcomes.
For the purpose of this chapter, alcohol-related disorders will be conceptualized as an advancing neurological disease that is the direct result of changes in many of the neurotransmitter channels in the human brain that excite craving desires for the continued ingestion of alcohol. Persistent alcohol abuse then leads to the neuronal state becoming increasingly hyper-excited. Withdrawal symptoms are consequently associated with efforts made by the individual toward abstinence and are suggestive of instability between the glutamate and y-aminobutyric acid that impacts the biological signaling of many other neurotransmitters in the brain. Pharmacotherapy treatments for alcoholism focus on the neurotransmitter sections of the brain in order to stabilize these alterations and to lower using urges while simultaneously inhibiting reinforcement of alcohol use by introducing an aversive reaction to the drug upon ingestion. This operationalized understanding of alcoholism provides a meaningful bridge in understanding the incorporation of pharmacotherapy options into a comprehensive treatment strategy for individuals who are motivated to treat alcohol-use disorders and their accompanying behaviors.
Alcohol consumption has significant neurobiological effects on the body, including alteration of many of the organic proteins secreted in the body that are sensitive to the binding effects of alcohol once ingested, which include dopamine and adenosine. These neurotransmitter systems are intimately involved in the development of alcohol dependence and are primary treatment objectives with respect to pharmacotherapy. Chronic alcohol use leads to long-term transformative reconfigurations within the excitatory glutamatergic neurotransmitters and GABAergic systems within the body and become primary determinants that make up the initial onset of alcohol-dependent behaviors (Williams, 2005). After prolonged exposure to alcohol, their body reacts in a compensatory effort by upregulating the glutamatergic system while simultaneously downregulating the GABA system. This response is enacted in order to set in motion the body's physiological response to stabilize the inhibitory effects of alcohol as a result of chronic ingestion.
Treating alcoholism consists of two primary phases, including detoxification of the patient and rehabilitation efforts (Jung & Namkoong, 2006). During the beginning detoxification stages, the person can undergo acute psychological and physiological withdrawal symptoms. Rehabilitation efforts are primarily oriented around addressing relapse prevention strategies for the individual and to create a lifestyle that can support long-term abstinence from alcohol consumption.
This section will focus exclusively on FDA-approved medications that have demonstrated positive treatment outcomes with patients who experience alcohol-use related disorders (AUD). Evidence will be presented in terms of understanding the psychotherapeutic implications of the efficacy of the pharmacological interventions discussed in Section One of this chapter, including, naltrexone, acamprosate, naltrexone administered in concert with acamprosate, and disulfiram. A brief overview will be provided concerning the “second” and “third” waves of pharmacological treatments for alcohol dependence (Heilig & Egli, 2006). Symptoms of alcohol withdrawal are summarized in Table 11.3.
TABLE 11.3 Early and Late Symptoms of Alcohol Dependence Withdrawal
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Anxiety |
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Depression |
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Fatigue |
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Irritability |
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Shakiness |
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Mood swings |
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Nightmares and tremors |
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Lucid thinking |
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Persistent headaches |
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Insomnia |
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Loss of appetite |
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Increased heart rate |
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Excessive perspiration |
© 2015 Cengage Learning®
Disulfiram (Antabuse or Antabus) blocks the expression of an enzyme that is necessary for the metabolism of ethanol in the body and produces extremely unpleasant physiological responses in the body, including nausea and vomiting, when alcohol is ingested (Johansson, 1992). Once ethyl alcohol is consumed, it is quickly transformed into acetaldehyde, which is then oxidized by the liver and converted into the mitochondrial enzyme known as aldehyde dehydrogenase (ALDH) (1992). The disulfiram then competes with the
ALDH for binding sites with the nicotinamide adenine coenzyme and produces a permanent inhibition of ALDH enzyme activity. Once even small amounts of alcohol are introduced to the body after consuming disulfiram, the amount of acetaldehyde increases substantially, which consequently results in aversive physical reactions that inhibit continued alcohol consumption. Administration of this pharmacological option is recommended for individuals who are very motivated to engage in treatment and to abstain from alcohol-seeking behaviors.
Supervised disulfiram treatment has been shown to result in fairly positive outcomes for patients who experience alcohol dependence (Brewer, 1993; Laaksonen, Koski-Jannes, Salaspuro, Ahtinen, & Alho, 2008), particularly with respect to reduction of heavy drinking days and extending the time to the first drink of alcohol, when compared to acamprosate or naltrexone. The most controlled study was conducted by Fuller et al. (1986) and examined the efficacy of 250 mg of disulfiram per day against a placebo group with a group of 605 alcohol-dependent patients. The participants who received the FDA recommended daily dose of 250 mg of disulfiram consumed alcohol on fewer days than those that received the placebo. It should be noted that medication compliance was relatively low in this study, which complicated the generalizability of the research findings. A randomized study conducted by Diehl, Ulmer, and Mutschler (2010) demonstrated that nearly two times the amount of patients who were treated with disulfiram were able to successfully maintain abstinence over the course of treatment when contrasted with patients who were treated solely with acamprosate. This study did report that patients who were treated with acamprosate did report reduced cravings to use alcohol. However, disulfiram presents a difficult clinical challenge due to ambiguous clinical results with respect to its overall efficacy (Garbutt et al., 1999).
It should be noted that disulfiram is not a pharmacological cure for alcohol dependence. Pharmacotherapy that implements disulfiram into the treatment process should strongly consider psychosocial supports, such as supportive counseling or group psychotherapy. Disulfiram encourages patients to develop resources (internal and external) and the self-confidence necessary to maintain abstinence once the drug is discontinued. One of the most significant challenges with respect to disulfiram treatment is noncompliance due to the aversive nature of its reaction on the body. Therapeutic support can provide encouragement to patients who struggle to remain medication compliant.
Naltrexone became the second medication approved by the FDA after disulfiram as a pharmacological treatment for alcohol dependence. Naltrexone is available in oral form (ReVia) or intramuscular as an extended release injection administered once a month (Vivitrol). In addition, naltrexone is an antagonist at the opioid receptors, which essentially means that once ingested and metabolized in the body, it intercedes the various pleasurable consequences of alcohol, which leads to a decrease in craving urges connected to alcohol consumption (Kiefer, Jahn, & Tarnaske, 2003). The FDA recommended Naltrexone dose of 50 mg per day has demonstrated some efficacy in decreasing the compulsive, behavioral component of alcohol craving and increases compliance to alcohol detoxification treatment (Addolorato, Abenavoli, Leggio, & Gasbarrini, 2005a). Individualized dosing regimens have been suggested for select patients, ranging from 12.5 mg per day to 150 mg per day (Saitz & O'Malley, 1997). It should additionally be noted that patients treated with a 380 mg monthly dose of Vivitrol (extended release intravenous injection) demonstrated a significant reduction in heavy drinking behaviors when compared to alcohol-dependent patients who were treated with a placebo (Garbutt, Kranzler, & O'Malley, 2005). Naltrexone has also been shown to decrease desire for alcohol intake. Common side effects of naltrexone are nausea, infrequent headaches, dizziness, insomnia, vomiting spells, increase in anxious feelings, and restlessness (Addolorato et al., 2005; Litten & Fertig, 1996).
Naltrexone is administered to patients who are currently drinking alcohol in large quantities in order to decrease using urges. Some of the advantages of naltrexone are that it can be taken prior to detoxification and does not exhibit addictive properties (Sinclair, 2001). In addition, numerous land-mark studies point to the treatment efficacy of naltrexone when used in conjunction with psychosocial supports to treat individuals who experience alcohol-use disorders at varying levels of severity (O'Malley et al., 1992; Volpicelli, Alterman, Hayashida, & O'Brien, 1992a). Volpiccelli et al. (1992) looked at 70 alcohol-dependent male outpatients at a VA hospital facility who were treated with 50 mg of naltrexone or a placebo daily for three consecutive months. It should be noted that in this study, all participating patients received four weeks of intensive abstinence oriented counseling. The participants in the study who received the naltrexone experienced fewer drinking days, were less likely to relapse into heavy drinking and self-reported decreased craving urges to use alcohol. The O'Malley et al. (1992) study demonstrated similar results over the course of six months of treatment, including follow-up measures. The group of patients who received the naltrexone dose exhibited fewer heavy drinking days and a decreasingly small number reported the reemergence of the full syndrome of alcoholism.
The pharmacotherapeutic effectiveness of naltrexone is directly associated with the interactive relationship between dopamine in the brain and the endogenous opioid neuropeptide systems in the body (Heinala et al., 2001). Endorphins are intimately involved in the unique expression of the reinforcing effects of alcohol consumption. Ingestion of ethanol encourages B-endorphin release in areas of the brain that encourage reward sensations. B-endorphins can also directly enhance DA (dopamine) excretion in the NAc (nucleus accumbens). Both processes are significant for alcohol-reward effects. The primary effects of B-endorphins are then negotiated via mu-opioid receptors. The administration of naltrexone into the body then operates as a competitive antagonist with opioid receptors and displays a strong affinity for the mu-receptor isoform. Thus, the primary treatment role for naltrexone is to decrease or stymy opioid receptors in the brain (antagonist) and to curb the endorphin-mediated reinforcing consequences of alcohol ingestion (Herz, 1997).
In the majority of studies concerning naltrexone administration, medication compliance is stressed. However, this is oftentimes a contraindicated variable that influences the feasibility of the research. Trials that included significant psychosocial supports, such as individual psychotherapy and intensive hospitalization, as an adjunct to the pharmacological treatment process demonstrated positive treatment outcomes with respect to decrease in drinking frequency and a reduction of heavy drinking behavior. The literature consistently points to the importance of implementing a comprehensive treatment approach that includes behavioral interventions, counseling and supportive psychotherapy and at times, depending on the motivation of the individual and the severity of the alcohol-use disorder, the introduction of pharmacotherapies to encourage abstinence, reduce drinking behaviors, and aid with acute withdrawal symptoms that would likely increase the likelihood of relapse within the first year of treatment (Kurtz-weil, 1996).
Acamprosate (Capral) was approved by the FDA in 2004 for the treatment of alcohol-dependent individuals. Positive treatment outcomes were first demonstrated in Europe. Acamprosate is available for oral administration in a delayed-release formula at an FDA recommended dose of 2 mg per day (Mann et al., 2004). Acamprosate is a glutamate regulator agonist that encourages abstinence by alleviating or decreasing the physical and psychological discomfort symptoms, such as excessive perspiration, sleep disturbance, and increased anxiety, that frequently accompany individuals once they attempt to decrease or stop drinking behaviors. In other words, acamprosate's primary function is to reduce the accumulation of glutamate during continuous episodic alcohol withdrawal (Anton,
O'Malley, & Ciraulo, 2006). The drug, once ingested, is not metabolized and is discarded through the body by renal excretion (Mann et al., 2004). Acamprosate has been shown to effectively stabilize the excitatory and inhibitory pathways that adjust to chronic alcohol abuse, thus targeting symptoms associated with acute withdrawal.
Acamprosate has shown effectiveness in reducing the likelihood of relapse and supporting efforts toward abstinence with alcohol-dependent patients who have recently undergone detoxification (Mason, Goodman, Chabac, & Lehert, 2006). In total, acamprosate has been investigated in nearly 20 controlled, published research trials with nearly 4000 patients, and the outcomes consequent to these studies have reflected consistent treatment results, indicating the efficacy of acamprosate for helping alcohol-dependent patients maintain abstinence (Mann et al., 2004). Some of the targeted outcomes relative to alcohol-dependent behaviors include a meaningful decrease in alcohol craving, reduction of relapse tendencies and an increased number of alcohol-free days (Addolorato et al., 2005b). The most commonly reported side effect associated with acamprosate use is diarrhea (Paille et al., 1995). It should be noted that acamprosate has been a commonly used pharmacotherapy treatment option in other countries before it was approved by the FDA for pharmacotherapy consumption in America.
Research over the past decade has been conducted that examines the efficacy of naltrexone used in concert with acamprosate as a treatment option for alcohol-dependent individuals (Anton et al., 2006; Kiefer et al., 2003). The largest clinical pharmacotherapy trial conducted for alcohol-related use disorders in the United States, known as the COMBINE study, examined the impact of acamprosate, in isolation from and in conjunction with naltrexone, with over 1400 participants who were diagnosed with an alcohol abuse and/or dependence disorder. This study showed that naltrexone demonstrated efficacy in helping participants maintain abstinence for longer durations and additionally aided participants in reducing heavy drinking behaviors. Kiefer et al. (2003) studied the impact of naltrexone and acamprosate used in concert with one another to treat 160 alcohol-dependent individuals. The number of patients that had maintained abstinence at the conclusion of the 12-week treatment period was two times the amount for the group that received the pharmacological treatments in isolation from one another. Recent research additionally suggests that acamprosate is a more appropriate treatment option for alcohol-dependent individuals when the primary goal is complete abstinence, and naltrexone is better suited to effectively manage consumption (Bouza, Angeles, Magro, Munoz, & Amate, 2004).
There are several published studies that compare naltrexone, disulfiram, and acamprosate treatment for alcohol-use disorders. One of these studies conducted by Diehl et al. (2010) examined the treatment outcomes of 353 alcohol-dependent patients, including the long-term effectiveness of acamprosate and disulfiram with the goal of maintaining abstinence. Supervised disulfiram treatment led to longer periods of abstinence and extended the time to the first relapse of drinking when compared to acamprosate. Another study (Laaksonen et al., 2008) tracked alcohol-dependent individuals for nearly two-and-a-half years and examined the pharmacological impact of naltrexone, disulfiram, and acamprosate under two phases of supervised treatment. Disulfiram treatment was viewed more favorably than acamprosate and naltrexone with respect to impact on the number of heavy drinking days and extending the time to the first relapse.
ADDITIONAL PHARMACOTHERAPIES FOR ALCOHOL-USE DISORDERS
Another pharmacotherapy used in the treatment of alcohol-dependent individuals is known as nalmefene (Selincro), an opioid receptor antagonist that was developed in the early 1970s (Litten & Fertig, 1996). Nalmefene has a longer half-life than naltrexone. Dosages used to treat alcohol-dependent individuals ranged from 20 to 80 mg per day. Litten and Fertig (1996) examined the effects of nalmefene on drinking behaviors and indicated a significant reduction in heavy drinking behaviors. More research is needed to understand the pharmacokinetic and pharmacodynamic relationship between the drinking behaviors in the alcohol-dependent patient and the ingestion and subsequent metabolism of the medication.
Additional research examines the efficacy of additional pharmacological treatment alternatives to address various aspects of alcohol-use disorders (Addolorato et al., 2005b; Heilig & Egli, 2006; Johnson et al., 2000). These pharmacotherapy options are classified as “second wave” and “third wave” future treatments for alcohol dependency (Heilig & Egli, 2006). Research has shown the potential for several psychotherapeutic medications to have positive treatment outcomes for individuals that are alcohol dependent. A few examples of second-wave treatments that are considered “near future” treatments due to some experimental research outcomes are: (a) fluoxetine (Prozac) and ondansetron (Zofran), SSRIs that appear to be well tolerated by alcohol-dependent individuals (Cornelius et al., 1997), and preliminary studies have demonstrated a reduction of drinking days that is attributable to marked improvement in depressive symptoms; (b) baclofen (Lioresal), a GABA receptor agonist that controls spasticity and has been shown to have some degree of efficacy in reducing intake behaviors, encouraging abstinence, relapse prevention, and reduction in alcohol-related cravings; and (c) topiramate (Topomax), an antiepileptic drug GABA receptor agonist that has shown some promise with respect to addressing obsessive and/or reward cravings. In all of these three experimental drug treatments, additional research is recommended, including comparisons with other approved drugs described above in this section.
The third wave of novel treatment approaches includes the following pharmacological interventions: (a) GHB (gamma-hydroxybutyric acid), an alcohol mimetic, endogenous compound with complex, neuromodulatory functions and has demonstrated some marginal therapeutic gains with respect to alcohol-dependent individuals and reduction of withdrawal symptoms; (b) Corticotropin-releasing factor, which looks to negotiate anxiety that often accompanies mood disturbances in people who experience alcohol dependency; and (c) Cannabinoid CB1 receptor antagonism, which has resulted in some efficacy with experiments conducted with rats, showing an elevation of this receptor that has been shown to contribute to phenotypes of excessive drinking behaviors.
This section outlined the pharmacological administration of medications to treat alcohol dependence, including the interaction of the drug in the body and the relationship of the interaction with behaviors consistent with individuals who suffer from an alcohol-use disorder. Dosing recommendations were provided, research efficacy was presented, and directions for future research concerning additional treatments were briefly introduced. The next section will discuss the pharmacological treatment of individuals who experience opioid dependence.
Review Questions
• How is alcohol dependence and/or alcohol-use disorders conceptualized within a treatment context?
• Briefly describe the three FDA-approved treatments for alcohol dependence, including the interaction of the drug in the body.
• What do comparative studies suggest regarding the integration of FDA-approved medications for alcohol-use disorders?
SECTION FOUR: PHARMACOTHERAPY OF INDIVIDUALS DIAGNOSED WITH SEVERE OPIOID DEPENDENCE
Learning Objectives
• Be able to understand the complexity of opioid dependence and/or opioid-use disorders, diagnostically.
• Become familiar with FDA approved pharmacological treatment approaches for opioid dependence.
• Understand recommended doses and pharmacodynamics and pharmacokinetics of the drug's interaction with the biological processes in the body of the opioid-dependent individual.
The World Health Organization [WHO] defined opioid dependence as a collection of cognitive, behavioral, and physiological features that constitute a complex diagnostic picture that contains six primary features: (a) strong desire or sense of compulsion to ingest opioids, (b) difficulties managing opioid use, (c) a strong physiological state of withdrawal, (d) increased tolerance to opioids, (e) progressive neglect of other activities of living and/or interests, including interpersonal, and (f) persistent opioid use in spite of clear, unequivocal evidence of blatantly harmful outcomes (WHO, 2009). The WHO created the “Guidelines for the Psychosocially Assisted Pharmacological Treatment of Opioid Dependence” in 2009. These guidelines provided minimum treatment requirements to inform the psychosocially supported pharmacological treatment of individuals who are opioid dependent. Opioid agonist treatment is defined as the administration of opioid agonists by trained and certified professionals within the federally authorized restraints of medical practice to individuals who are diagnosed with an opioid-use disorder in order to achieve desired treatment outcomes, usually including some form of drug abstinence. Opioid maintenance treatment used in concert with psychosocial assistance has consistently demonstrated the most efficacious treatment option. The most commonly administered opioid treatments are oral methadone liquid and sublingual buprenorphine tablets (WHO, 2009).
Opioid receptors are classified as G-protein coupled receptors and contain a variety of subtypes. The opioids effects of analgesia, euphoria, and sedation are facilitated by the mu-receptor. Opioid, once ingested, enlarge the secretion of DA (dopamine) in the body by lowering the production of gamma-aminobutyric acid (GABA) inhibition via mu-receptors in the ventral tegmental area of the brain (Johnson & North, 1992). Tolerance to opioids develops as a result of prolonged exposure to and desensitization of the opioid receptor. Consequentially, as a result of the alterations to multiple receptors, the cyclic adenosine monophosphate (cAMP)-producing enzymes become increasingly activated. When the opioid is withdrawn from the system, the cAMP becomes overstimulated, which results in opioid withdrawal (symptoms of opioid withdrawal are summarized in Table 11.4), compelling the opioid-dependent individual to ingest the substance to facilitate regulation (Williams, Christie, & Manzoni, 2001). Acute withdrawal symptoms are associated with watery eyes, excessive perspiration, increased irritability, sleep disturbance, nausea, vomiting, diarrhea, heightened blood pressure, bodily aches and chills, muscle spasms, and tremors, all of which can occur for several days.
Treatment of opioid dependence involves a multifaceted treatment delivery approach that emphasizes a variety of pharmacotherapeutic and behavioral interventions that address three treatment variables: (a) reduction and/or complete elimination
TABLE 11.4 Common Early and Late Opioid Withdrawal Symptoms of opioid use, (b) inhibiting future consequences that typically accompany opioid use, and (c) enhancing the quality of life and well-being of the opioid-dependent patient. Treating opioid dependence emphasizes pharmacological treatment of acute opioid withdrawal symptoms, agonist maintenance treatment to curtail the cessation of illegal opioids and psychosocial supports that oftentimes include a variety of therapeutic modalities, such as case management, psychotherapy, group and supportive environments such as NA, AA, or Al Anon.
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Agitation |
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Anxiety |
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Muscle aches |
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Increased tearing |
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Insomnia |
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Runny nose |
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Sweating |
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Yawning |
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Abdominal cramping |
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Diarrhea |
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Nausea |
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Vomiting |
© 2015 Cengage Learning®
The primary pharmacological treatments for opioid-dependent individuals consist of FDA-approved medications, methadone, naltrexone, buprenorphine and buprenorphine in combination with naloxone, also known as Suboxone or Subutex. These medications will be discussed in the following sections.
METHADONE MAINTENANCE TREATMENT (MMT)
Methadone (Dolophine) is a synthetic opioid and has been the primary form of medication-assisted treatment for opioid abuse and dependence for nearly four decades. Methadone is a treatment option available in the United States through federally approved and regulated MMT clinics. Methadone works primarily via mu-opioid receptors in the brain, where once ingested, it fuses itself to the receptors and when sufficient amounts of the drug are present, can inhibit or eliminate effects of other opioid agents, such as morphine or heroin (Payte, 2002). In essence, methadone, like buprenorphine (which will be discussed later in this section), tricks the brain into believing it is still getting the problem opiate, and the person consuming the medication likely feels normal or stabilized as opposed to feeling the euphoric consequences of opioid abuse. In addition, the person is not actively experiencing acute or complicated withdrawal symptoms, leading to a reduction in physiological and psychological craving urges. Once ingested, methadone is metabolized in order to produce a significant number of metabolites that are primarily inactive and nontoxic (Moody, Alburges, Parker, Collins, & Strong, 1997). The subsequent elimination of half-life of methadone ranges from 24 to 36 hours at a relatively consistent rate but also demonstrates some variability (Loimer & Schmid, 1992). The residual methadone is then stored in the liver and secondary bodily tissue. In order to attain steady-state SMLs (serum methadone levels), on average, four to five half-lives are required, enabling the presence of the drug to balance the left over amount of drug remaining in the body (Benet, Kroetz, & Sheiner, 1996). When the methadone induction period is introduced, prior to approximating the steady state, half of each day's dose remains in the body and is subsequently combined with the following day's dosing, which leads to an increase in SMLs, even in the absence of a dose increase (Payte, 2002). The primary purpose of the induction process is to approximate the patient's opioid tolerance levels with respect to methadone, which aids in reducing withdrawal and craving urges.
The current dosing rate in the United States for the initial treatment is not to exceed 30 mg or 40 mg in total on the first day (Federal Register, 2001). During the first week of treatment, doses should not exceed more than 5 to 10 mg on any given day and the consummate week increase should not go beyond 20 mg. Once the patient reaches a steady state and methadone amounts exist in a sufficient concentration, he or she is placed onto a daily dose of between 80 and 120 mg as demonstrated by research (Payte, Zweben, & Martin, 2003). FDA guidelines for recommended dose range from 60 and 100 mg per day.
Methadone is ingested in a variety of formats, including pill form, as a liquid or a rapidly dissolving wafer and is consumed daily via supervised distribution in highly regulated clinic settings. Additionally, methadone can be administered immediately at the start of treatment. However, the opioid-dependent individual must be slowly weaned off of methadone in order to prevent withdrawal symptoms.
Daily maintenance doses of methadone have demonstrated a number of research-supported treatment outcomes, including: (a) increased functioning in daily life without the presence of debilitating symptoms commonly associated with opioid withdrawal (Payte, 1991; Dole, 1988), (b) reduction of morbidity and mortality commonly associated with continued abuse of heroin and other illicit opiates (Mattick, Breen, & Kimber, 2003), and (c) reduction of craving urges (Zweben & Payte, 1990). Despite the proven efficacy of methadone maintenance treatment, methadone's relatively abbreviated duration of analgesic effect, combined with its extended elimination half-life and its interaction potential with multiple drugs, increases the risk of poisonous and aversive reactions, including overdose-related fatalities USDHHS (2009).
As a result of research studies that demonstrate increased mortality connected to pharmacological ingestion of methadone (SAMHSA, 2009), the Substance Abuse and Mental Health Services (SAMHSA) asked the American Society of Addiction Medicine (ASAM) to develop an action group that could provide recommendations for the safe administration of methadone treatment, which included: (a) patient education, (b) availability of support services to encourage medication compliance in a supervised environment, (c) appropriate calculation of the initial dose that reflects a deliberate and thoughtful attempt to understand the individual patient's level of tolerance and psychosocial history, (d) close monitoring of the patient's response to treatment, dose adjustment during the stabilization stages of treatment, and (e) constant attention to patient functioning.
It should be noted that research suggests the following treatment recommendations as an adjunct to MMT (Gerra et al., 2003): (a) integration of psychosocial supports dramatically increases medication compliance and reduces the likelihood of fatal overdose; (b) patients who achieved stable employment and who report satisfactory interpersonal supports responded favorably to treatment; (c) patients treated at a methadone treatment facility responded to treatment as compared to patients who received two treatments per week in their home environment; and (d) therapy that address comorbidity for depression and anxiety significantly improved mood symptoms, leading to increased treatment effectiveness (McDowell, Levin, Seracini, & Nunes, 2000). Additionally, the longer a person is engaged, continuously in MMT (between six months and three years), the higher the likelihood he or she will avoid relapse. It should also be noted that secondary benefits to methadone maintenance include a decrease in HIV transmission and a reduction of criminal-related arrests (Keen & Oliver, 2004).
Naltrexone (ReVia) was originally approved by the FDA for the treatment of opioid dependence in 1984 and research has demonstrated efficacy as a treatment option that reduces the probability of relapse. Naltrexone is an opioid receptor antagonist, in that it syncs with opioid receptors and essentially blocks them from being activated by agonist compounds such as heroin or prescription opioids. Naltrexone, once ingested, is metabolized via the liver, which alters the chemical and turns it into the active metabolite 6-beta-naltrexol. The half-life and elimination phase of naltrexone are adequate to allow for once-daily oral dosing (or less frequently depending on the dosage size) (Miotto, McCann, Basch, Rawson, & Ling, 2002).
Consistent use of naltrexone reduces or eliminates, all together, the effects of getting high. Naltrexone, consequently, interrupts the cycle of euphoric reinforcement and addiction by stopping opioid receptors. It simultaneously reduces the effects of opioids if the person attempts to abuse the target opioid. There are many pharmacological advantages to using naltrexone as a treatment option for opioid dependence, including: (a) naltrexone is not associated with addictive properties and does not lead to physical dependence, thus reducing the likelihood for tolerance; (b) has been successfully administered as a meaningful component of opioid-detoxification (Buntwall, Bearn, Gossop, & Strang, 2000); and (c) it can be used as a meaningful and effective supplement to a comprehensive treatment plan designed to eliminate opioid use.
There are also substantial disadvantages to the pharmacological use of naltrexone in the treatment of opioid dependence. Some of these disadvantages include:
• Naltrexone cannot be ingested if a person is actively using opioids, and the individual must wait 6 to 10 days after withdrawal symptoms manifest (Miotto et al., 2002)
• Once naltrexone is discontinued, withdrawal symptoms can return, which increases the potential for recidivism
• Naltrexone does not directly treat aversive symptoms connected to opioid abuse
• Many patients who use naltrexone may not be sufficiently motivated to consume it on a regular basis, and
• If patients are taking naltrexone, the risk of overdose increases if the patient does experience a relapse episode during the course of their treatment
A number of studies demonstrate the efficacy of naltrexone as a significant treatment variable for the reduction and/or elimination of drug craving and opioid-seeking behaviors (Gonzalez & Brogden, 1988). In a dozen controlled studies between 1973 and 1984, over 85% of urine screens were free of target opioids for patients who were undergoing continuous naltrexone pharmacotherapy. In Washton, Gold, and Pottash (1984) landmark study demonstrating the efficacy of naltrexone for treating 114 opioid-detoxified patients, nearly two-thirds completed six months of treatment (that also included psychosocial supports) without experiencing opioid relapse. At 12 and 18 month follow-ups, slightly more than two-thirds of the patient population had remained abstinent.
An average daily dose of 50 mg naltrexone typically inhibits the effects of 25 mg intravenous heroin for a minimum of 24 hours (Yeo, 1997). When a patient initiates treatment, the beginning dose is typically around 10 mg and the amount is gradually increased by 10 mg each day until a 50-mg threshold is reached. The recommended length of treatment is between 6 and 12 months. Discontinuing naltrexone is recommended after a successful, sustained period of complete abstinence (Resnick, 1998).
Buprenorphine (Butrans) is a mixed, opioid agonist-antagonist that behaves as a partial agonist at the mu-opioid receptor and as an antagonist at the kappa opioid receptor. When the mu receptor is activated, it sets into motion a series of nerve cell activities that constitute familiar opioid effects such as analgesia, euphoria, and suppression of the respiratory system. Buprenorphine partially stimulates the receptor and produces similar physiological responses in a less intense manner as compared to opioids such as heroin and morphine (Johnson & Strain, 1999). The consequence is that buprenorphine produces a moderate psychoactive response that decreases craving urges. Pharmacodynamically, once ingested, buprenorphine securely attaches itself to mu receptors in a more dramatic way than other problem opioids such as methadone. As a result, if an opioid-dependent patient consumes a problem opioid in addition to the buprenorphine, the pharmacological intervention will inhibit it, making it impossible for it to successfully reach the receptors and create the desired sensation and/or response in the body. In addition, if buprenorphine is administered to an individual who has already ingested another target opioid, then it essentially shoves the problem opioid off of the receptor. It is important to note that this kind of disruptive intervention, where the abused opioid is chemically detached from the receptor can produce withdrawal symptoms and many factors should be considered with care when administering the buprenorphine, such as the patient's level of physiological dependence and the timeline for when the abused opioid was ingested. As a partial agonist, withdrawal is mild to moderate compared to methadone and heroin, and buprenorphine can be used as maintenance or to transition a patient from an agonist, such as heroin or methadone, to an antagonist, like naltrexone (Donovan et al., 2013).
There are many advantages to using buprenorphine over methadone and naltrexone, including reduction of withdrawal symptoms and craving urges for opioids, and it inhibits the effects of other target opioids for at least one full day. In addition, patients do not have to engage in a federally regulated program such as a methadone clinic. Unlike naltrexone, buprenorphine can be ingested intravenously, sublingually (most common) or via the buccal route at the onset of withdrawal symptoms (Litten & Allen, 1999). Buprenorphine is available in two different formats, including in a buprenorphine hydrochloride (HCl) tablet known as Subutex and a synthesized, combination tablet, Suboxone, that consists of buprenorphine HCl and naloxone HCl in a ratio of 4:1 (Fudala et al., 1998). Suboxone was essentially developed due to the high potential for abuse for buprenorphine (Strain et al., 1997). In contrast to buprenorphine, naloxone is not easily metabolized and absorbed in the body and has a minimal effect when taking orally (Chiang & Hawks, 2003). Pharmacologically, buprenorphine has a limited risk for toxicity and overdose and low abuse rates are revealed in the research (DiPaula, Schwartz, Montoya, Barrett, & Tang, 2002).
There are three primary phases of buprenorphine maintenance therapy, including induction, stabilization, and maintenance. During the induction phase (Baxter, Scott, Vos, & Whiteford, 2013), medically supervised initiation of buprenorphine pharmacotherapy occurs. This phase requires the opioid-dependent individual to have successfully abstained from abusing opioids for a minimum of 12 hours. During this stage, the individual is in the early stages of acute opioid withdrawal. The stabilization phase is marked by the patient's efforts to discontinue to substantially reduce the abuse of the targeted problem opiate(s), has experienced a significant reduction of cravings and is experiencing minimal physiological side effects. During this phase, the buprenorphine will likely need to be adjusted to assist with stabilization. The maintenance phase of treatment is demarcated by the patient's progress toward recovery on a steady dose of buprenorphine or Suboxone. The length of time an individual remains in the maintenance phase is highly individualized. Medically supervised withdrawal or “detoxification” often takes place during this phase but in some unique cases, some individuals will remain on a stabilized dose of buprenorphine indefinitely.
The general recommendation for buprenorphine in maintenance treatment is between 8 and 24 mg daily. With ongoing opioid dependency, the dose should be increased gradually and on a case-by-case basis (WHO, 2009). In Soeffing, Martin, Fingerhood, Jasinski, and Rastegar (2009) study regarding buprenorphine maintenance treatment, 255 opioid-dependent patients were provided with at least one prescription for sublingual buprenorphine. The authors in this study determined treatment success as having six or more opioid negative blocks over the one year period in which the study spanned. At the completion of year one, 121 patients (47.5%) were opioid negative for six or more blocks and 16% were consistently negative for all 12 blocks of treatment.
There are several studies that have emerged in the last decade that help to illumine the efficacy of buprenorphine for treating opioid dependence by blocking the euphoria associated with opioid use and simultaneously preventing withdrawal (Donovan et al., 2013; Fiellin et al., 2002). It should be noted that in each of the studies that demonstrated buprenorphine effectiveness as a pharmacological treatment option for opioid dependence, counseling supports such as brief therapy were an integral part of the treatment process.
BUPRENORPHINE/NALOXONE TREATMENT (BUP/NX)
The final pharmacotherapy treatment approved by the FDA for use in the United States is Suboxone, which is an integrated medication approach that blends buprenorphine and naloxone (Bup/Nx) as a means of chemically treating opioid dependence. Suboxone combines buprenorphine, a synthetic opiate that enables the dependent individual to avoid the unpleasant feeling of drug withdrawal, and naloxone, which when integrated with street heroin effectively counteracts the euphoric effects of the heroin and facilitates the patient's movement into an active state of opiate withdrawal. By combining a partial opioid agonist with an opioid antagonist, a muted opioid effect is created that is capable of syncing with an opioid receptor in the brain. When the Suboxone is ingested by the opioid-dependent individual, he or she will experience a slight pleasurable sensation, but the majority of people report feeling “normal” during this phase of treatment. People who are diagnosed on the continuum of severity with respect to an opioid-use disorder do not report any euphoric consequence when taking Suboxone. With each administration of Suboxone, the person with opioid dependence essentially experiences a day-long sabbatical as a result of the buprenorphine becoming lodged within a person's brain opiate receptors, thus disallowing the full opioids access into the opiate receptors in the brain.
A study by McKeganey, Russell, and Cockayne (2013) regarding administration of Suboxone to patients who are opiate-dependent indicated that methadone and Suboxone proved to be equally effective in successfully preventing patients from returning to any heroin abuse in the 90 days prior to follow-up. Suboxone has been determined to assist in converting short- to long-term heroin abstinence. Recommended doses of 8 mg/2 mg to 24 mg/6 mg per day were explored in this research. Some of the noteworthy recovery-conducive outcomes that are reciprocally related to Suboxone treatment are:
• Improved cognitive performance compared to methadone use (Rapelli et al., 2007)
• Less severe side effects, physiological and psychological (O'Connor and Fiellin, 2000)
• Improved decision-making skills (Pirastu et al., 2005)
• Increased satisfaction with the use of Suboxone (Gordon, Burn, Campbell, & Baker, 2008)
• Enhanced respiratory functioning when compared with methadone (Law, Myles, Daglish, & Nutt, 2004)
• Cessation of heroin use (Johnson et al., 1995)
• More rapid stabilization (Doran, Holmes, Ladewig, & Ling, 2005)
• Fewer drug interactions (McCance-Katz et al., 2006)
The primary goal of Suboxone treatment is abstinence from opioid-using behaviors as opposed to maintenance. Patients are slowly tapered off from initial doses by 2 mg increments until she or he reaches the 1 mg threshold during the final week of pharmacotherapeutic treatment. As with other pharmacological treatments, educating patients about the drug, its usage, and other pertinent considerations is a vital part of the treatment process. Some recommendations regarding the use of buprenorphine include the following:
• Patients should be advised to let the sublingual buprenorphine tablets dissolve under their tongue to increase effectiveness of the drug.
• Avoid smoking for a minimum of 15 minutes before ingesting the medication.
• Consult your health care provider if any uncomfortable side effects are noticed.
• If taking pain-relieving medication for any medical procedure or injury, notify your practitioner as the interaction effects between the drugs could interfere with the treatment process.
This section highlighted the federally approved and research supported pharmacotherapies used as a comprehensive and individualized treatment approach to assist individuals experiencing opioid-use disorders on a wide continuum of severity. The concluding section of this chapter will provide the reader with a brief discussion of cultural considerations to hold in awareness when choosing, collaboratively with patients, a pharmacological response to the treatment of substance-use disorders.
Review Questions
• Describe, briefly, each of the federally approved medication maintenance programs for the treatment of opioid-use disorders.
• What are the pharmacokinetic and pharmacodynamic interactions with each of the drugs described above?
• As a practitioner, how might you present to a prospective client a multifaceted treatment approach to address opioid dependence?
• Describe pharmacological treatment considerations when working with clients who are not internally motivated to remain abstinent.
Learning Objectives
• Be encouraged to reflect on cultural complexity associated with chemical interventions that are designed to assist individuals experiencing severe substance-use disorders in changing lifestyle, maintaining abstinence, managing withdrawal symptoms that if left unattended to, could increase recidivism, and decrease drug-related cravings.
• Be knowledgeable about cultural factors that impact the treatment process, including intake, stabilization, and maintenance.
• Have understanding regarding cultural realities that face clients when seeking comprehensive substance abuse treatment options for problems of living.
What is implied in a comprehensive course of treatment that is targeted to address addictive, compulsive behaviors connected to a person's relationship with an illicit drug or substance? Essentially, the definitive criteria that frames substance-use disorders in the DSM-5 (APA, 2013a), is suggestive of a significant lack of control to change behaviors associated with using patterns. Perhaps when clients enter treatment, they are already experiencing a great deal of disempowerment due to the very nature of their dependency relationship with a drug. In addition, the cultural landscape that encompasses drug and alcohol treatment is often-times very demeaning and stigmatizing.
STIGMATIZATION OF SUBSTANCE-USE ADDICTION AND TREATMENT
In a qualitative study conducted by Gourlay, Ricciardelli, and Ridge (2005), they interviewed 10 participants in Melbourne, Australia, who were receiving program-regulated methadone treatment for opioid dependence. One of the primary themes that emerged from the interviews was that the participants were conflicted with respect to their experience of receiving methadone treatment due to the perceived/experienced “highly stigmatized and disempowering” (2005, p. 1876) nature of the treatment context. For many of the participants, due to the stigmatized nature that engulfed individuals participating in a federally regulated methadone maintenance treatment program, the costs of participating and remaining engaged in treatment outweighed some of the perceived and/or expected benefits. The findings from this research are consistent with prior research that is suggestive of the negative impact of stigmatization as a barrier to participation in MMT (Matheson, 1998). Link and Phelan (2001) conceptualize the process of stigmatization as taking place when the person who is seeking treatment for a substance-use disorder is branded as a drug addict, consequently linking him- or herself into a negative, stereotyped discourse with cultural implications. Matheson (1998) highlighted the importance of treatment personnel to display positive and facilitative interpersonal conditions, including unconditional positive regard, nonjudgment, and warmth when engaged in service delivery in large part due to patients' internalized stigma consciousness.
MULTICULTURAL COMPETENT PRACTICE AND ADVOCACY
The multicultural counseling competencies (Sue, Arredondo, & McDavis, 1992) recommend that practitioners work to become self-aware about culturally shaped biases and attitudes that might inhibit the ability to effectively and sensitively provide treatment in an empathic and nonjudgmental manner. Practitioners who work with individuals seeking treatment for substance-use disorders are encouraged to explore and understand internalized messages regarding people who experience drug addiction as well as people who participate in pharmacological treatment for dependence. It can be difficult to identify potentially limiting biases or to even acknowledge their existence. It is important to note that the nature of stigmatization effects people in different ways. This author recommends that critical reflection and journaling activities that encourage you to interrogate and understand your feelings and thoughts about people who suffer from substance-use problems, who seek drug treatment and who might potentially be resistant to engaging in the treatment process for a myriad of cultural factors. Other recommendations would be engaging in challenging conversations with colleagues and peers and remaining receptive and open to corrective feedback. Learning more about addiction, volunteering in community contexts that provide services to individuals who experience drug dependence, and even attending support groups might be other activities to promote increased sensitivity to the lived realities of drug- and alcohol-dependent individuals.
Sociopolitical factors are also at play in the erection of barriers to comprehensive treatment seeking behaviors (Appel, Ellison, Jansky, & Oldak, 2004). Some of these factors as reported by substance-dependent patients pretreatment include: (a) lack of or inadequate insurance, (b) deficient economic resources, (c) ignorance about treatment options, including pharmacotherapy that can assist in alleviating withdrawal symptoms and reduce craving, (d) suspicion about engaging in a highly regulated treatment process with culturally different people, (e) limited access to intake, including transportation concerns and location of treatment facilities, (f ) child care concerns, and (g) lack of a personal identification card. As a mental health professional, how do we conceptualize our role in disrupting systemic disparities that disempower, disconnect, and marginalize large segments of the population that could benefit from participating in a comprehensive treatment program that includes psychosocial supports, such as supportive psychotherapy and group counseling as well as the possibility for a referral for pharmacotherapy? These are important concerns to address when broadening our definition of our professional role into the realm of social advocacy that requires a broader and more complicated look at institutionalized systems that disadvantage entire subsets of the total population based on cultural factors, including economic, racial, and unequal distribution of resources.
It is also important to consider the disordered nature of substance use from the client's vantage point, including special consideration of cultural factors. The Culture Formulation Interview format proposed in the DSM-5 (APA, 2013a) is a useful resource for how a practitioner might explore the client's perception of her or his relationship with illicit drug and/or alcohol use. When assessing for the client's perception of the problem behavior, I often encourage the client to explore cultural resources for a deeper understanding of the problem. Situating the problem in a culturally specific context aids in client understanding and recommending a sensitive course of treatment. It also empowers client to understand cultural and systemic forces that might have been previously denied from or not held in awareness. An example question might be, “How is your problem with heroin understood within your community?” When using the word “community,” I add descriptors such as family (clan, tribe, family of choice, etc.), friends, spiritual and/or religious community and within whatever networks of an interpersonal nature where the client spends her or his time. This aids me in developing a culturally textured picture of how the client perceives the problem in her or his life as well as a detailed understanding of the messages the client internalizes (or distorts) from his or her participation in a culturally specific context.
While the research concerning pharmacological treatments for substance-use disorders has demonstrated some efficacy in terms of treating acute withdrawal symptoms, which can reduce recidivism and relapse, and promoting abstinent behaviors (Anton et al., 2006; Diehl et al., 2010; Jung & Namkoong, 2006; Karila et al., 2007; Kirchmayer et al., 2002; Laaksonen et al., 2008; Mason et al., 2006; Saitz & O'Malley, 1997; Veilleux, Covin,
Anderson, York, & Heinz, 2010), a comprehensive and multifaceted treatment delivery approach was recommended in all successful research studies that integrated assessment for pharmacotherapy (including individualized implementation for a prolonged period of time) and a number of psychosocial supports, including effective case management that can support substance-dependent patients with a number of primary and secondary treatment goals, including consistent adherence to pharmacological recommendations, and addressing psychosocial facets of the patient's life, including social, employment, and education, individual psychotherapy to promote lifestyle and behavioral change and other forms of supportive reinforcement such as group therapy and participating in supportive environments, including NA, AA, and/or Al Anon.
From an individual standpoint, empowering patients with education about substance-use disorders, the impact of the target drug on the body, teaching the client about behaviors that can promote treatment success, explaining the interaction of the medication on their body and highlighting medication compliance and follow through with other forms of behavioral supports while instilling hope in the patient's ability to be successful over the course of treatment are important practices for service delivery practitioners. Systemically, the multicultural competent practitioner is also sensitive to social issues that create barriers to help-seeking behaviors within the client's cultural-community context, including treatment follow-through. Possessing an advocacy consciousness enables the practitioner to not only implement strategies to encourage and empower clients toward their treatment goals but also to recognize the impact of social, political, economic, and cultural factors that shape and maintain barriers to treatment-seeking and treatment-compliant behaviors.
A PROBLEM CASE: THE CASE OF CARLOS
Carlos is a 39-year-old Latino man who is episodically homeless. He is rarely sober and his drug of choice is heroine. However, he gets by on weed, Jack, crack, whatever he can sniff, and street gin. He has four kids by three women and has never held a job for more than four months. Every three or four years, his two daughters talk him into going to the local treatment center/methadone clinic to detox. Carlos knows this game because he eventually gets street drugs from another patient or acquires enough methadone to really enjoy himself during his stay.
Carlos returns to his street life and his family wonders what to do next. The girls learn of a treatment center in a neighboring city that uses a drug, Suboxone, which makes heroin addicts very sick if they attempt using while taking it. They convince Carlos to go to this center and he begins a regimen of Suboxone. Carlos believes he can still use even on the Suboxone. He tries and becomes very ill. He is sick and unable to eat for five days with cramping and other gastric problems. After his recovery, Carlos begins to reflect on his life on the streets and his addictions. He becomes a little more responsive to the entire treatment milieu at the center. Carlos does use again, but this in-patient experience begins his very long road to recovery.
Questions on the Case of Carlos
1. Can people recover from a heroin addiction/dependence? How/Why?
2. What changed Carlos and how? Pharmacodynamics or pharmacokinetics?
3. How would you as a mental health professional work with Carlos?
4. What are your biases/countertransferences with addicted clients?
For mental health counselors and practitioners, many of the above questions from the case of Carlos encourage thoughtful consideration of how best to collaborate with Carlos in the treatment process in order to maintain his responsiveness to the treatment process. When a client makes the decision (and yes, it is decision on some level of consciousness) to engage in the treatment process to reduce or eliminate drug-using behaviors, it is important to understand and encourage the client's internal resources to facilitate meaningful change. This chapter has illustrated that pharmacotherapy options provide clients with a temporary reprieve from many of the physiological and/or psychological symptoms that accompany withdrawal from an addictive substance. This reprieve can free up energy and resources to address lifestyle and patterns of behavior that have reinforced dependency, oftentimes at the expense of relationships, personal goals, and well-being.
In the case of Carlos, it would be important to use a mixture of psychoeducation, instructing him about medication compliance and the physiological and treatment consequences of abusing problem opioids while consuming Suboxone, and supportive counseling to explore some of the reflective work he is doing that has encouraged increased engagement in the treatment process. As a participant in an in-patient setting, it would be important to closely monitor his responsiveness to the Suboxone treatments and attend to potential side effects that might complicate treatment. Recommendations for Carlos to participate in group therapy would also be important in order to promote therapeutic factors that can encourage and maintain abstinence and increasing coping behaviors. It is also apparent that he has supportive family members in his life. If the inpatient facility does not have a family treatment program as a component of Carlos's therapy, a recommendation would be made for him and supportive family members to attend Al Anon.