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IncreaseduseofHeroinasanInitiatingOpioidofAbuseFurtherConsiderationPolicyImplicationsCiceroetal201811.pptx

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Increased use of Heroin as an Initiating Opioid of Abuse Further Consideration & Policy Implications

Theodore J. Cicero, PhD; Matthew S. Ellis, and Zachary A. Kasper

Addictive Behaviors, 87, (2018), p. 267-271

Cicero et al. (2018)

Cicero et al. (2018) sought to update and expand a 2017 survey that reported a marked increase in the use of heroin as an initiating opioid in nontolerant, first time opioid users

Also, Cicero et al. (2018) added a discussion of the policy implications on the overall opioid epidemic

Before we discuss the Cicero et al. (2018) work we must review what are opioids and the 2017 paper that is the basis of the 2018 research

Aside: Opiate, Opium, Opioid and Heroin

Opiate, Opium, & Opioid

Opiate is a term classically used in pharmacology to mean a drug derived from opium. Wikipedia

Opium is a substance that is derived by collecting and later drying the milky juice that comes from the seed pods of the poppy plant (http://opium.com/what-is-opium/)

Opioid, a more modern term, is used to designate all substances, both natural and synthetic, that bind to opioid receptors in the brain. Wikipedia

More on Opioids

Opioids are substances that act on opioid receptors to produce morphine-like effects. Wikipedia

Medically they are primarily used for pain relief, including anesthesia. Wikipedia

Drugs in the class: Morphine, Tramadol, Oxycodone, Fentanyl, etc.

Opioids are also frequently used non-medically for their euphoric effects or to prevent withdrawal

Heroin

Heroin, also known as diamorphine among other names, is an opiate most commonly used as a recreational drug for its euphoric effects. Medically it is occasionally used to relieve pain and in opioid replacement therapy. Wikipedia

Heroin is an opioid drug made from morphine, a natural substance taken from the seed pod of the various opium poppy plants grown in Southeast and Southwest Asia, Mexico, and Colombia. Heroin can be a white or brown powder, or a black sticky substance known as black tar heroin. (https://www.drugabuse.gov/publications/drugfacts/heroin)

Oxycodone and Hydrocodone

Oxycodone is used to relieve moderate to severe pain. Oxycodone extended-release tablets and extended-release capsules are used to relieve severe pain in people who are expected to need pain medication around the clock for a long time and who cannot be treated with other medications.

Oxycodone may be habit-forming.

Hydrocodone is used to relieve severe pain. Hydrocodone is only used to treat people who are expected to need medication to relieve severe pain around-the-clock for a long time and who cannot be treated with other medications or treatments.

Hydrocodone can be habit forming, especially with prolonged use.

URL: https://medlineplus.gov/druginfo/meds/a682132.html#why

Cicero et al. (2017): Substratum Paper for Cicero et al. (2018)

Cicero et al. (2017) SKIP and RADARS® and Funding

The national survey data were collected from a subset of participants from the Survey of Key Informants' Patients (SKIP) Program, a component of the RADARS®

The RADARS (Researched Misuse, Diversion and Addiction-Related Surveillance) System is supported by subscriptions from pharmaceutical manufacturers for surveillance, research and reporting services.

SKIP in More Detail

The SKIP (Survey of Key Informants' Patients) program was developed in order to examine the abuse, misuse, and diversion of opioid drugs within the United States and Canada, and is conducted by Dr. Theodore J Cicero, PhD of Washington University in Saint Louis.

According to Cicero et al. (2014), “[t]he SKIP Program consists of more than 150 publicly and privately funded treatment centers…, balanced geographically with coverage in 48 states, that recruit patients/clients to complete an anonymous survey” (p. E2)

Participants must be 18 years of age or older and must meet DSM-IV criteria for substance abuse with a primary drug that is an opioid (prescription drug or heroin).

Key Informants at substance abuse programs (e.g., addiction specialist, counselor, or other relevant staff member) will be responsible for distributing the questionnaire to willing patients who report having abused any prescription opioid or heroin in the 30 days prior to being admitted into treatment.

Stylized Research Question & Hypothesis

The below hypothesis has been restated from the original to comply with figure 1 (Cicero et al., 2017, p.64).

Research Question:

Has there been an increase in the use of heroin as a first opioid of regular use?

Main Research Hypothesis:

An increasing number of persons with limited experience and tolerance to opioids will experiment with heroin as their first opioid of regular use rather than more common, but less accessible, prescription opioid analgesics.

Rehash of Cicero et al. (2017) Hypothesis

Main Hypothesis:

“…an increasing number of persons inexperienced with opioids might begin to experiment with readily available heroin as their first opioid of abuse, rather than a less risky, but also less accessible prescription opioid” (Cicero et al., 2017, p. 64).

Corollary hypothesis (not tested):

“Given the imprecision in titrating doses and the potential for potent adulterants (e.g., fentanyl analogues), we anticipated that, should our hypothesis be supported, this emerging trend could very well be associated with an increase in heroin related overdose fatalities, particularly in novice opioid users who lack the degree of tolerance found in more experienced ones” (Cicero et al., 2017, p. 64).

Main Variables in Cicero et al. (2017)

Independent Variables: Year Beginning Regular Use of Opioid(s),

Demographic variables: Age, Gender, Ethnicity,

Urbanicity of residence, Highest Education Completed

Dependent Variables: Percent of Opioid Initiators (cf, Figure 1, p. 64)

Drug: Heroin vs. Prescription opioid (cf, Table 1, p.65)

Opioid of first regular use (i.e., 2+ times a month):

hydrocodone, oxycodone, heroin, or other prescription

opioids (buprenorphine, fentanyl, hydromorphone,

methadone, morphine, oxymorphine, tapentadol, and

tramadol)

Year Beginning Regular Use

Cicero et al. (2017) employed Questions, 1, 3, and 28 to compute “Year Beginning Regular Use”

Sample & Data Collection

Cicero et al. (2017) analyzed data on opioid use initiation patterns (i.e., first opioid regularly used) using structured, self-administered surveys in opioid-dependent patients (N = 5,885) entering one of over 150 substance abuse treatment programs around the country from 2011 to 2016.

Essentially Cicero et al. (2017) used non-probability network sample with 150 treatment programs as the primary sampling unit and within each program Key Informants (treatment program staff) recruit substance abuse treatment patients into the sample (secondary sampling unit).

Participants were volunteers 18 years of age or older and met DSM-IV criteria for substance abuse with a primary drug that is an opioid (prescription drug or heroin).

Clients were asked by treatment center staff to complete an anonymous paper survey centered on opioid abuse patterns and related behaviors, with an 85% response rate

The survey packet included a $20 Wal-Mart gift card and a self-addressed stamped envelope which, after completion, was used by the respondent to mail the survey (identified by a unique case number) directly to Washington University in St. Louis.

Hedging Against Two Biases: Recall and Survival

To limit long-term recall and survival bias, analyses was restricted to opioid initiation that occurred in the past ten years (2005–2015); this period was deemed to manifest stable recall among respondents for opioid abuse (Shillington et al., 1995).

Recall bias is a systematic error that occurs when participants do not remember previous events or experiences accurately or omit details: the accuracy and volume of memories may be influenced by subsequent events and experiences (https://catalogofbias.org/biases/recall-bias)

Survival bias is a type of selection bias that occurs when the selection process of a study favors certain individuals who made it past a certain obstacle or point in time (viz., entry into opioid abuse treatment) and ignores the individuals who did not (e.g., individual overdose early into their heroin use history), https://first10em.com/ebm/survival-bias/.

Statistical Analysis

To determine whether there were significant changes in first opioid of regular use over time, Cicero et al. (2017) used Cochran-Armitage test for trend (cf, Fig 1, p. 64)

The Cochran-Armitage test can be used to test the following two-sided hypothesis for i = the type of first opioid of regular use:

H0: p2005, i = p2006, i = ... = p2015, i

vs.

H1: p2005, i < p2006, i < ... < p2015, i or p2005, i > p2006, i > ... > p2015, i

Chi-square tests of independence were used to assess differences in demographic characteristics between heroin and prescription opioid initiates, cf, table 1

Figure 1

Key Findings of Cicero et al. (2017)

In 2005, 8.7% of opioid initiates began with heroin; this rose to 33.3% in 2015.

In 2005, 42.4% of initiates began with hydrocodone and 42.3% with oxycodone;

this fell to 24.1% and 27.8%, respectively, in 2015.

Individuals who initiated with heroin were younger and less likely to have a college

education, be white, or reside in non-urban areas, but the differences were relatively small.

In fine, Cicero et al. (2017) concluded that there was a significant increase in the number of treatment-seeking opioid users whose first experience with an opioid was with heroin, rather than the more recently commonplace pattern of initiating opioid (e.g., oxycodone or hydrocodone)

Study Limitations

This study is limited by its focus on individuals seeking treatment and may not be representative of others with opioid use.

The study is retrospective and such a study suffers potential issues of recall

In addition, the time lag between onset of use and treatment entry resulted in a decrease in Ns available for recent years, which could impact the generalizability of our findings.

Additionally, it needs to be stressed that Cicero et al. (2017) results potentially underestimate the extent of harm to those who initiate regular opioid use with heroin – so called survival bias (i.e., those who overdosed early into their heroin use would obviously not be included in these studies).

Sample is a treatment-based sample and hence the results are not representative of those who use opioids “recreationally.”

Furthermore, differences in the factors influencing the decision to enter treatment, such as family/court pressures and financial ability, could limit the heterogeneity of the sample.

Future Directions

Future studies should examine, at a deeper level, the potential impact of these confounders on treatment-seeking behavior.

Cicero et al. (2018) felt the need to update their data after the original article (Cicero et al. 2017) went to press in order to validate their original findings and underscore the importance of the ‘treatment gap' in interpreting the data.

Cicero et al. (2018) examined the role of the `treatment gap’, refers to the time lag between initial opioid exposure and treatment admission, which accounted for the lower overall numbers in more recent years.

Additionally, Cicero et al. (2018) sought to update and expand upon these results, with a discussion of the policy implications on the overall opioid epidemic

Cicero et al. (2018)

Cicero et al. (2018) ABSTRACT

Introduction: Previously, Cicero et al. reported a marked increase in the use of heroin as an initiating opioid in nontolerant, ﬁrst time opioid users. In the current paper, Cicero et al. sought to update and expand upon these results, with a discussion of the policy implications on the overall opioid epidemic.

Methods: Opioid initiation data from the original study were updated to include surveys completed through 2017 (N=8,382) from a national sample of treatment-seeking opioid users. In addition, past month abuse of heroin and prescription were analyzed as raw numbers of treatment program entrant in the last ﬁve years (2013–2017), drawing from only those treatment centers that participated every year in that time frame.

Results: The updated data conﬁrm and extend the results of our original study: the use of heroin as an initiating opioid increased from 8.7% in 2005 to 31.6% in2015, with increases in overall Ns per initiation year reﬂecting a narrowing of the “treatment gap”, the time lag between opioid initiation from 2005 to 2015 and later treatment admission (up to 2017). Slight decreases were observed in treatment admissions, but this decline was totally conﬁned to prescription opioid use, with heroin use continuing to increase in absolute numbers.

Conclusions: Given that opioid novices have limited tolerance, the risk of fatal overdose for heroin initiates is elevated compared to prescription opioids, particularly given non-oral administration and often unknown purity/adulterants (i.e., fentanyl). Imprecision of titrating dose among opioid novices may explain observed increases opioid overdoses. Future policy decisions should note that prescription opioid-speciﬁc interventions may have little impact on a growing heroin epidemic.

Raison d'etre for the 2018 Paper

The authors’ noted that there were some ambiguities in their data given the relatively low numbers of individuals represented in more recent years for which they had data.

Cicero et al. (2018) felt the need to update their data after the original article went to press in order to validate their original findings and underscore the importance of the ‘treatment gap' in interpreting our data.

The treatment gap refers to, there is a time lag between initial opioid exposure and treatment admission, which accounted for the lower overall numbers in more recent years.

The data have been updated for this report using the same criteria and analysis period, with the inclusion of data from surveys received through the end of 2017.

OBSERVATIONAL DESIGN: SURVEY & DATA COLLECTION

Research Strategy: Survey

Using a survey methods approach, Cicero et al. (2018) analyzed data from and updated an ongoing study to include questionnaires completed in 2017 that uses structured, self-administered questionnaires to gather retrospective data on past drug use patterns among patients entering substance abuse treatment programs across the country who received a primary (DSM-IV) diagnosis of heroin use/dependence (sample size, n = 8,382, cf, figure 1)

Past month abuse of heroin and prescription were analyzed as raw numbers of treatment program entrants in the last ﬁve years (2013–2017), drawing from only those treatment centers that participated every year in that time frame (n = 66 programs, cf, figure 2).

Data Collection: Self-administered Questionnaire

Structured interview is a type of interview with highly specific objectives in which all questions are written beforehand and asked in the same order for all respondents, and the interviewer’s responses, and the interviewer’s remarks are standardized

A self-administered questionnaire refers to a questionnaire that has been designed specifically to be completed by a respondent without intervention of the researchers (e.g. an interviewer) collecting the data (http://methods.sagepub.com/reference/encyclopedia-of-survey-research-methods/n522.xml).

Revised Analysis of Survey of Key Informants' Patients (SKIP) Data

Figure 1: Heroin as an Initiating Opioid Increased from 8.7% in 2005 to 31.6% in 2015

Figure 1 (cf, p. 268)

Fig. 1 shows trendlines from the original published figure, represented as dotted lines, and updated trendlines (solid line).

The lower numbers on the x axis represent the original N at each time point whereas the upper numbers shows the increase in Ns after the inclusion of data through 2017 (N=8,382).

As can be seen, there was a considerable increase in numbers as data has accumulated, but the trends remained the same.

Heroin use as a first opioid grew sharply from 8.7% of the sample in 2005 to almost 31.6% in 2015. It should be noted that the numbers in more recent years increased due to the addition of new data bridging the treatment gap.

That is, there is a time gap between initial opioid exposure which occurred from 2005 to 2015 and treatment admission from 2011 to 2017, which accounts for the lower overall numbers in more recent years.

But, as this figure demonstrates, as data continue to be collected, these overall numbers will continue to increase as the treatment gap narrows.

Fig 2: The Number of Patients Entering 66 Treatment Centers Decreased (From 1,598 to 1,421) Modestly Over Time Due to Yearly Decline in Past Month Prescription Opioid Abuse

Figure 2

Cicero et al. (2018) examined the raw number of patients entering into a panel of 66 treatment clinics participating in the SKIP program in the last five years who indicated past month abuse of heroin and/or a prescription opioid (p. 269).

The total number of those entering our stable sample of treatment centers decreased modestly over time (from 1,598 to 1,421) implying a decrease in overall opioid use if viewed as a whole (cf, p. 269).

However, this overall decrease was solely attributable to decreases in past month prescription opioid abuse (from 1,453 to 1,197)

While participants could endorse both prescription opioids and heroin, the data is presented separately in order to depict the total number of users for each drug category.

Findings and Conclusions for Cicero et al. (2018)

Key Findings of Cicero et al. (2018)

Heroin as the first opioid of abuse has grown significantly in the past decade

Past month heroin use continues to grow as prescription opioid abuse declines

Policy Implications

“Our data indicate that while supply reduction efforts targeting prescription opioid abuse may have been successful in easing the prescription opioid epidemic, they have done little to reduce either past month abuse or opioid initiation of heroin. In fact, these prescription opioid-specific interventions may also have contributed, to some extent, to part of this increase in heroin use. However, our data suggest the possibility of a stand-alone heroin epidemic that current prescription opioid-centered interventions will have little to no effect on as the prescription opioid to heroin pathway is replaced by initiation to opioids with heroin directly. Clearly, there needs to be a concerted effort to adjust our prevention, intervention and treatment protocols to more adequately prepare for an expanding heroin epidemic” (Cicero et al., 2018, p. 270).

Bottom line: “Future policy decisions should note that prescription opioid-specific (Cicero et al., 2018, p.267).

References

Cicero, T. J. et al. (2014). The Changing Face of Heroin Use in the United States A Retrospective Analysis of the Past 50 Years.

JAMA Psychiatry, p. E1 – E6.

Cicero, T. J. et al. (2017). Increased use of Heroin as an Initiating Opioid of Abuse. Additive Behaviors, 74, 63-66.

Cicero, T. J. et al. (2018). Increased use of Heroin as an Initiating Opioid of Abuse: Further Considerations and Policy

Implications. Additive Behaviors, 87, 267-271.

http://opium.com/what-is-opium/

https://www.drugabuse.gov/publications/drugfacts/heroin

https://en.wikipedia.org/wiki/Opiate

https://en.wikipedia.org/wiki/Opioid