Long-term outcomes from the National Drug Abuse Treatment Clinical Trials Network Prescription Opioid Addiction Treatment Study☆
Introduction
Despite the high rate of prescription opioid abuse and dependence in the U.S. (Substance Abuse and Mental Health Services Administration, 2012), little research has been published on the treatment of patients dependent upon prescription opioids. Moreover, no follow-up studies to date have examined long-term response to treatment and course of illness in this population. Virtually all studies of the long-term course of opioid dependence examine heroin users (Darke et al., 2007, Flynn et al., 2003, Grella and Lovinger, 2011, Hser et al., 2001, Vaillant, 1973). However, as emerging data suggest that outcomes for those dependent upon prescription opioids may differ from those using heroin (Moore et al., 2007, Nielsen et al., 2013, Potter et al., 2010), we cannot assume that results from longer-term studies of heroin dependence apply to those abusing prescription opioids.
Longitudinal follow-up of substance-dependent patients generates important information regarding treatment response and course of illness. In particular, studies have shown that longer-term outcomes and predictors of outcome (Brecht and Herbeck, 2014, Grella et al., 2003, Project MATCH research group, 1998) at 3–5 years can differ from those found at shorter-term follow-up. This is consistent with viewing substance use disorder as a chronic disease with a course that spans years rather than a single episode (McLellan et al., 2000).
The Prescription Opioid Addiction Treatment Study (POATS), conducted by the National Drug Abuse Treatment Clinical Trials Network, is, to date, the only large randomized controlled study examining the treatment of patients dependent upon prescription opioids with a history of minimal or no heroin use (Weiss et al., 2011). POATS compared different combinations of buprenorphine-naloxone (bup-nx) and counseling in this population. As the first large-scale controlled trial for prescription opioid dependence, POATS presented a unique opportunity to follow this patient population beyond the treatment period. Therefore, during the main trial, we decided to extend the assessment period to follow POATS participants 18, 30, and 42 months after randomization in the main trial. We previously reported results from the 18-month follow-up (Potter et al., 2014); the current paper extends this work to present results from the entire 42-month POATS follow-up study. The aim of this exploratory study was to examine the course of opioid use and related outcomes post-treatment and their relationship to baseline characteristics, treatment response in the main POATS trial, and current treatment.
Section snippets
Description of the main POATS trial and outcomes
POATS was conducted from 2006 to 2009 at 10 sites from the National Drug Abuse Treatment Clinical Trials Network (Weiss et al., 2011). Briefly, individuals age ≥18 who met DSM-IV (American Psychiatric Association, 1994) criteria for current opioid dependence (i.e., not physical dependence alone) were eligible unless they used heroin on >4 of the past 30 days, had a lifetime opioid dependence diagnosis due to heroin alone, had ever injected heroin, required opioids for ongoing pain management,
Results
Among the 653 POATS participants, 375 (57%) enrolled in the follow-up study (Fig. 1). The number of participants completing each follow-up assessment was 252 for Month 18 (67% of the follow-up sample; 39% of the entire study sample), 312 for Month 30 (83% of the follow-up sample; 48% of the study sample), and 306 for Month 42 (82% of the follow-up sample; 47% of the study sample). We conducted the fewest Month 18 assessments in part due to logistics: 50 participants enrolled in the follow-up
Discussion
This 3.5-year follow-up of prescription opioid dependent patients participating in a clinical trial showed marked improvement: use of illicit opioids and other substances declined substantially from study entry. For example, although all trial participants had a DSM-IV diagnosis of opioid dependence at baseline, only 7.8% of those in the follow-up sample met current criteria for opioid dependence at Month 42, whereas another 29.4% met criteria for opioid dependence on agonist therapy. Past-year
Role of funding source
This work was supported by grants from NIDA as part of the Cooperative Agreement on the Clinical Trials Network (grants U10 DA015831 and U10 DA020024); and NIDA grants K24 DA022288, K23DA022297, and K23DA035297. NIDA had no further role in study design; in the collection, analysis and interpretation of data; or in the writing of the report. The NIDA Clinical Trials Network Publication Committee reviewed a draft of this manuscript and approved it for submission for publication.
Contributors
Drs. Weiss and Potter designed the study and wrote the protocol. Dr. Dreifuss, Mr. Provost, Ms. Dodd, and Ms. McDermott oversaw and participated in the conduct of study assessments. Ms. McDermott and Ms. Srisarajivakul managed the literature searches and summaries of previous related work. Drs. Griffin and Fitzmaurice undertook the statistical analysis. Drs. Weiss and Griffin wrote the first draft of the manuscript. Drs. Potter, McHugh, and Carroll participated in the conceptualization of the
Conflict of interest
Dr. Weiss has consulted to Reckitt-Benckiser.
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2022, Drug and Alcohol DependenceCitation Excerpt :For example, Hser et al. (2017) showed that individuals’ long-term treatment participation trends are inversely related to their long-term opioid use trends. Weiss et al., (2011, 2015) showed that even long after the conclusion of the clinical trials, the majority of those not in treatment regularly use opioids. In Phase 1 of CTN0027, among those who were briefly treated (for 4 weeks) for prescription opioid use disorder, only 6.6 % were not regular using opioids at 12 weeks of follow-up.
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2022, Drug and Alcohol DependenceCitation Excerpt :At 5 years (60 months) post-treatment, 20.7% of participants reported abstinence from opioids. Similar to Weiss et al. (Weiss et al., 2015), a restricted assessment of factors beyond substance use is a notable limitation of this study. Successful recovery from SUDs is increasingly recognized to consist of factors beyond abstinence, including employment, social and family relationships, and physical and mental wellness (Betty Ford Institute Consensus Panel, 2007; Kelly and Hoeppner, 2015).
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Clinical Trial Registration: ClinicalTrials.gov; registration number NCT00316277; http://clinicaltrials.gov/ct2/show/NCT00316277.