A multi-site, two-phase, Prescription Opioid Addiction Treatment Study (POATS): Rationale, design, and methodology

Abstract

The National Institute on Drug Abuse Clinical Trials Network launched the Prescription Opioid Addiction Treatment Study (POATS) in response to rising rates of prescription opioid dependence and gaps in understanding the optimal course of treatment for this population. POATS employed a multi-site, two-phase adaptive, sequential treatment design to approximate clinical practice. The study took place at 10 community treatment programs around the United States. Participants included men and women age ≥18 who met Diagnostic and Statistical Manual, 4 th Edition criteria for dependence upon prescription opioids, with physiologic features; those with a prominent history of heroin use (according to pre-specified criteria) were excluded. All participants received buprenorphine/naloxone (bup/nx). Phase 1 consisted of 4 weeks of bup/nx treatment, including a 14-day dose taper, with 8 weeks of follow-up. Phase 1 participants were monitored for treatment response during these 12 weeks. Those who relapsed to opioid use, as defined by pre-specified criteria, were invited to enter Phase 2; Phase 2 consisted of 12 weeks of bup/nx stabilization treatment, followed by a 4-week taper and 8 weeks of post-treatment follow-up. Participants were randomized at the beginning of Phase 1 to receive bup/nx, paired with either Standard Medical Management (SMM) or Enhanced Medical Management (EMM; defined as SMM plus individual drug counseling). Eligible participants entering Phase 2 were re-randomized to either EMM or SMM. POATS was Publisher's Disclaimer: This is a PDF file of an unedited manuscript that has been accepted for publication. As a service to our customers we are providing this early version of the manuscript. The manuscript will undergo copyediting, typesetting, and review of the resulting proof before it is published in its final citable form. Please note that during the production process errors may be discovered which could affect the content, and all legal disclaimers that apply to the journal pertain. developed to determine what benefit, if any, EMM offers over SMM in short-term and longer-term treatment paradigm. This paper describes the rationale and design of the study. NIH Public Access

Assessing craving and its relationship to subsequent prescription opioid use among treatment-seeking prescription opioid dependent patients

“…For a full description of POATS, see Weiss and colleagues (2010). POATS was conducted at 10 treatment programs across the United States.…”

“…Inclusion criteria included a diagnosis of opioid dependence specifically for prescription opioids and use of prescription opioids on at least 20 days in the previous month. Participants with significant heroin use (defined as 5 or more days of heroin use in the previous 30 days, history of heroin injecting, or history of opioid dependence based on heroin use alone), a significant pain condition for which ongoing opioid therapy was indicated, or any medical or psychiatric condition contraindicated for study participation were excluded (Weiss et al, 2010). …”

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“…In particular, the interpretation of results is complicated by the fact that variability in taper duration is inherently intertwined with assessment time point. Overall, however, risk for relapse to illicit opioid use after buprenorphine or methadone discontinuation is very high, regardless of variations in taper regimen or population (55). …”

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