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A Multi-Site, Two-Phase, Prescription Opioid Addiction Treatment Study (POATS): Rationale, Design, and Methodology.

Contemporary Clinical Trials 2010;31(2):189-199. [doi: 10.1016/j.cct.2010.01.003]

Roger D. Weiss, MD (McLean Hospital, NNE Node), Jennifer Sharpe Potter, PhD, MPH (McLean Hospital, NNE Node), Scott E. Provost, MSW, MM (McLean Hospital, NNE Node), Zhen Huang, MS (Duke Clinical Research Institute, DSC), Petra Jacobs, MD (NIDA CCTN), Albert Hasson, MSW (Integrated Substance Abuse Programs, University of California, PA Node), Robert Lindblad, MD (EMMES Corporation, CCC), Hilary Smith Connery, MD, PhD (McLean Hospital, NNE Node), Kristi Prather, MPH (McLean Hospital, NNE Node), Walter Ling, MD (Integrated Substance Abuse Programs, University of California, PA Node).

The National Drug Abuse Treatment Clinical Trials Network, sponsored by the National Institute on Drug Abuse (NIDA), launched the Prescription Opioid Addiction Treatment Study (POATS, protocol CTN-0030) 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, 4th 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 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. (Article (Peer-Reviewed), PDF, English, 2010)

Keywords: Buprenorphine | Buprenorphine/Naloxone | Opioid dependence | Opioid detoxification | Pharmacological therapy | Prescription-type opiates | Research design | Suboxone | Contemporary Clinical Trials (journal)

Document No: 413, PMID: 20116457, PMCID: PMC2831115.

Submitted by CTN Dissemination Librarians (2/2/2010).

Connery, Hilary Smith search mail
Hasson, Albert search mail
Huang, Zhen search mail
Lindblad, Robert search mail
Ling, Walter search mail
Potter, Jennifer Sharpe search mail
Prather, Kristi search
Provost, Scott E. search mail
Weiss, Roger D. search mail
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