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Use of an Adaptive Treatment Research Design in a CTN Study of Prescription Opioid Dependence Treatment.

Poster presented at the College on Problems of Drug Dependence (CPDD) annual meeting, Reno/Sparks, Nevada, June 20-25, 2009

Roger D. Weiss, MD (McLean Hospital, NNE Node), Jennifer Sharpe Potter, PhD, MPH (McLean Hospital, NNE Node), Mimmie Byrne, ACSW, CAC, LICSW (West Virginia University, AT Node), Carl Rollynn Sullivan, MD (Chestnut Ridge Hospital, AT Node), Walter Ling, MD (Integrated Substance Abuse Programs, University of California, PA Node).

This poster describes the use of an adaptive treatment research design (ATRD) in protocol CTN-0030 (Prescription Opioid Addiction Treatment Study (POATS)). The 10-site POATS trial aims to examine different lengths and intensities of buprenorphine and drug counseling for subjects with opioid analgesic dependence. The primary study aim is to determine whether adding counseling to buprenorphine plus medical management improves outcome in this population during Phase 1, an initial 4-week taper, and Phase 2, a subsequent 12-week stabilization treatment for those who relapsed during or soon after Phase 1. This study, which has complete recruitment (n=653), employs an ATRD in which subjects receive an initial treatment (pre-specified or randomly assigned), with a plan to evaluate treatment response and potentially make clinical adjustments when a pre-specified time point or clinical status (e.g., remission or relapse) is reached. In POATS, subjects with poor outcomes in Phase 1 enter Phase 2, at which time they are randomized to a new treatment. ATRDs have been used to study a number of disorders (e.g., depression), but they have been used infrequently in drug abuse studies. Advantages of an ATRD include 1) the ecological validity associated with a study designed to approximate real-world clinical practice (i.e., instituting one treatment, then trying something else if the first treatment fails), and 2) the ability to answer multiple research questions in one study. Thus, POATS is evaluating a treatment strategy, rather than a discrete treatment intervention. This poster describes both the advantages and challenges the POATS study team has encountered so far in the project. (Poster, PDF, English, 2009)

Keywords: Adaptive treatment strategies | Buprenorphine | Buprenorphine/Naloxone | Opioid detoxification | Pharmacological therapy | Prescription-type opiates | College on Problems of Drug Dependence (CPDD) annual meeting, 2009

Document No: 377

Submitted by Roger Weiss, MD, McLean Hospital, NNE Node (7/7/2009)

Byrne, Mimmie search mail
Ling, Walter search
Potter, Jennifer Sharpe search mail
Sullivan, Carl Rollynn search mail
Weiss, Roger D. search mail
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Supported by a grant from the National Institute on Drug Abuse to the University of Washington Alcohol and Drug Abuse Institute.
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Updated 7/2009 --