CLINICAL UNIT BASED RESEARCH
71st Annual Meeting of the College on Problems of Drug Dependence.
Reno/Sparks, Nevada June 20-25, 2009
654 USE OF AN ADAPTIVE TREATMENT RESEARCH DESIGN IN A CTN STUDY OF PRESCRIPTION OPIOID DEPENDENCE TREATMENT.
Roger D Weiss1, J Potter1, M Byrne2, C Sullivan2, W Ling3;
1McLean Hospital, Belmont, MA, 2West Virginia University School of Medicine, Morgantown, WV, 3University of California Los Angeles School of Medicine, Los Angeles, CA
Aims: The NIDA Clinical Trials Network is conducting the Prescription Opioid Addiction Treatment Study (POATS). This 10-site trial examines 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.
Methods: This study, which has completed recruitment (N=653), employs an adaptive treatment research design (ATRD); in an ATRD, 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.
Results: 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. Major challenges include 1) determining and masking from subjects the behavioral criteria that trigger randomization into Phase 2, and 2) powering a study when only a subset of the original population will enter the second phase of the trial. Conclusions: Designing and conducting a drug abuse study with an ATRD has both advantages (e.g., ecological validity) and associated challenges (e.g., masking).
Support: NIDA Grants DA15831, DA022288, DA022297, DA013045, DA020036