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CTN-0030
Primary
Outcomes

Adjunctive Counseling During Brief and Extended Buprenorphine-Naloxone Treatment for Prescription Opioid Dependence: A 2-Phase Randomized Controlled Trial.

Archives of General Psychiatry 2011;68(12):1238-1246. [doi: 10.1001/archgenpsychiatry.2011.121]

Roger D. Weiss, MD (McLean Hospital, NEC Node), Jennifer Sharpe Potter, PhD, MPH (McLean Hospital, NEC Node), David A. Fiellin, MD (McLean Hospital, NEC Node), Mimmie Byrne, MSW (Chestnut Ridge Center, ATS Node), Hilary Smith Connery, MD, PhD (McLean Hospital, NEC Node), William Dickinson, DO (Providence Behavioral Health Services, PN Node), John G. Gardin II, PhD (ADAPT, Inc., WS Node), Margaret L. Griffin, PhD (McLean Hospital, NEC Node), Marc N. Gourevitch, MD, MPH (New York University School of Medicine, GNY Node), Deborah L. Haller, PhD (Columbia University College of Physicians, GNY Node), Albert L. Hasson, MSW (University of California, Los Angelas, PR Node), Zhen Huang, MS (Duke Clinical Research Institute, DSC), Petra Jacobs, MD (CTN Clinical Coordinating Center, NIDA), Andrzej S . Kosinski, PhD (Duke Clinical Research Institute, DSC), Robert Lindblad, MD (EMMES Corporation, CTN Clinical Coordinating Center), Elinore F. McCance-Katz, MD, PhD (University of California, San Francisco, WS Node), Scott E. Provost, MSW, MM (McLean Hospital, NEC Node), Jeffrey A. Selzer, MD (Committee for Physician Health, GNY Node), Eugene C. Somoza, MD, PhD (University of Cincinnati/CinARC, OV Node), Susan C. Sonne, PharmD (Medical University of South Carolina, SC Node), Walter Ling, MD (Integrated Substance Abuse Programs, University of California, PR Node).

This is the primary outcomes article for CTN-0030. No randomized trials have examined treatments for prescription opioid dependence, despite its increasing prevalence. The objective of this study, National Drug Abuse Treatment Clinical Trials Network protocol CTN-0030 (Prescription Opioid Addiction Treatment Study (POATS)), was to evaluate the efficacy of brief and extended buprenorphine hydrochloride-naloxone hydrochloride treatment, with different counseling intensities, for patients dependent on prescription opioids. Ten US sites with a total of 653 treatment-seeking outpatients dependent on prescription opioids participated in this multisite, randomized clinical trial using a 2-phase adaptive treatment research design. Brief treatment (phase 1) included 2-week buprenorphine-naloxone stabilization, 2-week taper, and 8-week post-medication follow-up. Patients with successful opioid use outcomes exited the study; unsuccessful patients entered phase 2: extended (12-week) buprenorphine-naloxone treatment, 4-week taper, and 8-week post-medication follow-up. In both phases, patients were randomized into standard medical management (SMM) or SMM plus opioid dependence counseling; all received buprenorphine-naloxone.

During phase 1, only 6.6% (43 of 653) of patients had successful outcomes, with no difference between SMM and SMM plus opioid dependence counseling. In contrast, 49.2% (177 of 360) attained successful outcomes in phase 2 during extended buprenorphine-naloxone treatment (week 12), with no difference between counseling conditions. Success rates 8 weeks after completing the buprenorphine-naloxone taper (phase 2, week 24) dropped to 8.6% (31 of 360), again with no counseling difference. In secondary analyses, successful phase 2 outcomes were more common while taking buprenorphine-naloxone than 8 weeks after taper (49.2% vs 8.6%, P<.001). Chronic pain did not affect opioid use outcomes; a history of ever using heroin was associated with lower phase 2 success rates while taking buprenorphine-naloxone.

Conclusions: Prescription opioid–dependent patients are most likely to reduce opioid use during buprenorphine-naloxone treatment. However, if tapered off buprenorphine-naloxone, even after 12 weeks of treatment, the likelihood of an unsuccessful outcome is high, even in patients receiving counseling in addition to standard medical management. (Article (Peer-Reviewed), PDF, English, 2011)

See also: NIH Press Release about these results: http://www.nih.gov/news/health/nov2011/nida-08a.htm

Keywords: Buprenorphine | Buprenorphine/Naloxone | CTN primary outcomes | Heroin | Opioid dependence | Opioid detoxification | Pharmacological therapy | Prescription-type opiates | Suboxone | Taper schedules | Archives of General Psychiatry (journal)

Document No: 693, PMID: 22065255, PMCID: PMC3470422.

Submitted by CTN Dissemination Librarians, 11/8/2011.

AUTHORS SEARCH LINK
Byrne, Mimmie search mail
Connery, Hilary Smith search
Dickinson, William search mail
Fiellin, David A. search
Gardin, John G. II search mail
Griffin, Margaret L. search
Gourevitch, Marc N. search
Haller, Deborah L. search mail
Hasson, Albert L. search mail
Huang, Zhen search mail
Jacobs, Petra search mail
Kosinski, Andrzej S. search mail
Lindblad, Robert search mail
Ling, Walter search mail
McCance-Katz, Elinore F. search mail
Potter, Jennifer Sharpe search mail
Provost, Scott E. search mail
Selzer, Jeffrey A. search mail
Somoza, Eugene C. search mail
Sonne, Susan C. search mail
Weiss, Roger D. search mail
PROTOCOLS
NIDA-CTN-0030 search www
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Appalachian Tri-State search www
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