Contemporary Clinical Trials 2013;34(2):196-204. [doi: 10.1016/j.cct.2012.11.002]
Larissa J. Mooney, MD (Integrated Substance Abuse Programs, UCLA, PR Node), Suzanne Nielsen, PhD (University of Sydney, Australia), Andrew J. Saxon, MD (VA Puget Sound Health Care System, PN Node), Maureen Hillhouse, PhD (Integrated Substance Abuse Programs, UCLA, PR Node), Christie Thomas, MPH (Integrated Substance Abuse Programs, UCLA, PR Node), Albert Hasson, MSW (Integrated Substance Abuse Programs, UCLA, PR Node), Don Stablein, PhD (EMMES Corporation), Jennifer McCormack, MS (Data & Statistics Center, EMMES Corporation), Robert Lindblad, MD (Clinical Coordinating Center, EMMES Corporation), Walter Ling, MD (Integrated Substance Abuse Programs, UCLA, PR Node).
Effective medications to treat cocaine dependence have thus far not been identified. Recent pharmacotherapy trials, however, have begun to demonstrate the potential efficacy of buprenorphine (BUP) (alone or with naltrexone) for reducing cocaine use. The National Drug Abuse Treatment Clinical Trials Network (CTN) launched protocol CTN-0048, Cocaine Use Reduction with Buprenorphine (CURB), to examine the safety and efficacy of sublingual BUP (Suboxone) in the presence of extended-release injectable naltrexone (XR-NTX) for the treatment of cocaine dependence. This article describes the methods and aims of this multi-site, double-blind, placebo-controlled study, which will randomize 300 participants across 11 sites. Participants must meet the DSM-IV criteria for cocaine dependence and past or current opioid dependence or abuse. Participants are next inducted onto XR-NTX after self-reporting at least 7 days of abstinence from opioids and tolerating a naloxone challenge followed by oral naltrexone, then randomly assigned to one of three medication conditions (4 mg BUP, 16 mg BUP, or placebo) for 8 weeks. Participants receive a second injection of XR-NTX 4 weeks after the initial injection, and follow-up visits are scheduled at 1 and 3 months post-treatment. Additionally, participants receive weekly cognitive behavioral therapy (CBT). Recruitment commenced in September 2011. Enrollment, active medication, and follow-up phases are ongoing, and recruitment is exceeding targeted enrollment rates. This study aims to demonstrate whether BUP, administered in the presence of XR-NTS, reduces cocaine use in adults with cocaine dependence and opioid use disorders and to demonstrate if XR-NTS prevents development of physiologic dependence on BUP. (Article (Peer-Reviewed), PDF, English, 2013)
Keywords: Buprenorphine/Naloxone | Cocaine | CTN protocol development | Opioid dependence | Naltrexone | Pharmacological therapy | Research design | Suboxone | Contemporary Clinical Trials (journal)
Document No: 929, PMID: 23159524, PMCID: PMC3760415.
Submitted by CTN Dissemination Librarians, 11/26/2012.