BACKGROUND: Effective medications to treat cocaine dependence have not been identified. Recent pharmacotherapy trials demonstrate the potential efficacy of buprenorphine (BUP) (alone or with naltrexone) for reducing cocaine use. The National Institute on Drug Abuse Clinical Trials Network (CTN) launched the Cocaine Use Reduction with Buprenorphine (CURB) investigation to examine the safety and efficacy of sublingual BUP (as Suboxone®) in the presence of extended-release injectable naltrexone (XR-NTX, as Vivitrol®) for the treatment of cocaine dependence. This paper describes the design and rationale for this study. METHODS: This multi-site, double-blind, placebo-controlled study 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 inducted onto XR-NTX after self-reporting at least 7 days of abstinence from opioids and tolerating a naloxone challenge followed by oral naltrexone and are 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. 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. CONCLUSIONS: This research using 2 medications will demonstrate whether BUP, administered in the presence of XR-NTX, reduces cocaine use in adults with cocaine dependence and opioid use disorders and will demonstrate if XR-NTX prevents development of physiologic dependence on BUP.
RCT Entities:
BACKGROUND: Effective medications to treat cocaine dependence have not been identified. Recent pharmacotherapy trials demonstrate the potential efficacy of buprenorphine (BUP) (alone or with naltrexone) for reducing cocaine use. The National Institute on Drug Abuse Clinical Trials Network (CTN) launched the Cocaine Use Reduction with Buprenorphine (CURB) investigation to examine the safety and efficacy of sublingual BUP (as Suboxone®) in the presence of extended-release injectable naltrexone (XR-NTX, as Vivitrol®) for the treatment of cocaine dependence. This paper describes the design and rationale for this study. METHODS: This multi-site, double-blind, placebo-controlled study 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 inducted onto XR-NTX after self-reporting at least 7 days of abstinence from opioids and tolerating a naloxone challenge followed by oral naltrexone and are 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. 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. CONCLUSIONS: This research using 2 medications will demonstrate whether BUP, administered in the presence of XR-NTX, reduces cocaine use in adults with cocaine dependence and opioid use disorders and will demonstrate if XR-NTX prevents development of physiologic dependence on BUP.
Authors: Richard A Rawson; Patricia Marinelli-Casey; M Douglas Anglin; Alice Dickow; Yvonne Frazier; Cheryl Gallagher; Gantt P Galloway; James Herrell; Alice Huber; Michael J McCann; Jeanne Obert; Susan Pennell; Chris Reiber; Denna Vandersloot; Joan Zweben Journal: Addiction Date: 2004-06 Impact factor: 6.526
Authors: Ivan D Montoya; David A Gorelick; Kenzie L Preston; Jennifer R Schroeder; Annie Umbricht; Lawrence J Cheskin; W Robert Lange; Carlo Contoreggi; Rolley E Johnson; Paul J Fudala Journal: Clin Pharmacol Ther Date: 2004-01 Impact factor: 6.875
Authors: H A Navaline; E C Snider; C J Petro; D Tobin; D Metzger; A I Alterman; G E Woody Journal: AIDS Res Hum Retroviruses Date: 1994 Impact factor: 2.205
Authors: Walter Ling; Maureen P Hillhouse; Andrew J Saxon; Larissa J Mooney; Christie M Thomas; Alfonso Ang; Abigail G Matthews; Albert Hasson; Jeffrey Annon; Steve Sparenborg; David S Liu; Jennifer McCormack; Sarah Church; William Swafford; Karen Drexler; Carolyn Schuman; Stephen Ross; Katharina Wiest; P Todd Korthuis; William Lawson; Gregory S Brigham; Patricia C Knox; Michael Dawes; John Rotrosen Journal: Addiction Date: 2016-04-21 Impact factor: 6.526