title: Cocaine use reduction with buprenorphine (CURB): rationale, design, and methodology.
abstract: 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.affiliation: UCLA Integrated Substance Abuse Programs, Los Angeles, CA 90025, USA. lmooney@mednet.ucla.edu
authors.forename: Larissa J
authors.initials: LJ
authors.lastname: Mooney
authors.forename: Suzanne
authors.initials: S
authors.lastname: Nielsen
authors.forename: Andrew
authors.initials: A
authors.lastname: Saxon
authors.forename: Maureen
authors.initials: M
authors.lastname: Hillhouse
authors.forename: Christie
authors.initials: C
authors.lastname: Thomas
authors.forename: Albert
authors.initials: A
authors.lastname: Hasson
authors.forename: Don
authors.initials: D
authors.lastname: Stablein
authors.forename: Jennifer
authors.initials: J
authors.lastname: McCormack
authors.forename: Robert
authors.initials: R
authors.lastname: Lindblad
authors.forename: Walter
authors.initials: W
authors.lastname: Ling
mesh_terms: D000286:Administration, Sublingual; D000293:Adolescent; D000328:Adult; D000368:Aged; D002047:Buprenorphine / Q000627:therapeutic use*; D000069479:Buprenorphine, Naloxone Drug Combination; D019970:Cocaine-Related Disorders / Q000150:complications / Q000628:therapy*; D015928:Cognitive Behavioral Therapy / Q000379:methods*; D003131:Combined Modality Therapy; D004311:Double-Blind Method; D004338:Drug Combinations; D004359:Drug Therapy, Combination; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009270:Naloxone / Q000627:therapeutic use*; D009271:Naltrexone / Q000627:therapeutic use*; D009292:Narcotic Antagonists / Q000627:therapeutic use*; D009293:Opioid-Related Disorders / Q000150:complications / Q000628:therapy*; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D000069479:Buprenorphine, Naloxone Drug Combination; D004338:Drug Combinations; D009292:Narcotic Antagonists; D009270:Naloxone; D002047:Buprenorphine; D009271:Naltrexone