title: Buprenorphine + naloxone plus naltrexone for the treatment of cocaine dependence: the Cocaine Use Reduction with Buprenorphine (CURB) study.
abstract: To examine the safety and effectiveness of buprenorphine + naloxone sublingual tablets (BUP, as Suboxone(®) ) provided after administration of extended-release injectable naltrexone (XR-NTX, as Vivitrol(®) ) to reduce cocaine use in participants who met DSM-IV criteria for cocaine dependence and past or current opioid dependence or abuse.
  
  
  
  This multi-centered, double-blind, placebo-controlled study, conducted under the auspices of the National Drug Abuse Treatment Clinical Trials Network, randomly assigned 302 participants at sites in California, Oregon, Washington, Colorado, Texas, Georgia, Ohio, New York and Washington DC, USA to one of three conditions provided with XR-NTX: 4 mg/day BUP (BUP4, n = 100), 16 mg/day BUP (BUP16, n = 100, or no buprenorphine (placebo; PLB, n = 102). Participants received pharmacotherapy for 8 weeks, with three clinic visits per week. Cognitive behavioral therapy was provided weekly. Follow-up assessments occurred at 1 and 3 months post-intervention. The planned primary outcome was urine drug screen (UDS)-corrected, self-reported cocaine use during the last 4 weeks of treatment. Planned secondary analyses assessed cocaine use by UDS, medication adherence, retention and adverse events.
  
  
  
  No group differences were found between groups for the primary outcome (BUP4 versus PLB, P = 0.262; BUP16 versus PLB, P = 0.185). Longitudinal analysis of UDS data during the evaluation period using generalized linear mixed equations found a statistically significant difference between BUP16 and PLB [P = 0.022, odds ratio (OR) = 1.71] but not for BUP4 (P = 0.105, OR = 1.05). No secondary outcome differences across groups were found for adherence, retention or adverse events.
  
  
  
  Buprenorphine + naloxone, used in combination with naltrexone, may be associated with reductions in cocaine use among people who meet DSM-IV criteria for cocaine dependence and past or current opioid dependence or abuse.
authors.affiliation: University of California, Los Angeles, CA, USA.
authors.forename: Walter
authors.initials: W
authors.lastname: Ling
authors.affiliation: University of California, Los Angeles, CA, USA.
authors.forename: Maureen P
authors.initials: MP
authors.lastname: Hillhouse
authors.affiliation: Veterans Affairs Puget Sound Health Care System, Seattle, WA, USA.
authors.forename: Andrew J
authors.initials: AJ
authors.lastname: Saxon
authors.affiliation: University of California, Los Angeles, CA, USA.
authors.forename: Larissa J
authors.initials: LJ
authors.lastname: Mooney
authors.affiliation: University of California, Los Angeles, CA, USA.
authors.forename: Christie M
authors.initials: CM
authors.lastname: Thomas
authors.affiliation: University of California, Los Angeles, CA, USA.
authors.forename: Alfonso
authors.initials: A
authors.lastname: Ang
authors.affiliation: The Emmes Corporation, Rockville, MD, USA.
authors.forename: Abigail G
authors.initials: AG
authors.lastname: Matthews
authors.affiliation: University of California, Los Angeles, CA, USA.
authors.forename: Albert
authors.initials: A
authors.lastname: Hasson
authors.affiliation: University of California, Los Angeles, CA, USA.
authors.forename: Jeffrey
authors.initials: J
authors.lastname: Annon
authors.affiliation: National Institute on Drug Abuse, Bethesda, MD, USA.
authors.forename: Steve
authors.initials: S
authors.lastname: Sparenborg
authors.affiliation: National Institute on Drug Abuse, Bethesda, MD, USA.
authors.forename: David S
authors.initials: DS
authors.lastname: Liu
authors.affiliation: The Emmes Corporation, Rockville, MD, USA.
authors.forename: Jennifer
authors.initials: J
authors.lastname: McCormack
authors.affiliation: Albert Einstein College of Medicine, Bronx, NY, USA.
authors.forename: Sarah
authors.initials: S
authors.lastname: Church
authors.affiliation: Addiction Research and Treatment Services (ARTS), Denver, CO, USA.
authors.forename: William
authors.initials: W
authors.lastname: Swafford
authors.affiliation: Atlanta VA Medical Center, Atlanta, GA, USA.
authors.forename: Karen
authors.initials: K
authors.lastname: Drexler
authors.affiliation: BAART Programs, San Francisco, CA, USA.
authors.forename: Carolyn
authors.initials: C
authors.lastname: Schuman
authors.affiliation: Bellevue Hospital Center, New York, NY, USA.
authors.forename: Stephen
authors.initials: S
authors.lastname: Ross
authors.affiliation: CODA, Portlad, OR, USA.
authors.forename: Katharina
authors.initials: K
authors.lastname: Wiest
authors.affiliation: Oregon Health and Science University, Portland, OR, USA.
authors.forename: P Todd
authors.initials: PT
authors.lastname: Korthuis
authors.affiliation: Howard University, Washington, DC, USA.
authors.forename: William
authors.initials: W
authors.lastname: Lawson
authors.affiliation: Maryhaven Treatment Center, Columbus, OH, USA.
authors.forename: Gregory S
authors.initials: GS
authors.lastname: Brigham
authors.affiliation: Recovery Centers of King County (RCKC), Kent, WA, USA.
authors.forename: Patricia C
authors.initials: PC
authors.lastname: Knox
authors.affiliation: South Texas Veterans Health Care System, San Antonio, TX, USA.
authors.forename: Michael
authors.initials: M
authors.lastname: Dawes
authors.affiliation: New York University School of Medicine, New York, NY, USA.
authors.forename: John
authors.initials: J
authors.lastname: Rotrosen
mesh_terms: D000284:Administration, Oral; D000328:Adult; D000701:Analgesics, Opioid / Q000627:therapeutic use*; D000069479:Buprenorphine, Naloxone Drug Combination / Q000627:therapeutic use*; D019970:Cocaine-Related Disorders / Q000188:drug therapy*; D015928:Cognitive Behavioral Therapy; D003692:Delayed-Action Preparations; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D007273:Injections, Intramuscular; D008297:Male; D008875:Middle Aged; D009271:Naltrexone / Q000627:therapeutic use*; D009292:Narcotic Antagonists / Q000627:therapeutic use*; D016896:Treatment Outcome
chemical_list: D000701:Analgesics, Opioid; D000069479:Buprenorphine, Naloxone Drug Combination; D003692:Delayed-Action Preparations; D009292:Narcotic Antagonists; D009271:Naltrexone
keywords: Buprenorphine + naloxone; cocaine use disorder; double-blind; multi-site trial; naltrexone; pharmacotherapy; placebo-controlled; treatment