Cocaine Use Reduction With Buprenorphine
CURB
2 other identifiers
interventional
302
1 country
11
Brief Summary
The aim of this study is to investigate the safety and effectiveness of buprenorphine in the presence of naltrexone for the treatment of cocaine dependence.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Sep 2011
Shorter than P25 for phase_2
11 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 25, 2011
CompletedFirst Posted
Study publicly available on registry
July 26, 2011
CompletedStudy Start
First participant enrolled
September 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2013
CompletedResults Posted
Study results publicly available
October 29, 2021
CompletedOctober 29, 2021
June 1, 2021
1.3 years
July 25, 2011
November 9, 2016
October 1, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Cocaine Use Days as Measured by Self-report, Corroborated by Thrice-weekly Urine Drug Screens
Self-reported days of cocaine use corroborated with urine drug screens (UDS).
final 30 days of Treatment Phase, study days 25-54
Study Arms (3)
BUP4+XR-NTX
EXPERIMENTAL4mg buprenorphine plus naltrexone for 8 weeks of treatment
BUP16+XR-NTX
EXPERIMENTAL16mg buprenorphine plus naltrexone for 8 weeks of treatment
PLB+XR-NTX
ACTIVE COMPARATORnaltrexone for 8 weeks of treatment
Interventions
Following a successful naloxone challenge, induction onto extended-release naltrexone by injection (Vivitrol®), and a final assessment of eligibility, participants will be randomly assigned to one of the three conditions: 4mg buprenorphine plus naltrexone, 16 mg buprenorphine plus naltrexone, or placebo plus naltrexone for 8 weeks of treatment. Random assignment will be on a 1:1:1 ratio to one of three conditions. Randomization will be stratified according to site and opioid use levels.
Following a successful naloxone challenge, induction onto extended-release naltrexone by injection (Vivitrol®), and a final assessment of eligibility, participants will be randomly assigned to one of the three conditions: 4mg buprenorphine plus naltrexone, 16 mg buprenorphine plus naltrexone, or placebo plus naltrexone for 8 weeks of treatment. Random assignment will be on a 1:1:1 ratio to one of three conditions. Randomization will be stratified according to site and opioid use levels.
Eligibility Criteria
You may qualify if:
- to 65 years of age
- In good general health
- Meet Diagnostic and Statistical Manual (DSM)-IV criteria for cocaine dependence
- Meet DSM-IV criteria for past-year opioid dependence OR past-year opioid abuse OR have past-year opioid use and a history of opioid dependence during the lifetime
- Interested in receiving treatment for cocaine dependence
- Able to speak English sufficiently to understand the study procedures and provide written informed consent to participate in the study
- Able to satisfy and comply with study procedures and requirements
- If female of childbearing potential, willing to practice and effective method of birth control for the duration of the study
You may not qualify if:
- Pregnant or breastfeeding females
- Known allergy or sensitivity to study medications
- Recent or ongoing treatment with medications that, in the judgment of the study medical clinician, could interact adversely with study drugs or interfere with study participation
- Have a current pattern of alcohol, benzodiazepine, or other sedative-hypnotic use, as determined by the study medical clinician, which would preclude safe participation
- Serious medical condition or acute psychiatric disorder that would make study participation difficult or unsafe
- Pending action or situation that might prevent remaining in the area for the duration of the study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of California, Los Angeleslead
- National Institute on Drug Abuse (NIDA)collaborator
- The Emmes Company, LLCcollaborator
Study Sites (11)
UCLA Integrated Substance Abuse Programs (ISAP)
Los Angeles, California, 90025, United States
Bay Area Addiction Research and Treatment (BAART)
San Francisco, California, 94102, United States
Addiction Research and Treatment Services (ARTS)
Denver, Colorado, 80206, United States
Howard University Hospital
Washington D.C., District of Columbia, 20060, United States
Atlanta VA Medical Center
Atlanta, Georgia, 30345, United States
Bellevue Hospital Center
New York, New York, 10016, United States
Albert Einstein College of Medicine - Division of Substance Abuse
The Bronx, New York, 10461, United States
Maryhaven
Columbus, Ohio, 43207, United States
CODA, Inc.
Portland, Oregon, 97214, United States
South Texas Veterans Health Care System
San Antonio, Texas, 78229, United States
Recovery Centers of King County (RCKC)
Seattle, Washington, 98122, United States
Related Publications (2)
Ling W, Hillhouse MP, Saxon AJ, Mooney LJ, Thomas CM, Ang A, Matthews AG, Hasson A, Annon J, Sparenborg S, Liu DS, McCormack J, Church S, Swafford W, Drexler K, Schuman C, Ross S, Wiest K, Korthuis PT, Lawson W, Brigham GS, Knox PC, Dawes M, Rotrosen J. Buprenorphine + naloxone plus naltrexone for the treatment of cocaine dependence: the Cocaine Use Reduction with Buprenorphine (CURB) study. Addiction. 2016 Aug;111(8):1416-27. doi: 10.1111/add.13375. Epub 2016 Apr 21.
PMID: 26948856RESULTMooney LJ, Nielsen S, Saxon A, Hillhouse M, Thomas C, Hasson A, Stablein D, McCormack J, Lindblad R, Ling W. Cocaine use reduction with buprenorphine (CURB): rationale, design, and methodology. Contemp Clin Trials. 2013 Mar;34(2):196-204. doi: 10.1016/j.cct.2012.11.002. Epub 2012 Nov 16.
PMID: 23159524DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Walter Ling, MD
- Organization
- UCLA Integrated Substance Abuse Programs
Study Officials
- PRINCIPAL INVESTIGATOR
Walter Ling, M.D.
University of California, Los Angeles
- PRINCIPAL INVESTIGATOR
Andrew J. Saxon, M.D.
VA Puget Sound Health Care System
- PRINCIPAL INVESTIGATOR
Larissa J. Mooney, M.D.
University of California, Los Angeles
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 25, 2011
First Posted
July 26, 2011
Study Start
September 1, 2011
Primary Completion
January 1, 2013
Study Completion
March 1, 2013
Last Updated
October 29, 2021
Results First Posted
October 29, 2021
Record last verified: 2021-06