Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2/PHASE3
302 participants
INTERVENTIONAL
2011-09-30
2013-03-31
Brief Summary
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Detailed Description
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In this multi-center, double-blind, placebo-controlled trial, participants will randomly assigned to one of three medication conditions: 4mg buprenorphine plus naltrexone (BUP4+XR-NTX), 16mg buprenorphine plus naltrexone (BUP16+XR-NTX), or placebo plus naltrexone (PLB+XR-NTX) for 8 weeks of treatment. Participants will be scheduled for clinic visits three times weekly (for a total of 24 visits across the 8-week treatment period) for observed medication administration, provision of take-home medication, collection of safety, medical, drug use, psychological, and compliance measures. In addition, all participants will be scheduled for once-weekly individual Cognitive Behavioral Therapy (CBT) sessions.
This protocol will explore the effects of these three medication conditions to test buprenorphine as a possible treatment for cocaine dependence. This study will advance the science, provide dosing information, and characterize the effects of the combination of the two medications in this population.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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BUP4+XR-NTX
4mg buprenorphine plus naltrexone for 8 weeks of treatment
Buprenorphine + Naltrexone
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.
BUP16+XR-NTX
16mg buprenorphine plus naltrexone for 8 weeks of treatment
Buprenorphine + Naltrexone
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.
PLB+XR-NTX
naltrexone for 8 weeks of treatment
Placebo + Naltrexone
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.
Interventions
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Buprenorphine + Naltrexone
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.
Placebo + Naltrexone
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
* Liver function test results greater than 5 times the upper limit of normal or other exclusionary clinical lab test values
* 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
18 Years
65 Years
ALL
No
Sponsors
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National Institute on Drug Abuse (NIDA)
NIH
The Emmes Company, LLC
INDUSTRY
University of California, Los Angeles
OTHER
Responsible Party
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Principal Investigators
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Walter Ling, M.D.
Role: PRINCIPAL_INVESTIGATOR
University of California, Los Angeles
Andrew J. Saxon, M.D.
Role: PRINCIPAL_INVESTIGATOR
VA Puget Sound Health Care System
Larissa J. Mooney, M.D.
Role: PRINCIPAL_INVESTIGATOR
University of California, Los Angeles
Locations
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UCLA Integrated Substance Abuse Programs (ISAP)
Los Angeles, California, United States
Bay Area Addiction Research and Treatment (BAART)
San Francisco, California, United States
Addiction Research and Treatment Services (ARTS)
Denver, Colorado, United States
Howard University Hospital
Washington D.C., District of Columbia, United States
Atlanta VA Medical Center
Atlanta, Georgia, United States
Bellevue Hospital Center
New York, New York, United States
Albert Einstein College of Medicine - Division of Substance Abuse
The Bronx, New York, United States
Maryhaven
Columbus, Ohio, United States
CODA, Inc.
Portland, Oregon, United States
South Texas Veterans Health Care System
San Antonio, Texas, United States
Recovery Centers of King County (RCKC)
Seattle, Washington, United States
Countries
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References
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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.
Mooney 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.
Related Links
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National Institute on Drug Abuse Clinical Trials Network Website
Clinical Trials Network Dissemination Library Website
UCLA Integrated Substance Abuse Programs Website
Other Identifiers
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NIDA-CTN-0048
Identifier Type: -
Identifier Source: org_study_id