Cocaine Use Reduction With Buprenorphine
Information source: University of California, Los Angeles
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Cocaine Dependence
Intervention: Buprenorphine + Naltrexone (Drug); Placebo + Naltrexone (Drug)
Phase: Phase 2/Phase 3
Status: Completed
Sponsored by: Walter Ling Official(s) and/or principal investigator(s): Walter Ling, M.D., Principal Investigator, Affiliation: University of California, Los Angeles Andrew J. Saxon, M.D., Principal Investigator, Affiliation: VA Puget Sound Health Care System Larissa J. Mooney, M.D., Principal Investigator, Affiliation: University of California, Los Angeles
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.
Clinical Details
Official title: Cocaine Use Reduction With Buprenorphine (CURB)
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Primary outcome: Cocaine use days as measured by self-report, corroborated by thrice-weekly urine drug screens
Detailed description:
This project will assess the utility of buprenorphine in the presence of naltrexone as a
potential medication useful in reducing cocaine use, commencing a research direction of
great importance to both theoretical and practical addiction medicine. Buprenorphine will be
provided as sublingual buprenorphine+naloxone tablets (Suboxone®, "BUP"). Naltrexone will be
provided as extended-release naltrexone by injection (Vivitrol®, "XR-NTX").
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.
Eligibility
Minimum age: 18 Years.
Maximum age: 65 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- 18 to 65 years of age
- In good general health
- Meet 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:
- 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
- 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
Locations and Contacts
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, District of Columbia 20060, United States
Atlanta VA Medical Center, Atlanta, Georgia 30345, United States
Albert Einstein College of Medicine - Division of Substance Abuse, Bronx, New York 10461, United States
Bellevue Hospital Center, New York, New York 10016, 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
Additional Information
National Institute on Drug Abuse Clinical Trials Network Website Clinical Trials Network Dissemination Library Website UCLA Integrated Substance Abuse Programs Website
Starting date: September 2011
Last updated: November 5, 2013
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