Status:
COMPLETED
Cocaine Use Reduction With Buprenorphine
Lead Sponsor:
University of California, Los Angeles
Collaborating Sponsors:
National Institute on Drug Abuse (NIDA)
The Emmes Company, LLC
Conditions:
Cocaine Dependence
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
PHASE3
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.
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 bot...
Eligibility Criteria
Inclusion
- 18 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
Exclusion
- 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
Key Trial Info
Start Date :
September 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2013
Estimated Enrollment :
302 Patients enrolled
Trial Details
Trial ID
NCT01402492
Start Date
September 1 2011
End Date
March 1 2013
Last Update
October 29 2021
Active Locations (11)
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1
UCLA Integrated Substance Abuse Programs (ISAP)
Los Angeles, California, United States, 90025
2
Bay Area Addiction Research and Treatment (BAART)
San Francisco, California, United States, 94102
3
Addiction Research and Treatment Services (ARTS)
Denver, Colorado, United States, 80206
4
Howard University Hospital
Washington D.C., District of Columbia, United States, 20060