Cocaine Use Reduction With Buprenorphine

Completed · Phase 2/Phase 3 · Has a placebo group

Conditions studied: Cocaine Dependence

In brief

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.

Key facts

Study ID

NCT01402492

Run by

University of California, Los Angeles

People needed

302

Starts

2011-09-01

Expected to finish

2013-03-01

Last updated by the study team

2021-10-29

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

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
• 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

Where it is running

• 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

Full record on ClinicalTrials.gov

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