Cocaine Use Reduction With Buprenorphine

• Status: Completed
• Trial end date: 2013-03-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of California, Los Angeles; Walter Ling
• Collaborators: National Institute on Drug Abuse (NIDA); The Emmes Company, LLC; The EMMES Corporation
• Treatments: Analgesics, Opioid; Buprenorphine; Buprenorphine, Naloxone Drug Combination; Cocaine; Naloxone; Naltrexone

Criteria

Inclusion Criteria:

• 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 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