Cocaine Use Reduction With Buprenorphine

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 (XR) 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.

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