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 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 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