Cocaine Use Reduction With Buprenorphine

Study Overview
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Brief Summary
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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
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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.

Official Title
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Cocaine Use Reduction With Buprenorphine (CURB)

Conditions
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Cocaine Dependence

Intervention / Treatment
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* Drug: Buprenorphine + Naltrexone
* Drug: Placebo + Naltrexone


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BUP4+XR-NTX<br>4mg buprenorphine plus naltrexone for 8 weeks of treatment | Drug: Buprenorphine + Naltrexone<br>* Following a successful naloxone challenge, induction onto extended-release naltrexone by injection (Vivitrol®), and a final assessment of eligibility, participants will be randomly assigned to one of the three conditions: 4mg buprenorphine plus naltrexone, 16 mg buprenorphine plus naltrexone, or placebo plus naltrexone for 8 weeks of treatment. Random assignment will be on a 1:1:1 ratio to one of three conditions. Randomization will be stratified according to site and opioid use levels.<br>* Other names: extended release injectable naltrexone;|
| Experimental: BUP16+XR-NTX<br>16mg buprenorphine plus naltrexone for 8 weeks of treatment | Drug: Buprenorphine + Naltrexone<br>* Following a successful naloxone challenge, induction onto extended-release naltrexone by injection (Vivitrol®), and a final assessment of eligibility, participants will be randomly assigned to one of the three conditions: 4mg buprenorphine plus naltrexone, 16 mg buprenorphine plus naltrexone, or placebo plus naltrexone for 8 weeks of treatment. Random assignment will be on a 1:1:1 ratio to one of three conditions. Randomization will be stratified according to site and opioid use levels.<br>* Other names: extended release injectable naltrexone;|
| Active Comparator: PLB+XR-NTX<br>naltrexone for 8 weeks of treatment | Drug: Placebo + Naltrexone<br>* Following a successful naloxone challenge, induction onto extended-release naltrexone by injection (Vivitrol®), and a final assessment of eligibility, participants will be randomly assigned to one of the three conditions: 4mg buprenorphine plus naltrexone, 16 mg buprenorphine plus naltrexone, or placebo plus naltrexone for 8 weeks of treatment. Random assignment will be on a 1:1:1 ratio to one of three conditions. Randomization will be stratified according to site and opioid use levels.<br>* Other names: extended release injectable naltrexone;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cocaine Use Days as Measured by Self-report, Corroborated by Thrice-weekly Urine Drug Screens | Self-reported days of cocaine use corroborated with urine drug screens (UDS). | final 30 days of Treatment Phase, study days 25-54 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cocaine-Related disorders, Cocaine, Substance-Related disorders, Opioid abuse, Opioid dependence, abuse, addiction, treatment, buprenorphine, naltrexone, Suboxone, Vivitrol