Cocaine Use Reduction With Buprenorphine

Phase 2

Completed

• Conditions: Cocaine Dependence
• Interventions: Drug: Buprenorphine + Naltrexone; Drug: Placebo + Naltrexone

• Registration Number: NCT01402492
• Lead Sponsor: University of California, Los Angeles

Brief 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.

Detailed Description

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2011-07-25
• Study First Submitted QC: 2011-07-25
• Study First Posted: 2011-07-26
• Study Start: 2011-09
• Primary Completion: 2013-01
• Study Completion: 2013-03
• Results First Submitted: 2016-11-09
• Status Verified: 2021-06
• Results First Submitted QC: 2021-10-01
• Last Update Submitted: 2021-10-01
• Results First Posted: 2021-10-29
• Last Update Posted: 2021-10-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 302

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
BUP4+XR-NTX	Buprenorphine + Naltrexone	4mg buprenorphine plus naltrexone for 8 weeks of treatment
BUP16+XR-NTX	Buprenorphine + Naltrexone	16mg buprenorphine plus naltrexone for 8 weeks of treatment
PLB+XR-NTX	Placebo + Naltrexone	naltrexone for 8 weeks of treatment

Primary Outcome Measures

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

Trial Locations

Locations (11)

Bay Area Addiction Research and Treatment (BAART); 🇺🇸 San Francisco, California, United States

Addiction Research and Treatment Services (ARTS); 🇺🇸 Denver, Colorado, United States

Maryhaven; 🇺🇸 Columbus, Ohio, United States

South Texas Veterans Health Care System; 🇺🇸 San Antonio, Texas, United States

Atlanta VA Medical Center; 🇺🇸 Atlanta, Georgia, United States

Recovery Centers of King County (RCKC); 🇺🇸 Seattle, Washington, United States

UCLA Integrated Substance Abuse Programs (ISAP); 🇺🇸 Los Angeles, California, United States

Albert Einstein College of Medicine - Division of Substance Abuse; 🇺🇸 Bronx, New York, United States

Bellevue Hospital Center; 🇺🇸 New York, New York, United States

CODA, Inc.; 🇺🇸 Portland, Oregon, United States

Howard University Hospital; 🇺🇸 Washington, District of Columbia, United States