Cocaine Use Reduction With Buprenorphine

Cocaine Dependence Clinical Trial

— CURB  

Official title:

Cocaine Use Reduction With Buprenorphine (CURB)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01402492
• Other study ID #: NIDA-CTN-0048
• Secondary ID: U10DA013045
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: September 2011
• Est. completion date: March 2013

Study information

• Verified date: June 2021
• Source: University of California, Los Angeles
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 302
• Est. completion date: March 2013
• Est. primary completion date: January 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Cocaine Dependence
• Cocaine-Related Disorders

Intervention

Drug:
• Buprenorphine + Naltrexone
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.
• Placebo + Naltrexone
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.

Locations

Country	Name	City	State
United States	Atlanta VA Medical Center	Atlanta	Georgia
United States	Albert Einstein College of Medicine - Division of Substance Abuse	Bronx	New York
United States	Maryhaven	Columbus	Ohio
United States	Addiction Research and Treatment Services (ARTS)	Denver	Colorado
United States	UCLA Integrated Substance Abuse Programs (ISAP)	Los Angeles	California
United States	Bellevue Hospital Center	New York	New York
United States	CODA, Inc.	Portland	Oregon
United States	South Texas Veterans Health Care System	San Antonio	Texas
United States	Bay Area Addiction Research and Treatment (BAART)	San Francisco	California
United States	Recovery Centers of King County (RCKC)	Seattle	Washington
United States	Howard University Hospital	Washington	District of Columbia

Sponsors (3)

Lead Sponsor	Collaborator
University of California, Los Angeles	National Institute on Drug Abuse (NIDA), The Emmes Company, LLC

Country where clinical trial is conducted

United States, 

References & Publications (1)

Ling W, Hillhouse MP, Saxon AJ, Mooney LJ, Thomas CM, Ang A, Matthews AG, Hasson A, Annon J, Sparenborg S, Liu DS, McCormack J, Church S, Swafford W, Drexler K, Schuman C, Ross S, Wiest K, Korthuis PT, Lawson W, Brigham GS, Knox PC, Dawes M, Rotrosen J. B — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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

External Links

•   Clinical Trials Network Dissemination Library Website
•   National Institute on Drug Abuse Clinical Trials Network Website
•   UCLA Integrated Substance Abuse Programs Website