Clinical trial NCT01402492: Cocaine Use Reduction With Buprenorphine
Official title: Cocaine Use Reduction With Buprenorphine (CURB)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Cocaine Dependence
Keywords: Cocaine-Related disorders
Cocaine
Substance-Related disorders
Opioid abuse
Opioid dependence
abuse
addiction
treatment
buprenorphine
naltrexone
Suboxone
Vivitrol
Lead sponsor: University of California, Los Angeles
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
name: The Emmes Company, LLC
First posted: 2011-07-26
Enrollment: 302
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Cocaine Use Days as Measured by Self-report, Corroborated by Thrice-weekly Urine Drug Screens
timeFrame: final 30 days of Treatment Phase, study days 25-54
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: UCLA Integrated Substance Abuse Programs (ISAP)
state: California
city: San Francisco
country: United States
facility: Bay Area Addiction Research and Treatment (BAART)
state: California
city: Denver
country: United States
facility: Addiction Research and Treatment Services (ARTS)
state: Colorado
city: Washington
country: United States
facility: Howard University Hospital
state: District of Columbia
city: Atlanta
country: United States
facility: Atlanta VA Medical Center
state: Georgia
city: Bronx
country: United States
facility: Albert Einstein College of Medicine - Division of Substance Abuse
state: New York
city: New York
country: United States
facility: Bellevue Hospital Center
state: New York
city: Columbus
country: United States
facility: Maryhaven
state: Ohio
city: Portland
country: United States
facility: CODA, Inc.
state: Oregon
city: San Antonio
country: United States
facility: South Texas Veterans Health Care System
state: Texas
city: Seattle
country: United States
facility: Recovery Centers of King County (RCKC)
state: Washington
Study officials:
affiliation: University of California, Los Angeles
name: Walter Ling, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: VA Puget Sound Health Care System
name: Andrew J. Saxon, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: University of California, Los Angeles
name: Larissa J. Mooney, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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. Buprenorphine + naloxone plus naltrexone for the treatment of cocaine dependence: the Cocaine Use Reduction with Buprenorphine (CURB) study. Addiction. 2016 Aug;111(8):1416-27. doi: 10.1111/add.13375. Epub 2016 Apr 21.
citation: Mooney LJ, Nielsen S, Saxon A, Hillhouse M, Thomas C, Hasson A, Stablein D, McCormack J, Lindblad R, Ling W. Cocaine use reduction with buprenorphine (CURB): rationale, design, and methodology. Contemp Clin Trials. 2013 Mar;34(2):196-204. doi: 10.1016/j.cct.2012.11.002. Epub 2012 Nov 16.