Cocaine Use Reduction With Buprenorphine (CURB)

University of California, Los Angeles (UCLA)

Status and phase: Completed; Phase 3; Phase 2

Conditions: Cocaine Dependence

Treatments: Drug: Placebo + Naltrexone; Drug: Buprenorphine + Naltrexone

Study type: Interventional

Funder types: Other; Industry; NIH

Identifiers

NCT01402492

U10DA013045 (U.S. NIH Grant/Contract)

NIDA-CTN-0048

Details and patient eligibility

About

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.

Full 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.

Enrollment: 302 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

302 participants in 3 patient groups

BUP4+XR-NTX

Experimental group

Description:

4mg buprenorphine plus naltrexone for 8 weeks of treatment

Treatment:

Drug: Buprenorphine + Naltrexone

BUP16+XR-NTX

Experimental group

Description:

16mg buprenorphine plus naltrexone for 8 weeks of treatment

Treatment:

Drug: Buprenorphine + Naltrexone

PLB+XR-NTX

Active Comparator group

Description:

naltrexone for 8 weeks of treatment

Treatment:

Drug: Placebo + Naltrexone