Cocaine Use Reduction With Buprenorphine (CURB)

October 1, 2021 updated by: University of California, Los Angeles

Cocaine Use Reduction With Buprenorphine (CURB)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

302

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90025
        • UCLA Integrated Substance Abuse Programs (ISAP)
      • San Francisco, California, United States, 94102
        • Bay Area Addiction Research and Treatment (BAART)
    • Colorado
      • Denver, Colorado, United States, 80206
        • Addiction Research and Treatment Services (ARTS)
    • District of Columbia
      • Washington, District of Columbia, United States, 20060
        • Howard University Hospital
    • Georgia
      • Atlanta, Georgia, United States, 30345
        • Atlanta VA Medical Center
    • New York
      • Bronx, New York, United States, 10461
        • Albert Einstein College of Medicine - Division of Substance Abuse
      • New York, New York, United States, 10016
        • Bellevue Hospital Center
    • Ohio
      • Columbus, Ohio, United States, 43207
        • Maryhaven
    • Oregon
      • Portland, Oregon, United States, 97214
        • CODA, Inc.
    • Texas
      • San Antonio, Texas, United States, 78229
        • South Texas Veterans Health Care System
    • Washington
      • Seattle, Washington, United States, 98122
        • Recovery Centers of King County (RCKC)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: BUP4+XR-NTX
4mg buprenorphine plus naltrexone for 8 weeks of treatment
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.
Other Names:
  • Vivitrol
  • Suboxone
  • buprenorphine/naloxone
  • extended release injectable naltrexone
EXPERIMENTAL: BUP16+XR-NTX
16mg buprenorphine plus naltrexone for 8 weeks of treatment
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.
Other Names:
  • Vivitrol
  • Suboxone
  • buprenorphine/naloxone
  • extended release injectable naltrexone
ACTIVE_COMPARATOR: PLB+XR-NTX
naltrexone for 8 weeks of treatment
Drug: 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.
Other Names:
  • Vivitrol
  • extended release injectable naltrexone

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, Los Angeles

Collaborators

National Institute on Drug Abuse (NIDA)
The Emmes Company, LLC

Investigators

  • Principal Investigator: Andrew J. Saxon, M.D., VA Puget Sound Health Care System
  • Principal Investigator: Larissa J. Mooney, M.D., University of California, Los Angeles

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2011

Primary Completion (ACTUAL)

January 1, 2013

Study Completion (ACTUAL)

March 1, 2013

Study Registration Dates

First Submitted

July 25, 2011

First Submitted That Met QC Criteria

July 25, 2011

First Posted (ESTIMATE)

July 26, 2011

Study Record Updates

Last Update Posted (ACTUAL)

October 29, 2021

Last Update Submitted That Met QC Criteria

October 1, 2021

Last Verified

June 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NIDA-CTN-0048
  • U10DA013045 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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