Extended-Release Naltrexone and Monthly Extended-Release Buprenorphine for Cocaine Use Disorder (CURB-2)

Description

This is an 8-week, double-blind, randomized placebo-controlled trial of the efficacy of a combination of extended-release naltrexone (XR-NTX) and extended-release buprenorphine (XR-BUP) compared to matched placebo injections (PBO-Inj) for the treatment of cocaine use disorder (CUD).

Conditions

Cocaine Use Disorder

Study Overview

Study Details

Study overview

This is an 8-week, double-blind, randomized placebo-controlled trial of the efficacy of a combination of extended-release naltrexone (XR-NTX) and extended-release buprenorphine (XR-BUP) compared to matched placebo injections (PBO-Inj) for the treatment of cocaine use disorder (CUD).

Randomized, Placebo-Controlled Trial of Extended-Release Naltrexone and Monthly Extended-Release Buprenorphine for Cocaine Use Disorder (CURB-2)

Extended-Release Naltrexone and Monthly Extended-Release Buprenorphine for Cocaine Use Disorder (CURB-2)

Condition
Cocaine Use Disorder
Intervention / Treatment

-

Contacts and Locations

Birmingham

University of Alabama at Birmingham, Birmingham, Alabama, United States, 35209

Little Rock

University of Arkansas for Medical Sciences, Little Rock, Arkansas, United States, 72205

Los Angeles

UCLA Vine Street Clinic, Los Angeles, California, United States, 90038

San Francisco

Center on Substance Use and Health (CSUH), San Francisco, California, United States, 94102

Tampa

Cove Behavioral Health, Tampa, Florida, United States, 33605

Chicago

University of Illinois at Chicago, Chicago, Illinois, United States, 60608

Chicago

University of Chicago, Chicago, Illinois, United States, 60637

Baltimore

Mountain Manor Treatment Center, Baltimore, Maryland, United States, 21229

Minneapolis

Berman Center for Outcomes and Clinical Research at Hennepin Healthcare, Minneapolis, Minnesota, United States, 55404

New York

Addictions Institute of Mount Sinai, New York, New York, United States, 10029

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.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • 1. Be 18 to 65 years of age;
  • 2. Be interested in reducing or stopping cocaine use.
  • 3. Be willing to comply with all study procedures and medication instructions.
  • 1. Have any condition for which, in the opinion of the site investigator or designee, study participation would not be in their best interest or that could prevent, limit, or confound the protocol-specified assessments.

Ages Eligible for Study

18 Years to 65 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

University of Texas Southwestern Medical Center,

Madhukar Trivedi, MD, PRINCIPAL_INVESTIGATOR, UT Southwestern Medical Center

Study Record Dates

2026-09