Status:
COMPLETED
Extended-Release Naltrexone and Monthly Extended-Release Buprenorphine for Cocaine Use Disorder (CURB-2)
Lead Sponsor:
University of Texas Southwestern Medical Center
Collaborating Sponsors:
National Institute on Drug Abuse (NIDA)
Conditions:
Cocaine Use Disorder
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief Summary
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 ma...
Detailed Description
The primary objective of this study is to assess the efficacy of XR-NTX plus XR-BUP as a combination pharmacotherapy for CUD. Approximately four hundred and twenty-six adults will be randomized into t...
Eligibility Criteria
Inclusion
- Individuals must meet all of the inclusion criteria and no exclusion criteria in order to be eligible to participate in the study, including but not limited to:
- Be 18 to 65 years of age;
- Be interested in reducing or stopping cocaine use.
- Be willing to comply with all study procedures and medication instructions.
Exclusion
- 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.
Key Trial Info
Start Date :
April 18 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 21 2025
Estimated Enrollment :
427 Patients enrolled
Trial Details
Trial ID
NCT05262270
Start Date
April 18 2023
End Date
July 21 2025
Last Update
October 21 2025
Active Locations (12)
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1
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35209
2
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States, 72205
3
UCLA Vine Street Clinic
Los Angeles, California, United States, 90038
4
Center on Substance Use and Health (CSUH)
San Francisco, California, United States, 94102