Combination treatment for cocaine use disorder

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

This study is testing if a combination of two medications can help adults with cocaine addiction feel better over an 8-week period.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 426 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: University of Texas Southwestern Medical Center (Academic / other)
• Locations: 12 sites (Birmingham, Alabama and 11 other locations)
• Trial ID: NCT05262270 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the effectiveness of a combination of extended-release naltrexone and extended-release buprenorphine for treating cocaine use disorder. It involves approximately 426 adults who will be randomized to receive either the active medication or a placebo over an 8-week period. Participants will undergo a screening phase followed by a medication induction phase and regular assessments to monitor their progress. The study aims to determine if this combination therapy can improve outcomes for individuals struggling with cocaine addiction.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 65 who are interested in reducing or stopping their cocaine use.

Not a fit: Patients with conditions that may confound the study assessments or those for whom participation is not in their best interest will not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new effective option for individuals with cocaine use disorder.

How similar studies have performed: Other studies have shown promise with similar pharmacotherapy approaches for substance use disorders, indicating potential for success in this trial.

Eligibility criteria

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:

Inclusion 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.

Exclusion Criteria:

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.

Where this trial is running

Birmingham, Alabama and 11 other locations

• University of Alabama at Birmingham — Birmingham, Alabama, United States (Terminated)
• University of Arkansas for Medical Sciences — Little Rock, Arkansas, United States (Recruiting)
• UCLA Vine Street Clinic — Los Angeles, California, United States (Recruiting)
• Center on Substance Use and Health (CSUH) — San Francisco, California, United States (Recruiting)
• Cove Behavioral Health — Tampa, Florida, United States (Recruiting)
• University of Illinois at Chicago — Chicago, Illinois, United States (Recruiting)
• University of Chicago — Chicago, Illinois, United States (Recruiting)
• Mountain Manor Treatment Center — Baltimore, Maryland, United States (Recruiting)
• Berman Center for Outcomes and Clinical Research at Hennepin Healthcare — Minneapolis, Minnesota, United States (Recruiting)
• Addictions Institute of Mount Sinai — New York, New York, United States (Recruiting)
• UTSW Medical Center, Center for Depression Research and Clinical Care — Dallas, Texas, United States (Recruiting)
• University of Texas Health San Antonio — San Antonio, Texas, United States (Terminated)

Study contacts

• Principal investigator: Madhukar Trivedi, MD — UT Southwestern Medical Center
• Study coordinator: Madhukar H Trivedi, MD

Conditions Cocaine Use Disorder; Naltrexone; Buprenorphine; Extended release injectable Naltrexone; Extended release injectable Buprenorphine; CUD; Cocaine; Cocaine Abuse