Extended-Release Naltrexone and Monthly Extended-Release Buprenorphine for Cocaine Use Disorder (CURB-2)
Key facts
- Who runs it
- University of Texas Southwestern Medical Center
- Where
- Baltimore, Birmingham, Chicago, Dallas, Little Rock, Los Angeles, Minneapolis, New York, San Antonio, San Francisco, and Tampa, United StatesSee the 12 sites
- Trial code
- Status
- Completed
- Phase
- Phase 2
- People taking part
- 427 people enrolled
- Started
- 18 Apr 2023
- Ended
- 21 Jul 2025
- Type of study
- Interventional, 2 groupsOne group gets a placebo (a dummy treatment), for comparison.
- Treatments tested
- Extended-Release Naltrexone
- Extended Release Buprenorphine
- Placebo (PLB) Injectable matched to XR-NTX
- Placebo (PLB) Injectable matched to XR-BUP
- Record updated
- 21 October 2025
Who can take part
- Age
- 18 years to 65 years
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 5 criteriaShow less
Who can take part
- 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
Who cannot take part
- 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
Other 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:
Where in United States
- Mountain Manor Treatment CenterBaltimore, United States
- University of Alabama at BirminghamBirmingham, United States
- University of ChicagoChicago, United States
- University of Illinois at ChicagoChicago, United States
- UTSW Medical Center, Center for Depression Research and Clinical CareDallas, United States
- University of Arkansas for Medical SciencesLittle Rock, United States
- UCLA Vine Street ClinicLos Angeles, United States
- Berman Center for Outcomes and Clinical Research at Hennepin HealthcareMinneapolis, United States
- Addictions Institute of Mount SinaiNew York, United States
- University of Texas Health - San AntonioSan Antonio, United States
- Center on Substance Use and Health (CSUH)San Francisco, United States
- Cove Behavioral HealthTampa, United States
About the trial
What the trial wants to find out
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).
The 2 groups in the trial
- Drug intervention (XR-NTX+XR-BUP)Treatment being tested
The study intervention is three doses of 380mg XR-NTX (Weeks 0, 3 and 6) and two doses of 300mg XR-BUP (Weeks 0, 4). Drug: XR-NTX XR-NTX: 3 intramuscular injections administered Week 0, 3, 6. Other Names: Extended Release Injectable Naltrexone Arm: Experimental Drug: XR-BUP XR-BUP: 2 subcutaneous injections administered Week 0, 4. Other Names: Extended Release Injectable Buprenorphine Arm: Experimental
Treatment: Extended-Release Naltrexone and Extended Release Buprenorphine
- PlaceboPlacebo, for comparison
Matched placebo injections (PBO-Inj) for the treatment of cocaine use disorder (CUD). Drug: Placebo (PLB) Injectable Placebo: 3 intramuscular injections administered Week 0, 3, 6. Other Names: Injectable matching (to XR-NTX) placebo Arm: Placebo Comparator - matched Placebo (PLB) Drug: Placebo (PLB) Injectable Placebo: 2 subcutaneous injections administered Week 0, 4. Other Names: Injectable matching (to XR-BUP) placebo Arm: Placebo Comparator - matched Placebo (PLB)
Treatment: Placebo (PLB) Injectable matched to XR-NTX and Placebo (PLB) Injectable matched to XR-BUP
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Randomized, Placebo-Controlled Trial of Extended-Release Naltrexone and Monthly Extended-Release Buprenorphine for Cocaine Use Disorder (CURB-2)
- Publications
- Record updated
- 21 October 2025