CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 427 enrolled
Drug / intervention
Extended-Release Naltrexone +3 moredrug
Likely dose
Extended-Release Naltrexone 380mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05262270
NCT05262270Phase 2Completed
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Randomized, Placebo-Controlled Trial of Extended-Release Naltrexone and Monthly Extended-Release Buprenorphine for Cocaine Use Disorder (CURB-2)

University of Texas Southwestern Medical Center·interventional·Posted Mar 2, 2022·Updated Oct 21, 2025

In Brief

A Phase 2 clinical trial evaluating Extended-Release Naltrexone, Extended Release Buprenorphine, and 2 other interventions for Cocaine Use Disorder. Completed, enrolled 427 participants across 12 sites.

Detailed 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 matched placebo injections (PBO-Inj) for the treatment of cocaine use disorder (CUD).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCocaine Use Disorder
CountriesUnited States
CollaboratorsNational Institute on Drug Abuse (NIDA)

Timeline

Phase 2CompletedFinished
2023202420252026
First PostedMar 2, 2022
Enrollment StartApr 18, 2023
Primary CompletionJun 27, 2025
Study CompletionJul 21, 2025
TodayJul 2, 2026
Enrollment to primary: 2.2 yearsPosted 4.3 years ago

Interventions

Extended-Release Naltrexonedrug

XR-NTX (Extended-Release Naltrexone) doses of 380mg (Weeks 0, 3 and 6) via intramuscular (IM) injections in the gluteus.

Extended Release Buprenorphinedrug

Extended-Release buprenorphine (XR-BUP) two doses of 300mg XR-BUP (Weeks 0, 4) via subcutaneous injections in the abdomen. Option for 100mg at Weeks 3 and 6 (if needed to alleviate side effects).

Placebo (PLB) Injectable matched to XR-NTXdrug

3 doses of intramuscular injections (Week 0, 3, 6)

Placebo (PLB) Injectable matched to XR-BUPdrug

2 doses of subcutaneous injections (Week 0, 4)