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NCT05262270 · ClinicalTrials.gov registry record · Phase 2
Extended-Release Naltrexone and Monthly Extended-Release Buprenorphine for Cocaine Use Disorder (CURB-2)
A Phase 2 study, sponsored by University of Texas Southwestern Medical Center.
- Completed
- Registry status
- Phase 2
- Development phase
- 427
- Enrollment target
NCT05262270: Completed Phase 2 study, sponsored by University of Texas Southwestern Medical Center.
NCT05262270 is a Phase 2 study that has completed, run by University of Texas Southwestern Medical Center. The registered enrollment target is 427 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (221% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05262270, a Phase 2 study, has completed, sponsored by University of Texas Southwestern Medical Center.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 427 participants
- Enrollment target
Study 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).
Primary Outcome
The primary outcome measure is the proportion of cocaine-negative UDS obtained during Weeks 5 through 8 of the medication phase as measured for the XR-NTX + XR-BUP and PBO-Inj conditions. The primary outcome (UDS) has been chosen because it is an objective measure of cocaine use and was the outcome showing significant improvement over placebo in the original CURB trial.
Interventions
- DRUG Extended Release Buprenorphine
- DRUG Extended-Release Naltrexone
- DRUG Placebo (PLB) Injectable matched to XR-NTX
- DRUG Placebo (PLB) Injectable matched to XR-BUP
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 427 participants |
| Start Date | 2023-04-18 |
| Est. Completion | 2025-07-21 |
| Phase | Phase 2 |
What the finished NCT05262270 record still lists
NCT05262270 is an interventional study that assigns participants to a tested intervention. The registered 427 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (221% higher).
The record links to 0 conditions, and to 4 interventions - of which Extended Release Buprenorphine is the first listed.
NCT05262270 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05262270 about?
NCT05262270 is a clinical study titled "Extended-Release Naltrexone and Monthly Extended-Release Buprenorphine for Cocaine Use Disorder (CURB-2)". 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).
What is the current status of trial NCT05262270?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 427 participants. The study started on 2023-04-18. Estimated completion is 2025-07-21.
What interventions are being tested in trial NCT05262270?
The interventions under investigation include: Extended Release Buprenorphine (DRUG), Extended-Release Naltrexone (DRUG), Placebo (PLB) Injectable matched to XR-NTX (DRUG), Placebo (PLB) Injectable matched to XR-BUP (DRUG).
Who is sponsoring clinical trial NCT05262270?
This trial is sponsored by University of Texas Southwestern Medical Center, which has 837 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05262270's enrollment target sits among peer trials
427 91st of 2000 higher than 1,910 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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