Trial · NCT05262270
Extended-Release Naltrexone and Monthly Extended-Release Buprenorphine for Cocaine Use Disorder (CURB-2)
NCT05262270, Phase 2, Completed, University of Texas Southwestern Medical Center
3 sourcestrials-2026-11-12-0.4.0
Cite this record
ConductScience Library. Extended-Release Naltrexone and Monthly Extended-Release Buprenorphine for Cocaine Use Disorder (CURB-2). Trials, record NCT05262270. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05262270
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Extended-Release Naltrexone and Monthly Extended-Release Buprenorphine for Cocaine Use Disorder (CURB-2)
- NCT number
- NCT05262270
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 427 participants, actual
- Lead sponsor
- University of Texas Southwestern Medical Center
- Conditions
- Cocaine Use Disorder
- Interventions
- Extended-Release Naltrexone, Extended Release Buprenorphine, Placebo (PLB) Injectable matched to XR-NTX, Placebo (PLB) Injectable matched to XR-BUP
- First posted
- 2022-03-02
- Last updated
- 2025-10-21
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Proportion of Cocaine-negative UDS | Week 5 up to Week 8 | 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. |
| Secondary | Number of participants who Self-report cocaine use | 8 Weeks | Self-report elicited through Timeline Followback (TLFB) on days of cocaine use during Weeks 0-8; |
| Secondary | Mean self reported cocaine craving score | 8 Weeks | Cocaine craving as measured by the Visual Analog Craving Scales (VAS) during Weeks 0-8. Possible scores range from 0 to 100, with higher scores indicating worse craving. |
| Secondary | Measures of safety (adverse events) | 8 weeks | Number and severity of adverse events reported during Weeks 0-8; Number and outcomes (non-fatal and fatal) of overdose events during Weeks 0-8 |
| Secondary | Mean self reported overall functioning | Week 8 | Self-report overall functioning as measured by the Treatment Effectiveness Assessment (TEA) at Week 8. Possible scores range from 1 to 10 for each of the 4 domains, with higher scores indicating better outcome. |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers11
The papers the trial lists on ClinicalTrials.gov.
Grants1
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| UG1DA020024 | NIDA Clinical Trials Network: Big South/West Node | TRIVEDI, MADHUKAR H.; SHOPTAW, STEVEN J | UT SOUTHWESTERN MEDICAL CENTER | NATIONAL INSTITUTE ON DRUG ABUSE | 2015 to 2025 |
Source NIH RePORTER
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Source
- Release
- trials-2026-11-12-0.4.0
- Release manifest SHA-256
- 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4
- Registry capture
- 2026-11-12
- Results copy, AACT
- 2026-03-23
- NIH clinical studies file
- 2026-11-13
Source ClinicalTrials.gov
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNone stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT05262270
GET https://conductscience.org/api/trials/v1/NCT05262270/registered