Trial · NCT05164549
Extended-release Pharmacotherapy for Opioid Use Disorder
NCT05164549, Phase 3, Completed, King's College London
3 sourcestrials-2026-11-12-0.4.0
Cite this record
ConductScience Library. Extended-release Pharmacotherapy for Opioid Use Disorder. Trials, record NCT05164549. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05164549
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Extended-release Pharmacotherapy for Opioid Use Disorder
- NCT number
- NCT05164549
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 342 participants, actual
- Lead sponsor
- King's College London
- Conditions
- Opiate Substitution Treatment
- Interventions
- Buprenorphine Injectable Product, Methadone, Buprenorphine
- First posted
- 2021-12-20
- Last updated
- 2024-01-19
Source ClinicalTrials.gov
Registered outcomes24
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Count of days abstinent From illicit/non-medical opioids during weeks 2 to 24 (range: 0-161 days) | 24 weeks | Combining self-report information from Time-Line Follow-Back interview adapted from the Treatment Outcomes Profile and incorporating data from 12 scheduled urine drug screens. |
| Secondary | Clinical superiority of XR-Bup plus PSI versus Bup/Met plus PSI | 24 weeks | Number of days abstinent from cocaine Days 8 - 168 Number of days abstinent from Benzodiazepines Days 8 - 168 Longest time in days continuously abstinent from heroin Days 8 - 168 Longest time in days continuously abstinent from cocaine Days 8 - 168 Longest time in days continuously abstinent from Benzodiazepines Days 8 - 168 |
| Secondary | Cost-effectiveness of XR-BUP versus Bup and Met | 24 weeks | Based on the incremental cost per quality-adjusted life year (QALY) gained. |
| Secondary | Safety of XR-Bup | 24 weeks | Number of safety events from study enrolment to 24 weeks |
| Secondary | Time (days) enrolled in study treatment (retention) to week 24 | 24 weeks | |
| Secondary | OUD remission status (DSM5 OUD severity; SCID-5-RV) | 24 weeks | |
| Secondary | Clinician rating of severity, complexity and recovery strengths: ADAPT | 24 weeks | |
| Secondary | Clinician global impression of severity and improvement): CGI-S/I; | 24 weeks | |
| Secondary | Count of days abstinent from cocaine and illicit/non-medical benzodiazepines | 24 weeks | During weeks 2 to 24 (range: 0-161 days); combining self-report information from Time-Line Follow-Back interview adapted from the Treatment Outcomes Profile and incorporating data from 12 scheduled urine drug screens |
| Secondary | Frequency of opioid (H) and cocaine (C) craving experience: CEQ-F(H) and CEQ-F(C) | 24 weeks |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 registered outcomesOutcomes0
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.
Papers2
The papers the trial lists on ClinicalTrials.gov.
Grants0
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.
None in this release.
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/NCT05164549
GET https://conductscience.org/api/trials/v1/NCT05164549/registered?page=2