Trial · NCT04464980
Optimizing Retention, Duration and Discontinuation Strategies for Opioid Use Disorder Pharmacotherapy (RDD)
NCT04464980, Phase 2, Active not recruiting, NYU Langone Health
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Optimizing Retention, Duration and Discontinuation Strategies for Opioid Use Disorder Pharmacotherapy (RDD). Trials, record NCT04464980. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04464980
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Optimizing Retention, Duration and Discontinuation Strategies for Opioid Use Disorder Pharmacotherapy (RDD)
- NCT number
- NCT04464980
- Status
- Active not recruiting
- Phases
- Phase 2
- Enrollment
- 1,516 participants, actual
- Lead sponsor
- NYU Langone Health
- Conditions
- Opioid Use Disorder (OUD)
- Interventions
- SL-BUP, XR-BUP, XR-NTX, MM, MMR, MMD
- First posted
- 2020-07-09
- Last updated
- 2026-11-10
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Retention: Continuous retention in MOUD treatment through 26 weeks | Retention: from randomization through week 26 | Binary (yes/no). Continuously enrolled in maintenance treatment on one or more of the evidence-based MOUD modalities (e.g., SL-BUP, XR-BUP, XR-NTX, or methadone maintenance) with no more than a 28-day gap on MOUD over the 26-week period. |
| Primary | Discontinuation: Completed Discontinuation without Relapse | Discontinuation: from randomization through week 24 follow up | Binary (yes/no). Discontinuing MOUD during the taper period, no return to MOUD, and no relapse to opioid use, either during the taper (up to 48 weeks for those entering on BUP or 24 weeks for those entering on XR-NTX) or during the 24 weeks after MOUD is discontinued. |
| Secondary | Retention KS1: Weekly opioid abstinence | Retention: from randomization through week 26 | Weekly opioid abstinence (measured by Timeline Followback, not contradicted by toxicology test). Repeated yes/no measure for each of weeks 1 through 26. |
| Secondary | Retention KS2: Treatment effectiveness | Retention: at week 26 | Retention treatment effectiveness, measured by the Treatment Effectiveness Assessment (TEA, Ling et. al, 2012); a brief instrument to assess patient progress in treatment and recovery along 4 domains (substance use, health, lifestyle and community) at week 26. |
| Secondary | Retention KS3: Treatment by baseline severity | Retention: at week 26 | Treatment by baseline severity interaction where severity is indicated by the randomization stratum injection use (yes/no). |
| Secondary | Discontinuation KS1: Completed Discontinuation | Discontinuation: from randomization through week 24 follow up | Completed Discontinuation without regard to relapse status |
| Secondary | Discontinuation KS2: Relapse | Discontinuation: from randomization through week 24 follow up | Relapse - separate binary outcome without regard to discontinuation status |
| Secondary | Discontinuation KS3: Safety | Discontinuation: from randomization through week 24 follow up | Safety outcomes (binary, any one or more occurrences): overdoses, all non-fatal plus fatal. |
| Secondary | Discontinuation KS4: Treatment effectiveness | Discontinuation: at end of taper (EoT) and week 24 follow up | Discontinuation treatment effectiveness, measured by the Treatment Effectiveness Assessment (TEA, Ling et. al, 2012); a brief instrument to assess patient progress in treatment and recovery along 4 domains (substance use, health, lifestyle and community) at week 24. Measured at the end of taper (EOT): up to 24 weeks for tapers with XR-NTX and up to 48 weeks for tapers with BUP; and at the week 24 follow up (primary outcome timepoint). |
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.
Papers2
The papers the trial lists on ClinicalTrials.gov.
Grants2
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 | Source |
|---|---|---|---|---|---|---|
| UG1DA013035 | NIDA Clinical Trials Network: New York Node - Renewal-GY24 | MCNEELY, JENNIFER; CAMPBELL, AIMEE N; NUNES, EDWARD V. | NEW YORK UNIVERSITY SCHOOL OF MEDICINE | NATIONAL INSTITUTE ON DRUG ABUSE | 2015 to 2025 | NIH RePORTER |
| UG1DA015831 | CTN New England Consortium Node | D'ONOFRIO, GAIL; WEISS, ROGER D. | YALE UNIVERSITY | NATIONAL INSTITUTE ON DRUG ABUSE | 2015 to 2025 | 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.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license 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/NCT04464980
GET https://conductscience.org/api/trials/v1/NCT04464980/registered