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NCT04219540 · ClinicalTrials.gov registry record · Phase 4
Long-acting Buprenorphine vs. Naltrexone Opioid Treatments in CJS-involved Adults
A Phase 4 study, sponsored by NYU Langone Health.
- Completed
- Registry status
- Phase 4
- Development phase
- 675
- Enrollment target
NCT04219540: Completed Phase 4 study, sponsored by NYU Langone Health.
NCT04219540 is a Phase 4 study that has completed, run by NYU Langone Health. The registered enrollment target is 675 participants, above the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (30% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04219540, a Phase 4 study, has completed, sponsored by NYU Langone Health.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 675 participants
- Enrollment target
Study Summary
This study seeks to compare the effectiveness of two medications used to treat opioid use disorder, extended-release buprenorphine (XR-B) vs. extended-release naltrexone (XR-NTX), among adults currently incarcerated in U.S. jails and prisons at 5 distinct trial sites. This open-label, non-inferiority, head-to-head study design will offer providers, correctional and public health authorities, payers and policy makers' timely and relevant data to assess the effectiveness of XR-B (and XR-NTX) as potentially useful re-entry and relapse prevention treatment options. It is hypothesized that XR-B is non-inferior to XR-NTX when comparing retention-in-study-medication treatment options.
Primary Outcome
The primary outcome measure is retention-in-study-medication-treatment post-release during weeks 1-24; retention is defined as the proportion of scheduled study medication injections received. The total score ranges from 0-6 and is scored as following: less than 6 XR-B injections will contribute to lower retention (\<5 of 6), and 7+ XR-NTX will contribute only to maximum retention (6 of 6).
Interventions
- DRUG XR-NTX
- DRUG XR-B (SUBLOCADETM)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 675 participants |
| Start Date | 2021-01-07 |
| Est. Completion | 2025-02-28 |
| Phase | Phase 4 |
What the finished NCT04219540 record still lists
NCT04219540 is an interventional study that assigns participants to a tested intervention. The registered 675 participants enrollment target is mid-sized for trials with a published cap, above the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (30% higher).
The record links to 0 conditions, and to 2 interventions - of which XR-NTX is the first listed.
NCT04219540 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04219540 about?
NCT04219540 is a clinical study titled "Long-acting Buprenorphine vs. Naltrexone Opioid Treatments in CJS-involved Adults". This study seeks to compare the effectiveness of two medications used to treat opioid use disorder, extended-release buprenorphine (XR-B) vs. extended-release naltrexone (XR-NTX), among adults currently incarcerated in U.S. jails and prisons at 5 distinct trial sites. This open-label, non-inferiorit...
What is the current status of trial NCT04219540?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 675 participants. The study started on 2021-01-07. Estimated completion is 2025-02-28.
What interventions are being tested in trial NCT04219540?
The interventions under investigation include: XR-NTX (DRUG), XR-B (SUBLOCADETM) (DRUG).
Who is sponsoring clinical trial NCT04219540?
This trial is sponsored by NYU Langone Health, which has 1,164 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04219540's enrollment target sits among peer trials
675 119th of 2000 higher than 1,882 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 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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