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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 is a Phase 4 study that has completed, run by NYU Langone Health. The registered enrollment target is 675 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04219540
The ClinicalTrials.gov registry entry for NCT04219540 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 675 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is NYU Langone Health, which has 1,164 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which XR-NTX is the first listed.
NCT04219540 reports 0 study locations.
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.
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