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NCT01999946 · ClinicalTrials.gov registry record · Phase 4
Extended-Release Naltrexone Opioid Treatment at Jail Re-Entry
A Phase 4 study, sponsored by NYU Langone Health.
- Completed
- Registry status
- Phase 4
- Development phase
- 217
- Enrollment target
NCT01999946 is a Phase 4 study that has completed, run by NYU Langone Health. The registered enrollment target is 217 participants.
The verdict
NCT01999946, a Phase 4 study, has completed, sponsored by NYU Langone Health.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 217 participants
- Enrollment target
Study Summary
The purpose of this study is to compare the effectiveness of extended-release naltrexone (XR-NTX) vs. enhanced treatment-as-usual (TAU) among opioid dependent adults leaving NYC jails. In parallel, we propose to recruit a matched, quasi-experimental methadone cohort, which will result in a naturalistic comparison of XR-NTX vs. an established jail-based methadone treatment program standard-of-care. Our primary aim is to compare time-to-relapse among participants treated with XR-NTX vs. randomized TAU controls and time-to-relapse among XR-NTX arm vs. jail-based MTP participants, following release from jail. Secondary aims will compare related opioid treatment outcomes post-release across all arms.
Interventions
- DRUG Extended-Release Naltrexone
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 217 participants |
| Start Date | 2014-06-27 |
| Est. Completion | 2020-12-24 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01999946
The ClinicalTrials.gov registry entry for NCT01999946 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 217 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 1 intervention - of which Extended-Release Naltrexone is the first listed.
NCT01999946 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01999946 about?
NCT01999946 is a clinical study titled "Extended-Release Naltrexone Opioid Treatment at Jail Re-Entry". The purpose of this study is to compare the effectiveness of extended-release naltrexone (XR-NTX) vs. enhanced treatment-as-usual (TAU) among opioid dependent adults leaving NYC jails. In parallel, we propose to recruit a matched, quasi-experimental methadone cohort, which will result in a naturalis...
What is the current status of trial NCT01999946?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 217 participants. The study started on 2014-06-27. Estimated completion is 2020-12-24.
What interventions are being tested in trial NCT01999946?
The interventions under investigation include: Extended-Release Naltrexone (DRUG).
Who is sponsoring clinical trial NCT01999946?
This trial is sponsored by NYU Langone Health, which has 1,164 total clinical trials registered on ClinicalTrials.gov.
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