Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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: Completed Phase 4 study, sponsored by NYU Langone Health.
NCT01999946 is a Phase 4 study that has completed, run by NYU Langone Health. The registered enrollment target is 217 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (58% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Our primary aim is to compare time-to-relapse among participants treated with XR-NTX vs. randomized ETAU following release from jail measured up to 24 weeks by Urine Toxicology results and self-report on the TLFB.
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 |
What the finished NCT01999946 record still lists
NCT01999946 is an interventional study that assigns participants to a tested intervention. The registered 217 participants enrollment target is mid-sized for trials with a published cap, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (58% lower).
The record links to 0 conditions, and to 1 intervention - of which Extended-Release Naltrexone is the first listed.
NCT01999946 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01999946's enrollment target sits among peer trials
217 393rd of 2000 higher than 1,608 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
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT05079282 · 217 participants · Phase 1
Study of ONO-4685 in Patients With Relapsed or Refractory T Cell Lymphoma
- NCT05470439 · 217 participants · NA
My Interprofessional Care Team for Adherence and Research Engagement Disparities
- NCT05981703 · 217 participants · Phase 1
A Study Investigating BGB-26808 Alone or in Combination With Tislelizumab in Participants With Advanced Solid Tumors
- NCT06342258 · 217 participants · Phase 1
COES: Curing Order Effects on Sealants
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI