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NCT02445339 · ClinicalTrials.gov registry record · Phase 4
Extended-release Naltrexone and Care Management for Alcohol Dependent Frequent Emergency Department Users
A Phase 4 study, sponsored by NYU Langone Health.
- Completed
- Registry status
- Phase 4
- Development phase
- 50
- Enrollment target
NCT02445339: Completed Phase 4 study, sponsored by NYU Langone Health.
NCT02445339 is a Phase 4 study that has completed, run by NYU Langone Health. The registered enrollment target is 50 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (90% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02445339, a Phase 4 study, has completed, sponsored by NYU Langone Health.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 50 participants
- Enrollment target
Study Summary
Our primary aim is to assess the feasibility of initiating treatment in the ED with extended-release naltrexone (XR-NTX) plus care management (CM) vs. standard care and continuing care in cooperation with clinic providers as well as how best to assess outcomes. Secondarily, the investigators will explore its effect on various health outcomes (healthcare utilization and engagement, expenditures, drinking and consequences, quality of life) as well as the association of patient-level characteristics (e.g. sex, race, baseline drinking, health and psychosocial factors, mu opioid receptor genotype) with effectiveness. Determining both how to implement XR-NTX+CM and rigorously test its effects in the ED (phase 1) is essential before planning a large-scale effectiveness trial (phase 2).
Primary Outcome
Self-reported
Interventions
- DRUG XR-NTX+CM (Extended-Release Naltrexone plus Care Management)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 50 participants |
| Start Date | 2015-07 |
| Est. Completion | 2019-02-08 |
| Phase | Phase 4 |
What the finished NCT02445339 record still lists
NCT02445339 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 50 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (90% lower).
The record links to 0 conditions, and to 1 intervention - of which XR-NTX+CM (Extended-Release Naltrexone plus Care Management) is the first listed.
NCT02445339 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02445339 about?
NCT02445339 is a clinical study titled "Extended-release Naltrexone and Care Management for Alcohol Dependent Frequent Emergency Department Users". Our primary aim is to assess the feasibility of initiating treatment in the ED with extended-release naltrexone (XR-NTX) plus care management (CM) vs. standard care and continuing care in cooperation with clinic providers as well as how best to assess outcomes. Secondarily, the investigators will ex...
What is the current status of trial NCT02445339?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 50 participants. The study started on 2015-07. Estimated completion is 2019-02-08.
What interventions are being tested in trial NCT02445339?
The interventions under investigation include: XR-NTX+CM (Extended-Release Naltrexone plus Care Management) (DRUG).
Who is sponsoring clinical trial NCT02445339?
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 NCT02445339's enrollment target sits among peer trials
50 1255th of 2000 higher than 678 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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