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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 is a Phase 4 study that has completed, run by NYU Langone Health. The registered enrollment target is 50 participants.
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).
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02445339
The ClinicalTrials.gov registry entry for NCT02445339 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 50 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 XR-NTX+CM (Extended-Release Naltrexone plus Care Management) is the first listed.
NCT02445339 reports 0 study locations.
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.
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