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NCT04817410 · ClinicalTrials.gov registry record · Phase 1
ED Initiated Oral Naltrexone for AUD
A Phase 1 study, sponsored by Icahn School of Medicine at Mount Sinai.
- Completed
- Registry status
- Phase 1
- Development phase
- 30
- Enrollment target
NCT04817410 is a Phase 1 study that has completed, run by Icahn School of Medicine at Mount Sinai. The registered enrollment target is 30 participants.
The verdict
NCT04817410, a Phase 1 study, has completed, sponsored by Icahn School of Medicine at Mount Sinai.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 30 participants
- Enrollment target
Study Summary
This study will recruit Emergency Department (ED) patients with moderate to severe alcohol use disorder (AUD) who are interested in initiating medication assisted treatment (MAT). The study is split into two phases. The first phase (N=10) will use implementation science strategies to strengthen existing non-targeted ED based AUD screening program and optimize feasibility, acceptability, and linkage pathways. The second phase (N=20) will incorporate lessons learned from phase 1 to initiate ED patients on MAT for AUD in the form of oral naltrexone. The primary outcome for both phase 1 and phase 2 is engagement in comprehensive addiction treatment at 14 and 30 days post enrollment.
Interventions
- DRUG Emergency Department Initiated Oral Naltrexone
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2021-09-28 |
| Est. Completion | 2023-11-02 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04817410
The ClinicalTrials.gov registry entry for NCT04817410 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 30 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Icahn School of Medicine at Mount Sinai, which has 708 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Emergency Department Initiated Oral Naltrexone is the first listed.
NCT04817410 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04817410 about?
NCT04817410 is a clinical study titled "ED Initiated Oral Naltrexone for AUD". This study will recruit Emergency Department (ED) patients with moderate to severe alcohol use disorder (AUD) who are interested in initiating medication assisted treatment (MAT). The study is split into two phases. The first phase (N=10) will use implementation science strategies to strengthen exis...
What is the current status of trial NCT04817410?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 30 participants. The study started on 2021-09-28. Estimated completion is 2023-11-02.
What interventions are being tested in trial NCT04817410?
The interventions under investigation include: Emergency Department Initiated Oral Naltrexone (DRUG).
Who is sponsoring clinical trial NCT04817410?
This trial is sponsored by Icahn School of Medicine at Mount Sinai, which has 708 total clinical trials registered on ClinicalTrials.gov.
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