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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: Completed Phase 1 study, sponsored by Icahn School of Medicine at Mount Sinai.
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, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (50% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Number of participant enrolled with engagement in care of comprehensive addiction treatment
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 |
What the finished NCT04817410 record still lists
NCT04817410 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (50% lower).
The record links to 0 conditions, and to 1 intervention - of which Emergency Department Initiated Oral Naltrexone is the first listed.
NCT04817410 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04817410's enrollment target sits among peer trials
30 1332nd of 2000 higher than 561 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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