CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 30 enrolled
Drug / intervention
Emergency Department Initiated Oral Naltrexonedrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04817410
NCT04817410Phase 1Completed

Emergency Department Initiated Oral Naltrexone for Patients With Moderate to Severe Alcohol Use Disorder: A Pilot Feasibility Study

Icahn School of Medicine at Mount Sinai·interventional·Posted Mar 26, 2021·Updated Aug 26, 2025

In Brief

A Phase 1 clinical trial evaluating Emergency Department Initiated Oral Naltrexone for Alcohol Use Disorder. Completed, enrolled 30 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 1CompletedFinished
20222023202420252026
First PostedMar 26, 2021
Enrollment StartSep 28, 2021
Primary CompletionOct 31, 2023
Study CompletionNov 2, 2023
TodayJul 2, 2026
Enrollment to primary: 2.1 yearsPosted 5.3 years ago

Interventions

Emergency Department Initiated Oral Naltrexonedrug

Emergency Department Initiated Oral Naltrexone