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ED Initiated Oral Naltrexone for AUD

NCT04817410 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2025-08-26

Study results available
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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.

Conditions

Interventions

DRUG

Emergency Department Initiated Oral Naltrexone

Emergency Department Initiated Oral Naltrexone

Sponsors & Collaborators

Principal Investigators

  • Ethan Cowan, MD · Icahn School of Medicine at Mount Sinai

Study Design

Allocation
NA
Purpose
SCREENING
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-09-28
Primary Completion
2023-10-31
Completion
2023-11-02
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04817410 on ClinicalTrials.gov