ED Initiated Oral Naltrexone for AUD

NCT04817410 | Completed Phase 1 Results FDA Drug

• 1 other identifier: IRB-21-00278
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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

Alcohol Use Disorder

Keywords

Medication Assisted Treatment; Emergency Department; Naltrexone

Outcome Measures

Primary Outcomes (2)

• Number of Participants Enrolled and Receiving Formal Addiction Treatment at Day 14

  Number of participant enrolled with engagement in care of comprehensive addiction treatment

  Day 14

• Number of Participants Enrolled and Receiving Formal Addiction Treatment at Day 30

  Number of participant enrolled with engagement in care of comprehensive addiction treatment

  Day 30

Secondary Outcomes (13)

• Number of Alcoholic Drinks Per Day

  7-days prior to enrollment to day of enrollment (baseline)

• Number of Daily Drinks

  30-days

• Daily Alcohol Craving Scale

  up to 30 days

• Guidelines Regimen Information Program (GRIP) Guide at Day 14

  Day 14

• Guidelines Regimen Information Program (GRIP) Guide at Day 30

  Day 30

Study Arms (1)

Oral Naloxone

EXPERIMENTAL

Oral Naltrexone initiation

Drug: Emergency Department Initiated Oral Naltrexone

Interventions

Emergency Department Initiated Oral Naltrexone DRUG

Emergency Department Initiated Oral Naltrexone

Oral Naloxone

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Emergency Department patients 18 years of age or older
• Treated in the ED during screening hours
• Moderate to severe AUD as determined by DSM-5 criteria
• Able to speak and understand English
• Medically stable for an interview as determined by their primary ED provider
• Willing and able to consent to study participation
• Two points of contact available for follow-up

You may not qualify if:

• ED patients younger than 18 years of age
• Medically or psychiatrically unstable as determined by the ED provider
• Unable to speak or understand English
• Unable to provide consent for study participation
• Past year opioid dependence
• Urine drug screen positive for opioids
• Current or anticipated need for opioid medications for pain
• Anticipated surgical procedure within 14-day of ED visit
• Serologic evidence of liver disease (LFTs 3X normal) within 7 days of enrollment
• Cirrhosis either by PMH or self-report
• Pregnant or breastfeeding
• Lacking contact information for follow-up
• Requiring in-patient admission for medical or psychiatric reasons
• Patient receiving a sexual assault forensics exam (SAFE)
• Patient suspected of having COVID-19

Sponsors & Collaborators

• Icahn School of Medicine at Mount Sinai: lead

Study Sites (1)

Mount Sinai Beth Israel

New York, New York, 10003, United States

Location

MeSH Terms

Conditions

Alcoholism; Emergencies

Condition Hierarchy (Ancestors)

Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

Due to the nonrandomized design, lack of a nontreatment control and small sample size, drawing inferences about efficacy of ED-initiated naltrexone on short-term engagement in care is not possible.

Results Point of Contact

• Title: Ethan Cowan
• Organization: Rutgers New Jersey Medical School

ethan.cowan@rutgers.edu

917-447-4964

Study Officials

• Ethan Cowan, MD

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Emergency Medicine

Study Record Dates

• First Submitted: March 23, 2021
• First Posted: March 26, 2021
• Study Start: September 28, 2021
• Primary Completion: October 31, 2023
• Study Completion: November 2, 2023
• Last Updated: August 26, 2025
• Results First Posted: August 26, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)