NCT04817410

ED Initiated Oral Naltrexone for AUD

Completed Phase 1 Results posted Last updated 26 August 2025

What this trial tests

Phase 1 trial testing Emergency Department Initiated Oral Naltrexone in Alcohol Use Disorder in 30 participants. Completed in 2 November 2023.

Timeline

28 September 2021

Primary endpoint
31 October 2023

2 November 2023

Quick facts

Lead sponsor	Icahn School of Medicine at Mount Sinai
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	screening
Enrollment	30
Start date	28 September 2021
Primary completion	31 October 2023
Estimated completion	2 November 2023
Sites	1 location across United States

Drugs / interventions tested

• Emergency Department Initiated Oral Naltrexone — full drug profile →

Conditions studied

• Alcohol Use Disorder — all drugs for Alcohol Use Disorder →

Sponsor

Icahn School of Medicine at Mount Sinai

Who can join

18 and older, any sex, with Alcohol Use Disorder. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

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

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

Group	Value	95% CI
Oral Naltrexone	6
Oral Naltrexone	15

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

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

Group	Value	95% CI
Enrolled Participant Characteristics	7
Enrolled Participant Characteristics	14

Number of Alcoholic Drinks Per Day Secondary · 7-days prior to enrollment to day of enrollment (baseline)

Baseline

Group	Value	95% CI
Oral Naltrexone	4.29	2.29 – 7.57

Number of Daily Drinks Secondary · 30-days

30-days

Group	Value	95% CI
Enrolled Participant Characteristics	0.73	0 – 2.81

Daily Alcohol Craving Scale Secondary · up to 30 days

Daily alcohol craving scale using Qualtrics - Full scale from 0 to 36, higher score represents more severity.

Group	Value	95% CI
Enrolled Participant Characteristics	8.27	4.65 – 11.75

Guidelines Regimen Information Program (GRIP) Guide at Day 14 Secondary · Day 14

Adherence to daily oral naltrexone measured using Guidelines Regimen Information Program (GRIP) guide - GRIP guide is a self-report to assess adherence, with 6 categorical items: excellent, very good, good, fair, poor, and very poor. The maximum value is 6 and the minimum value is 1. Higher scores mean better adherence.

Group	Value	95% CI
Oral Naltrexone	4.5	3 – 5

Guidelines Regimen Information Program (GRIP) Guide at Day 30 Secondary · Day 30

Adherence to daily oral naltrexone measured using the Guidelines Regimen Information Program (GRIP) guide - GRIP guide is a self-report to assess adherence, with 6 categorical items: excellent, very good, good, fair, poor, and very poor. The maximum value is 6 and the minimum value is 1. Higher scores represent better adherence.

Group	Value	95% CI
Oral Naltrexone	4	4 – 5

Number of Heavy Drinking Days Secondary · up to 30 days

Number of heavy drinking days defined as 4 or more drinks for a woman or 5 or more drinks for a man on the same occasion in a 24 hour period.

Group	Value	95% CI
Oral Naltrexone	0.0	0 – 0.17

Health Services Utilization Survey Secondary · up to 30-days

Participants indicated the number of inpatient admissions, outpatient visits and emergency department visits over the preceding 7-days at baseline up to 30-days. Comparison of total reported admissions or visits were made using the Friedman test. No admissions or visits counted as a 0 for comparing across timepoints. If no response was provided at any of the three time points, the participant data was not used in the comparison.

Inpatient Admissions - baseline

Group	Value	95% CI
Oral Naltrexone	0	0 – 0

outpatient visits -baseline

Group	Value	95% CI
Oral Naltrexone	0	0 – 1

ED visits - baseline

Group	Value	95% CI
Oral Naltrexone	0	0 – 0

Inpatient admissions-day 14 preceding 7-days at baseline)

Group	Value	95% CI
Oral Naltrexone	0	0 – 0

Outpatient visits-day 14

Group	Value	95% CI
Oral Naltrexone	0.5	0 – 1

Emergency Department Visits - day 14

Group	Value	95% CI
Oral Naltrexone	0	0 – 0

Inpatient admission - day 30

Group	Value	95% CI
Oral Naltrexone	0	0 – 0

Outpatient visits - day 30

Group	Value	95% CI
Oral Naltrexone	0	0 – 1

Number of Unhealthy Days Assessed by Health Related Quality of Life (HRQoL) Secondary · Day 30

Number of unhealthy days using the HRQoL. The HRQoL assesses core health days and activity limitations. Self-reported general health was collected on a 5-item scale ranging from: excellent, very good, good, fair, and poor. An unhealthy days score was obtained by summing the number of physically unhealthy and mentally unhealthy days. The minimum score is 0 and the maximum score is 30 unhealthy days, even if the number of unhealthy days totals more than 30. If no response was provided at the time points under comparison, the participant data was not used in the comparison.

Group	Value	95% CI
Oral Naltrexone	11.5	0 – 30

The Patient Rated Inventory of Side Effects (PRISE) Survey Secondary · Day 30

Medication side effects of oral naltrexone measured using PRISE survey - is a patient self-report measure used to identify and evaluate the tolerability of side effect symptom. This scale is a 7-item assessment of the side effects in the following symptom areas; gastrointestinal, heart, skin, nervous system, eyes/ears, genital/urinary, sleep, sexual functioning, and other. Each domain has multiple symptoms and for each domain the patient rates whether these symptoms are tolerable or distressing. Higher score represents more side-effects. What is reported below are the number of participants re

Gastrointestinal

Group	Value	95% CI
Oral Naltrexone	10

Heart

Group	Value	95% CI
Oral Naltrexone	6

Skin

Group	Value	95% CI
Oral Naltrexone	3

Nervous System

Group	Value	95% CI
Oral Naltrexone	6

Genital/Urinary

Group	Value	95% CI
Oral Naltrexone	8

Sleep

Group	Value	95% CI
Oral Naltrexone	10

Sexual Functioning

Group	Value	95% CI
Oral Naltrexone	6

Other

Group	Value	95% CI
Oral Naltrexone	11

AUD Program Satisfaction Survey at Baseline Secondary · Baseline

Three elements of satisfaction were assessed: 1) convenience of screening, 2) difficulty of screening and 3) satisfaction with screening. Each question could be scored on scale of 0-6. For convenience of screening, lower numbers indicated more convenience. For difficulty of screening, lower numbers represent less difficulty. For satisfaction, higher numbers represent greater satisfaction.

Satisfaction with screening

Group	Value	95% CI
Oral Naltrexone	1
Oral Naltrexone	1
Oral Naltrexone	1
Oral Naltrexone	0

Convenience of screening

Group	Value	95% CI
Oral Naltrexone	14
Oral Naltrexone	1
Oral Naltrexone	1
Oral Naltrexone	2

Difficulty of screening

Group	Value	95% CI
Oral Naltrexone	13
Oral Naltrexone	3
Oral Naltrexone	2
Oral Naltrexone	0

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Emergency department-initiated oral naltrexone for patients with moderate to severe alcohol use disorder: A pilot feasibility study.
   Cowan E, O'Brien-Lambert C, Eiting E, Bull E, et al · · 2025 · cited 4× · PMID 39776077 · DOI 10.1111/acem.15059