ED Initiated Oral Naltrexone for AUD

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

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 Overview

• Status: Completed
• Conditions: Alcohol Use Disorder
• Intervention / Treatment: Drug: Emergency Department Initiated Oral Naltrexone

Detailed Description

Overview

The study will be comprised of two components outlined below:

1. Site Implementation Component

   In this component implementation science strategies will be used to strengthen existing non-targeted ED based AUD screening program and optimize feasibility, acceptability and linkage pathways. Three specific aims are to, 1) optimize registered nurse (RN) driven non-targeted alcohol use screening supplemented with secondary screening using DSM-5 criteria for AUD and an SBIRT (screening, brief intervention and referral to treatment) intervention administered by trained staff. 2) During a 3-month period, use continuous quality improvement methods to decrease the time for completion of AUD screening to an interval that is acceptable to ED patients and ED providers and 3) Assess willingness to initiate oral naltrexone among ED patients with moderate to severe AUD. Ten (10) patients will be enrolled in phase 1.

2. Oral Naltrexone Feasibility Component

In this component the study team aims to assess the feasibility of initiating treatment in ED patients with moderate to severe AUD on oral naltrexone, an evidence based and accepted standard of care treatment for AUD. Specifically, 1) over an 8-month period the study team aims to identify 20 patients with moderate to severe AUD eligible and interested in immediate initiation of oral naltrexone. Consenting patients will be receive a standard SBIRT intervention and be provided with immediate oral naltrexone initiation in the ED with a 14-day starter pack at the time of ED discharge. All participants will receive facilitated linkage to comprehensive out-patient care. 2) The study team aims will evaluate the impact of immediate ED initiated oral naltrexone with the primary outcome being engagement in comprehensive addiction care at 14 and 30 days post enrollment. Secondary outcomes include medication adherence, changes in daily alcohol consumption, number of heavy drinking days, hospital admissions and ED utilization, transition to long-acting injectable naltrexone and alcohol craving. 3) Lastly, the study team will collect data on recruitment and attrition rates, as well as means and standard deviations for key measures that will be needed to plan a definitive randomized controlled trial of ED-initiated oral naltrexone.

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10003
      • Mount Sinai Beth Israel

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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
• Patient is actively suicidal or homicidal
• Previously enrolled in either the implementation or feasibility phase of the study
• Be a prisoner or in police custody at the time of the index ED visit
• Be currently (anytime within the last 14 days) enrolled in formal addiction treatment, including by court order.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Oral Naloxone; Oral Naltrexone initiation	Drug: Emergency Department Initiated Oral Naltrexone; Emergency Department Initiated Oral Naltrexone

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Heavy Drinking 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.	up to 30 days
Number of Alcoholic Drinks Per Day	Baseline	7-days prior to enrollment to day of enrollment (baseline)
Number of Daily Drinks	30-days	30-days
Daily Alcohol Craving Scale	Daily alcohol craving scale using Qualtrics - Full scale from 0 to 36, higher score represents more severity.	up to 30 days
Guidelines Regimen Information Program (GRIP) Guide at 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.	Day 14
Guidelines Regimen Information Program (GRIP) Guide at 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.	Day 30
Number of Pills in Bottle at Day 14	Adherence to daily oral naltrexone measured using pill counts.	Day 14
Number of Pills in Bottle at Day 30	Adherence to daily oral naltrexone measured using pill counts.	Day 30
Health Services Utilization Survey	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.	up to 30-days
Number of Unhealthy Days Assessed by Health Related Quality of Life (HRQoL)	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.	Day 30
The Patient Rated Inventory of Side Effects (PRISE) Survey	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 reporting side effects for each symptom.	Day 30
AUD Program Satisfaction Survey at 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.	Baseline
Number of Participants Who Transition to LA Injectable	Number of participants who transition from oral to long acting injectable naloxone.	Day 30

Collaborators and Investigators

• Sponsor: Icahn School of Medicine at Mount Sinai
• Investigators: Principal Investigator: Ethan Cowan, MD, ICAHN School of Medicine at Mount Sinai

Study record dates

Study Major Dates

• Study Start (Actual): September 28, 2021
• Primary Completion (Actual): October 31, 2023
• Study Completion (Actual): November 2, 2023

Study Registration Dates

• First Submitted: March 23, 2021
• First Submitted That Met QC Criteria: March 23, 2021
• First Posted (Actual): March 26, 2021

Study Record Updates

• Last Update Posted (Estimated): August 26, 2025
• Last Update Submitted That Met QC Criteria: August 7, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Keywords: Emergency Department; Naltrexone; Medication Assisted Treatment
• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Disease Attributes; Substance-Related Disorders; Chemically-Induced Disorders; Alcohol-Related Disorders; Pathological Conditions, Signs and Symptoms; Emergencies; Alcoholism; Physiological Effects of Drugs; Peripheral Nervous System Agents; Sensory System Agents; Narcotic Antagonists; Alcohol Deterrents; Naltrexone
• Other Study ID Numbers: IRB-21-00278

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No