ED Initiated Oral Naltrexone for AUD

NCT ID: NCT04817410

Last Updated: 2025-08-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-09-28
• Study Completion Date: 2023-11-02

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.

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.

Conditions

Alcohol Use Disorder

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SCREENING
• Blinding Strategy: NONE

Study Groups

Oral Naloxone

Oral Naltrexone initiation

Group Type: EXPERIMENTAL

Emergency Department Initiated Oral Naltrexone

Intervention Type: DRUG

Emergency Department Initiated Oral Naltrexone

Interventions

Emergency Department Initiated Oral Naltrexone

Emergency Department Initiated Oral Naltrexone

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Icahn School of Medicine at Mount Sinai

OTHER

Sponsor Role: lead

Responsible Party

Ethan Cowan

Professor of Emergency Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ethan Cowan, MD

Role: PRINCIPAL_INVESTIGATOR

Icahn School of Medicine at Mount Sinai

Locations

Mount Sinai Beth Israel

New York, New York, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

IRB-21-00278

Identifier Type: -

Identifier Source: org_study_id