Emergency Department-Initiated Medications for Alcohol Use Disorder

Summary

The proposed study will be the first randomized clinical trial to evaluate a comprehensive Emergency Department (ED)-based intervention for moderate to severe Alcohol Use Disorder (AUD) combining Screening, Brief Intervention and Referral to Treatment (SBIRT) with ED-initiated medications for treatment of alcohol use disorder (MAUD).

The primary objective of this phase 3 study is to evaluate for differences in treatment engagement 30 days after ED visit between emergency department patients with moderate to severe alcohol use disorder (AUD) who are randomized to initiate medications for the treatment for AUD in the ED in addition to receiving a brief intervention and referral to ongoing treatment, which all participants will receive.

The secondary objective of this study is to evaluate the difference in reduction of heavy drinking days between the two ED treatment models during the 30 days post ED visit.

Conditions

• Alcohol Use Disorder

Interventions

DRUG

Naltrexone Pill

In the MAUD component, some participants will receive oral Naltrexone in the ED.

DRUG

Naltrexone Injection

In the MAUD component, some participants will receive a dose of XR-NTX (injection) in the ED.

BEHAVIORAL

Brief Negotiation Interview

Brief Negotiation Interview (BNI) has four key components: (1) permission to discuss substance use, (2) feedback on the health consequences of ongoing substance use, including making a connection between the ED visit and substance use, (3) motivational enhancement, and (4) negotiation and advice.

DRUG

Gabapentin Pill

In the MAUD component, ancillary treatment with gabapentin will be provided.

Sponsors & Collaborators

• National Institute on Alcohol Abuse and Alcoholism (NIAAA)

  collaborator NIH

• Yale University

  lead OTHER

Principal Investigators

• Kathryn Hawk, MD, MHS · Yale University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

80 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-08-17

Primary Completion

2027-12-01

Completion

2028-03-01

FDA Drug

Yes

Countries

• United States

Study Locations