NCT05827159

Emergency Department-Initiated Medications for Alcohol Use Disorder

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 240 (estimated)
• Sponsor: Yale University · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The proposed study will evaluate a comprehensive ED-based intervention for moderate to severe AUD combining SBIRT with ED-initiated MAUD. It is an extension and a novel application of a highly effective ED intervention model that has been successfully developed and broadly disseminated for other conditions, such as diabetes, hypertension and more recently opioid use disorder. No prospective randomized controlled trials of ED-initiated medications for the treatment of AUD, with or without psychosocial interventions, have been published to date. If found efficacious this novel intervention model has a potential to increase AUD treatment participation rates among individuals with AUD who frequently receive care in the ED. The proposed study will evaluate two ED-based interventions that have a potential to be broadly disseminated to narrow the gap between treatment need and treatment access. Study participants will be identified through targeted screening for DSM-5 criteria for moderate to severe AUD and the study inclusion/exclusion criteria. Therefore, the Screening component of the SBIRT intervention in the proposed RCT will be conducted before eligible ED patients who are interested in study participation are consented and randomized. This study will compare outcomes among individuals who are initiated on MAUD treatment in the ED, including AUD treatment with naltrexone, with ancillary support of gabapentin to assist with withdrawal symptoms. Hypothesis 1: The rates of AUD treatment engagement will be higher among patients receiving SBIRT+ED-MAUD. Hypothesis 2: Those randomized to SBIRT+ED-MAUD will have greater reductions of heavy drinking days. This study is not designed to change the FDA labeling of gabapentin.

Conditions

• Alcohol Use Disorder

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2024-08-17
• Primary completion: 2027-12-01
• Completion: 2028-03-01
• First posted: 2023-04-24
• Last updated: 2025-05-18

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study