Clinical Research Directory
Browse clinical research sites, groups, and studies.
Emergency Department-Initiated Medications for Alcohol Use Disorder
Sponsor: Yale University
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.
Key Details
Gender
All
Age Range
18 Years - 80 Years
Study Type
INTERVENTIONAL
Enrollment
240
Start Date
2024-08-17
Completion Date
2028-03-01
Last Updated
2025-05-18
Healthy Volunteers
No
Conditions
Interventions
Naltrexone Pill
In the MAUD component, some participants will receive oral Naltrexone in the ED.
Naltrexone Injection
In the MAUD component, some participants will receive a dose of XR-NTX (injection) in the ED.
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.
Gabapentin Pill
In the MAUD component, ancillary treatment with gabapentin will be provided.
Locations (1)
Yale New Haven Hospital
New Haven, Connecticut, United States