RecruitingPhase 3NCT05827159

Emergency Department-Initiated Medications for Alcohol Use Disorder


Sponsor

Yale University

Enrollment

240 participants

Start Date

Aug 17, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a behavioral approach called Brief Negotiation Interview, a drug called Gabapentin Pill, and others for people with alcohol use disorder. The study is currently recruiting participants at 1 location.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGNaltrexone Pill

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

DRUGNaltrexone Injection

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

BEHAVIORALBrief 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.

DRUGGabapentin Pill

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


Locations(1)

Yale New Haven Hospital

New Haven, Connecticut, United States

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NCT05827159


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