drugset / Trial / NCT05827159

Emergency Department-Initiated Medications for Alcohol Use Disorder

NCT05827159

RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2024-08-17
Primary completion
2027-12-01
Completion
2028-03-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Naltrexone Small molecule Oral
Background Gabapentin Small molecule Oral