Alcohol Disorder hOsPital Treatment Trial

Phase 4 Completed 248 enrolled Boston University National Institute on Alcohol Abuse and Alcoholism (NIAAA) · collab

RandomizedParallel-groupOpen-labelTreatment

Summary

The specific aims of this pragmatic randomized controlled trial are to compare initiating injectable extended release naltrexone (XR-NTX) or oral naltrexone (PO-NTX) at the time of discharge from a medical hospitalization for patients with alcohol use disorder (AUD) on: 1) alcohol consumption and consequences, and 2) acute healthcare utilization (including hospital readmission and emergency visits) and cost-effectiveness. In exploratory analyses, the investigators will assess moderators of medication effects including demographic, behavioral, and genetic factors.

Timeline

Start: 2016-06
Primary completion: 2020-07
Completion: 2020-10

Outcome

Missed primary endpoint

paper there was not a significant difference in the reduction of percentage of HDDs in the past 30 days or acute health care utilization between groups. PMID 40257810 ↗

Publications

Magane KM, Dukes KA, Fielman S, Palfai TP, Regan D, Cheng DM, Lee H, Kraemer KL, Bullard MJ, Chen CA, Samet JH. Oral vs Extended-Release Injectable Naltrexone for Hospitalized Patients With Alcohol Use Disorder: A Randomized Clinical Trial. JAMA Intern Med. 2025 Jun 1;185(6):635-645. doi: 10.1001/jamainternmed.2025.0522.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Naltrexone	Small molecule	50 mg	Oral
Subject	Naltrexone	Small molecule	100 mg	Oral
Subject	Naltrexone	Small molecule	380 mg	Intramuscular