drugset / Trial / NCT02478489

Alcohol Disorder hOsPital Treatment Trial

NCT02478489

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

Drugs

EvaluationDrugModalityDoseRoute
Subject Naltrexone Small molecule 50 mg Oral
Subject Naltrexone Small molecule 100 mg Oral
Subject Naltrexone Small molecule 380 mg Intramuscular