drugset / Trial / NCT02478489
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
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 |