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Oral v. Injection Naltrexone in Hospital: Comparative Effectiveness for Alcoholism (ADOPT)
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.
Details
| Lead sponsor | Boston University |
|---|---|
| Phase | Phase 4 |
| Status | COMPLETED |
| Enrolment | 248 |
| Start date | 2016-06 |
| Completion | 2020-10 |
Conditions
- Heavy Drinking
- Alcohol Dependence
- Alcohol Use Disorder
Interventions
- Oral naltrexone (PO-NTX)
- Extended-release injectable naltrexone (XR-NTX)
Primary outcomes
- Change in Percent Heavy Drinking Days (%HDDs) Over the Past 30 Days From Baseline to 3 Month Follow-up, Assessed Using the Timeline Follow-Back — Baseline, 3 months
The primary alcohol use outcome will be change in percent heavy drinking days (%HDDs) from baseline to 3 month follow-up. %HDDs out of the past 30 days is assessed using the Timeline Follow-Back. %HDDs is the most likely (and most sensitive) to be affected by NTX and is clinically important (any reduction means less risk of harm). We chose self-report because biological testing is not sufficiently valid for detecting drinking levels and changes of clinical importance. The self-report tool is valid, particularly so when staff are well trained, and when the context for the subject is: they are informed they are being tested for consumption (breath alcohol and carbohydrate deficient transferrin (CDT), there are no consequences related to consumption levels, and that results are being recorded confidentially.
Countries
United States