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NCT02478489 · ClinicalTrials.gov registry record · Phase 4
Alcohol Disorder hOsPital Treatment Trial
A Phase 4 study, sponsored by Boston University.
- Completed
- Registry status
- Phase 4
- Development phase
- 248
- Enrollment target
NCT02478489: Completed Phase 4 study, sponsored by Boston University.
NCT02478489 is a Phase 4 study that has completed, run by Boston University. The registered enrollment target is 248 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (52% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02478489, a Phase 4 study, has completed, sponsored by Boston University.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 248 participants
- Enrollment target
Study 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.
Primary Outcome
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 val
Interventions
- DRUG Oral naltrexone (PO-NTX)
- DRUG Extended-release injectable naltrexone (XR-NTX)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 248 participants |
| Start Date | 2016-06 |
| Est. Completion | 2020-10 |
| Phase | Phase 4 |
What the finished NCT02478489 record still lists
NCT02478489 is an interventional study that assigns participants to a tested intervention. The registered 248 participants enrollment target is mid-sized for trials with a published cap, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (52% lower).
The record links to 0 conditions, and to 2 interventions - of which Oral naltrexone (PO-NTX) is the first listed.
NCT02478489 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02478489 about?
NCT02478489 is a clinical study titled "Alcohol Disorder hOsPital Treatment Trial". 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 co...
What is the current status of trial NCT02478489?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 248 participants. The study started on 2016-06. Estimated completion is 2020-10.
What interventions are being tested in trial NCT02478489?
The interventions under investigation include: Oral naltrexone (PO-NTX) (DRUG), Extended-release injectable naltrexone (XR-NTX) (DRUG).
Who is sponsoring clinical trial NCT02478489?
This trial is sponsored by Boston University, which has 185 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02478489's enrollment target sits among peer trials
248 353rd of 2000 higher than 1,646 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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