CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 248 enrolled
Drug / intervention
Oral naltrexone (PO-NTX) +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02478489
NCT02478489Phase 4Completed

Oral v. Injection Naltrexone in Hospital: Comparative Effectiveness for Alcoholism

Boston University·interventional·Posted Jun 23, 2015·Updated Jun 29, 2021

In Brief

A Phase 4 clinical trial evaluating Oral naltrexone (PO-NTX) and Extended-release injectable naltrexone (XR-NTX) for Heavy Drinking and 2 related conditions. Completed, enrolled 248 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Phase 4CompletedFinished
20162017201820192020202120222023202420252026
First PostedJun 23, 2015
Enrollment StartJun 1, 2016
Primary CompletionJul 1, 2020
Study CompletionOct 1, 2020
TodayJul 2, 2026
Enrollment to primary: 4.1 yearsPosted 11.0 years ago

Interventions

Oral naltrexone (PO-NTX)drug

oral naltrexone

Extended-release injectable naltrexone (XR-NTX)drug

injectable naltrexone