CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 65 enrolled
Drug / intervention
Placebo +2 moredrug
Likely dose
Naltrexone 25mgfrom 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/NCT00667875
NCT00667875Phase 2Completed

An Exploratory Study of Naltrexone Plus Aripiprazole for Alcohol Dependence

Medical University of South Carolina·interventional·Posted Apr 28, 2008·Updated Sep 29, 2017

In Brief

A Phase 2 clinical trial evaluating Placebo, Naltrexone, and 1 other intervention for Alcohol Dependence. Completed, enrolled 65 participants across 1 site.

Detailed Summary

The principal aim of this exploratory study is to examine whether the addition of aripiprazole to naltrexone will enhance efficacy over naltrexone alone in a 16-week randomized, placebo-controlled clinical trial, in which all subjects will be provided medical management as delivered in the COMBINE Study (Anton et al, 2006). To test whether medication treatment will reduce drinking compared to placebo treatment alone in the context of medical management and whether naltrexone plus aripiprazole will reduce drinking compared to naltrexone treatment alone in the context of medical management.

Study Details

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

Timeline

Phase 2CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedApr 28, 2008
Enrollment StartApr 1, 2008
Primary CompletionMay 1, 2011
TodayJul 2, 2026
Enrollment to primary: 3.1 yearsPosted 18.2 years ago

Interventions

Placebodrug

placebo

Naltrexonedrug

Naltrexone (25mg or 50 mg per titration schedule)

Naltrexone + Aripiprazoledrug

Naltrexone + Aripiprazole (5mg - 15mg per titration schedule)