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NCT00667875 · ClinicalTrials.gov registry record · Phase 2

An Exploratory Study of Naltrexone Plus Aripiprazole for Alcohol Dependence

A Phase 2 study of Alcohol Dependence, sponsored by Medical University of South Carolina.

Completed
Registry status
Phase 2
Development phase
65
Enrollment target
1
Study location

NCT00667875 is a Phase 2 study of Alcohol Dependence that has completed, run by Medical University of South Carolina. The registered enrollment target is 65 participants, below the 312-participant average among 43 other Alcohol Dependence trials with a reported enrollment target (79% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT00667875, a Phase 2 study of Alcohol Dependence, has completed, sponsored by Medical University of South Carolina.

COMPLETED
Registry status
Phase 2
Development phase
65 participants
Enrollment target
1
Study location

Study 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.

Conditions Studied

Interventions

  • DRUG Placebo
  • DRUG Naltrexone
  • DRUG Naltrexone + Aripiprazole

Study Locations (1)

South Carolina

  • Medical University of South Carolina, Center for Drug and Alcohol Programs - Charleston

Trial Details

FieldValue
Enrollment Target 65 participants
Start Date 2008-04
Est. Completion 2011-05
Phase Phase 2

What the Registry Record Tells You About NCT00667875

The ClinicalTrials.gov registry entry for NCT00667875 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 65 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 312-participant average among 43 other Alcohol Dependence trials with a reported enrollment target (79% lower). The listed sponsor is Medical University of South Carolina, which has 755 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Alcohol Dependence appearing as the primary indexed condition, and to 3 interventions - of which Placebo is the first listed.

NCT00667875 reports 1 study location spanning 1 distinct geographic area - top geographies include South Carolina.

Frequently Asked Questions

What is clinical trial NCT00667875 about?

NCT00667875 is a clinical study titled "An Exploratory Study of Naltrexone Plus Aripiprazole for Alcohol Dependence". 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 S...

What is the current status of trial NCT00667875?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 65 participants. The study started on 2008-04. Estimated completion is 2011-05.

What conditions does trial NCT00667875 study?

This clinical trial studies the following conditions: Alcohol Dependence.

What interventions are being tested in trial NCT00667875?

The interventions under investigation include: Placebo (DRUG), Naltrexone (DRUG), Naltrexone + Aripiprazole (DRUG).

Who is sponsoring clinical trial NCT00667875?

This trial is sponsored by Medical University of South Carolina, which has 755 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00667875 being conducted?

This trial has 1 study location across South Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.