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NCT00000456 · ClinicalTrials.gov registry record · Phase 4

Behavioral Therapy Plus Naltrexone for Alcoholism

A Phase 4 study, sponsored by Medical University of South Carolina.

Completed
Registry status
Phase 4
Development phase
160
Enrollment target

NCT00000456: Completed Phase 4 study, sponsored by Medical University of South Carolina.

NCT00000456 is a Phase 4 study that has completed, run by Medical University of South Carolina. The registered enrollment target is 160 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (69% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00000456, a Phase 4 study, has completed, sponsored by Medical University of South Carolina.

COMPLETED
Registry status
Phase 4
Development phase
160 participants
Enrollment target

Study Summary

This study will compare cognitive behavioral therapy with a time-limited motivational enhancement therapy to which naltrexone (Revia) or placebo medication is added. In this randomized clinical trial, 160 alcohol-dependent outpatients, after 5 days of abstinence, will receive one of the two psychosocial therapies and either naltrexone (Revia) or placebo for a 12-week treatment period. Abstinence rates, alcohol use, and time to alcohol relapse will be evaluated in all four groups along with measures of alcohol craving, biological measures of alcohol consumption, drinking consequences, changes in self-confidence for avoiding alcohol, and medication compliance. All study participants will be assessed for measures of outcome variables at 3 and 6 months after completing the treatment protocol.

Interventions

  • BEHAVIORAL cognitive behavior therapy
  • DRUG naltrexone (Revia)
  • BEHAVIORAL motivational enhancement therapy

Trial Details

FieldValue
Enrollment Target 160 participants
Start Date 1992-09
Est. Completion 2002-08
Phase Phase 4

What the finished NCT00000456 record still lists

NCT00000456 is an interventional study that assigns participants to a tested intervention. The registered 160 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 (69% lower).

The record links to 0 conditions, and to 3 interventions - of which cognitive behavior therapy is the first listed.

NCT00000456 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00000456 about?

NCT00000456 is a clinical study titled "Behavioral Therapy Plus Naltrexone for Alcoholism". This study will compare cognitive behavioral therapy with a time-limited motivational enhancement therapy to which naltrexone (Revia) or placebo medication is added. In this randomized clinical trial, 160 alcohol-dependent outpatients, after 5 days of abstinence, will receive one of the two psychoso...

What is the current status of trial NCT00000456?

This trial is currently completed. It is a Phase 4 study. The enrollment target is 160 participants. The study started on 1992-09. Estimated completion is 2002-08.

What interventions are being tested in trial NCT00000456?

The interventions under investigation include: cognitive behavior therapy (BEHAVIORAL), naltrexone (Revia) (DRUG), motivational enhancement therapy (BEHAVIORAL).

Who is sponsoring clinical trial NCT00000456?

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

How this trial's enrollment target compares

Where NCT00000456's enrollment target sits among peer trials

160 507th of 2000 higher than 1,485 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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Source: ClinicalTrials.gov NCT00000456, the US trial registry maintained by the National Library of Medicine. NCT00000456 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.