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NCT00000455 · ClinicalTrials.gov registry record · Phase 4

Naltrexone for Early Problem Drinkers

A Phase 4 study, sponsored by UConn Health.

Completed
Registry status
Phase 4
Development phase
160
Enrollment target

NCT00000455: Completed Phase 4 study, sponsored by UConn Health.

NCT00000455 is a Phase 4 study that has completed, run by UConn Health. 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

NCT00000455, a Phase 4 study, has completed, sponsored by UConn Health.

COMPLETED
Registry status
Phase 4
Development phase
160 participants
Enrollment target

Study Summary

Early problem drinkers are prevalent in the United States. Recent controlled trials have shown that brief interventions in the primary care setting can reduce drinking and alcohol-related problems in patients who lack evidence of alcohol dependence. Although naltrexone (Revia) has been approved for the treatment of alcohol dependence, few pharmacotherapy studies have been undertaken with early problem drinkers. This study is an 8-week trial of naltrexone versus placebo, combined with coping skills treatment that either focuses on targeted use of medication or serves as background to daily use of the medication. A total of 160 early problem drinkers recruited through screening in primary care medical settings will be randomly assigned to one of four treatment groups. Followup evaluations will be conducted at the end of treatment and again 3, 6, and 12 months.

Interventions

  • DRUG naltrexone

Trial Details

FieldValue
Enrollment Target 160 participants
Est. Completion 2002-09
Phase Phase 4
UConn Health

178 total trials

What the finished NCT00000455 record still lists

NCT00000455 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 1 intervention - of which naltrexone is the first listed.

NCT00000455 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00000455 about?

NCT00000455 is a clinical study titled "Naltrexone for Early Problem Drinkers". Early problem drinkers are prevalent in the United States. Recent controlled trials have shown that brief interventions in the primary care setting can reduce drinking and alcohol-related problems in patients who lack evidence of alcohol dependence. Although naltrexone (Revia) has been approved for...

What is the current status of trial NCT00000455?

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

What interventions are being tested in trial NCT00000455?

The interventions under investigation include: naltrexone (DRUG).

Who is sponsoring clinical trial NCT00000455?

This trial is sponsored by UConn Health, which has 178 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00000455'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 NCT00000455, the US trial registry maintained by the National Library of Medicine. NCT00000455 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.