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NCT00000445 · ClinicalTrials.gov registry record · Phase 4

Use of Naltrexone in a Clinical Setting

A Phase 4 study, sponsored by National Institute on Alcohol Abuse and Alcoholism (NIAAA).

Completed
Registry status
Phase 4
Development phase
300
Enrollment target

NCT00000445: Completed Phase 4 study, sponsored by National Institute on Alcohol Abuse and Alcoholism (NIAAA).

NCT00000445 is a Phase 4 study that has completed, run by National Institute on Alcohol Abuse and Alcoholism (NIAAA). The registered enrollment target is 300 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (42% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00000445, a Phase 4 study, has completed, sponsored by National Institute on Alcohol Abuse and Alcoholism (NIAAA).

COMPLETED
Registry status
Phase 4
Development phase
300 participants
Enrollment target

Study Summary

This 12-week trial will compare individuals receiving naltrexone or placebo plus substance abuse counseling therapy versus those receiving only substance abuse counseling therapy in a rural, nonacademic setting. A followup period of 12 months is included. The effect on service utilization and the cost of the addition of naltrexone to treatment services for alcohol dependence also will be assessed. The study will expand existing research concerning the effectiveness of naltrexone in clinical trials versus a clinical setting.

Interventions

  • DRUG naltrexone (Revia)

Trial Details

FieldValue
Enrollment Target 300 participants
Est. Completion 2002-09
Phase Phase 4

What the finished NCT00000445 record still lists

NCT00000445 is an interventional study that assigns participants to a tested intervention. The registered 300 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 (42% lower).

The record links to 0 conditions, and to 1 intervention - of which naltrexone (Revia) is the first listed.

NCT00000445 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00000445 about?

NCT00000445 is a clinical study titled "Use of Naltrexone in a Clinical Setting". This 12-week trial will compare individuals receiving naltrexone or placebo plus substance abuse counseling therapy versus those receiving only substance abuse counseling therapy in a rural, nonacademic setting. A followup period of 12 months is included. The effect on service utilization and the co...

What is the current status of trial NCT00000445?

This trial is currently completed. It is a Phase 4 study. The enrollment target is 300 participants. Estimated completion is 2002-09.

What interventions are being tested in trial NCT00000445?

The interventions under investigation include: naltrexone (Revia) (DRUG).

Who is sponsoring clinical trial NCT00000445?

This trial is sponsored by National Institute on Alcohol Abuse and Alcoholism (NIAAA), which has 93 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00000445's enrollment target sits among peer trials

300 269th of 2000 higher than 1,709 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 NCT00000445, the US trial registry maintained by the National Library of Medicine. NCT00000445 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.