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NCT00006204 · ClinicalTrials.gov registry record · Phase 4

Drug Treatment for Depressed Alcoholics (Naltrexone/Fluoxetine)

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

Completed
Registry status
Phase 4
Development phase
106
Enrollment target
1
Study location

NCT00006204: Completed Phase 4 study of Depression and Alcoholism, sponsored by National Institute on Alcohol Abuse and Alcoholism (NIAAA).

NCT00006204 is a Phase 4 study of Depression and Alcoholism that has completed, run by National Institute on Alcohol Abuse and Alcoholism (NIAAA). The registered enrollment target is 106 participants, below the 786-participant average among 679 other Depression trials with a reported enrollment target (87% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00006204, a Phase 4 study of Depression and Alcoholism, has completed, sponsored by National Institute on Alcohol Abuse and Alcoholism (NIAAA).

COMPLETED
Registry status
Phase 4
Development phase
106 participants
Enrollment target
1
Study location

Study Summary

This study will examine the effects of combing naltrexone and fluoxetine (Prozac) versus fluoxetine and placebo in alcoholics with co-occurring major depression. Both groups will actively participate in the 6-month study, which includes weekly individual Dual Disorders Recovery Counseling during the first month and every two weeks during the second through sixth months, plus the naltrexone and fluoxetine or fluoxetine and placebo. Subjects will complete follow-up assessments at 9 and 12 months.

Interventions

  • DRUG naltrexone (Revia)
  • DRUG fluoxetine (Prozac)

Study Locations (1)

Pennsylvania

  • Department of Psychiatry, Western Psychiatric Institute and Clinic of the University of Pittsburgh Medical Center - Pittsburgh

Trial Details

FieldValue
Enrollment Target 106 participants
Start Date 2000-03
Est. Completion 2006-01
Phase Phase 4

What the finished NCT00006204 record still lists

NCT00006204 is an interventional study that assigns participants to a tested intervention. The registered 106 participants enrollment target is mid-sized for trials with a published cap, below the 786-participant average among 679 other Depression trials with a reported enrollment target (87% lower).

The record links to 3 conditions, with Depression appearing as the primary indexed condition, and to 2 interventions - of which naltrexone (Revia) is the first listed.

NCT00006204 reports a single indexed study location in Pennsylvania.

Frequently Asked Questions

What is clinical trial NCT00006204 about?

NCT00006204 is a clinical study titled "Drug Treatment for Depressed Alcoholics (Naltrexone/Fluoxetine)". This study will examine the effects of combing naltrexone and fluoxetine (Prozac) versus fluoxetine and placebo in alcoholics with co-occurring major depression. Both groups will actively participate in the 6-month study, which includes weekly individual Dual Disorders Recovery Counseling during the...

What is the current status of trial NCT00006204?

This trial is currently completed. It is a Phase 4 study. The enrollment target is 106 participants. The study started on 2000-03. Estimated completion is 2006-01.

What conditions does trial NCT00006204 study?

This clinical trial studies the following conditions: Depression, Alcoholism, Alcohol Dependence.

What interventions are being tested in trial NCT00006204?

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

Who is sponsoring clinical trial NCT00006204?

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

Where is trial NCT00006204 being conducted?

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

Similar trials for Depression

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT00006204's enrollment target sits among peer trials

106 317th of 679 higher than 361 of 679 other Depression trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Depression 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 NCT00006204, the US trial registry maintained by the National Library of Medicine. NCT00006204 (mid enrollment · single site footprint · completed) retrieved and formatted by PlainTrial, see methodology.