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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 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.
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.
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 106 participants |
| Start Date | 2000-03 |
| Est. Completion | 2006-01 |
| Phase | Phase 4 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00006204
The ClinicalTrials.gov registry entry for NCT00006204 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 106 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 786-participant average among 679 other Depression trials with a reported enrollment target (87% lower). The listed sponsor is National Institute on Alcohol Abuse and Alcoholism (NIAAA), which has 93 total studies on file at ClinicalTrials.gov.
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 1 study location spanning 1 distinct geographic area - top geographies include 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.
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Related
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