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NCT00027079 · ClinicalTrials.gov registry record · Phase 2

Combined Pharmacotherapies for Alcoholism (Naltrexone/Ondansetron)

A Phase 2 study of Alcoholism, sponsored by National Institute on Alcohol Abuse and Alcoholism (NIAAA).

Completed
Registry status
Phase 2
Development phase
360
Enrollment target
1
Study location

NCT00027079 is a Phase 2 study of Alcoholism that has completed, run by National Institute on Alcohol Abuse and Alcoholism (NIAAA). The registered enrollment target is 360 participants, roughly in line with the 370-participant average among 65 other Alcoholism trials with a reported enrollment target. The trial reports 1 study location across 1 state.

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The verdict

NCT00027079, a Phase 2 study of Alcoholism, has completed, sponsored by National Institute on Alcohol Abuse and Alcoholism (NIAAA).

COMPLETED
Registry status
Phase 2
Development phase
360 participants
Enrollment target
1
Study location

Study Summary

This study will compare the effectiveness of ondansetron (Zofran) and naltrexone (ReVia) both alone and in combination in treating Early Onset Alcoholics versus Late Onset Alcoholics. All subjects will received standardized Cognitive Behavioral Therapy. Followup assessments will be completed at 1, 3, 6, and 9 months after treatment.

Conditions Studied

Alcoholism

Interventions

  • BEHAVIORAL Cognitive Behavioral Therapy
  • DRUG ondansetron (Zofran)
  • DRUG naltrexone (ReVia)

Study Locations (1)

Texas

  • University of Texas Health Science Center - San Antonio

Trial Details

FieldValue
Enrollment Target 360 participants
Start Date 2001-09
Est. Completion 2004-08
Phase Phase 2

Sponsor

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

93 total trials

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What the Registry Record Tells You About NCT00027079

The ClinicalTrials.gov registry entry for NCT00027079 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 360 participants, a figure that helps gauge the scale of data the investigators plan to collect, roughly in line with the 370-participant average among 65 other Alcoholism trials with a reported enrollment target. 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 1 condition, with Alcoholism appearing as the primary indexed condition, and to 3 interventions - of which Cognitive Behavioral Therapy is the first listed.

NCT00027079 reports 1 study location spanning 1 distinct geographic area - top geographies include Texas.

Frequently Asked Questions

What is clinical trial NCT00027079 about?

NCT00027079 is a clinical study titled "Combined Pharmacotherapies for Alcoholism (Naltrexone/Ondansetron)". This study will compare the effectiveness of ondansetron (Zofran) and naltrexone (ReVia) both alone and in combination in treating Early Onset Alcoholics versus Late Onset Alcoholics. All subjects will received standardized Cognitive Behavioral Therapy. Followup assessments will be completed at 1, 3...

What is the current status of trial NCT00027079?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 360 participants. The study started on 2001-09. Estimated completion is 2004-08.

What conditions does trial NCT00027079 study?

This clinical trial studies the following conditions: Alcoholism.

What interventions are being tested in trial NCT00027079?

The interventions under investigation include: Cognitive Behavioral Therapy (BEHAVIORAL), ondansetron (Zofran) (DRUG), naltrexone (ReVia) (DRUG).

Who is sponsoring clinical trial NCT00027079?

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 NCT00027079 being conducted?

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

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