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

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. According to ClinicalTrials.gov, the official US trial registry.

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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

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

What the finished NCT00027079 record still lists

NCT00027079 is an interventional study that assigns participants to a tested intervention. The registered 360 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 370-participant average among 65 other Alcoholism trials with a reported enrollment target.

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 a single indexed study location in 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.

Similar trials for Alcoholism

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 NCT00027079's enrollment target sits among peer trials

360 10th of 65 higher than 56 of 65 other Alcoholism trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Alcoholism 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 NCT00027079, the US trial registry maintained by the National Library of Medicine. NCT00027079 (mid enrollment · single site footprint · completed) retrieved and formatted by PlainTrial, see methodology.