MedTrace Logo

Pharmacological Treatment for Alcoholism

NCT00382642 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 283

Last updated 2012-02-07

No results posted yet for this study

Summary

The purpose of this study is to learn whether ondansetron is safe and effective in the treatment of alcohol dependence. We also want to learn whether the study drug ondansetron combined with Cognitive Behavioral Therapy will assist researchers to determine whether having a certain gene is responsible for determining how a person benefits or does not benefit from the use of ondansetron for alcohol dependence.

Conditions

  • Alcohol Dependence

Interventions

DRUG

Ondansetron + Cognitive Behavioral Therapy

13 week outpatient trial

DRUG

Placebo + Cognitive Behavioral Therapy

13 week outpatient trial

Sponsors & Collaborators

  • National Institute on Alcohol Abuse and Alcoholism (NIAAA)

    collaborator NIH

  • Bankole Johnson

    lead OTHER

Principal Investigators

  • Bankole Johnson, M.D., Ph.D. · University of Virginia

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-06-30
Primary Completion
2009-03-31
Completion
2009-12-31

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00382642 on ClinicalTrials.gov