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Ondansetron With Olanzapine for the Treatment of Alcohol Dependence: A Preliminary Clinical Trial

Alcohol Dependence Clinical Trial

Official title:
Ondansetron With Olanzapine for the Treatment of Alcohol Dependence: A Preliminary Clinical Trial

Clinical Trial Summary

This study would like to test whether the combination of ondansetron and olanzapine will be superior to placebo at decreasing self-reported heavy drinking among early onset alcoholics.

Clinical Trial Description

Target population: We will enroll male and female who meet DSM IV criteria for alcohol dependence and who are currently drinking equal or more than 21 alcohol units/week for women and equal or more than 28 alcohol units/week for men in the 7 day period prior to enrollment.

This is a double-blind placebo-controlled study. Eligible subjects will be randomized to ondansetron (4 ug/kg) and olanzapine (9, 18, 36 ug/kg) vs placebo. All subjects will participate in a 9 week regimen of weekly BBCET and outpatient medication treatment. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00678457
Study type Interventional
Source University of Virginia
Contact
Status Completed
Phase Phase 2
Start date January 2007
Completion date May 2008
View Details
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