NCT00678457

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: University of Virginia · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Alcohol Dependence

Interventions

Type	Name	Description
DRUG	Ondansetron	ondansetron (4 μg/kg b.i.d.)
DRUG	Olanzapine	olanzapine (9, 18, and 36 μg/kg)
DRUG	Placebo	placebo

Timeline

• Start date: 2007-01-01
• Primary completion: 2008-05-01
• Completion: 2008-05-01
• First posted: 2008-05-15
• Last updated: 2009-01-30

Locations

2 sites across 1 country: United States