NCT00382642

Pharmacological Treatment for Alcoholism

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 283 (actual)
• Sponsor: Bankole Johnson · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This is a 13 week outpatient clinical trial. Participants will either receive ondansetron or placebo and behavioral therapy. There is a 1, 2, and 3 month post-study follow up visit.Screening for this study is initially done over the telephone and takes 15-20 minutes. If participants are eligible after the initial screen, they will be invited to come in for a more thorough in house screen which takes about 5 to 6 hours. The screening will include a physical exam, review of medical, alcohol and drug histories and blood collection. If participants are found to be eligible after the in house screen, they will be enrolled in the 13 week outpatient clinical trial.

Conditions

• Alcohol Dependence

Interventions

Type	Name	Description
DRUG	Ondansetron + Cognitive Behavioral Therapy	13 week outpatient trial
DRUG	Placebo + Cognitive Behavioral Therapy	13 week outpatient trial

Timeline

• Start date: 2006-06-01
• Primary completion: 2009-03-01
• Completion: 2009-12-01
• First posted: 2006-09-29
• Last updated: 2012-02-07

Locations

1 site across 1 country: United States