NCT00006205

Alcohol Dependency Study: Combining Medication Treatment for Alcoholism

Combining Medications Treatment for Alcoholism

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 320 (estimated)
• 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 and topiramate either alone or in combination is safe and effective in the treatment of alcohol dependence. This 13 week out-patient clinical trial is randomized, double-blind, and placebo-controlled. There are post-study follow up visits 1, 2 and 3 months after the end of the study. Participants will receive ondansetron and topiramate either alone or in combination or a placebo coupled with psychotherapy.

Detailed description

This study is a 13 week clinical trial. During the 13 weeks participants receive placebo, ondansetron and topiramate alone or in combination. During the 13 weeks participants come to an outpatient clinic to receive the study medication, physical checks, and cognitive behavioral therapy. The duration of the weekly visit is 3 hours. 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 there is nothing found to make someone ineligible to participate, they come to the out-patient clinic for a more thorough in-clinic screening.

Conditions

• Alcoholism

Interventions

Type	Name	Description
DRUG	ondansetron + cognitive behavioral therapy	ondansetron (4 mcg/kg b.i.d)
DRUG	topiramate + cognitive behavioral therapy	topiramate (up to 300 mg/day)
DRUG	Placebo + cognitive behavioral therapy	placebo
DRUG	ondansetron + topiramate + cognitive behavioral therapy	ondansetron (4 mcg/kg b.i.d) + topiramate (up to 300 mg/day)

Timeline

• Start date: 2005-03-01
• Primary completion: 2013-06-01
• Completion: 2013-12-01
• First posted: 2000-09-12
• Last updated: 2013-03-15

Locations

2 sites across 1 country: United States