NCT00448825

Novel Pharmacotherapy for Dual Dependence

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 180 (estimated)
• Sponsor: Bankole Johnson · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the effects of Topiramate and Cognitive Behavioral Therapy for the treatment of alcohol and cocaine dependence.

Detailed description

Our objective is to understand the basic mechanisms that underpin substance dependence, and to develop efficacious treatments for individuals with comorbid cocaine and alcohol dependence. Participants in this study will be randomly assigned to receive either 300 mg per day of topiramate or placebo. In addition, participants will receive weekly cognitive behavioral therapy for 12 weeks.Follow-up visits will occur at 2 weeks and 1,2,, and 3 months following completion of treatment.

Conditions

• Alcohol Dependence
• Cocaine Dependence

Interventions

Type	Name	Description
DRUG	Topiramate + Cognitive Behavioral Therapy	Topiramate up to 300 mg per day
DRUG	Placebo + Cognitive Behavioral Therapy	Placebo twice a day

Timeline

• Start date: 2007-03-01
• Primary completion: 2013-06-01
• Completion: 2013-06-01
• First posted: 2007-03-19
• Last updated: 2013-03-15

Locations

2 sites across 1 country: United States