NCT00167245

Topiramate for Alcohol and Cocaine Dependence

A Phase II, Randomized, Double-blind, Placebo-Controlled, Pilot Trial of Topiramate for Alcohol and Comorbid Cocaine Dependence

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 170 (actual)
• Sponsor: Kyle Kampman · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The primary purpose of this study is to test the effectiveness of topiramate for the treatment of combined alcohol and cocaine dependence. Topiramate is approved for the treatment of seizures. It has not been proven to be effective for the treatment of alcohol or cocaine dependence.

Detailed description

The purpose of this study is to evaluate the efficacy of 300 mg/day of topiramate for the treatment of 200 treatment-seeking alcohol dependent outpatients with comorbid cocaine dependence in a double-blind, placebo-controlled 14-week trial, with a 6-month follow-up (3 months after completing medications).

Conditions

• Alcoholism
• Cocaine Dependence

Interventions

Type	Name	Description
DRUG	Topiramate	300mg/day for 13 weeks
DRUG	placebo	placebo pills

Timeline

• Start date: 2004-09-01
• Primary completion: 2010-03-01
• Completion: 2010-06-01
• First posted: 2005-09-14
• Last updated: 2020-07-07
• Results posted: 2014-09-01

Locations

1 site across 1 country: United States