Clinical Trial: Effectiveness of Topiramate in Treating Cocaine Dependent Individuals - 1
Study Status: Completed
Recruit Status: Unknown status
Study Type: Interventional
Official Title: Medication Development for Cocaine Dependence
Brief Summary: Although a great amount of research has been conducted to resolve cocaine dependence, an effective treatment has yet to be discovered. Topiramate is a drug that was found to be useful in treating alcohol dependence. The purpose of this study is to determine the effectiveness of topiramate in treating cocaine dependent individuals.
Detailed Summary:
Despite considerable scientific effort in the last two decades to develop treatment for cocaine dependent individuals, no medication has proven to be effective for treating cocaine dependence. Cocaine's rewarding effects are primarily a result of altering nerve pathways involving dopamine, a naturally-occurring chemical in the brain. Past research has focused on developing medications that either block dopamine or inhibit its release. However, these medications have not proven effective in treating cocaine dependence. This study will evaluate a new strategy of treating cocaine dependence by altering dopamine's functional expression. Dopamine-associated expression may be mediated through inhibition of gamma-aminobutyric acid (GABA), another brain chemical. Topiramate is a GABA inhibitor that has proven effective in treating alcohol dependent individuals. The purpose of this study is to determine the efficacy of topiramate in treating cocaine dependent individuals.
Participants 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, and will include evaluations of cocaine use and psychosocial functioning.
Sponsor: Bankole Johnson
Current Primary Outcome: Effectiveness of topiramate to reduce cocaine use(assessed by a combination of self-report of use and urine assays for benzoylecgonine, the major metabolite of cocaine). [ Time Frame: Throughout the study (Visit 0 to Visit 12, and at 2 weeks, 1, 2, and 3 months following completion of treatment) ]
Original Primary Outcome: Effectiveness of topiramate to reduce cocaine use; measured at 2 weeks, and 1, 2, and 3 months following completion of treatment
Current Secondary Outcome: Improved psychosocial functioning; measured throughout the study, and at 2 weeks and 1, 2, and 3 months following completion of treatment [ Time Frame: measured throughout the study, and at 2 weeks and 1, 2, and 3 months following completion of treatment ]
Original Secondary Outcome: Improved psychosocial functioning; measured throughout the study, and at 2 weeks and 1, 2, and 3 months following completion of treatment
Information By: University of Virginia
Dates:
Date Received: November 3, 2005
Date Started: October 2005
Date Completion: October 2012
Last Updated: March 6, 2012
Last Verified: March 2012
