Cocaine-Related Disorders Clinical Trial
Official title:
Medication Development for Cocaine Dependence
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.
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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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