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.
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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
170
300mg/day for 13 weeks
placebo pills
University of Pennsylvania, Treatment Research Center
Philadelphia, Pennsylvania, United States
Percent of Participants Abstinent From Cocaine During Last 3 Weeks of 13 Week Trial
Samples were analyzed for benzoylecgonine by fluorescent polarization assay. Samples containing equal to or greater than 300 ng/ml of benzoylecgonine were considered to be positive for cocaine.
Time frame: Last 3 weeks of 13 week trial
Number of Heavy Drinking Days
Heavy drinking days, defined as more than 4 standard drinks for men and 3 standard drinks for women
Time frame: 13 weeks
Cocaine Withdrawal Symptoms Measured by Cocaine Selective Severity Assessment.
Total cssa score at the end of the medication phase of the trial. The CSSA is a measure of cocaine withdrawal severity. The minimum score is 0 the maximum score is 119. Higher score means more severe cocaine withdrawal symptoms
Time frame: 13 weeks
The Penn Alcohol Craving Scale
This Scale measures alcohol craving. The maximum score is 30, the minimum score is 0. Higher scores are indicative of more severe alcohol craving.
Time frame: 13 weeks
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