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Topiramate for Alcohol and Comorbid Cocaine Dependence
NCT00167245Phase 2
Key facts
- Status
- Completed
- Start
- Sep 2004
- Primary completion
- Mar 2010
- Countries
- 1
- Modality
- Small Molecules
- Drugs
- topiramate
- Conditions
- alcohol dependencecocaine dependence
01
Overview
Phase 2, randomised, double-blind trial in alcohol dependence and cocaine dependence comparing Topiramate with Placebo (2 arms). Primary endpoints: Percent of Participants Abstinent From Cocaine During Last 3 Weeks of 13 Week Trial and Number of Heavy Drinking Days at 13 weeks. Started Sep 2004; status: completed.
02
Design
2 arms- Study design
- RandomizedDouble-blind
Topiramate
Topiramate capsules titrated up to 300 mg daily.
Placebo
Placebo capsules identical to topiramate.
03
Who it enrols
Adults with comorbid alcohol and cocaine dependence who have achieved 2-3 days of abstinence.
04
Endpoints
Primary
Percent of Participants Abstinent From Cocaine During Last 3 Weeks of 13 Week Trial
Number of Heavy Drinking Days
Secondary
Cocaine Withdrawal Symptoms Measured by Cocaine Selective Severity Assessment
The Penn Alcohol Craving Scale
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