HEAL Study
Phase 2, Double-Blind, Placebo-Controlled Trial Of Tiagabine For The Treatment Of Cocaine Dependence
Short Description
The study objective is to assess the efficacy and safety of tiagabine in reducing cocaine use in subjects with cocaine dependence. It is hypothesized that tiagabine treatment, compared to placebo, will be associated with fewer days of cocaine use as assessed by self-report confirmed with urine assays for benzoylecgonine (BE).
Release Date
Jan 15, 2019

This is a double-blind, placebo-controlled, parallel-group design study in which, after screening and a 2-week baseline assessment period, subjects will be equally randomly assigned to one of two treatment groups, tiagabine or matched placebo. All patients will receive manualguided cognitive behavioral therapy (CBT). Medication dosing will occur over 15 weeks with the first three weeks being dose escalation and the last three weeks being dose taper. Follow-up will consist of assessments once each week during weeks 13, 14, 15, and 19. Randomization strata include study site, gender and frequency of cocaine use in the 30 days prior to screening.

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