Alcoholism Clinical Trial
Official title:
A Phase II, Double-Blind, Placebo-Controlled, Pilot Trial of Vigabatrin for the Treatment of Cocaine and Alcohol Dependence
The purpose of this study is to evaluate the effectiveness of vigabatrin at reducing drug and alcohol use in individuals addicted to cocaine and alcohol. Vigabatrin is approved for the treatment of seizures. It has not been proven to be effective for the treatment of alcohol or cocaine dependence.
The hypotheses in the proposed study will be tested with a 2-group design to assess the
efficacy of vigabatrin compared to placebo. We will follow NIAAA's COMBINE Medical Management
(MM) manual in weekly dispensing medications, safety checks and medication adherence. The
psychosocial treatment will be Cognitive Behavioral Coping Skills Therapy (CBT). Subjects
will be 60 men and women with current DSM-IV diagnoses of both cocaine and alcohol dependence
who will be randomized to vigabatrin or placebo (30 subjects per group). All subjects will
receive weekly sessions of CBT. The study length for each subject is comprised of a1-3 weeks
of screening and baseline evaluations, an 8-week double-blind, placebo-controlled trial with
CBT (medication phase), and one follow-up visit 12 weeks after starting study medication.
Study medication will be initiated in Week 2. The research physician will explain the dosing
regimen and subjects will be randomly assigned to receive either vigabatrin or identical
placebo tablets. Subjects will receive 1 gram of vigabatrin or identical placebo tablets on
medication days 1-3 then 1.5 grams or identical placebo tablets on days 4-7. The dose ids
increased to 2 grams in week 2, 3 grams in weeks 4-7 and then reduced to 2 grams days 50-53,
and to 1 gram on days 54-56
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