Randomized, double-blind, placebo-controlled trial of vigabatrin for the
treatment of cocaine dependence in Mexican parolees.
Author(s): Brodie JD, Case BG, Figueroa E, Dewey SL, Robinson JA, Wanderling JA, Laska EM.
Affiliation(s): Department of Psychiatry, New York University School of Medicine, New York, NY
10016, USA. jonathan.brodie@nyumc.org
Publication date & source: 2009, Am J Psychiatry. , 166(11):1269-77
OBJECTIVE: Cocaine dependence is associated with severe medical, psychiatric, and
social morbidity, but no pharmacotherapy is approved for its treatment in the
United States. The atypical antiepileptic vigabatrin (gamma-vinyl
gamma-aminobutyric acid [GABA]) has shown promise in animal studies and
open-label trials. The purpose of the present study was to assess the efficacy of
vigabatrin for short-term cocaine abstinence in cocaine-dependent individuals.
METHOD: Participants were treatment seeking parolees who were actively using
cocaine and had a history of cocaine dependence. Subjects were randomly assigned
to a fixed titration of vigabatrin (N=50) or placebo (N=53) in a 9-week
double-blind trial and 4-week follow-up assessment. Cocaine use was determined by
directly observed urine toxicology testing twice weekly. The primary endpoint was
full abstinence for the last 3 weeks of the trial.
RESULTS: Full end-of-trial abstinence was achieved in 14 vigabatrin-treated
subjects (28.0%) versus four subjects in the placebo arm (7.5%). Twelve subjects
in the vigabatrin group and two subjects in the placebo group maintained
abstinence through the follow-up period. The retention rate was 62.0% in the
vigabatrin arm versus 41.5% in the placebo arm. Among subjects who reported
prestudy alcohol use, vigabatrin, relative to placebo, was associated with
superior self-reported full end-of-trial abstinence from alcohol (43.5% versus
6.3%). There were no differences between the two groups in drug craving,
depressed mood, anxiety, or Clinical Global Impression scores, and no group
differences in adverse effects emerged.
CONCLUSIONS: This first randomized, double-blind, placebo-controlled trial
supports the safety and efficacy of short-term vigabatrin treatment of cocaine
dependence.
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