Randomized, double-blind, placebo-controlled trial of vigabatrin for the treatment of cocaine dependence in Mexican parolees.
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.


METHODS
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.
Brodie
Jonathan D
JD
Department of Psychiatry, New York University School of Medicine, New York, NY 10016, USA. jonathan.brodie@nyumc.org
Case
Brady G
BG
Figueroa
Emilia
E
Dewey
Stephen L
SL
Robinson
James A
JA
Wanderling
Joseph A
JA
Laska
Eugene M
EM
D000328:Adult; D000437:Alcoholism / Q000534:rehabilitation / Q000628:therapy; D000927:Anticonvulsants / Q000627:therapeutic use*; D019970:Cocaine-Related Disorders / Q000188:drug therapy* / Q000534:rehabilitation; D003131:Combined Modality Therapy; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D017058:Mexican Americans / Q000331:legislation & jurisprudence / Q000523:psychology / Q000706:statistics & numerical data*; D010919:Placebos; D012720:Severity of Illness Index; D015813:Substance Abuse Detection / Q000706:statistics & numerical data; D013695:Temperance / Q000706:statistics & numerical data; D016896:Treatment Outcome; D014505:Urban Population; D020888:Vigabatrin / Q000627:therapeutic use*
D000927:Anticonvulsants; D010919:Placebos; D020888:Vigabatrin