Double Blind Study of Vigabatrin for the Treatment of Cocaine Dependence
Status:
Completed
Trial end date:
2007-11-01
Target enrollment:
Participant gender:
Summary
The primary objective of this study is to assess the efficacy of vigabatrin for the treatment
of cocaine dependence, based on the twice-weekly qualitative urine toxicologies for cocaine.
Based on two prior unblinded human studies and 15 years of animal studies, this 100 subject
double- blind, randomized study is designed to show if with vigabatrin treatment but not
placebo, even non-hospitalized cocaine dependent individuals with ready access to cocaine
will become cocaine abstinent if they are self motivated to stop their cocaine habit. To
accomplish this, cocaine dependent subjects will be randomly assigned to either a placebo or
vigabatrin treatment group and treated for a nine week period. The primary hypothesis is that
as compared to the placebo arm, the vigabatrin treatment arm will show a significant increase
in the number of subjects who are abstinent for the final 3 weeks of the study.
Phase:
Phase 2
Details
Lead Sponsor:
New York University School of Medicine NYU Langone Health