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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
100
crystalline drug dissolved in orange juice, dosage escalates from 500 mg twice daily to 1.5 g twice daily over a 3 week period. This dose is maintained for 4 weeks and then tapered to zero over the next two weeks
orange juice is administered twice daily in containers indistinguishable from the treatment arm.
Participants attend group sessions once a week
Clinica Integral de Tratamiento Contra las Adicciones SA de CV
Mexico City, Mexico City, Mexico
Three consecutive weeks of negative urine tests (benzoyl ecgonine) for cocaine use (no slips allowed).
Time frame: These must be the last three weeks (7,8,9) of the trial.
3 consecutive weeks of negative urines (one slip allowed)
Time frame: Last 3 weeks (7,8,9) of the trial
cocaine craving
Time frame: Weeks 1, 5,9
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