NCT00527683

Double Blind Study of Vigabatrin for the Treatment of Cocaine Dependence

Double-Blind, Randomized, Placebo- Controlled Trial of Vigabatrin for Short Term Abstinence From Cocaine in Cocaine Dependent Parolees

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: NYU Langone Health · Academic / Other
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Cocaine Dependence

Interventions

Type	Name	Description
DRUG	Vigabatrin	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
DRUG	Placebo	orange juice is administered twice daily in containers indistinguishable from the treatment arm.
BEHAVIORAL	Group therapy	Participants attend group sessions once a week

Timeline

• Start date: 2007-04-01
• Primary completion: 2007-11-01
• Completion: 2007-11-01
• First posted: 2007-09-11
• Last updated: 2008-04-11

Locations

1 site across 1 country: Mexico