Vigabatrin for Cocaine and Alcohol Dependence

Summary

The purpose of this study is to evaluate the effectiveness of vigabatrin at reducing drug and alcohol use in individuals addicted to cocaine and alcohol. Vigabatrin is approved for the treatment of seizures. It has not been proven to be effective for the treatment of alcohol or cocaine dependence.

Timeline

Start

2011-04

Primary completion

2013-04

Completion

2013-12

Outcome

Missed primary endpoint

Stopped: “interim analysis of efficacy completed and termination recommended”

registry analysis (superiority test); Vigabatrin vs Placebo; p = .14; Chi-squared NCT01335867 ↗

registry NUMBER Vigabatrin: 0 participants NCT01335867 ↗

registry NUMBER Placebo: 2 participants NCT01335867 ↗

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Vigabatrin	Small molecule	3 g	—

Indications