NCT00730522

Safety and Efficacy Study of Vigabatrin to Treat Methamphetamine Dependence

Vigabatrin for Treatment of Methamphetamine Dependence: A Phase II Study

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 55 (actual)
• Sponsor: Catalyst Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The objective of this study is to demonstrate that a larger proportion of vigabatrin-treated subjects than placebo-treated subjects will be methamphetamine-free in the last 2 weeks of the study's Treatment Phase (Weeks 11 and 12).

Detailed description

This is a Phase II, randomized, double-blind, placebo-controlled, intent-to-treat, 2-arm, parallel design, multicenter study to evaluate vigabatrin as a treatment for methamphetamine addiction. The study will involve approximately 180 subjects (90/group) who meet DSM IV criteria for methamphetamine dependence. Subjects will be evaluated for their compliance with protocol inclusion/exclusion criteria during Screening/Baseline Phase, lasting up to 4 weeks. At the conclusion of the Screening/Baseline Phase, subjects meeting all inclusion/exclusion criteria will be randomized to one of two treatment groups: vigabatrin or placebo. Subjects will proceed to a 12 week Treatment Phase and then undergo a 12 week follow-up period. Subjects will be scheduled for clinic visits 3 times per week for efficacy and/or safety assessments during the Screening/Baseline Phase and the 12 week Treatment Phase. Subjects will return for follow up visits at Weeks 13, 16, 20 and 24.

Conditions

• Methamphetamine Dependence

Interventions

Type	Name	Description
DRUG	CPP-109 vigabatrin	tablets, bid for 12 weeks
DRUG	Matching Placebo	tablets, bid, 12 weeks

Timeline

• Start date: 2008-07-01
• Primary completion: 2009-06-01
• Completion: 2009-11-01
• First posted: 2008-08-08
• Last updated: 2020-12-09
• Results posted: 2020-12-09

Locations

8 sites across 1 country: United States