NCT01281202

Vigabatrin for the Treatment of Cocaine Dependency

Vigabatrin for Treatment of Cocaine Dependence: A Phase II Study

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 207 (actual)
• Sponsor: Catalyst Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The objective of this 26-28 week study is to demonstrate that the rate of cocaine dependent subjects treated with CPP-109 vigabatrin in addition to counseling, who completely stop use of cocaine in the last 2 weeks of the study's Treatment Phase (Weeks 8 and 9) will be higher than seen in subjects treated with placebo in addition to counseling.

Detailed description

The objective of this 26-28 week study is to demonstrate that the rate of cocaine dependent subjects treated with CPP-109 vigabatrin in addition to counseling, who completely stop use of cocaine in the last 2 weeks of the study's Treatment Phase (Weeks 8 and 9) will be higher than seen in subjects treated with placebo in addition to counseling. There are 3 Phases to this study: * a 2-4 week Screening/Baseline Phase during which eligibility to be included in the trial will be tested; * a 9 week Treatment Phase during which subjects will receive CPP-109 or placebo tablets in addition to counseling; and * a 15 week Follow-up Phase, during the first 4 weeks (Weeks 10-13) of which subjects will continue to receive counseling.

Conditions

• Cocaine Addiction
• Cocaine Dependence

Interventions

Type	Name	Description
DRUG	Vigabatrin	Tablets
DRUG	Matching Placebo	Tablets

Timeline

• Start date: 2011-01-01
• Primary completion: 2012-10-01
• Completion: 2012-12-01
• First posted: 2011-01-21
• Last updated: 2016-05-18
• Results posted: 2016-02-23

Locations

13 sites across 1 country: United States