Vigabatrin for the Treatment of Cocaine Dependency

Status Completed

Clinical Trial Summary

Clinical Trial 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. ;

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT01281202
Study type	Interventional
Source	National Institute on Drug Abuse (NIDA)
Contact
Status	Completed
Phase	Phase 2/Phase 3
Start date	January 2011
Completion date	December 2012

View Details

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