Conditions: Cocaine Addiction Cocaine Dependence
Keywords: Cocaine Cocaine Addiction Treatment Cocaine Treatment Vigabatrin CPP-109 Catalyst National Institute on Drug Abuse
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 207
Healthy volunteers: no

Brief 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.

Arms:
arm 1: Subjects were evaluated for their compliance with protocol inclusion/exclusion criteria during a -2 to -4 week Screening/Baseline Phase

During treatment, subjects received 3 CPP-109 Vigabatrin 500 mg Tablets, bid, for 9 weeks

Subjects were provided with on-site, supervised, standardized, manualized Individual Drug Counseling 1x per week for 9 weeks and the first 4 weeks for the follow-up phase (weeks 10-13) arm 2: Subjects were evaluated for their compliance with protocol inclusion/exclusion criteria during a -2 to -4 week Screening/Baseline Phase

During treatment, subjects received Vigabatrin matching placebo tablets, bid, for 9 weeks

Subjects were provided with on-site, supervised, standardized, manualized Indivdiual Drug Counseling 1x per week for 9 weeks and the first 4 weeks for the follow-up phase (weeks 10-13)

Interventions: intervention 1: Vigabatrin intervention 2: Matching Placebo
Intervention descriptions: intervention 1: Tablets intervention 2: Tablets

Protocol document: