Cocaine Dependence Clinical Trial
Official title:
Vigabatrin for Treatment of Cocaine Dependence: A Phase II Study
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.
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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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