Vigabatrin for the Treatment of Cocaine Dependency

Study Overview
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Brief Summary
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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
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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.

Official Title
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Vigabatrin for Treatment of Cocaine Dependence: A Phase II Study

Conditions
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Cocaine Addiction, Cocaine Dependence

Intervention / Treatment
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* Drug: Vigabatrin
* Drug: Matching Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Able to understand the study and provide written informed consent. Male or female at least 18 years of age. Meet DSM-IV criteria for cocaine dependence as primary diagnosis, as determined by the Substance Abuse Structured Clinical Interview (SCID) for Diagnostic and Statistical Manual-IV (DSM-IV) module. Have a verifiable place of primary residence. Seeking treatment for cocaine dependence. Be in generally good health based on history, physical examination, electrocardiogram, eye exam and laboratory findings. If female of childbearing potential, use acceptable contraceptive methods (oral contraceptives (the pill), intrauterine device (IUD), contraceptive implants under the skin, contraceptive rings or patches or injections, diaphragms with spermicide, and condoms with spermicide). Surgical sterilization by tubal ligation or hysterectomy is acceptable. Exclusion Criteria: Please contact site for more information

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: CPP-109 Vigabatrin Tablets<br>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) | Drug: Vigabatrin<br>* Tablets<br>* Other names: VGB;|
| Placebo Comparator: Placebo<br>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) | Drug: Matching Placebo<br>* Tablets<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Abstinence | The number of subjects in each treatment group who are cocaine abstinent during the last 2 weeks of the Treatment Phase (Weeks 8 and 9). | Weeks 8-9 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Cocaine Use |  | Week 3 - 9 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cocaine, Cocaine Addiction Treatment, Cocaine Treatment, Vigabatrin, CPP-109, Catalyst, National Institute on Drug Abuse