Vigabatrin for Treatment of Cocaine Dependence

This study has been completed.
Information provided by (Responsible Party):
Catalyst Pharmaceuticals, Inc. Identifier:
First received: January 28, 2008
Last updated: May 10, 2012
Last verified: May 2012
Results First Received: April 13, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Cocaine Dependence
Interventions: Drug: vigabatrin
Drug: placebo

  Participant Flow

  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
CPP-109 Vigabatrin CPP-109 tablets, 500 mg. 3 Tablets bid.
Placebo Matching Placebo Tablets. 3 tablets bid.
Total Total of all reporting groups

Baseline Measures
    CPP-109 Vigabatrin     Placebo     Total  
Number of Participants  
[units: participants]
  92     94     186  
[units: years]
Mean (Standard Deviation)
  44.6  (7.62)     45.0  (8.33)     44.8  (7.92)  
[units: participants]
Female     32     30     62  
Male     60     64     124  
Region of Enrollment  
[units: participants]
United States     92     94     186  

  Outcome Measures
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1.  Primary:   Proportion of Subjects in Each Treatment Group Abstinent During the Last 2 Weeks of Treatment.   [ Time Frame: Week 13 ]

2.  Post-Hoc:   Medication Compliance   [ Time Frame: Week 2, 4, 6 & 9-11 ]

  Serious Adverse Events

  Other Adverse Events

  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Lack of subject medication compliance, site-to-site variability in medication compliance possibly indicative of differing site capabilities to attract subjects sufficiently motivated to stop using cocaine.

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