Vigabatrin for Treatment of Cocaine Dependence

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Catalyst Pharmaceutical Partners, Inc
ClinicalTrials.gov Identifier:
NCT00611130
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
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
01/08-01/09 at 11 US research trial sites.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
After Informed Consent obtained, subjects entered a 2-4 week Screening/Baseline Phase to determine whether all Inclusion/Exclusion Criteria were met. Randomization strata included gender, primary method of cocaine administration (snort or intravenous/smoke) & use in last 30 days (≤18 days or >18 days)

Reporting Groups
  Description
CPP-109 Vigabatrin CPP-109 tablets, 500 mg. 3 Tablets bid.
Placebo Matching Placebo Tablets. 3 tablets bid.

Participant Flow:   Overall Study
    CPP-109 Vigabatrin     Placebo  
STARTED     92     94  
Completed 12 Week Treatment Phase     61     64  
COMPLETED     43     47  
NOT COMPLETED     49     47  
Lost to Follow-up                 25                 29  
Protocol noncompliance                 7                 6  
Withdrawal by Subject                 6                 5  
Unspecified                 5                 4  
Incarceration                 3                 2  
Administrative                 1                 1  
Adverse Event                 1                 0  
Death                 1                 0  



  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.
No text entered.

Reporting Groups
  Description
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  
Age  
[units: years]
Mean ± Standard Deviation
  44.6  ± 7.62     45.0  ± 8.33     44.8  ± 7.92  
Gender  
[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
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Time Frame No text entered.
Additional Description No text entered.

Reporting Groups
  Description
CPP-109 Vigabatrin Tablets, 500 mg Vigabatrin Tablets, 1.5 g bid po, 12 weeks. Subjects proceeded to a 12 week Treatment Phase, including a 2 week dose escalation period, a 9 week maintenance period (3.0 gm/day of vigabatrin), and a 1 week medication taper period. Finally, subjects then proceeded to a 12 week follow-up period. Subjects were scheduled for clinic visits 3 times per week (typically on Monday, Wednesday, and Friday) during the Screening/Baseline Phase and the 12 week Treatment Phase. Subjects returned for follow up visits at Weeks 13, 16, 20 and 24.
Matching Placebo Tablet Subjects proceeded to a 12 week Treatment Phase,receiving 3 tablets bid po Finally, subjects then proceeded to a 12 week follow-up period. Subjects were scheduled for clinic visits 3 times per week (typically on Monday, Wednesday, and Friday) during the Screening/Baseline Phase and the 12 week Treatment Phase. Subjects returned for follow up visits at Weeks 13, 16, 20 and 24.

Serious Adverse Events
    CPP-109 Vigabatrin Tablets, 500 mg     Matching Placebo Tablet  
Total, serious adverse events      
# participants affected / at risk     6/92 (6.52%)     0/94 (0.00%)  
Cardiac disorders      
Tachycardia    
# participants affected / at risk     1/92 (1.09%)     0/94 (0.00%)  
Hepatobiliary disorders      
Hepatitis, acute      
# participants affected / at risk     1/92 (1.09%)     0/94 (0.00%)  
Infections and infestations      
Meningitis & Pneumonia      
# participants affected / at risk     1/92 (1.09%)     0/94 (0.00%)  
Injury, poisoning and procedural complications      
Gun shot wound, road traffic accident & tibia fracture      
# participants affected / at risk     2/92 (2.17%)     0/94 (0.00%)  
Psychiatric disorders      
Drug Abuse & Major Depression      
# participants affected / at risk     2/92 (2.17%)     0/94 (0.00%)  
Events were collected by systematic assessment




  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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