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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
History of Changes
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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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 ]
  Show Outcome Measure 1

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


  Serious Adverse Events
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  Other Adverse Events
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Limitations and Caveats
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.  


Results Point of Contact:  
Name/Title: M Douglas Winship
Organization: Catalyst Pharmaceutical Partners, Inc.
phone: 305-529-2522 ext 12
e-mail: dwinship@catalystpharma.com


No publications provided by Catalyst Pharmaceutical Partners, Inc

Publications automatically indexed to this study:


Responsible Party: Catalyst Pharmaceutical Partners, Inc
ClinicalTrials.gov Identifier: NCT00611130     History of Changes
Other Study ID Numbers: CPP-01004
Study First Received: January 28, 2008
Results First Received: April 13, 2012
Last Updated: May 10, 2012
Health Authority: United States: Food and Drug Administration