Topiramate for Alcohol and Cocaine Dependence (TOP2)

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Kyle Kampman, University of Pennsylvania
ClinicalTrials.gov Identifier:
NCT00167245
First received: September 9, 2005
Last updated: August 21, 2014
Last verified: June 2014
Results First Received: April 24, 2013  
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
Conditions: Alcoholism
Cocaine Dependence
Interventions: Drug: Topiramate
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
Recruitment for this study began on 11/1/2004 and ended five years later in November 2009. Participants were treatment-seeking cocaine and alcohol users recruited at the UPenn Treatment Research Center.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Topiramate

topiramate

Topiramate : 300mg/day for 13 weeks

Placebo placebo : placebo pills

Participant Flow:   Overall Study
    Topiramate     Placebo  
STARTED     83     87  
COMPLETED     54     46  
NOT COMPLETED     29     41  
Lost to Follow-up                 20                 31  
Withdrawal by Subject                 5                 8  
Incarcerated                 3                 2  
Drowsy                 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
Group 1

topiramate

Topiramate : 300mg/day for 13 weeks

Group 2 placebo : placebo pills
Total Total of all reporting groups

Baseline Measures
    Group 1     Group 2     Total  
Number of Participants  
[units: participants]
  83     87     170  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     83     87     170  
>=65 years     0     0     0  
Age  
[units: years]
Mean ± Standard Deviation
  45  ± 7.0     43  ± 8.0     44  ± 7.0  
Gender  
[units: participants]
     
Female     18     18     36  
Male     65     69     134  
Region of Enrollment  
[units: participants]
     
United States     83     87     170  



  Outcome Measures
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1.  Primary:   Percent of Participants Abstinent From Cocaine During Last 3 Weeks of 13 Week Trial   [ Time Frame: Last 3 weeks of 13 week trial ]

2.  Primary:   Number of Heavy Drinking Days   [ Time Frame: 13 weeks ]

3.  Secondary:   Days Abstinent From Drinking and Frequency of Heavy Drinking Days as Measured by the Time Line Follow-Back During the Follow-up Period After Discontinuing Medication, Compared to Placebo-treated Subjects.   [ Time Frame: 12 weeks ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

4.  Secondary:   Fewer Days of Cocaine Use as Measured by the Time Line Follow Back in the Follow-up Period After Discontinuing Medication, Compared to Placebo-treated Subjects.   [ Time Frame: 12 weeks ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

5.  Secondary:   Days Abstinent From Drinking, Frequency of Heavy Drinking Days, and Cocaine Use (Confirmed by Urine Drug Screen) as Measured by the Time Line Follow-Back During the Treatment Phase, Compared to Less Topiramate-adherent (<80% Pills Taken).   [ Time Frame: 13 weeks ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

6.  Secondary:   The Penn Alcohol Craving Scale and the Minnesota Cocaine Craving Scale During the Medication Treatment Phase, Compared to Placebo-treated Subjects.   [ Time Frame: 13 weeks ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No


  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
The total number of subjects was relatively small and thus the results should be considered preliminary. The study drop-out rate was formidable, though it was comparable with most trials involving cocaine-dependent patients.


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Dr. Kyle Kampman
Organization: University of Pennsylvania
phone: 2152223200 ext 109
e-mail: kampman@mail.med.upenn.edu


No publications provided


Responsible Party: Kyle Kampman, University of Pennsylvania
ClinicalTrials.gov Identifier: NCT00167245     History of Changes
Other Study ID Numbers: 801385, R01AA014657
Study First Received: September 9, 2005
Results First Received: April 24, 2013
Last Updated: August 21, 2014
Health Authority: United States: Food and Drug Administration