Modafinil Treatment for Cocaine Dependence and HIV High-Risk Behavior (MOD6)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Kyle Kampman, University of Pennsylvania
ClinicalTrials.gov Identifier:
NCT00368290
First received: August 22, 2006
Last updated: December 12, 2013
Last verified: December 2013
Results First Received: December 12, 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
Condition: Cocaine Dependence
Interventions: Drug: Modafinil
Drug: placebo
Behavioral: Cognitive Behavioral Therapy (CBT)

  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
No text entered.

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
Modafinil

modafinil plus CBT

Modafinil: 300mg a day for 8 weeks

Cognitive Behavioral Therapy (CBT): Weekly cognitive behavioral therapy sessions for a period of 8 weeks.

Placebo

placebo plus CBT

placebo: placebo pills for 8 weeks

Cognitive Behavioral Therapy (CBT): Weekly cognitive behavioral therapy sessions for a period of 8 weeks.


Participant Flow:   Overall Study
    Modafinil     Placebo  
STARTED     47     47  
COMPLETED     34     37  
NOT COMPLETED     13     10  



  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
Modafinil

modafinil plus CBT

Modafinil: 300mg a day for 8 weeks

Cognitive Behavioral Therapy (CBT): Weekly cognitive behavioral therapy sessions for a period of 8 weeks.

Placebo

placebo plus CBT

placebo: placebo pills for 8 weeks

Cognitive Behavioral Therapy (CBT): Weekly cognitive behavioral therapy sessions for a period of 8 weeks.

Total Total of all reporting groups

Baseline Measures
    Modafinil     Placebo     Total  
Number of Participants  
[units: participants]
  47     47     94  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     47     47     94  
>=65 years     0     0     0  
Gender  
[units: participants]
     
Female     9     8     17  
Male     38     39     77  
Region of Enrollment  
[units: participants]
     
United States     47     47     94  



  Outcome Measures
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1.  Primary:   Percent of Participants Reporting no Cocaine Craving   [ Time Frame: 8 weeks ]

Measure Type Primary
Measure Title Percent of Participants Reporting no Cocaine Craving
Measure Description Percent of participants reporting no cocaine craving based on Brief Substance Craving Scale (BSCS) - a 4 point likert scale.
Time Frame 8 weeks  
Safety Issue No  

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
Modafinil

modafinil plus CBT

Modafinil: 300mg a day for 8 weeks

Cognitive Behavioral Therapy (CBT): Weekly cognitive behavioral therapy sessions for a period of 8 weeks.

Placebo

placebo plus CBT

placebo: placebo pills for 8 weeks

Cognitive Behavioral Therapy (CBT): Weekly cognitive behavioral therapy sessions for a period of 8 weeks.


Measured Values
    Modafinil     Placebo  
Number of Participants Analyzed  
[units: participants]
  47     47  
Percent of Participants Reporting no Cocaine Craving  
[units: Percent of participants]
  64     41  

No statistical analysis provided for Percent of Participants Reporting no Cocaine Craving



2.  Primary:   Cocaine Use as Measured by Urine Drug Screen   [ Time Frame: 8 weeks ]

Measure Type Primary
Measure Title Cocaine Use as Measured by Urine Drug Screen
Measure Description The primary outcome measure was cocaine use measured by self-report, and confirmed by twice weekly urine drug screens. The percentage of participants shows the percentage who were abstinent from cocaine during the last 3 weeks of the trial.
Time Frame 8 weeks  
Safety Issue No  

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
Modafinil

modafinil plus CBT

Modafinil: 300mg a day for 8 weeks

Cognitive Behavioral Therapy (CBT): Weekly cognitive behavioral therapy sessions for a period of 8 weeks.

Placebo

placebo plus CBT

placebo: placebo pills for 8 weeks

Cognitive Behavioral Therapy (CBT): Weekly cognitive behavioral therapy sessions for a period of 8 weeks.


Measured Values
    Modafinil     Placebo  
Number of Participants Analyzed  
[units: participants]
  47     47  
Cocaine Use as Measured by Urine Drug Screen  
[units: Percentage of Participants]
  23     9  

No statistical analysis provided for Cocaine Use as Measured by Urine Drug Screen




  Serious Adverse Events


  Other Adverse Events


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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.


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
No text entered.  


Results Point of Contact:  
Name/Title: Dr. Kyle Kampman
Organization: University of Pennsylvania
phone: 215-222-3200 ext 109
e-mail: kampman@mail.med.upenn.edu


No publications provided


Responsible Party: Kyle Kampman, University of Pennsylvania
ClinicalTrials.gov Identifier: NCT00368290     History of Changes
Other Study ID Numbers: 804537
Study First Received: August 22, 2006
Results First Received: December 12, 2013
Last Updated: December 12, 2013
Health Authority: United States: Food and Drug Administration