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

This study has been completed.
Information provided by (Responsible Party):
Kyle Kampman, University of Pennsylvania Identifier:
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;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Cocaine Dependence
Interventions: Drug: Modafinil
Drug: placebo
Behavioral: Cognitive Behavioral Therapy (CBT)

  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

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 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 
Overall Participants Analyzed 
[Units: Participants]
 47   47   94 
[Units: Participants]
<=18 years   0   0   0 
Between 18 and 65 years   47   47   94 
>=65 years   0   0   0 
[Units: Participants]
Female   9   8   17 
Male   38   39   77 
Region of Enrollment 
[Units: Participants]
United States   47   47   94 

  Outcome Measures
  Show All Outcome Measures

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

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

  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
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