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


  Baseline Characteristics
  Hide Baseline Characteristics

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
  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
  Hide 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.


  More Information