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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00368290
Recruitment Status : Completed
First Posted : August 24, 2006
Results First Posted : January 29, 2014
Last Update Posted : March 15, 2018
Information provided by (Responsible Party):
Kyle Kampman, University of Pennsylvania

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Cocaine Dependence
Interventions: Drug: Modafinil
Drug: placebo
Behavioral: Cognitive Behavioral Therapy (CBT)

  Participant Flow

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

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.

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

  Baseline Characteristics

  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

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

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.

Results Point of Contact:  
Name/Title: Dr. Kyle Kampman
Organization: University of Pennsylvania
phone: 215-222-3200 ext 109

Responsible Party: Kyle Kampman, University of Pennsylvania Identifier: NCT00368290     History of Changes
Other Study ID Numbers: 804537
First Submitted: August 22, 2006
First Posted: August 24, 2006
Results First Submitted: December 12, 2013
Results First Posted: January 29, 2014
Last Update Posted: March 15, 2018