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

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ClinicalTrials.gov Identifier: NCT00368290
Recruitment Status : Completed
First Posted : August 24, 2006
Results First Posted : January 29, 2014
Last Update Posted : March 15, 2018
Sponsor:
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
  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

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 
Overall Participants Analyzed 
[Units: Participants]
 47   47   94 
Age 
[Units: Participants]
Count of Participants
     
<=18 years      0   0.0%      0   0.0%      0   0.0% 
Between 18 and 65 years      47 100.0%      47 100.0%      94 100.0% 
>=65 years      0   0.0%      0   0.0%      0   0.0% 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      9  19.1%      8  17.0%      17  18.1% 
Male      38  80.9%      39  83.0%      77  81.9% 
Region of Enrollment 
[Units: Participants]
     
United States   47   47   94 


  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

Time Frame No text entered.
Additional Description 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.


Serious Adverse Events
    Modafinil   Placebo
Total, Serious Adverse Events     
# participants affected / at risk   6/47 (12.77%)   9/47 (19.15%) 
Eye disorders     
Hospitalization for eye injury † [2]     
# participants affected / at risk   0/47 (0.00%)   1/47 (2.13%) 
# events   0   1 
General disorders     
Loss of Conciousness † [3]     
# participants affected / at risk   1/47 (2.13%)   0/47 (0.00%) 
# events   1   0 
Exacerbation of Cocaine Dependence † [4]     
# participants affected / at risk   3/47 (6.38%)   5/47 (10.64%) 
# events   4   5 
Infections and infestations     
Infection in laceration on right hand †     
# participants affected / at risk   0/47 (0.00%)   1/47 (2.13%) 
# events   0   1 
Psychiatric disorders     
Hospitalization for Depression † [5]     
# participants affected / at risk   1/47 (2.13%)   2/47 (4.26%) 
# events   1   2 
Respiratory, thoracic and mediastinal disorders     
Hospitalization for Asthama † [6]     
# participants affected / at risk   1/47 (2.13%)   0/47 (0.00%) 
# events   2   0 
Events were collected by systematic assessment
[2] Subject was hospitalized for eye surgery
[3] Subject was driving and reportedly lost consciousness, causing his car to hit the side of a house. The expected charges are driving under the influence and malicious mischief with a motor vehicle.
[4] Subject's cocaine dependence let subject to enter an inpatient program.
[5] Subject entered psychiatric treatment facility
[6] Subject hospitalized for worsening asthma symptoms




  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
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  More Information