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Trial record 98 of 239 for:    (armodafinil)

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.
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)
Enrollment 94
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Modafinil Placebo
Hide Arm/Group Description

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.

Period Title: Overall Study
Started 47 47
Completed 34 37
Not Completed 13 10
Arm/Group Title Modafinil Placebo Total
Hide Arm/Group Description

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 of all reporting groups
Overall Number of Baseline Participants 47 47 94
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 47 participants 47 participants 94 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  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 47 participants 47 participants 94 participants
Female
9
  19.1%
8
  17.0%
17
  18.1%
Male
38
  80.9%
39
  83.0%
77
  81.9%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 47 participants 47 participants 94 participants
47 47 94
1.Primary Outcome
Title Percent of Participants Reporting no Cocaine Craving
Hide Description Percent of participants reporting no cocaine craving based on Brief Substance Craving Scale (BSCS) - a 4 point likert scale.
Time Frame 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Modafinil Placebo
Hide Arm/Group Description:

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.

Overall Number of Participants Analyzed 47 47
Measure Type: Number
Unit of Measure: Percent of participants
64 41
2.Primary Outcome
Title Cocaine Use as Measured by Urine Drug Screen
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Modafinil Placebo
Hide Arm/Group Description:

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.

Overall Number of Participants Analyzed 47 47
Measure Type: Number
Unit of Measure: Percentage of Participants
23 9
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Modafinil Placebo
Hide Arm/Group Description

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.

All-Cause Mortality
Modafinil Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Modafinil Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   6/47 (12.77%)      9/47 (19.15%)    
Eye disorders     
Hospitalization for eye injury  [1]  0/47 (0.00%)  0 1/47 (2.13%)  1
General disorders     
Loss of Conciousness  [2]  1/47 (2.13%)  1 0/47 (0.00%)  0
Exacerbation of Cocaine Dependence  [3]  3/47 (6.38%)  4 5/47 (10.64%)  5
Infections and infestations     
Infection in laceration on right hand   0/47 (0.00%)  0 1/47 (2.13%)  1
Psychiatric disorders     
Hospitalization for Depression  [4]  1/47 (2.13%)  1 2/47 (4.26%)  2
Respiratory, thoracic and mediastinal disorders     
Hospitalization for Asthama  [5]  1/47 (2.13%)  2 0/47 (0.00%)  0
Indicates events were collected by systematic assessment
[1]
Subject was hospitalized for eye surgery
[2]
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.
[3]
Subject's cocaine dependence let subject to enter an inpatient program.
[4]
Subject entered psychiatric treatment facility
[5]
Subject hospitalized for worsening asthma symptoms
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Modafinil Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   23/47 (48.94%)      12/47 (25.53%)    
General disorders     
Headache   6/47 (12.77%)  7/47 (14.89%) 
Insomnia   10/47 (21.28%)  3/47 (6.38%) 
Psychiatric disorders     
Anxiety   7/47 (14.89%)  2/47 (4.26%) 
Indicates events were collected by systematic assessment
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
ClinicalTrials.gov 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