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Trial record 65 of 239 for:    (armodafinil)

Modafinil Combined With Cognitive Behavior Therapy to Treat Cocaine Addiction - 1

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ClinicalTrials.gov Identifier: NCT00218387
Recruitment Status : Completed
First Posted : September 22, 2005
Results First Posted : April 10, 2019
Last Update Posted : April 10, 2019
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Robert Malcolm, Medical University of South Carolina

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Cocaine Dependence
Interventions Drug: Modafinil
Drug: Matching Placebo
Enrollment 123
Recruitment Details  
Pre-assignment Details  
Arm/Group Title 200mg Modafinil 400mg Modafinil Matching Placebo
Hide Arm/Group Description

200mg Modafinil

Modafinil: 200mg Modafinil

400mg Modafinil

Modafinil: 400mg Modafinil

Matching Placebo

Matching Placebo: Matching Placebo

Period Title: Overall Study
Started 40 43 40
Completed 25 25 17
Not Completed 15 18 23
Arm/Group Title 200mg Modafinil 400mg Modafinil Matching Placebo Total
Hide Arm/Group Description

200mg Modafinil

Modafinil: 200mg Modafinil

400mg Modafinil

Modafinil: 400mg Modafinil

Matching Placebo

Matching Placebo: Matching Placebo

Total of all reporting groups
Overall Number of Baseline Participants 40 43 40 123
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 40 participants 43 participants 40 participants 123 participants
39.0  (7.1) 40.4  (7.2) 40.0  (8.8) 39.8  (7.2)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 40 participants 43 participants 40 participants 123 participants
Female
10
  25.0%
10
  23.3%
9
  22.5%
29
  23.6%
Male
30
  75.0%
33
  76.7%
31
  77.5%
94
  76.4%
1.Primary Outcome
Title Number of Cocaine Non-use Days
Hide Description Number of cocaine non-use days was determined by Urine Drug Screen tests which confirmed presence (or no presence) of benzoylecgonine levels.
Time Frame 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The amount of subjects represent those that completed 8 weeks of treatment. The exclusion of alcohol dependence listed in the exclusion criteria within the protocol is referring to a physiological dependence on alcohol requiring a medical detox.
Arm/Group Title 200mg Modafinil 400mg Modafinil Matching Placebo
Hide Arm/Group Description:

200mg Modafinil

Modafinil: 200mg Modafinil

400mg Modafinil

Modafinil: 400mg Modafinil

Matching Placebo

Matching Placebo: Matching Placebo

Overall Number of Participants Analyzed 25 25 17
Mean (Standard Error)
Unit of Measure: Number of Days
No Alcohol Dependence Number Analyzed 13 participants 15 participants 9 participants
10.1  (2.4) 17.1  (2.3) 9.3  (2.7)
Alcohol Dependence Number Analyzed 12 participants 10 participants 8 participants
14.1  (2.5) 9.4  (2.5) 12.8  (2.4)
2.Primary Outcome
Title Percent of Participants With New Use
Hide Description New Use is defined as a period of at least 7 days abstinence followed by a positive urine drug screen.
Time Frame 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The amount of subjects represent those that completed 8 weeks of treatment. The exclusion of alcohol dependence listed in the exclusion criteria within the protocol is referring to a physiological dependence on alcohol requiring a medical detox.
Arm/Group Title 200mg Modafinil 400mg Modafinil Matching Placebo
Hide Arm/Group Description:

200mg Modafinil

Modafinil: 200mg Modafinil

400mg Modafinil

Modafinil: 400mg Modafinil

Matching Placebo

Matching Placebo: Matching Placebo

Overall Number of Participants Analyzed 25 25 17
Measure Type: Number
Unit of Measure: Percentage of participants
No Alcohol Dependence Number Analyzed 13 participants 15 participants 9 participants
54.2 42.0 55.8
Alcohol Dependence Number Analyzed 12 participants 10 participants 8 participants
39.7 42.0 49.0
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title 200mg Modafinil 400mg Modafinil Matching Placebo
Hide Arm/Group Description

200mg Modafinil

Modafinil: 200mg Modafinil

400mg Modafinil

Modafinil: 400mg Modafinil

Matching Placebo

Matching Placebo: Matching Placebo

All-Cause Mortality
200mg Modafinil 400mg Modafinil Matching Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
200mg Modafinil 400mg Modafinil Matching Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/40 (0.00%)      0/43 (0.00%)      0/40 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
200mg Modafinil 400mg Modafinil Matching Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   33/40 (82.50%)      34/43 (79.07%)      27/40 (67.50%)    
Cardiac disorders       
Heart Racing  5/40 (12.50%)  5 5/43 (11.63%)  6 1/40 (2.50%)  1
Rapid Heart Rate  3/40 (7.50%)  3 3/43 (6.98%)  3 0/40 (0.00%)  0
Chest Pain  2/40 (5.00%)  2 0/43 (0.00%)  0 1/40 (2.50%)  1
Gastrointestinal disorders       
Nausea  5/40 (12.50%)  5 8/43 (18.60%)  8 5/40 (12.50%)  5
Dry Mouth  1/40 (2.50%)  1 3/43 (6.98%)  3 0/40 (0.00%)  0
Heartburn  1/40 (2.50%)  1 2/43 (4.65%)  2 3/40 (7.50%)  3
Infections and infestations       
Upper Respiratory Infection  2/40 (5.00%)  2 2/43 (4.65%)  2 0/40 (0.00%)  0
Musculoskeletal and connective tissue disorders       
Muscle Ache  4/40 (10.00%)  4 1/43 (2.33%)  1 1/40 (2.50%)  1
Nervous system disorders       
Numbness  1/40 (2.50%)  1 2/43 (4.65%)  3 1/40 (2.50%)  1
Headache  13/40 (32.50%)  17 16/43 (37.21%)  17 10/40 (25.00%)  11
Psychiatric disorders       
Irritability  0/40 (0.00%)  0 0/43 (0.00%)  0 2/40 (5.00%)  2
Insomnia  7/40 (17.50%)  7 12/43 (27.91%)  12 3/40 (7.50%)  3
Sleepiness  1/40 (2.50%)  1 2/43 (4.65%)  3 6/40 (15.00%)  6
Jitteriness  2/40 (5.00%)  3 0/43 (0.00%)  0 0/40 (0.00%)  0
Skin and subcutaneous tissue disorders       
Toothache  1/40 (2.50%)  1 0/43 (0.00%)  0 2/40 (5.00%)  2
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Robert Malcolm, MD
Organization: Medical University of SC
Phone: 843-792-1901
Responsible Party: Robert Malcolm, Medical University of South Carolina
ClinicalTrials.gov Identifier: NCT00218387     History of Changes
Other Study ID Numbers: NIDA-16368-1
R01DA016368 ( U.S. NIH Grant/Contract )
R01-16368-1
DPMC
First Submitted: September 16, 2005
First Posted: September 22, 2005
Results First Submitted: December 19, 2018
Results First Posted: April 10, 2019
Last Update Posted: April 10, 2019