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Trial record 74 of 239 for:    (armodafinil)

Modafinil Treatment for Cocaine-Dependent Individuals

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: NCT00129285
Recruitment Status : Completed
First Posted : August 11, 2005
Results First Posted : May 8, 2018
Last Update Posted : May 8, 2018
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
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-Related Disorders
Interventions Drug: Low Dose Modafinil
Drug: High Dose Modafinil
Drug: Placebo
Enrollment 210
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Low Dose Modafinil High Dose Modafinil Placebo
Hide Arm/Group Description

Low Dose Modafinil

Modafinil Low Dose: participants received modafinil 200 mg/day

High Dose Modafinil

Modafinil High Dose: participants received modafinil 400 mg/day

Placebo

Placebo: participants received placebo 400 mg/day

Period Title: Overall Study
Started 65 70 75
Completed 40 43 37
Not Completed 25 27 38
Arm/Group Title Low Dose Modafinil High Dose Modafinil Placebo Total
Hide Arm/Group Description

Low Dose Modafinil

Modafinil Low Dose: modafinil 200 mg/day

High Dose Modafinil

Modafinil High Dose: modafinil 400 mg/day

Placebo

Placebo: placebo 400 mg/day

Total of all reporting groups
Overall Number of Baseline Participants 65 70 75 210
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 65 participants 70 participants 75 participants 210 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
65
 100.0%
70
 100.0%
75
 100.0%
210
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 65 participants 70 participants 75 participants 210 participants
41.72  (6.9) 43.64  (7.7) 42.46  (7.5) 42.64  (8.7)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 65 participants 70 participants 75 participants 210 participants
Female
18
  27.7%
18
  25.7%
19
  25.3%
55
  26.2%
Male
47
  72.3%
52
  74.3%
56
  74.7%
155
  73.8%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 65 participants 70 participants 75 participants 210 participants
65 70 75 210
1.Primary Outcome
Title Urine Toxicology for Cocaine
Hide Description Abstinent in the final 3 weeks of treatment
Time Frame 3 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Low Dose Modafinil High Dose Modafinil Placebo
Hide Arm/Group Description:

Low Dose Modafinil

Modafinil Low Dose: participants received modafinil 200 mg/day

High Dose Modafinil

Modafinil High Dose: participants received modafinil 400 mg/day

Placebo

Placebo: participants received placebo 400 mg/day

Overall Number of Participants Analyzed 65 70 75
Measure Type: Count of Participants
Unit of Measure: Participants
3
   4.6%
8
  11.4%
3
   4.0%
2.Secondary Outcome
Title Retention; Number of Evaluation Visits Attended
Hide Description Number of visits attended compared between the three conditions using anova
Time Frame 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title 1Low Dose Modafinil 2 High Dose Modafinil 3. Placebo
Hide Arm/Group Description:

Low Dose Modafinil 200 mg daily

Modafinil Low Dose: modafinil 200 mg/day

High Dose Modafinil 400 mg daily

Modafinil High Dose: modafinil 400 mg/day

Placebo

Placebo: placebo 400 mg/day

Overall Number of Participants Analyzed 65 70 75
Mean (Standard Deviation)
Unit of Measure: number of evaluation sessions attended
16.8  (7.1) 16.5  (6.7) 14.3  (7.1)
3.Secondary Outcome
Title Cocaine Selective Severity Assessment (CSSA) Total Score
Hide Description Cocaine Selective Severity assessment (CSSA) total score has a range 0-126. Higher scores indicating greater severity of cocaine withdrawal obtained weekly. Groups compared using GEE model over 8 weeks of treatment.
Time Frame 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
patients exposed to low dose and high dose modafinil
Arm/Group Title Low Dose Modafinil High Dose Modafinil Placebo
Hide Arm/Group Description:

Low Dose Modafinil

Modafinil Low Dose: participants received modafinil 200 mg/day

High Dose Modafinil

Modafinil High Dose: participants received modafinil 400 mg/day

received placebo
Overall Number of Participants Analyzed 65 70 75
Mean (Standard Deviation)
Unit of Measure: units on a scale
12.89  (11.70) 15.04  (13.52) 15.2  (14.32)
Time Frame Adverse events were collected over the course of the 8 week trial
Adverse Event Reporting Description Adverse events for low and high dose modafinil were combined and compared to adverse events occurring in the placebo comparator group.
 
Arm/Group Title Modafinil High Dose Placebo Modafinil Low Dose
Hide Arm/Group Description Modafinil 400 mg daily Placebo daily modafinil 200 mg daily
All-Cause Mortality
Modafinil High Dose Placebo Modafinil Low Dose
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Modafinil High Dose Placebo Modafinil Low Dose
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/70 (1.43%)      0/75 (0.00%)      0/65 (0.00%)    
Psychiatric disorders       
Treatment Emergent Mania   1/70 (1.43%)  1 0/75 (0.00%)  0 0/65 (0.00%)  0
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Modafinil High Dose Placebo Modafinil Low Dose
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   63/70 (90.00%)      62/75 (82.67%)      50/65 (76.92%)    
Gastrointestinal disorders       
appetite changes   4/70 (5.71%)  8/75 (10.67%)  6/65 (9.23%) 
Nausea   4/70 (5.71%)  4/75 (5.33%)  5/65 (7.69%) 
Diarrhea   6/70 (8.57%)  4/75 (5.33%)  2/65 (3.08%) 
Stomach problems   6/70 (8.57%)  4/75 (5.33%)  2/65 (3.08%) 
General disorders       
Headache   15/70 (21.43%)  14/75 (18.67%)  11/65 (16.92%) 
Insomnia   9/70 (12.86%)  5/75 (6.67%)  6/65 (9.23%) 
teeth problems   6/70 (8.57%)  7/75 (9.33%)  6/65 (9.23%) 
Dry mouth   3/70 (4.29%)  3/75 (4.00%)  5/65 (7.69%) 
Fatigue   4/70 (5.71%)  4/75 (5.33%)  3/65 (4.62%) 
Infections and infestations       
Upper respiratory tract infection   18/70 (25.71%)  22/75 (29.33%)  14/65 (21.54%) 
Musculoskeletal and connective tissue disorders       
Body Aches   23/70 (32.86%)  27/75 (36.00%)  17/65 (26.15%) 
Nervous system disorders       
Increased energy   10/70 (14.29%)  2/75 (2.67%)  6/65 (9.23%) 
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: Kyle Kampman
Organization: University of Pennsylvania Treatment Research Center
Phone: 215-746-2764
Responsible Party: University of Pennsylvania
ClinicalTrials.gov Identifier: NCT00129285     History of Changes
Other Study ID Numbers: NIDA-15366-1
R01DA015366 ( U.S. NIH Grant/Contract )
DPMC ( Other Identifier: NIDA )
704450
First Submitted: August 4, 2005
First Posted: August 11, 2005
Results First Submitted: March 27, 2017
Results First Posted: May 8, 2018
Last Update Posted: May 8, 2018