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Trial record 82 of 239 for:    (armodafinil)

Effects of Modafinil in Methamphetamine Dependence

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ClinicalTrials.gov Identifier: NCT00751023
Recruitment Status : Completed
First Posted : September 11, 2008
Results First Posted : June 13, 2019
Last Update Posted : June 13, 2019
Sponsor:
Information provided by (Responsible Party):
Medical University of South Carolina

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Methamphetamine Dependence
Interventions Drug: Modafinil
Drug: Placebo
Enrollment 40
Recruitment Details  
Pre-assignment Details The Enrollment number in the Protocol Section has been corrected (n=40) to appropriately match the number of participants listed in the Results Participant Flow section. The previous Protocol section incorrectly included a cohort (n=31) of healthy control subjects who underwent cognitive testing but did not participate in the modafinil trial.
Arm/Group Title Modafinil Placebo
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Modafinil 400 mg daily

Modafinil: 400 mg daily for four weeks

Placebo

Placebo: Placebo 2 tablets daily for 4 weeks

Period Title: Overall Study
Started 20 20
Completed 9 13
Not Completed 11 7
Reason Not Completed
Lost to Follow-up             11             7
Arm/Group Title Modafinil Placebo Total
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Modafinil 400 mg daily

Modafinil: 400 mg daily for four weeks

Placebo

Placebo: Placebo 2 tablets daily for 4 weeks

Total of all reporting groups
Overall Number of Baseline Participants 20 20 40
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 20 participants 20 participants 40 participants
30.3  (8.2) 32.1  (7.4) 31.2  (7.8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants 20 participants 40 participants
Female
14
  70.0%
13
  65.0%
27
  67.5%
Male
6
  30.0%
7
  35.0%
13
  32.5%
1.Primary Outcome
Title Percentage of Participants With Methamphetamine-positive Urine Drug Screens
Hide Description Percentage of participants with at least one biweekly urine drug screen positive for methamphetamine (4 weeks active treatment phase + medication-free safety visit at week 5)
Time Frame 5 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Modafinil Placebo
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Modafinil 400 mg daily

Modafinil: 400 mg daily for four weeks

Placebo

Placebo: Placebo 2 tablets daily for 4 weeks

Overall Number of Participants Analyzed 20 20
Measure Type: Number
Unit of Measure: Percentage of participants
85 65
2.Secondary Outcome
Title Percent Change in California Verbal Learning Test From Baseline to Study Endpoint
Hide Description Mean percent change in T scores (average total score of 6 trials) from baseline to study endpoint (Week 5) in study completers. Larger (more positive) percent change values indicate better outcomes.
Time Frame Study baseline to study endpoint (Week 5)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Modafinil Placebo
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Modafinil 400 mg daily

Modafinil: 400 mg daily for four weeks

Placebo

Placebo: Placebo 2 tablets daily for 4 weeks

Overall Number of Participants Analyzed 9 13
Mean (Standard Deviation)
Unit of Measure: Percent change, baseline-study endpoint
20.6  (13.4) 14.8  (4.9)
3.Secondary Outcome
Title Percent Change in Symbol Digit Modalities Test From Baseline to Study Endpoint
Hide Description Mean percent change in T scores from baseline to study endpoint (Week 5) in study completers. Larger (more positive) percent change values indicate better outcomes.
Time Frame 5 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Modafinil Placebo
Hide Arm/Group Description:

Modafinil 400 mg daily

Modafinil: 400 mg daily for four weeks

Placebo

Placebo: Placebo 2 tablets daily for 4 weeks

Overall Number of Participants Analyzed 9 13
Mean (Standard Deviation)
Unit of Measure: Percent change, baseline-study endpoint
6.4  (15.2) 10.0  (23.6)
4.Secondary Outcome
Title Percent Change in Paced Auditory Serial Addition Test Scores From Baseline to Study Endpoint
Hide Description Mean percent change of T scores from baseline to study endpoint (Week 5) in study completers. Min T score = 0, max T score = 100. Higher scores, greater (more positive) percent change indicate better outcomes.
Time Frame 5 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Modafinil Placebo
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Modafinil 400 mg daily

Modafinil: 400 mg daily for four weeks

Placebo

Placebo: Placebo 2 tablets daily for 4 weeks

Overall Number of Participants Analyzed 9 13
Mean (Standard Deviation)
Unit of Measure: Percent change, baseline-study endpoint
11.3  (23.5) 28.5  (61.0)
5.Secondary Outcome
Title Score on the Wisconsin Card Sort Test
Hide Description Scores (T scores) on the Wisconsin Card Sort Test (total errors) at study endpoint (Week 5) in study completers, adjusted for age and education; min=0, max=100, higher numbers indicate better outcomes.
Time Frame 5 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Note: Total number of study completers = 22 (9 in Modafinil group and 13 in Placebo group). The Wisconsin Card Sort Test was able to be completed in only 19 of 22 study completers (8 participants assigned to Modafinil and 11 participants assigned to Placebo).
Arm/Group Title Modafinil Placebo
Hide Arm/Group Description:

Modafinil 400 mg daily

Modafinil: 400 mg daily for four weeks

Placebo

Placebo: Placebo 2 tablets daily for 4 weeks

Overall Number of Participants Analyzed 8 11
Mean (Standard Deviation)
Unit of Measure: T scores at study endpoint
44.6  (14.0) 41.9  (14.5)
6.Secondary Outcome
Title Percent Change in the Grooved Pegboard Test Score From Baseline to Study Endpoint
Hide Description Percent change of T scores from baseline to study endpoint (Week 5) in study completers; T score min=0, max=100; higher scores (more positive change) indicate better outcome.
Time Frame 5 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Modafinil Placebo
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Modafinil 400 mg daily

Modafinil: 400 mg daily for four weeks

Placebo

Placebo: Placebo 2 tablets daily for 4 weeks

Overall Number of Participants Analyzed 9 13
Mean (Standard Deviation)
Unit of Measure: Percent change, baseline-study endpoint
10.8  (40.7) 65.0  (149.9)
7.Secondary Outcome
Title Percent Change in Shipley Institute of Living Scale Scores From Baseline to Study Endpoint
Hide Description Percent change in scores (T scores) on the Shipley Abstract subscale from baseline to study endpoint (Week 5) in study completers; T scores min=0, max=100; larger positive values indicate better outcome.
Time Frame 5 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Modafinil Placebo
Hide Arm/Group Description:

Modafinil 400 mg daily

Modafinil: 400 mg daily for four weeks

Placebo

Placebo: Placebo 2 tablets daily for 4 weeks

Overall Number of Participants Analyzed 9 13
Mean (Standard Deviation)
Unit of Measure: T scores, percent change
4.1  (7.1) 4.6  (16.3)
8.Secondary Outcome
Title Percentage Change in Beck Depression Inventory Scores
Hide Description Percent change in BDI score from baseline to study endpoint in study completers; range =-100% to 100%, larger (more negative) change indicates better outcome.
Time Frame 5 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Note: Total number of study completers = 22 (9 in Modafinil group and 13 in Placebo group). Beck Depression Inventory Scores at study endpoint were obtained in only 20 of 22 study completers (9 participants assigned to Modafinil and 11 participants assigned to Placebo).
Arm/Group Title Modafinil Placebo
Hide Arm/Group Description:

Modafinil 400 mg daily

Modafinil: 400 mg daily for four weeks

Placebo

Placebo: Placebo 2 tablets daily for 4 weeks

Overall Number of Participants Analyzed 9 11
Mean (Standard Deviation)
Unit of Measure: Percent change
-58.4  (52.7) -43.5  (35.4)
Time Frame Five weeks: Four weeks of active study medication, safety visit one week after medication washout
Adverse Event Reporting Description Adverse events were systematically collected using a standardized questionnaire at each semi-weekly visit (9 visits total over 5 weeks)
 
Arm/Group Title Modafinil Placebo
Hide Arm/Group Description Modafinil: 400 mg daily for four weeks Placebo: 2 tablets daily for four weeks
All-Cause Mortality
Modafinil Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/20 (0.00%)      0/20 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Modafinil Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/20 (0.00%)      0/20 (0.00%)    
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   16/20 (80.00%)      14/20 (70.00%)    
Gastrointestinal disorders     
Nausea   4/20 (20.00%)  4 2/20 (10.00%)  2
Abdominal cramps   0/20 (0.00%)  0 4/20 (20.00%)  4
Diarrhea   2/20 (10.00%)  2 0/20 (0.00%)  0
General disorders     
Insomnia   2/20 (10.00%)  2 3/20 (15.00%)  3
Headache   4/20 (20.00%)  4 1/20 (5.00%)  1
Common cold symptoms   2/20 (10.00%)  2 3/20 (15.00%)  3
Hypersomnia   2/20 (10.00%)  2 3/20 (15.00%)  3
Decreased appetite   3/20 (15.00%)  3 0/20 (0.00%)  0
Dry mouth / thirst   2/20 (10.00%)  3 1/20 (5.00%)  1
Elevated blood pressure   0/20 (0.00%)  0 2/20 (10.00%)  2
Infections and infestations     
Ear / sinus infection   2/20 (10.00%)  2 0/20 (0.00%)  0
Psychiatric disorders     
Anxiety   5/20 (25.00%)  5 2/20 (10.00%)  2
Skin and subcutaneous tissue disorders     
Rash   2/20 (10.00%)  2 1/20 (5.00%)  1
Indicates events were collected by systematic assessment
Limited sample size (n=40, n=20 in each group), relatively low retention (55% overall; 45% in modafinil group, 65% in placebo group)
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: Bryan K. Tolliver, MD PhD
Organization: Medical University of South Carolina
Phone: 843-792-4869
Responsible Party: Medical University of South Carolina
ClinicalTrials.gov Identifier: NCT00751023     History of Changes
Other Study ID Numbers: HR#18440
First Submitted: September 10, 2008
First Posted: September 11, 2008
Results First Submitted: November 29, 2018
Results First Posted: June 13, 2019
Last Update Posted: June 13, 2019