Trial Outcomes & Findings for Effects of Modafinil in Methamphetamine Dependence (NCT NCT00751023)

NCT ID: NCT00751023

Last Updated: 2019-06-13

Results Overview

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)

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 40 participants
• Primary outcome timeframe: 5 weeks
• Results posted on: 2019-06-13

Participant Flow

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.

Participant milestones

Measure	Modafinil Modafinil 400 mg daily Modafinil: 400 mg daily for four weeks	Placebo Placebo Placebo: Placebo 2 tablets daily for 4 weeks
Overall Study STARTED	20	20
Overall Study COMPLETED	9	13
Overall Study NOT COMPLETED	11	7

Reasons for withdrawal

Measure	Modafinil Modafinil 400 mg daily Modafinil: 400 mg daily for four weeks	Placebo Placebo Placebo: Placebo 2 tablets daily for 4 weeks
Overall Study Lost to Follow-up	11	7

Baseline Characteristics

Effects of Modafinil in Methamphetamine Dependence

Baseline characteristics by cohort

Measure	Modafinil n=20 Participants Modafinil 400 mg daily Modafinil: 400 mg daily for four weeks	Placebo n=20 Participants Placebo Placebo: Placebo 2 tablets daily for 4 weeks	Total n=40 Participants Total of all reporting groups
Age, Continuous	30.3 years STANDARD_DEVIATION 8.2 • n=5 Participants	32.1 years STANDARD_DEVIATION 7.4 • n=7 Participants	31.2 years STANDARD_DEVIATION 7.8 • n=5 Participants
Sex: Female, Male Female	14 Participants n=5 Participants	13 Participants n=7 Participants	27 Participants n=5 Participants
Sex: Female, Male Male	6 Participants n=5 Participants	7 Participants n=7 Participants	13 Participants n=5 Participants

PRIMARY outcome

Timeframe: 5 weeks

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)

Outcome measures

Measure	Modafinil n=20 Participants Modafinil 400 mg daily Modafinil: 400 mg daily for four weeks	Placebo n=20 Participants Placebo Placebo: Placebo 2 tablets daily for 4 weeks
Percentage of Participants With Methamphetamine-positive Urine Drug Screens	85 Percentage of participants	65 Percentage of participants

SECONDARY outcome

Timeframe: Study baseline to study endpoint (Week 5)

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.

Outcome measures

Measure	Modafinil n=9 Participants Modafinil 400 mg daily Modafinil: 400 mg daily for four weeks	Placebo n=13 Participants Placebo Placebo: Placebo 2 tablets daily for 4 weeks
Percent Change in California Verbal Learning Test From Baseline to Study Endpoint	20.6 Percent change, baseline-study endpoint Standard Deviation 13.4	14.8 Percent change, baseline-study endpoint Standard Deviation 4.9

SECONDARY outcome

Timeframe: 5 Weeks

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.

Outcome measures

Measure	Modafinil n=9 Participants Modafinil 400 mg daily Modafinil: 400 mg daily for four weeks	Placebo n=13 Participants Placebo Placebo: Placebo 2 tablets daily for 4 weeks
Percent Change in Symbol Digit Modalities Test From Baseline to Study Endpoint	6.4 Percent change, baseline-study endpoint Standard Deviation 15.2	10.0 Percent change, baseline-study endpoint Standard Deviation 23.6

SECONDARY outcome

Timeframe: 5 weeks

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.

Outcome measures

Measure	Modafinil n=9 Participants Modafinil 400 mg daily Modafinil: 400 mg daily for four weeks	Placebo n=13 Participants Placebo Placebo: Placebo 2 tablets daily for 4 weeks
Percent Change in Paced Auditory Serial Addition Test Scores From Baseline to Study Endpoint	11.3 Percent change, baseline-study endpoint Standard Deviation 23.5	28.5 Percent change, baseline-study endpoint Standard Deviation 61.0

SECONDARY outcome

Timeframe: 5 weeks

Population: 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).

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.

Outcome measures

Measure	Modafinil n=8 Participants Modafinil 400 mg daily Modafinil: 400 mg daily for four weeks	Placebo n=11 Participants Placebo Placebo: Placebo 2 tablets daily for 4 weeks
Score on the Wisconsin Card Sort Test	44.6 T scores at study endpoint Standard Deviation 14.0	41.9 T scores at study endpoint Standard Deviation 14.5

SECONDARY outcome

Timeframe: 5 weeks

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.

Outcome measures

Measure	Modafinil n=9 Participants Modafinil 400 mg daily Modafinil: 400 mg daily for four weeks	Placebo n=13 Participants Placebo Placebo: Placebo 2 tablets daily for 4 weeks
Percent Change in the Grooved Pegboard Test Score From Baseline to Study Endpoint	10.8 Percent change, baseline-study endpoint Standard Deviation 40.7	65.0 Percent change, baseline-study endpoint Standard Deviation 149.9

SECONDARY outcome

Timeframe: 5 weeks

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.

Outcome measures

Measure	Modafinil n=9 Participants Modafinil 400 mg daily Modafinil: 400 mg daily for four weeks	Placebo n=13 Participants Placebo Placebo: Placebo 2 tablets daily for 4 weeks
Percent Change in Shipley Institute of Living Scale Scores From Baseline to Study Endpoint	4.1 T scores, percent change Standard Deviation 7.1	4.6 T scores, percent change Standard Deviation 16.3

SECONDARY outcome

Timeframe: 5 weeks

Population: 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).

Percent change in BDI score from baseline to study endpoint in study completers; range =-100% to 100%, larger (more negative) change indicates better outcome.

Outcome measures

Measure	Modafinil n=9 Participants Modafinil 400 mg daily Modafinil: 400 mg daily for four weeks	Placebo n=11 Participants Placebo Placebo: Placebo 2 tablets daily for 4 weeks
Percentage Change in Beck Depression Inventory Scores	-58.4 Percent change Standard Deviation 52.7	-43.5 Percent change Standard Deviation 35.4

Adverse Events

Modafinil

Serious events: 0 serious events

Other events: 16 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 14 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Modafinil n=20 participants at risk Modafinil: 400 mg daily for four weeks	Placebo n=20 participants at risk Placebo: 2 tablets daily for four weeks
Psychiatric disorders Anxiety	25.0% 5/20 • Number of events 5 • Five weeks: Four weeks of active study medication, safety visit one week after medication washout Adverse events were systematically collected using a standardized questionnaire at each semi-weekly visit (9 visits total over 5 weeks)	10.0% 2/20 • Number of events 2 • Five weeks: Four weeks of active study medication, safety visit one week after medication washout Adverse events were systematically collected using a standardized questionnaire at each semi-weekly visit (9 visits total over 5 weeks)
Gastrointestinal disorders Nausea	20.0% 4/20 • Number of events 4 • Five weeks: Four weeks of active study medication, safety visit one week after medication washout Adverse events were systematically collected using a standardized questionnaire at each semi-weekly visit (9 visits total over 5 weeks)	10.0% 2/20 • Number of events 2 • Five weeks: Four weeks of active study medication, safety visit one week after medication washout Adverse events were systematically collected using a standardized questionnaire at each semi-weekly visit (9 visits total over 5 weeks)
General disorders Insomnia	10.0% 2/20 • Number of events 2 • Five weeks: Four weeks of active study medication, safety visit one week after medication washout Adverse events were systematically collected using a standardized questionnaire at each semi-weekly visit (9 visits total over 5 weeks)	15.0% 3/20 • Number of events 3 • Five weeks: Four weeks of active study medication, safety visit one week after medication washout Adverse events were systematically collected using a standardized questionnaire at each semi-weekly visit (9 visits total over 5 weeks)
General disorders Headache	20.0% 4/20 • Number of events 4 • Five weeks: Four weeks of active study medication, safety visit one week after medication washout Adverse events were systematically collected using a standardized questionnaire at each semi-weekly visit (9 visits total over 5 weeks)	5.0% 1/20 • Number of events 1 • Five weeks: Four weeks of active study medication, safety visit one week after medication washout Adverse events were systematically collected using a standardized questionnaire at each semi-weekly visit (9 visits total over 5 weeks)
General disorders Common cold symptoms	10.0% 2/20 • Number of events 2 • Five weeks: Four weeks of active study medication, safety visit one week after medication washout Adverse events were systematically collected using a standardized questionnaire at each semi-weekly visit (9 visits total over 5 weeks)	15.0% 3/20 • Number of events 3 • Five weeks: Four weeks of active study medication, safety visit one week after medication washout Adverse events were systematically collected using a standardized questionnaire at each semi-weekly visit (9 visits total over 5 weeks)
General disorders Hypersomnia	10.0% 2/20 • Number of events 2 • Five weeks: Four weeks of active study medication, safety visit one week after medication washout Adverse events were systematically collected using a standardized questionnaire at each semi-weekly visit (9 visits total over 5 weeks)	15.0% 3/20 • Number of events 3 • Five weeks: Four weeks of active study medication, safety visit one week after medication washout Adverse events were systematically collected using a standardized questionnaire at each semi-weekly visit (9 visits total over 5 weeks)
Gastrointestinal disorders Abdominal cramps	0.00% 0/20 • Five weeks: Four weeks of active study medication, safety visit one week after medication washout Adverse events were systematically collected using a standardized questionnaire at each semi-weekly visit (9 visits total over 5 weeks)	20.0% 4/20 • Number of events 4 • Five weeks: Four weeks of active study medication, safety visit one week after medication washout Adverse events were systematically collected using a standardized questionnaire at each semi-weekly visit (9 visits total over 5 weeks)
General disorders Decreased appetite	15.0% 3/20 • Number of events 3 • Five weeks: Four weeks of active study medication, safety visit one week after medication washout Adverse events were systematically collected using a standardized questionnaire at each semi-weekly visit (9 visits total over 5 weeks)	0.00% 0/20 • Five weeks: Four weeks of active study medication, safety visit one week after medication washout Adverse events were systematically collected using a standardized questionnaire at each semi-weekly visit (9 visits total over 5 weeks)
Skin and subcutaneous tissue disorders Rash	10.0% 2/20 • Number of events 2 • Five weeks: Four weeks of active study medication, safety visit one week after medication washout Adverse events were systematically collected using a standardized questionnaire at each semi-weekly visit (9 visits total over 5 weeks)	5.0% 1/20 • Number of events 1 • Five weeks: Four weeks of active study medication, safety visit one week after medication washout Adverse events were systematically collected using a standardized questionnaire at each semi-weekly visit (9 visits total over 5 weeks)
General disorders Dry mouth / thirst	10.0% 2/20 • Number of events 3 • Five weeks: Four weeks of active study medication, safety visit one week after medication washout Adverse events were systematically collected using a standardized questionnaire at each semi-weekly visit (9 visits total over 5 weeks)	5.0% 1/20 • Number of events 1 • Five weeks: Four weeks of active study medication, safety visit one week after medication washout Adverse events were systematically collected using a standardized questionnaire at each semi-weekly visit (9 visits total over 5 weeks)
Infections and infestations Ear / sinus infection	10.0% 2/20 • Number of events 2 • Five weeks: Four weeks of active study medication, safety visit one week after medication washout Adverse events were systematically collected using a standardized questionnaire at each semi-weekly visit (9 visits total over 5 weeks)	0.00% 0/20 • Five weeks: Four weeks of active study medication, safety visit one week after medication washout Adverse events were systematically collected using a standardized questionnaire at each semi-weekly visit (9 visits total over 5 weeks)
Gastrointestinal disorders Diarrhea	10.0% 2/20 • Number of events 2 • Five weeks: Four weeks of active study medication, safety visit one week after medication washout Adverse events were systematically collected using a standardized questionnaire at each semi-weekly visit (9 visits total over 5 weeks)	0.00% 0/20 • Five weeks: Four weeks of active study medication, safety visit one week after medication washout Adverse events were systematically collected using a standardized questionnaire at each semi-weekly visit (9 visits total over 5 weeks)
General disorders Elevated blood pressure	0.00% 0/20 • Five weeks: Four weeks of active study medication, safety visit one week after medication washout Adverse events were systematically collected using a standardized questionnaire at each semi-weekly visit (9 visits total over 5 weeks)	10.0% 2/20 • Number of events 2 • Five weeks: Four weeks of active study medication, safety visit one week after medication washout Adverse events were systematically collected using a standardized questionnaire at each semi-weekly visit (9 visits total over 5 weeks)

Additional Information

Bryan K. Tolliver, MD PhD

Medical University of South Carolina

Phone: 843-792-4869

Email: tollive@musc.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place