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CompletedNCT00751023Updated Jun 13, 2019Results posted

Effects of Modafinil in Methamphetamine Dependence

A Phase 4 interventional study of Modafinil and Placebo in Methamphetamine Dependence, sponsored by Medical University of South Carolina. Completed at 1 site in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2019-06-13.

Sponsored by Medical University of South Carolina · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study summary

Methamphetamine dependence is a serious public health problem with no pharmacologic treatments currently available. Relapse rates are high in this population. Exposure to cues previously associated with methamphetamine use may induce profound craving in abstinent individuals. Chronic methamphetamine abuse is associated with selective cognitive deficits that may undermine successful participation in psychosocial treatments. Medications which improve cognitive deficits in methamphetamine-dependent individuals may improve abstinence rates, especially in the critical early period of recovery. Modafinil is an atypical stimulant medication with evidence to support its use in treating cocaine dependence and attention deficit/hyperactivity disorder. The proposed studies are designed to evaluate modafinil as a potential treatment for methamphetamine dependence and its cognitive sequelae.

02

Conditions studied

  • Methamphetamine Dependence

Keywords

  • Methamphetamine
  • Modafinil
  • Addiction
  • Craving
  • Cognitive
03

In context

Lead sponsor

Medical University of South Carolina is the lead sponsor of 852 studies on the registry; 165 are open to participants now.

Of its 128 completed or terminated interventional studies of FDA-regulated products, 101 (79%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Subjects must be able to provide informed consent and function at an intellectual level sufficient to allow accurate completion of all assessment instruments.
  2. Subjects must meet DSM-IV criteria for methamphetamine dependence within the past six months. Subjects may meet criteria for abuse, but not dependence on any other substance with the exception of nicotine. Because of the high comorbidity of methamphetamine and nicotine dependence, excluding nicotine dependence would seriously compromise the feasibility of recruitment. Nicotine use immediately prior to the cue reactivity testing session will be controlled.
  3. Subjects must consent to remain abstinent from all drugs of abuse (except nicotine) for 24 hours prior to the cue reactivity testing sessions.
  4. Subjects must consent to random assignment to the modafinil vs. placebo conditions.

Exclusion criteria

Exclusion Criteria:

  1. Women who are pregnant, nursing or of childbearing potential and not practicing an effective means of birth control.
  2. Subjects with evidence of or a history of significant hematological, endocrine, cardiovascular, pulmonary, renal, gastrointestinal, or neurological disease as these conditions may affect heart rate or skin conductance measurement.
  3. Subjects with a history of or current psychotic disorder or bipolar affective disorder as these may impact cue reactivity.
  4. Subjects who are unwilling or unable to maintain abstinence from alcohol and other drugs of abuse (except nicotine) for 24 hours prior the cue procedures.
  5. Subjects meeting DSM-IV criteria for substance dependence (other than nicotine or methamphetamine as appropriate) within the past 60 days.
  6. Subjects currently taking B-blockers, anti-arrhythmic agents, psychostimulants or any other agents known to interfere with heart rate and skin conductance monitoring.
  7. Known or suspected hypersensitivity to modafinil.
  8. Individuals taking medications that could adversely interact with study medications.
  9. Subjects with a history of epilepsy or seizure disorder.
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
40 participants (actual)

Study arms

  • Experimental
    1

    Modafinil 400 mg daily

    Drug: Modafinil

  • Placebo comparator
    2

    Placebo

    Drug: Placebo

Interventions

  • DrugModafinil

    400 mg daily for four weeks

    Also known as: Provigil

  • DrugPlacebo

    Placebo 2 tablets daily for 4 weeks

06

What researchers measure

Primary outcomes

  1. Percentage of Participants With Methamphetamine-positive Urine Drug Screens

    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

Secondary outcomes

  1. Percent Change in California Verbal Learning Test From Baseline to Study Endpoint

    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)

  2. Percent Change in Symbol Digit Modalities Test From Baseline to Study Endpoint

    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

  3. Percent Change in Paced Auditory Serial Addition Test Scores From Baseline to Study Endpoint

    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

  4. Score on the Wisconsin Card Sort Test

    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

  5. Percent Change in the Grooved Pegboard Test Score From Baseline to Study Endpoint

    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

  6. Percent Change in Shipley Institute of Living Scale Scores From Baseline to Study Endpoint

    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

  7. Percentage Change in Beck Depression Inventory Scores

    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

07

Results

Posted Jun 13, 2019
Limitations and caveats
Limited sample size (n=40, n=20 in each group), relatively low retention (55% overall; 45% in modafinil group, 65% in placebo group)

Participant flow

Participant flow — Overall Study
MilestoneModafinilPlacebo
Started2020
Completed913
Not completed117
Withdrew: Lost to follow-up117

Outcome measures

PrimaryPercentage of Participants With Methamphetamine-positive Urine Drug Screens

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
Reported as:
Number · Percentage of participants
Percentage of Participants With Methamphetamine-positive Urine Drug Screens
Percentage of participantsModafinilPlacebo
Percentage of Participants With Methamphetamine-positive Urine Drug Screens8565
SecondaryPercent Change in California Verbal Learning Test From Baseline to Study Endpoint

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)
Reported as:
Mean · Percent change, baseline-study endpoint
Percent Change in California Verbal Learning Test From Baseline to Study Endpoint
Percent change, baseline-study endpointModafinilPlacebo
Percent Change in California Verbal Learning Test From Baseline to Study Endpoint20.6 ± 13.414.8 ± 4.9
SecondaryPercent Change in Symbol Digit Modalities Test From Baseline to Study Endpoint

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
Reported as:
Mean · Percent change, baseline-study endpoint
Percent Change in Symbol Digit Modalities Test From Baseline to Study Endpoint
Percent change, baseline-study endpointModafinilPlacebo
Percent Change in Symbol Digit Modalities Test From Baseline to Study Endpoint6.4 ± 15.210.0 ± 23.6
SecondaryPercent Change in Paced Auditory Serial Addition Test Scores From Baseline to Study Endpoint

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
Reported as:
Mean · Percent change, baseline-study endpoint
Percent Change in Paced Auditory Serial Addition Test Scores From Baseline to Study Endpoint
Percent change, baseline-study endpointModafinilPlacebo
Percent Change in Paced Auditory Serial Addition Test Scores From Baseline to Study Endpoint11.3 ± 23.528.5 ± 61.0
SecondaryScore on the Wisconsin Card Sort Test

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
Reported as:
Mean · T scores at study endpoint
Score on the Wisconsin Card Sort Test
T scores at study endpointModafinilPlacebo
Score on the Wisconsin Card Sort Test44.6 ± 14.041.9 ± 14.5
SecondaryPercent Change in the Grooved Pegboard Test Score From Baseline to Study Endpoint

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
Reported as:
Mean · Percent change, baseline-study endpoint
Percent Change in the Grooved Pegboard Test Score From Baseline to Study Endpoint
Percent change, baseline-study endpointModafinilPlacebo
Percent Change in the Grooved Pegboard Test Score From Baseline to Study Endpoint10.8 ± 40.765.0 ± 149.9
SecondaryPercent Change in Shipley Institute of Living Scale Scores From Baseline to Study Endpoint

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
Reported as:
Mean · T scores, percent change
Percent Change in Shipley Institute of Living Scale Scores From Baseline to Study Endpoint
T scores, percent changeModafinilPlacebo
Percent Change in Shipley Institute of Living Scale Scores From Baseline to Study Endpoint4.1 ± 7.14.6 ± 16.3
SecondaryPercentage Change in Beck Depression Inventory Scores

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
Reported as:
Mean · Percent change
Percentage Change in Beck Depression Inventory Scores
Percent changeModafinilPlacebo
Percentage Change in Beck Depression Inventory Scores-58.4 ± 52.7-43.5 ± 35.4

Adverse events

Collected over Five weeks: Four weeks of active study medication, safety visit one week after medication washout. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Modafinil0/20 (0%)0/20 (0%)16/20 (80%)
Placebo0/20 (0%)0/20 (0%)14/20 (70%)
Most frequent other events
Showing 10 of 13
Most frequent other events
EventModafinilPlacebo
AnxietyPsychiatric disorders5/202/20
NauseaGastrointestinal disorders4/202/20
HeadacheGeneral disorders4/201/20
Abdominal crampsGastrointestinal disorders0/204/20
InsomniaGeneral disorders2/203/20
Common cold symptomsGeneral disorders2/203/20
HypersomniaGeneral disorders2/203/20
Decreased appetiteGeneral disorders3/200/20
RashSkin and subcutaneous tissue disorders2/201/20
Dry mouth / thirstGeneral disorders2/201/20

Baseline characteristics

Age, Continuous
Age, Continuous(years)ModafinilPlaceboTotal
Mean30.3 ± 8.232.1 ± 7.431.2 ± 7.8
Sex: Female, Male
Sex: Female, Male(Participants)ModafinilPlaceboTotal
Female141327
Male6713
08

Study locations

1 site
  • Behavioral Health Services of Pickens County
    Pickens, South Carolina 29671, United States
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 13, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00751023
Lead sponsor
Medical University of South Carolina
Responsible party
Sponsor
First posted
Sep 11, 2008
Start date
Feb 2009
Primary completion
Jul 2010
Completion
Jul 2010
Results posted
Jun 13, 2019
Last update
Jun 13, 2019

Study contacts

Bryan K Tolliver, MD, PhD
principal investigator · Medical University of South Carolina

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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