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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
40
400 mg daily for four weeks
Placebo 2 tablets daily for 4 weeks
Behavioral Health Services of Pickens County
Pickens, South Carolina, United States
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
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)
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
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
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
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
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
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
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