Acute Effect of Three Neuroactive Drugs Measured by Magnetoencephalography (MEG), Electroencephalography (EEG) and the Synchronous Neural Interaction Test
Condition: Healthy
Study type: Interventional

Summary: 
      This placebo-controlled crossover study is intended to measure the effect of three, common
      neuroactive medications on brain activity measured by magnetoencephalography (MEG) and
      electroencephalography (EEG). This study will conduct MEG and EEG scans as well as simple
      cognition testing on 15 healthy volunteers over 4 study days. Subjects will receive placebo
      on one of the study days, and either 100 mg modafinil p.o., 20 mg methylphenidate p.o., or 1
      mg lorazepam p.o. on remaining study days. Medication administration will be randomized
      according to study day so that each subject will receive the medications in random order.
      Brain activity will be measured by MEG and EEG in each subject a total of 4 times each study
      day: prior to medication administration and 2, 4, and 6 hours after medication
      administration. Cognition testing will be performed at pre-medication baseline and
      immediately after each post-medication scan time. This study will test the hypothesis that
      changes in brain functional activity can be accurately measured in healthy volunteer subjects
      after single, acute doses of modafinil, methylphenidate and lorazepam.
    

Detailed description: 
      This study uses a placebo-controlled, crossover design to investigate the effect of modafinil
      (100 mg, p.o.), methylphenidate (20 mg, p.o.), and lorazepam (1 mg, p.o.) in 15 healthy male
      volunteers. The acute effect of the medications will be measured by MEG, EEG and simple
      cognition testing. Study procedures will be performed over 5 separate days. During an initial
      screening visit, Study Day 1, subjects will consent to enroll and undergo clinical evaluation
      sufficient to determine they are eligible to participate in the study. Upon qualification and
      enrollment, subjects will be randomly assigned to receive either placebo or one of the active
      medications on Study Days 2 - 5. Medications or placebo will be administered orally. Subjects
      will arrive at the MEG center in the morning on Study Day 2 and baseline MEG and EEG scans
      will be performed along with baseline cognition testing. The medication or placebo will be
      administered immediately following the baseline scans and cognition testing. Additional MEG
      and EEG scans will be conducted 2, 4, and 6 hours after medication or placebo administration.
      On Study Days 3 - 5, subjects will undergo identical procedures but will be crossed over to
      receive the alternate medication or placebo.
    

Intervention name(s): modafinil; methylphenidate; lorazepam; placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): oral tablet, 100 mg, single acute dose; oral tablet, 20 mg, single acute dose; oral tablet, 1 mg, single, acute dose; oral tablet, single acute dose
Other intervention name(s): Provigil; Ritalin; Ativan; sugar pill
Intervention MeSH terms: Lorazepam; Methylphenidate; Modafinil
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Keywords: Healthy Control subjects