Modafinil Effects on EEG Biomarkers of Reward and Motivation

Overview

The effects of modafinil on measures of brain electrical activity will be tested.

Full Title of Study: “Neurophysiological Biomarkers of Behavioral Dimensions From Cross-species Paradigms”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Crossover Assignment
    • Primary Purpose: Other
    • Masking: Triple (Participant, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: October 31, 2019

Interventions

  • Drug: Modafinil
    • Drug: modafinil Each participant receives a single pill of placebo or active drug (modafinil 100 mg or 200 mg) 30 minutes after arriving at the lab. The participant then completes approximately 6 hours of testing in the laboratory. The participant stays at the lab for 7.5 hours in order to monitor physical condition in case the participant received the active pill. One week later, that participant receives a single pill of an alternate comparator and is again tested in the laboratory. Thus, in total, each participant receives one placebo pill and two active pills, each time separated by one week. Other Names: Provigil Alertec Modavigil
  • Drug: placebo
    • Drug: Placebo Each participant receives a single pill of placebo or active drug (modafinil 100 mg or 200 mg) 30 minutes after arriving at the lab. The participant then completes approximately 6 hours of testing in the laboratory. The participant stays at the lab for 7.5 hours in order to monitor physical condition in case the participant received the active pill. One week later, that participant receives a single pill of an alternate comparator and is again tested in the laboratory. Thus, in total, each participant receives one placebo pill and two active pills, each time separated by one week.

Arms, Groups and Cohorts

  • Active Comparator: modafinil 100 mg
    • Drug: modafinil, Provigil, Alertec, Modavigil Dosage form, frequency and duration: Each participant receives a single pill of placebo or active drug (modafinil 100 mg or 200 mg) 30 minutes after arriving at the lab. The participant then completes approximately 6 hours of testing in the laboratory. The participant stays at the lab for 7.5 hours in order to monitor physical condition in case the participant received the active pill. One week later, that participant receives a single pill of an alternate comparator and is again tested in the laboratory. Thus, in total, each participant receives one placebo pill and two active pills, each time separated by one week.
  • Active Comparator: modafinil 200 mg
    • Drug: modafinil, Provigil, Alertec, Modavigil Dosage form, frequency and duration: Each participant receives a single pill of placebo or active drug (modafinil 100 mg or 200 mg) 30 minutes after arriving at the lab. The participant then completes approximately 6 hours of testing in the laboratory. The participant stays at the lab for 7.5 hours in order to monitor physical condition in case the participant received the active pill. One week later, that participant receives a single pill of an alternate comparator and is again tested in the laboratory. Thus, in total, each participant receives one placebo pill and two active pills, each time separated by one week.
  • Placebo Comparator: placebo
    • Drug: modafinil, Provigil, Alertec, Modavigil Dosage form, frequency and duration: Each participant receives a single pill of placebo or active drug (modafinil 100 mg or 200 mg) 30 minutes after arriving at the lab. The participant then completes approximately 6 hours of testing in the laboratory. The participant stays at the lab for 7.5 hours in order to monitor physical condition in case the participant received the active pill. One week later, that participant receives a single pill of an alternate comparator and is again tested in the laboratory. Thus, in total, each participant receives one placebo pill and two active pills, each time separated by one week.

Clinical Trial Outcome Measures

Primary Measures

  • Reward Positivity
    • Time Frame: 1 year
    • Frontal alpha power by block in the probabilistic learning task
  • Motivation Signal
    • Time Frame: 1 year
    • Parietal EEG alpha power peak in first – final step toward breakpoint

Participating in This Clinical Trial

Exclusion Criteria

  • history of substance abuse
  • mental illness in a first degree relative
  • significant medical illness (e.g. cancer, diabetes, heart disease, HIV)
  • history of seizure
  • open head injury or closed head injury with loss of consciousness > 1 min
  • pregnancy
  • current psychotropic drug use
  • R-hand injury
  • hearing or visual impairment
  • urine toxicology positive for recreational drug use

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 35 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • University of California, San Diego
  • Provider of Information About this Clinical Study
    • Principal Investigator: Jared W. Young, Principal Investigator – University of California, San Diego
  • Overall Official(s)
    • Jared W Young, Ph.D., Principal Investigator, UCSD
  • Overall Contact(s)
    • Jo Talledo Benrubi, B.A., 6195433093, atalledo@ucsd.edu

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