Recruiting
Phase 3

Modafinil

Sponsor:

University of Minnesota

Code:

NCT07231497

Conditions

Cognition

Healthy Participants

Eligibility Criteria

Sex: All

Age: 18 - 35

Healthy Volunteers: Accepted

Interventions

Modafinil

Study Details

Brief summary:

The goal of this clinical is to learn more about decision making in psychosis spectrum disorders, like schizophrenia. The investigators will ask people who do not have psychosis to take a single dose of modafinil and then complete some brain games on the computer that measure decision making. They hope to improve our understanding of psychosis to help people in the future. The main research questions are:

Does a single dose of modafinil change how people play the brain games? Does a single dose of modafinil change brain activity?

Participants will:

Complete an interview and self-report questionnaires. Complete safety screening activities, like a blood draw, a urine drug test, and an alcohol breathalyzer test.

Take a single dose of modafinil. Complete brain games while wearing an electroencephalography (EEG) cap, before and after taking the single dose of modafinil. EEG measures electrical activity in the brain.

Conditions

Cognition

Healthy Participants

Study ID

NCT07231497

Start date

Oct 31, 2025

Status verified date

Feb, 2026

Completion date

Apr 30, 2030

Anticipated

Primary completion date

Apr 30, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 35

Healthy Volunteers: Accepted

Inclusion Criteria:

  • English proficiency, as determined by staff observation and participant self-report
  • Estimated IQ at or above 70, as estimated by the cognitive assessments
  • Is clinical stable, defined as outpatient status for at least one month prior to study participation
  • Has clinically stable doses of medication for at least one month prior to study participation as determined by the PI

  • Participants may have minor adjustments in medication doses in the past 30 days, per PI discretion, but may not have major increases or decreases in dosses, or additions or removal of medications in the past 30 days
  • Participants are to have no changes to medications in the past 7 days before study medication administration (i.e., must have been on a stable dose for at least 7 days prior to receiving the study drug).

Exclusion Criteria:

Medical criteria:

  • Presence of the following medical concerns, as determined by the study PI:

  • Major neurological disorder
  • History of head injury with or without prolonged consciousness
  • Any major medical condition that, in the opinion of the PI, would impede participation in the study or would put the participant at additional risk by participating
  • History of any of the following as reported by the participant:

  • Renal impairment, injury, or disease
  • Hepatic impairment, injury, or disease
  • Myocardial infarction or heart disease.
  • The following cardiac symptoms requiring medical follow-up that, in the opinion of the investigator, would impede participation in the study or would put the participant at additional risk by participating

  • Dsypnea
  • Palpitations
  • Orthopnea
  • Pedal oedema
  • Significant dizziness
  • Syncope
  • Claudication ---Low white blood cell count, or is diagnosed with leukopenia, neutropenia, or agranulocytosis
  • Presence of unmanaged hypertension (>140/90) or elevated resting heart rate (>100 bpm)
  • Abnormal clinical laboratory values:

  • uACR > 30 mg/g
  • creatinine level >0/95 mg/dL
  • AST or ALT >50 U/L
  • Bilirubin >1.2 mg/dL
  • Total Protein <6 g/dL
  • Participant is pregnant, planning to become pregnant, or is breastfeeding
  • Participant cannot pass the visual acuity test (e.g., a score lower than 20/25 on the Snellen)
  • Takes medications or supplements that have major interactions with modafinil (e.g., ketamine, MAOIs, clomipramine, diazepam, propranolol, warfarin, amphetamine or dextroamphetamine, dexmethylphenidate or methylphenidate)
  • Has an allergy to modafinil
  • Is currently taking modafinil as a prescription
  • Has previously experienced Stevens-Johnson syndrome in response to taking a medication

Mental health criteria:

  • Meets criteria for severe substance or alcohol use disorder within 3 months of enrollment
  • Lifetime history of stimulant use disorder
  • Meets criteria for clinical risk of suicidal behavior, as defined by:

  • Clinician judgment
  • Active suicidal ideation at screening or other appointments
  • Previous intent to act on suicidal ideation with a specific plan and/or preparatory acts within 6 months of enrollment
  • A suicide attempt within 6 months of enrollment
  • Meets criteria for a depressive episode within the past month as determined by the diagnostic interview or for a severe or extremely severe depressive episode in the abbreviated battery within the past month
  • Meets DSM-5 criteria for, or reports professional diagnosis of, a psychotic, bipolar, or autism spectrum disorder
  • Has a family history (1st degree relative) of psychotic, bipolar, or autism spectrum disorder
  • Is prescribed psychotropic medications or takes supplements with psychotropic effects (e.g., Nootropics)
  • Any other psychiatric symptoms or conditions that, in the opinion of the PI, would impede participation in the study or put the participant at additional risk by participating

Other Criteria:

  • Unable or unwilling to provide informed consent
  • Unable to demonstrate adequate decisional capacity, in the judgment of the consenting study staff member, to make a choice about participating in the research study
  • Participant is illiterate
  • Have engaged in significant cognitive training, in the opinion of the PI, in the last year

Study Design

Enrollment

103 participants

Anticipated

Intervention Model

Single group

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

experimental: COSTEP 1

Interventions

Modafinil

Single dose of 200mg

Primary outcome measure

  • Test My Brain - Digit Symbol Coding [ Time Frame: Baseline ]
  • Test My Brain - Digit Symbol Coding [ Time Frame: Day 7 (EEG + Modafinil Appointment) ]
  • Test My Brain - Verbal Paired Associates Memory [ Time Frame: Baseline ]
  • Test My Brain - Verbal Paired Associates Memory [ Time Frame: Day 7 (EEG + Modafinil Appointment) ]
  • Test My Brain - Matrix Reasoning [ Time Frame: Baseline ]
  • Test My Brain - Matrix Reasoning [ Time Frame: Day 7 (EEG + Modafinil Appointment) ]
  • Test My Brain - Multiracial Emotion Identification [ Time Frame: Baseline ]
  • Test My Brain - Multiracial Emotion Identification [ Time Frame: Day 7 (EEG + Modafinil Appointment) ]
  • Electroencaphalography (EEG) - Resting alpha synchrony [ Time Frame: Day 7 (EEG + Modafinil Appointment) ]
  • Electroencaphalography (EEG) - Oscillatory frontal gamma synchrony [ Time Frame: Day 7 (EEG + Modafinil Appointment) ]
  • Electroencaphalography (EEG) - Task-related reward positivity/P900 [ Time Frame: Day 7 (EEG + Modafinil Appointment) ]
  • Electroencaphalography (EEG) - N1 amplitude [ Time Frame: Day 7 (EEG + Modafinil Appointment) ]
  • Dot Pattern Expectancy variation (TOPX) Task - Accuracy [ Time Frame: Day 7 (EEG + Modafinil Appointment) ]
  • Dot Pattern Expectancy variation (TOPX) Task - Response Time [ Time Frame: Day 7 (EEG + Modafinil Appointment) ]
  • Translational Bandit Task (TBT) - Accuracy [ Time Frame: Day 7 (EEG + Modafinil Appointment) ]
  • Translational Bandit Task (TBT) - Response time [ Time Frame: Day 7 (EEG + Modafinil Appointment) ]
  • Translational Bandit Task (TBT) - Reward Seeking Behavior [ Time Frame: Day 7 (EEG + Modafinil Appointment) ]

Central Contacts and Locations

Central contacts

Kaylee Enevold

612-403-4585costep1@umn.edu

Locations

University of Minnesota

Recruiting

Minneapolis, Minnesota, United States, 55455

Contacts

Ariel Currie

612-626-7261curri015@umn.edu

More Information

Sponsor

University of Minnesota

Last update posted

Feb 17, 2026

Last verified

Feb, 2026

Keywords

  • Cognition
  • Decision making
  • Electroencephalography (EEG)
  • Psychosis

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Minnesota on 2026-02-17.