Modafinil Effects on EEG Biomarkers of Reward and Motivation

NCT03616717 | Completed Phase 4 FDA Drug

• 1 other identifier: 4UH3MH109168-03
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Healthy Adults

Outcome Measures

Primary Outcomes (2)

• Reward Positivity

  Frontal alpha power by block in the probabilistic learning task

  1 year

• Motivation Signal

  Parietal EEG alpha power peak in first - final step toward breakpoint

  1 year

Study Arms (3)

modafinil 100 mg

ACTIVE COMPARATOR

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.

Drug: Modafinil

modafinil 200 mg

ACTIVE COMPARATOR

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.

Drug: Modafinil

placebo

PLACEBO COMPARATOR

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.

Drug: placebo

Interventions

Modafinil DRUG

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

modafinil 100 mg; modafinil 200 mg

placebo DRUG

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.

placebo

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, San Diego: lead

Study Sites (1)

University of California, San Diego; Clinical Teaching Facilities, Hillcrest

San Diego, California, 92103, United States

Location

MeSH Terms

Interventions

Modafinil

Intervention Hierarchy (Ancestors)

Benzhydryl Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Jared W Young, Ph.D.

  UCSD

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: University of California, San Diego Experimental Pharmacy randomizes dose order and provides masked pills
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Experimental medicine model; not an intervention. Within-subject double-blind placebo-controlled dose-response study.

Study Record Dates

• First Submitted: July 18, 2018
• First Posted: August 6, 2018
• Study Start: October 16, 2018
• Primary Completion: May 31, 2021
• Study Completion: September 30, 2021
• Last Updated: April 6, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)