Modafinil Effects on EEG Biomarkers of Reward and Motivation

Phase 4

Completed

• Conditions: Healthy Adults
• Interventions: Drug: placebo; Drug: Modafinil

• Registration Number: NCT03616717
• Lead Sponsor: University of California, San Diego

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-07-18
• Study First Submitted QC: 2018-08-03
• Study First Posted: 2018-08-06
• Study Start: 2018-10-16
• Primary Completion: 2021-05-31
• Study Completion: 2021-09-30
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-04
• Last Update Posted: 2022-04-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 23

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
placebo	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.
modafinil 100 mg	Modafinil	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.
modafinil 200 mg	Modafinil	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.

Primary Outcome Measures

Name	Time	Method
Motivation Signal	1 year	Parietal EEG alpha power peak in first - final step toward breakpoint
Reward Positivity	1 year	Frontal alpha power by block in the probabilistic learning task

Trial Locations

Locations (1)

University of California, San Diego; Clinical Teaching Facilities, Hillcrest; 🇺🇸 San Diego, California, United States