Modafinil Effects on EEG Biomarkers of Reward and Motivation

Healthy Adults Clinical Trial

Official title:

Neurophysiological Biomarkers of Behavioral Dimensions From Cross-species Paradigms

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03616717
• Other study ID #: 4UH3MH109168-03
• Status: Completed
• Phase: Phase 4
• Start date: October 16, 2018
• Est. completion date: September 30, 2021

Study information

• Verified date: April 2022
• Source: University of California, San Diego
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: September 30, 2021
• Est. primary completion date: May 31, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 35 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy Adults

Intervention

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
• 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.

Locations

Country	Name	City	State
United States	University of California, San Diego; Clinical Teaching Facilities, Hillcrest	San Diego	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, San Diego

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reward Positivity	Frontal alpha power by block in the probabilistic learning task	1 year
Primary	Motivation Signal	Parietal EEG alpha power peak in first - final step toward breakpoint	1 year