Modafinil Effects on EEG Biomarkers of Reward and Motivation

Sponsor

University of California, San Diego (Other)

Overall Status

Completed

CT.gov ID

NCT03616717

Collaborator

(none)

Enrollment

Location

Arms

35.5

Actual Duration (Months)

0.6

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Healthy Adults	Drug: Modafinil Drug: placebo	Phase 4

Study Design

Study Type:

Interventional

Actual Enrollment :

23 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Intervention Model Description:

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

Masking:

Triple (Participant, Investigator, Outcomes Assessor)

Masking Description:

University of California, San Diego Experimental Pharmacy randomizes dose order and provides masked pills

Primary Purpose:

Other

Official Title:

Neurophysiological Biomarkers of Behavioral Dimensions From Cross-species Paradigms

Actual Study Start Date :

Oct 16, 2018

Actual Primary Completion Date :

May 31, 2021

Actual Study Completion Date :

Sep 30, 2021

Arms and Interventions

Arm	Intervention/Treatment
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.	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
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.	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 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.	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.

Arm

Intervention/Treatment

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.

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

Active Comparator: modafinil 200 mg

Drug: Modafinil

Placebo Comparator: placebo

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.

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 35 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of California, San Diego; Clinical Teaching Facilities, Hillcrest	San Diego	California	United States	92103

Sponsors and Collaborators

University of California, San Diego

Investigators

Principal Investigator: Jared W Young, Ph.D., UCSD

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Jared W. Young, Principal Investigator, University of California, San Diego

ClinicalTrials.gov Identifier:

NCT03616717

Other Study ID Numbers:

4UH3MH109168-03

First Posted:

Aug 6, 2018

Last Update Posted:

Apr 6, 2022

Last Verified:

Apr 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Yes

Additional relevant MeSH terms:

Modafinil

Study Results

No Results Posted as of Apr 6, 2022