Modafinil Effects on EEG Biomarkers of Reward and Motivation

NCT ID: NCT03616717

Last Updated: 2022-04-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

23 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-10-16

Study Completion Date

2021-09-30

Brief Summary

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

Detailed Description

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Conditions

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Healthy Adults

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

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

OTHER

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors
University of California, San Diego Experimental Pharmacy randomizes dose order and provides masked pills

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Modafinil

Intervention Type 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 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.

Group Type ACTIVE_COMPARATOR

Modafinil

Intervention Type 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

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.

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type 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.

Interventions

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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

Intervention Type 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.

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

35 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of California, San Diego

OTHER

Sponsor Role lead

Responsible Party

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Jared W. Young

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jared W Young, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

UCSD

Locations

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

San Diego, California, United States

Site Status

Countries

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United States

Other Identifiers

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4UH3MH109168-03

Identifier Type: NIH

Identifier Source: org_study_id

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