Modafinil Effects on EEG Biomarkers of Reward and Motivation

University of California San Diego

Status and phase: Completed; Phase 4

Conditions: Healthy Adults

Treatments: Drug: Modafinil; Drug: placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT03616717

4UH3MH109168-03

Details and patient eligibility

About

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

Enrollment: 23 patients

Sex: All

Ages: 18 to 35 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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23 participants in 3 patient groups, including a placebo group

modafinil 100 mg

Active Comparator group

Description:

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.

Treatment:

Drug: Modafinil

modafinil 200 mg

Active Comparator group

Description:

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.

Treatment:

Drug: Modafinil

placebo

Placebo Comparator group

Description:

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.

Treatment:

Drug: placebo