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Modafinil Effects on EEG Biomarkers of Reward and Motivation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03616717
Recruitment Status : Recruiting
First Posted : August 6, 2018
Last Update Posted : November 13, 2019
Sponsor:
Information provided by (Responsible Party):
Jared W. Young, University of California, San Diego

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

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Study Type : Interventional  (Clinical Trial)
Estimated 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.
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 : October 16, 2018
Actual Primary Completion Date : October 31, 2019
Estimated Study Completion Date : November 30, 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Modafinil

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.




Primary Outcome Measures :
  1. Reward Positivity [ Time Frame: 1 year ]
    Frontal alpha power by block in the probabilistic learning task

  2. Motivation Signal [ Time Frame: 1 year ]
    Parietal EEG alpha power peak in first - final step toward breakpoint



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03616717


Contacts
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Contact: Jo Talledo Benrubi, B.A. 6195433093 atalledo@ucsd.edu

Locations
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United States, California
University of California, San Diego; Clinical Teaching Facilities, Hillcrest Recruiting
San Diego, California, United States, 92103
Contact: Jo Benrubi, B.A.    619-543-3093    eeglearning@ucsd.edu   
Principal Investigator: Jared W Young, Ph.D.         
Sponsors and Collaborators
University of California, San Diego
Investigators
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Principal Investigator: Jared W Young, Ph.D. UCSD

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Responsible Party: Jared W. Young, Principal Investigator, University of California, San Diego
ClinicalTrials.gov Identifier: NCT03616717    
Other Study ID Numbers: 4UH3MH109168-03 ( U.S. NIH Grant/Contract )
First Posted: August 6, 2018    Key Record Dates
Last Update Posted: November 13, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Modafinil
Central Nervous System Stimulants
Physiological Effects of Drugs
Wakefulness-Promoting Agents
Cytochrome P-450 CYP3A Inducers
Cytochrome P-450 Enzyme Inducers
Molecular Mechanisms of Pharmacological Action