The Effect of Modafinil on Affective and Cognitive Processing

June 14, 2019 updated by: Benjamin Becker, University of Electronic Science and Technology of China

The Effect of Modafinil on Neural Processing During the Interference and Feedback Based Learning Task

The study aims to examine whether a single dose of modafinil (200mg, p.o.) can affect feedback-based learning and interference processing in healthy male subjects.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Based on previous animal and human research suggesting a catecholamine-mediated, potentially pro-cognitive, mechanism of action of modafinil, the present study seeks to explore effects of modafinil on feedback-based learning and interference processing in healthy subjects. To this end, the present randomized double-blind, between-subject, placebo-controlled pharmaco-fMRI experiment plans to determine the behavioral and neural effects of a single dose of p.o.modafinil (200mg) versus placebo on validated feedback-based learning and emotional/non-emotional cognitive conflict paradigms. To control for potential effects of pre-medication personality traits as well as effects of modafinil on subjective task performance, subjects will be administered pre-treatment assessing relevant personality traits and post-treatment assessments of meta-cognitive confidence estimation.

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Sichuan
      • Chengdu, Sichuan, China, 611731
        • Recruiting
        • School of Life Science and Technology
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 30 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Healthy subjects without past or current psychiatric or neurological disorders
  • Non-smokers
  • Right-handedness

Exclusion Criteria:

  • Medical or psychiatric illness
  • Allergy against medications or general strong allergies
  • Sleep disorders
  • High blood pressure, general cardio-vascular alterations
  • History of head injury
  • Visual or motor impairments

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: modafinil group
a single dose of p.o. modafinil (200mg)
Drug: Modafinil Oral Tablet
modafinil 200mg
Experimental: placebo group
a single dose of p.o. placebo (200mg)
Drug: Placebo Oral Tablet
placebo 200mg

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Neural processing during the interference processing
Time Frame: 4h after treatment
fMRI BOLD indices of neural processing in interference related brain regions will be compared between the treatment and placebo group.
4h after treatment
Neural processing during feedback based learning
Time Frame: 4h after treatment
fMRI BOLD indices of neural processing learning related brain regions will be compared between the treatment and placebo group.
4h after treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Behavioral interference performance - Response Time
Time Frame: 4h after treatment
Behavioral performance of interference performance for congruent and incongruent stimuli (picture vs word) will be compared between the treatment and placebo group.
4h after treatment
Behavioral interference performance - Accuracy
Time Frame: 4h after treatment
Behavioral performance of interference in terms of accuracy for congruent and incongruent trials (picture vs word) will be compared between the treatment and placebo group.
4h after treatment
Behavioral learning performance - Reaction time
Time Frame: 4h after treatment
Learning performance in terms of reaction times will be compared between the treatment and placebo group.
4h after treatment
Behavioral learning performance - Accuracy
Time Frame: 4h after treatment
Learning performance in terms of accuracy (learning curve, trials to reach plateau) will be compared between the treatment and placebo group.
4h after treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Electronic Science and Technology of China

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2018

Primary Completion (Anticipated)

January 1, 2020

Study Completion (Anticipated)

July 1, 2020

Study Registration Dates

First Submitted

February 1, 2018

First Submitted That Met QC Criteria

February 6, 2018

First Posted (Actual)

February 8, 2018

Study Record Updates

Last Update Posted (Actual)

June 17, 2019

Last Update Submitted That Met QC Criteria

June 14, 2019

Last Verified

June 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UESTC-neuSCAN-49

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Healthy

Clinical Trials on Modafinil Oral Tablet

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Belgium

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe