The Effect of Modafinil on Affective and Cognitive Processing

Overview

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.

Full Title of Study: “The Effect of Modafinil on Neural Processing During the Interference and Feedback Based Learning Task”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Basic Science
    • Masking: Double (Participant, Investigator)
  • Study Primary Completion Date: January 1, 2020

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.

Interventions

  • Drug: Modafinil Oral Tablet
    • modafinil 200mg
  • Drug: Placebo Oral Tablet
    • placebo 200mg

Arms, Groups and Cohorts

  • Experimental: modafinil group
    • a single dose of p.o. modafinil (200mg)
  • Experimental: placebo group
    • a single dose of p.o. placebo (200mg)

Clinical Trial Outcome Measures

Primary Measures

  • 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.
  • 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.

Secondary Measures

  • 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.
  • 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.
  • 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.
  • 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.

Participating in This Clinical Trial

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

Gender Eligibility: Male

Minimum Age: 18 Years

Maximum Age: 30 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • University of Electronic Science and Technology of China
  • Provider of Information About this Clinical Study
    • Principal Investigator: Benjamin Becker, Professor – University of Electronic Science and Technology of China

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