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The Role of Methylphenidate on Performance in the Cold

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ClinicalTrials.gov Identifier: NCT04283877
Recruitment Status : Recruiting
First Posted : February 25, 2020
Last Update Posted : February 25, 2020
Sponsor:
Information provided by (Responsible Party):
Stephen Cheung, Brock University

Brief Summary:
The purpose is to study the effects of dopamine activity, using methylphenidate ingestion, on exercise and cognitive function over the course of a progressive cooling protocol. The investigators hypothesize that methylphenidate will minimize the previously reported impairment in exercise performance and cognitive function with mild hypothermia and cold stress (air temperature: 0˚C) compared to placebo, suggesting that dopamine activity preserves exercise and cognitive capacity with mild hypothermia.

Condition or disease Intervention/treatment Phase
Hypothermia Exercise Test Cognition Drug: Methylphenidate Drug: Placebo oral tablet Phase 4

Detailed Description:

Temperature regulation and decision-making are vital aspects of human survival where relatively small deviations in whole-body heat balance lead to decrements in physical performance and cognitive function. Prolonged exposure to cold stress combined with inadequate clothing and/or insufficient heat production can lead to decreases in body temperature causing mild hypothermia (≤ -1.0˚C in body temperature). Performance in the cold is more physically demanding compared to neutral environments (~22˚C) as there is increased cardiovascular strain due to a strong peripheral vasoconstriction reducing cerebral and muscle blood flow and oxygenation, reduced neuromuscular capacity, as well as changes in energy metabolism during shivering and increased catecholamine release. Additionally, there is an increased psychological strain where perceptually there is a high thermal discomfort, alterations in neurotransmitters (e.g. dopamine, norepinephrine), and alterations in mood. These changes lead to decreases in self-paced cycling time-trial performance in the cold with mild hypothermia compared to thermoneutral environments. Additionally, there appears to be task-dependent cognitive changes with acute cold stress, where higher-order functions such as executive function, working memory, and inhibitory control decrease before simple task performance such as reaction time and visual recognition/awareness. Currently, it is unknown what the potential mechanisms are that lead to these performance decrements.

The decrements in both self-paced exercise and cognitive function may be due to alterations in neurotransmitters caused by hypothermia. Exposure to cold leads to alterations in dopamine, and norepinephrine which may affect prefrontal cortex function, which may explain why higher-order executive function tasks such as inhibitory control and spatial planning are impaired compared to simple task performance. Previously, it has been determined that the use of tyrosine (amino acid precursor to dopamine and norepinephrine neurotransmitters) supplementation improves working memory and executive function despite a -2.0˚C drop in body temperature through cold-water immersion, but not in thermoneutral conditions. However, it is unknown what the role of dopamine or central nervous system stimulants are in the cold. Methylphenidate is a central nervous system stimulant through dopamine re-uptake inhibition is demonstrated to improve executive function task performance in healthy adults in thermoneutral conditions. Additionally, methylphenidate has been demonstrated to improve self-paced cycling performance by 16% in the heat (30˚C) but not thermoneutral environments (1). Methylphenidate is also demonstrated to improve maximal force production during fatiguing exercise, indicating it may play a role in reducing the effects of fatigue during endurance exercise. The investigators aim to determine the role of the central nervous system using methylphenidate on cognitive function and self-paced exercise in the cold.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: Single Group Assignment
Masking: Single (Investigator)
Masking Description: Double-blinding of participants and investigator, with independent investigator in charge of placebo and drug
Primary Purpose: Basic Science
Official Title: The Role of Methylphenidate on Performance in the Cold
Actual Study Start Date : December 15, 2019
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : April 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Methylphenidate
30 mg methylphenidate, 60 minutes before testing
Drug: Methylphenidate
3 x 10 mg oral tablets. Single acute dose for all participants

Placebo Comparator: Control
30 mg of lactose pill, 60 minutes before testing
Drug: Placebo oral tablet
3 x 10 mg oral lactose tablet for all participants




Primary Outcome Measures :
  1. 20 km cycling time trial [ Time Frame: 2-4 hours post ingestion ]
    completion time in minutes

  2. Cognitive function [ Time Frame: 1-4 hours after ingestion ]
    mean reaction time in ms

  3. cognitive function [ Time Frame: 1-4 hours post ingestion ]
    # of errors made



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Males and females

Exclusion Criteria:

  • Diagnosed cardiovascular, respiratory, and/ or neuromuscular disease
  • Prescription of MPH or any drugs for hyperactivity within the past 1 year
  • Diagnosed mental health condition (e.g. depression, anxiety disorder)
  • Raynaud's Disease or Cold Urticaria
  • Current prescription medication (except for asthma or allergy medication)
  • Pregnancy

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): NCT04283877


Contacts
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Contact: Stephen Cheung, PhD 905 688 5550 ext 5662 scheung@brocku.ca

Locations
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Canada, Ontario
Environmental Ergonomic Laboratory - Brock University Recruiting
St. Catharines, Ontario, Canada, L2S 3A1
Contact: Stephen Cheung, PhD    905 688 5550 ext 5662    scheung@brocku.ca   
Sponsors and Collaborators
Brock University
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Responsible Party: Stephen Cheung, Professor, Brock University
ClinicalTrials.gov Identifier: NCT04283877    
Other Study ID Numbers: EEL124
First Posted: February 25, 2020    Key Record Dates
Last Update Posted: February 25, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: We will not be sharing individual participant data with other researchers.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Hypothermia
Body Temperature Changes
Signs and Symptoms
Methylphenidate
Central Nervous System Stimulants
Physiological Effects of Drugs
Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Dopamine Agents
Neurotransmitter Agents