search
Back to results

The Role of Methylphenidate on Performance in the Cold

Primary Purpose

Hypothermia, Exercise Test, Cognition

Status
Unknown status
Phase
Phase 4
Locations
Canada
Study Type
Interventional
Intervention
Methylphenidate
Placebo oral tablet
Sponsored by
Brock University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Hypothermia

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Environmental Ergonomic Laboratory - Brock University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Methylphenidate

Control

Arm Description

30 mg methylphenidate, 60 minutes before testing

30 mg of lactose pill, 60 minutes before testing

Outcomes

Primary Outcome Measures

20 km cycling time trial
completion time in minutes
Cognitive function
mean reaction time in ms
cognitive function
# of errors made

Secondary Outcome Measures

Full Information

First Posted
September 13, 2019
Last Updated
February 8, 2021
Sponsor
Brock University
search

1. Study Identification

Unique Protocol Identification Number
NCT04283877
Brief Title
The Role of Methylphenidate on Performance in the Cold
Official Title
The Role of Methylphenidate on Performance in the Cold
Study Type
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Unknown status
Study Start Date
December 15, 2019 (Actual)
Primary Completion Date
December 31, 2021 (Anticipated)
Study Completion Date
December 31, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Brock University

4. Oversight

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

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypothermia, Exercise Test, Cognition

7. Study Design

Primary Purpose
Basic Science
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Model Description
Single Group Assignment
Masking
Investigator
Masking Description
Double-blinding of participants and investigator, with independent investigator in charge of placebo and drug
Allocation
Randomized
Enrollment
24 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Methylphenidate
Arm Type
Experimental
Arm Description
30 mg methylphenidate, 60 minutes before testing
Arm Title
Control
Arm Type
Placebo Comparator
Arm Description
30 mg of lactose pill, 60 minutes before testing
Intervention Type
Drug
Intervention Name(s)
Methylphenidate
Intervention Description
3 x 10 mg oral tablets. Single acute dose for all participants
Intervention Type
Drug
Intervention Name(s)
Placebo oral tablet
Intervention Description
3 x 10 mg oral lactose tablet for all participants
Primary Outcome Measure Information:
Title
20 km cycling time trial
Description
completion time in minutes
Time Frame
2-4 hours post ingestion
Title
Cognitive function
Description
mean reaction time in ms
Time Frame
1-4 hours after ingestion
Title
cognitive function
Description
# of errors made
Time Frame
1-4 hours post ingestion

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Facility Information:
Facility Name
Environmental Ergonomic Laboratory - Brock University
City
St. Catharines
State/Province
Ontario
ZIP/Postal Code
L2S 3A1
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
We will not be sharing individual participant data with other researchers.

Learn more about this trial

The Role of Methylphenidate on Performance in the Cold

We'll reach out to this number within 24 hrs