The Role of Methylphenidate on Performance in the Cold

NCT04283877 | Unknown Phase 4

• 1 other identifier: EEL124
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypothermia; Exercise Test; Cognition

Outcome Measures

Primary Outcomes (3)

• 20 km cycling time trial

  completion time in minutes

  2-4 hours post ingestion

• Cognitive function

  mean reaction time in ms

  1-4 hours after ingestion

• cognitive function

  \# of errors made

  1-4 hours post ingestion

Study Arms (2)

Methylphenidate

EXPERIMENTAL

30 mg methylphenidate, 60 minutes before testing

Drug: Methylphenidate

Control

PLACEBO COMPARATOR

30 mg of lactose pill, 60 minutes before testing

Drug: Placebo oral tablet

Interventions

Methylphenidate DRUG

3 x 10 mg oral tablets. Single acute dose for all participants

Methylphenidate

Placebo oral tablet DRUG

3 x 10 mg oral lactose tablet for all participants

Control

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Males and females

You may not qualify if:

• 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

Sponsors & Collaborators

• Brock University: lead

Study Sites (1)

Environmental Ergonomic Laboratory - Brock University

St. Catharines, Ontario, L2S 3A1, Canada

Location

MeSH Terms

Conditions

Hypothermia

Interventions

Methylphenidate

Condition Hierarchy (Ancestors)

Body Temperature Changes; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Phenylacetates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: Double-blinding of participants and investigator, with independent investigator in charge of placebo and drug
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Single Group Assignment

Study Record Dates

• First Submitted: September 13, 2019
• First Posted: February 25, 2020
• Study Start: December 15, 2019
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2021
• Last Updated: February 9, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)