NCT03515668

Brief Summary

our goal is to study the effects of dopamine activity, using Ritalin ingestion, on neuromuscular function over the course of a progressive heating and cooling protocol developed in our lab. We hypothesize that Ritalin will minimize the previously reported progressive impairment in neuromuscular function with hyperthermia compared to placebo, suggesting that dopamine activity preserves neuromuscular capacity with hyperthermia.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
6

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 20, 2018

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

April 23, 2018

Completed
10 days until next milestone

First Posted

Study publicly available on registry

May 3, 2018

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2021

Completed
Last Updated

February 10, 2021

Status Verified

February 1, 2021

Enrollment Period

3.7 years

First QC Date

April 23, 2018

Last Update Submit

February 8, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • Wrist flexion torque

    Maximal voluntary contraction of wrist flexion

    2-4 hours after ingestion

Study Arms (2)

Ritalin

EXPERIMENTAL

20 mg Ritalin, 90 min before testing

Drug: Ritalin 20 mg Tablet

Control

PLACEBO COMPARATOR

Identical size/taste placebo pill, 90 min before testing

Drug: Placebo Oral Tablet

Interventions

Single dose for all participants

Ritalin

Placebo with same appearance/taste

Control

Eligibility Criteria

Age18 Years - 30 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • High aerobic fitness (\>55 mL/kg/min maximal aerobic capacity)

You may not qualify if:

  • diagnosed cardiovascular, respiratory and/or neuromuscular disease, prescription of Ritalin or any drugs for hyperactivity within the past 1 year, any current prescription medication (except for asthma/allergy inhalers), any contraindications to Ritalin.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Brock University

St. Catharines, Ontario, L2S 3A1, Canada

Location

MeSH Terms

Conditions

Hyperthermia

Interventions

MethylphenidateTablets

Condition Hierarchy (Ancestors)

Body Temperature ChangesSigns and SymptomsPathological Conditions, Signs and SymptomsHeat Stress DisordersWounds and Injuries

Intervention Hierarchy (Ancestors)

PhenylacetatesAcids, CarbocyclicCarboxylic AcidsOrganic ChemicalsPiperidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsDosage FormsPharmaceutical Preparations

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Masking Details
Double-blinding of participant and investigator, with independent investigator in charge of placebo and drug.
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Model Details: Healthy males 18-30 years of age
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

April 23, 2018

First Posted

May 3, 2018

Study Start

April 20, 2018

Primary Completion

December 31, 2021

Study Completion

December 31, 2021

Last Updated

February 10, 2021

Record last verified: 2021-02

Data Sharing

IPD Sharing
Will not share

No sharing planned

Locations