Muscle ForceNCT03515668
Dopamine and Muscle Function in the Heat
A study testing Ritalin 20 mg Tablet in people with Muscle Force and Hyperthermia, run by Brock University at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 30 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Muscle Force, Hyperthermia
- What is being tested?
- Ritalin 20 mg Tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 6 participants
- Where
- 1 siteCanada
- Study dates
- 20 Apr 2018to 31 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 30 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- High aerobic fitness (>55 mL/kg/min maximal aerobic capacity)
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Influence of Dopamine Activity on Neuromuscular Function During Passive Heat Stress
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.
Read the detailed description
Increased core temperature (hyperthermia) has been associated with impaired neuromuscular performance, with the majority of research suggesting that the observed fatigue is related to the central nervous system. Small doses of Ritalin has been used to study how changes in dopamine activity affects exercise capacity in the heat. This study found that 20 mg of Ritalin had no effect on exercise capacity in a thermoneutral environment of 18°C. However, when in a hot (30°C) environment, the Ritalin resulted in a 16% improvement in finishing time compared to the placebo trial. Interestingly, the higher output during the Ritalin-hot condition also resulted in higher rates of heat production and a higher (~0.6°C) core temperature, suggesting that dopamine enabled greater voluntary tolerance of hyperthermia. This matches recent work from our own work showing that motivational skills training increased both exercise tolerance and final core temperature, and it is possible that dopamine activity played a role in this improvement.
Ultimately, fatigue is shown in an inability to sustain muscular force. However, the role of dopamine activity on neuromuscular function (e.g., central activation and recruitment of muscle) during hyperthermia is unknown. One study reported that 20 mg of Ritalin did not alter neuromuscular function, but this study was done without thermal stress.
Therefore, 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 (5, 7) compared to placebo, suggesting that dopamine activity preserves neuromuscular capacity with hyperthermia.
- Conditions
- Muscle Force, Hyperthermia
- Being tested
- Ritalin 20 mg Tablet, Placebo Oral Tablet
- Medical subject headings
- Hyperthermia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ritalin 20 mg TabletDrug
Single dose for all participants
Placebo Oral TabletDrug
Placebo with same appearance/taste
| Study group | Role | What they receive |
|---|---|---|
| Ritalin | Experimental | 20 mg Ritalin, 90 min before testing Receives: Drug: Ritalin 20 mg Tablet |
| Control | Placebo comparator | Identical size/taste placebo pill, 90 min before testing Receives: Drug: Placebo Oral Tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Wrist flexion torque
Maximal voluntary contraction of wrist flexion
Measured: 2-4 hours after ingestion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2018
- Study start20 Apr 2018
- Primary completion31 Dec 2021 (estimated)
- Study completion31 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Muscle ForceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Single group
- Model description
- Healthy males 18-30 years of age
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brock University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stephen Cheung, Brock University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03515668
- Sponsor's protocol ID
- 17-123
- Status last verified
- Feb 2021
- First submitted
- 23 Apr 2018
- Last updated
- 10 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No sharing planned
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influence of Dopamine Activity on Neuromuscular Function During Passive Heat Stress
- ClinicalTrials.gov ID
- NCT03515668
- Acronym / sponsor ID
- 17-123
- Conditions
- Muscle Force, Hyperthermia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Brock UniversityUniversity, hospital or other
- Study start
- 20 Apr 2018 (actual)
- Primary completion
- 31 Dec 2021 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 3 May 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Increased core temperature (hyperthermia) has been associated with impaired neuromuscular performance, with the majority of research suggesting that the observed fatigue is related to the central nervous system. Small doses of Ritalin has been used to study how changes in dopamine activity affects exercise capacity in the heat. This study found that 20 mg of Ritalin had no effect on exercise capacity in a thermoneutral environment of 18°C. However, when in a hot (30°C) environment, the Ritalin resulted in a 16% improvement in finishing time compared to the placebo trial. Interestingly, the higher output during the Ritalin-hot condition also resulted in higher rates of heat production and a higher (~0.6°C) core temperature, suggesting that dopamine enabled greater voluntary tolerance of hyperthermia. This matches recent work from our own work showing that motivational skills training increased both exercise tolerance and final core temperature, and it is possible that dopamine activity played a role in this improvement.
Ultimately, fatigue is shown in an inability to sustain muscular force. However, the role of dopamine activity on neuromuscular function (e.g., central activation and recruitment of muscle) during hyperthermia is unknown. One study reported that 20 mg of Ritalin did not alter neuromuscular function, but this study was done without thermal stress.
Therefore, 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 (5, 7) compared to placebo, suggesting that dopamine activity preserves neuromuscular capacity with hyperthermia.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- Healthy males 18-30 years of age
| Arm | Type | Receives |
|---|---|---|
| Ritalin | Experimental | Drug: Ritalin 20 mg Tablet20 mg Ritalin, 90 min before testing |
| Control | Placebo comparator | Drug: Placebo Oral TabletIdentical size/taste placebo pill, 90 min before testing |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- High aerobic fitness (>55 mL/kg/min maximal aerobic capacity)
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ritalin 20 mg TabletSingle dose for all participants | Drug | Ritalin |
| Placebo Oral TabletPlacebo with same appearance/taste | Drug | Control |
Primary outcome
Wrist flexion torque
Time frame: 2-4 hours after ingestion
Maximal voluntary contraction of wrist flexion
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2021.
- Individual participant dataSharing planned: No. No sharing planned
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ritalin 20 mg Tablet in people with Muscle Force and Hyperthermia, run by Brock University at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Wrist flexion torque (time frame: 2-4 hours after ingestion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2021.