Cannabis Inhalation: Effects on Cardiovascular Function During Rest and Exercise

April 16, 2025 updated by: Jamie Burr

The Influence of Cannabis Inhalation During Exercise on Cardiovascular Health and Function: Exploring the Optimal Balance of Cannabinoids and Mode of Administration to Decrease Risk and Maximize Benefits

This two-phase project seeks to examine the cardiovascular response to consumption of cannabis variants of different cannabinoid composition through different methods (smoking vs. vaporizing), at rest and during aerobic exercise. Multiple measures that have been shown to predict risk factors for chronic-disease and negative health outcomes will be assessed following cannabis consumption at rest or in combination with exercise. These techniques will examine arterial stiffness, vascular function, and cardiac function. In phase I and II, subjects will visit the lab on 6 different occasions; with 1 visit acting as an introductory visit, 1 as an exercise control visit, 2 as resting cannabis visits, and 2 as cannabis + exercise visits. Cannabis used in phase I of this study will consist of approximately 10% THC. On all visits, pulse wave velocity, flow mediated dilation, and echocardiography measures will be performed following cannabis consumption by smoking or vaporizing, and cannabis consumption by smoking or vaporizing followed by 20 minutes of exercise on a cycle ergometer. Phase II of the study will implore a similar design. In favor of altering method of consumption, in all visits cannabis will be consumed by vaporization and will be either a high cannabidiol (CBD: (~10%)) and low delta-9-tetrahydrocannabinol (THC: (<1%)), or a high THC (~10%) and low CBD (<1%) variant.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
22

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Guelph, Ontario, Canada, N1G2W1
        • University of Guelph

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

19 years to 45 years (Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  1. Provision of signed and dated informed consent form
  2. Stated willingness to comply with all study procedures and availability for the duration of the study
  3. Male or female, aged 19-45yr
  4. In good general health as evidenced by medical history and free of chronic disease
  5. Must be experienced with cannabis use. This requires recreational cannabis use of a minimum of once per week in the past 30 days as confirmed by urine test
  6. Experience consuming cannabis recreationally by vaping dried cannabis

Exclusion Criteria:

  1. Deemed unfit to exercise by the PARQ+.
  2. Current or past diagnoses of substance abuse disorder
  3. Failure of recreational substance urine screening test
  4. Current, past, or strong family history of psychosis, or has previously experienced a cannabis-related psychotic episode
  5. Current or past diagnoses of cannabis use disorder
  6. Current or past diagnoses of any mood or anxiety disorder
  7. Identified ECG abnormalities
  8. Systolic blood pressure exceeding 160mmHg
  9. Diastolic blood pressure exceeding 90mmHg
  10. Resting heart rate exceeding 100bpm, or lower than 40bpm
  11. Diagnosed with respiratory disease
  12. Diagnosed with cardiovascular disease
  13. Diagnosed with liver disease
  14. Diagnosed with kidney disease
  15. Is Pregnant or planning to be pregnant
  16. Currently taking prescription medication (excluding contraceptive medication)
  17. Is a cigarette smoker

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: High THC, Smoked
Drug: Cannabis
Cannabis of (~10% THC concentration <1% CBD concentration) will be smoked.
Other Names:
  • High THC, Smoked
Drug: Cannabis
Cannabis of (~10% THC concentration <1% CBD concentration) will be vaporized.
Other Names:
  • High THC, Vaporized
Drug: Cannabis
Cannabis of (~10% CBD concentration <1% THC concentration) will be smoked.
Other Names:
  • High CBD, Smoked
Drug: Cannabis
Cannabis of (~10% CBD concentration <1% THC concentration) will be vaporized.
Other Names:
  • High CBD, Vaporized
Experimental: High THC, Vaporized
Drug: Cannabis
Cannabis of (~10% THC concentration <1% CBD concentration) will be smoked.
Other Names:
  • High THC, Smoked
Drug: Cannabis
Cannabis of (~10% THC concentration <1% CBD concentration) will be vaporized.
Other Names:
  • High THC, Vaporized
Drug: Cannabis
Cannabis of (~10% CBD concentration <1% THC concentration) will be smoked.
Other Names:
  • High CBD, Smoked
Drug: Cannabis
Cannabis of (~10% CBD concentration <1% THC concentration) will be vaporized.
Other Names:
  • High CBD, Vaporized
Experimental: High CBD, Smoked
Drug: Cannabis
Cannabis of (~10% THC concentration <1% CBD concentration) will be smoked.
Other Names:
  • High THC, Smoked
Drug: Cannabis
Cannabis of (~10% THC concentration <1% CBD concentration) will be vaporized.
Other Names:
  • High THC, Vaporized
Drug: Cannabis
Cannabis of (~10% CBD concentration <1% THC concentration) will be smoked.
Other Names:
  • High CBD, Smoked
Drug: Cannabis
Cannabis of (~10% CBD concentration <1% THC concentration) will be vaporized.
Other Names:
  • High CBD, Vaporized
Experimental: High CBD, Vaporized
Drug: Cannabis
Cannabis of (~10% THC concentration <1% CBD concentration) will be smoked.
Other Names:
  • High THC, Smoked
Drug: Cannabis
Cannabis of (~10% THC concentration <1% CBD concentration) will be vaporized.
Other Names:
  • High THC, Vaporized
Drug: Cannabis
Cannabis of (~10% CBD concentration <1% THC concentration) will be smoked.
Other Names:
  • High CBD, Smoked
Drug: Cannabis
Cannabis of (~10% CBD concentration <1% THC concentration) will be vaporized.
Other Names:
  • High CBD, Vaporized

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in Aortic Stiffness From Baseline Following Cannabis Consumption
Time Frame: Baseline, Post-Intervention (<2 Hours)
Assessed via carotid-femoral pulse wave velocity (PWV)
Baseline, Post-Intervention (<2 Hours)
Change in Brachial Artery Vascular Function From Baseline Following Cannabis Consumption
Time Frame: Baseline, Post-Intervention (<2 Hours)
Assessed via brachial artery flow mediated dilation (FMD)
Baseline, Post-Intervention (<2 Hours)
Change in Sympathetic Nervous System Activity From Baseline Following Cannabis Consumption
Time Frame: Baseline, Post-Intervention (<2 Hours)
Assessed via microneurographic recordings of the peroneal nerve
Baseline, Post-Intervention (<2 Hours)
Change in Cardiac Function From Baseline Following Cannabis Consumption
Time Frame: Baseline, Post-Intervention (<2 Hours)
Measured by echocardiography
Baseline, Post-Intervention (<2 Hours)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Exercise Capacity
Time Frame: Baseline, Post-Intervention (<2 Hours)
Assessed by maximal average power attainable during 20 minutes of continuous cycling exercise
Baseline, Post-Intervention (<2 Hours)
Heart Rate
Time Frame: Baseline, Post-Intervention (<2 Hours)
Measured at rest and during exercise
Baseline, Post-Intervention (<2 Hours)
Systolic Blood Pressure
Time Frame: Baseline, Post-Intervention (<2 Hours)
Measured at rest and during exercise
Baseline, Post-Intervention (<2 Hours)
Diastolic Blood Pressure
Time Frame: Baseline, Post-Intervention (<2 Hours)
Measured at rest and during exercise
Baseline, Post-Intervention (<2 Hours)
Perceived Exertion
Time Frame: Baseline, Post-Intervention (<2 Hours)
Measured during exercise
Baseline, Post-Intervention (<2 Hours)
Oxygen Consumption
Time Frame: Baseline, Post-Intervention (<2 Hours)
Measure of metabolic activity
Baseline, Post-Intervention (<2 Hours)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Jamie Burr

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 16, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 16, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 3, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 30, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 5, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 18, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 16, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • UOG-HPL-CAN (REB# 18-11-013)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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