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CannabisEarly Phase 1NCT04693884

Cannabis Inhalation: Effects on Cardiovascular Function During Rest and Exercise

A Early Phase 1 study testing Cannabis in people with Cannabis and Cardiovascular Risk Factor, run by Jamie Burr at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 19 to 45 yearsHealthy volunteers can take part
Conditions the study is for
Cannabis, Cardiovascular Risk Factor
What is being tested?
Cannabis
Could I receive a placebo?
No, everyone receives an active treatment
How many people
22 participants
Where
1 siteCanada
Study dates
1 Sep 2021to 16 Apr 2025
Phase
Early Phase 1
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 19 to 45 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Provision of signed and dated informed consent form
  • Stated willingness to comply with all study procedures and availability for the duration of the study
  • Male or female, aged 19-45yr
  • In good general health as evidenced by medical history and free of chronic disease
  • 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
  • Experience consuming cannabis recreationally by vaping dried cannabis

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • University of Guelph

    Guelph, Ontario, N1G2W1

Other trials in Canada

About this study

Official title: 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.

Being tested
Cannabis
Medical subject headings
Marijuana Abuse

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CannabisDrug

    Also called High THC, Smoked

    Cannabis of (~10% THC concentration <1% CBD concentration) will be smoked.

  • CannabisDrug

    Also called High THC, Vaporized

    Cannabis of (~10% THC concentration <1% CBD concentration) will be vaporized.

  • CannabisDrug

    Also called High CBD, Smoked

    Cannabis of (~10% CBD concentration <1% THC concentration) will be smoked.

  • CannabisDrug

    Also called High CBD, Vaporized

    Cannabis of (~10% CBD concentration <1% THC concentration) will be vaporized.

Study groups in NCT04693884
Study groupRoleWhat they receive
High THC, SmokedExperimentalNot described
Receives: Drug: Cannabis
High THC, VaporizedExperimentalNot described
Receives: Drug: Cannabis
High CBD, SmokedExperimentalNot described
Receives: Drug: Cannabis
High CBD, VaporizedExperimentalNot described
Receives: Drug: Cannabis

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Aortic Stiffness From Baseline Following Cannabis Consumption

    Assessed via carotid-femoral pulse wave velocity (PWV)

    Measured: Baseline, Post-Intervention (<2 Hours)

  2. Change in Brachial Artery Vascular Function From Baseline Following Cannabis Consumption

    Assessed via brachial artery flow mediated dilation (FMD)

    Measured: Baseline, Post-Intervention (<2 Hours)

  3. Change in Sympathetic Nervous System Activity From Baseline Following Cannabis Consumption

    Assessed via microneurographic recordings of the peroneal nerve

    Measured: Baseline, Post-Intervention (<2 Hours)

  4. Change in Cardiac Function From Baseline Following Cannabis Consumption

    Measured by echocardiography

    Measured: Baseline, Post-Intervention (<2 Hours)

Secondary outcomes (6)

  1. Exercise Capacity

    Assessed by maximal average power attainable during 20 minutes of continuous cycling exercise

    Measured: Baseline, Post-Intervention (<2 Hours)

  2. Heart Rate

    Measured at rest and during exercise

    Measured: Baseline, Post-Intervention (<2 Hours)

  3. Systolic Blood Pressure

    Measured at rest and during exercise

    Measured: Baseline, Post-Intervention (<2 Hours)

  4. Diastolic Blood Pressure

    Measured at rest and during exercise

    Measured: Baseline, Post-Intervention (<2 Hours)

  5. Perceived Exertion

    Measured during exercise

    Measured: Baseline, Post-Intervention (<2 Hours)

  6. Oxygen Consumption

    Measure of metabolic activity

    Measured: Baseline, Post-Intervention (<2 Hours)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Jan 2021
  2. Study start1 Sep 2021
  3. Primary completion16 Apr 2025
  4. Study completion16 Apr 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Early Phase 1
Primary purpose
Basic science
Allocation
Randomised
Intervention model
Crossover
Masking
Single blind
Who is masked
Participant
Enrolment
22 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04693884
Sponsor's protocol ID
UOG-HPL-CAN (REB# 18-11-013)
Status last verified
Apr 2025
First submitted
3 Nov 2020
Last updated
18 Apr 2025
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Cheung CP, Coates AM, Baker RE, Burr JF. Acute Effects of Cannabis Inhalation on Arterial Stiffness, Vascular Endothelial Function, and Cardiac Function. J Am Heart Assoc. 2024 Dec 3;13(23):e037731. doi: 10.1161/JAHA.124.037731. Epub 2024 Nov 22.

    PubMed 39575727

  • Cheung CP, Nardone M, Lee JB, Baker RE, Millar PJ, Burr JF. Cannabis Inhalation Acutely Reduces Muscle Sympathetic Nerve Activity in Humans. Circulation. 2022 Dec 20;146(25):1972-1974. doi: 10.1161/CIRCULATIONAHA.122.062564. Epub 2022 Oct 31. No abstract available.

    PubMed 36314198

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing Cannabis in people with Cannabis and Cardiovascular Risk Factor, run by Jamie Burr 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 6 inclusion and 17 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: finished, as of the sponsor's last update on 18 Apr 2025. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Change in Aortic Stiffness From Baseline Following Cannabis Consumption (time frame: Baseline, Post-Intervention (<2 Hours)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04693884, which also lists 2 linked publications.

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 18 Apr 2025.

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