- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04693884
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
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
22
Phase
- 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
-
-
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
Ages Eligible for Study
19 years to 45 years (Adult)
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
- 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
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 |
Intervention / Treatment |
|---|---|
|
Experimental: High THC, Smoked
|
Cannabis of (~10% THC concentration <1% CBD concentration) will be smoked.
Other Names:
Cannabis of (~10% THC concentration <1% CBD concentration) will be vaporized.
Other Names:
Cannabis of (~10% CBD concentration <1% THC concentration) will be smoked.
Other Names:
Cannabis of (~10% CBD concentration <1% THC concentration) will be vaporized.
Other Names:
|
|
Experimental: High THC, Vaporized
|
Cannabis of (~10% THC concentration <1% CBD concentration) will be smoked.
Other Names:
Cannabis of (~10% THC concentration <1% CBD concentration) will be vaporized.
Other Names:
Cannabis of (~10% CBD concentration <1% THC concentration) will be smoked.
Other Names:
Cannabis of (~10% CBD concentration <1% THC concentration) will be vaporized.
Other Names:
|
|
Experimental: High CBD, Smoked
|
Cannabis of (~10% THC concentration <1% CBD concentration) will be smoked.
Other Names:
Cannabis of (~10% THC concentration <1% CBD concentration) will be vaporized.
Other Names:
Cannabis of (~10% CBD concentration <1% THC concentration) will be smoked.
Other Names:
Cannabis of (~10% CBD concentration <1% THC concentration) will be vaporized.
Other Names:
|
|
Experimental: High CBD, Vaporized
|
Cannabis of (~10% THC concentration <1% CBD concentration) will be smoked.
Other Names:
Cannabis of (~10% THC concentration <1% CBD concentration) will be vaporized.
Other Names:
Cannabis of (~10% CBD concentration <1% THC concentration) will be smoked.
Other Names:
Cannabis of (~10% CBD concentration <1% THC concentration) will be vaporized.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
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
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
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)
September 1, 2021
Primary Completion (Actual)
April 16, 2025
Study Completion (Actual)
April 16, 2025
Study Registration Dates
First Submitted
November 3, 2020
First Submitted That Met QC Criteria
December 30, 2020
First Posted (Actual)
January 5, 2021
Study Record Updates
Last Update Posted (Actual)
April 18, 2025
Last Update Submitted That Met QC Criteria
April 16, 2025
Last Verified
April 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID 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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