Cannabis Inhalation: Effects on Cardiovascular Function During Rest and Exercise

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Cannabis, Cardiovascular Risk Factor

Intervention / Treatment
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* Drug: Cannabis
* Drug: Cannabis
* Drug: Cannabis
* Drug: Cannabis


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: High THC, Smoked<br> | Drug: Cannabis<br>* Cannabis of ( 10% THC concentration <1% CBD concentration) will be smoked.<br>* Other names: High THC, Smoked;|
| Experimental: High THC, Vaporized<br> | Drug: Cannabis<br>* Cannabis of ( 10% THC concentration <1% CBD concentration) will be vaporized.<br>* Other names: High THC, Vaporized;|
| Experimental: High CBD, Smoked<br> | Drug: Cannabis<br>* Cannabis of ( 10% CBD concentration <1% THC concentration) will be smoked.<br>* Other names: High CBD, Smoked;|
| Experimental: High CBD, Vaporized<br> | Drug: Cannabis<br>* Cannabis of ( 10% CBD concentration <1% THC concentration) will be vaporized.<br>* Other names: High CBD, Vaporized;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Aortic Stiffness From Baseline Following Cannabis Consumption | Assessed via carotid-femoral pulse wave velocity (PWV) | Baseline, Post-Intervention (<2 Hours) | 
| Change in Brachial Artery Vascular Function From Baseline Following Cannabis Consumption | Assessed via brachial artery flow mediated dilation (FMD) | Baseline, Post-Intervention (<2 Hours) | 
| Change in Sympathetic Nervous System Activity From Baseline Following Cannabis Consumption | Assessed via microneurographic recordings of the peroneal nerve | Baseline, Post-Intervention (<2 Hours) | 
| Change in Cardiac Function From Baseline Following Cannabis Consumption | Measured by echocardiography | Baseline, Post-Intervention (<2 Hours) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Exercise Capacity | Assessed by maximal average power attainable during 20 minutes of continuous cycling exercise | Baseline, Post-Intervention (<2 Hours) | 
| Heart Rate | Measured at rest and during exercise | Baseline, Post-Intervention (<2 Hours) | 
| Systolic Blood Pressure | Measured at rest and during exercise | Baseline, Post-Intervention (<2 Hours) | 
| Diastolic Blood Pressure | Measured at rest and during exercise | Baseline, Post-Intervention (<2 Hours) | 
| Perceived Exertion | Measured during exercise | Baseline, Post-Intervention (<2 Hours) | 
| Oxygen Consumption | Measure of metabolic activity | Baseline, Post-Intervention (<2 Hours) |