Clinical trial NCT04693884: Cannabis Inhalation: Effects on Cardiovascular Function During Rest and Exercise
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Cannabis
Cardiovascular Risk Factor
Lead sponsor: University of Guelph
Sponsor class: OTHER
First posted: 2021-01-05
Enrollment: 22
Sex: ALL
Minimum age (years): 19
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief 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. 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.


Eligibility criteria: 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

Primary outcomes:
measure: Change in Aortic Stiffness From Baseline Following Cannabis Consumption
timeFrame: Baseline, Post-Intervention (<2 Hours)
measure: Change in Brachial Artery Vascular Function From Baseline Following Cannabis Consumption
timeFrame: Baseline, Post-Intervention (<2 Hours)
measure: Change in Sympathetic Nervous System Activity From Baseline Following Cannabis Consumption
timeFrame: Baseline, Post-Intervention (<2 Hours)
measure: Change in Cardiac Function From Baseline Following Cannabis Consumption
timeFrame: Baseline, Post-Intervention (<2 Hours)
Secondary outcomes:
measure: Exercise Capacity
timeFrame: Baseline, Post-Intervention (<2 Hours)
measure: Heart Rate
timeFrame: Baseline, Post-Intervention (<2 Hours)
measure: Systolic Blood Pressure
timeFrame: Baseline, Post-Intervention (<2 Hours)
measure: Diastolic Blood Pressure
timeFrame: Baseline, Post-Intervention (<2 Hours)
measure: Perceived Exertion
timeFrame: Baseline, Post-Intervention (<2 Hours)
measure: Oxygen Consumption
timeFrame: Baseline, Post-Intervention (<2 Hours)
Other outcomes:
Locations:
city: Guelph
country: Canada
facility: University of Guelph
state: Ontario
Study officials:
References: