Cannabis Inhalation: Effects on Cardiovascular Function During Rest and Exercise

Cardiovascular Risk Factor Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04693884
• Other study ID #: UOG-HPL-CAN (REB# 18-11-013)
• Status: Active, not recruiting
• Phase: Early Phase 1
• Start date: September 1, 2021
• Est. completion date: December 2023

Study information

• Verified date: November 2023
• Source: University of Guelph
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 20
• Est. completion date: December 2023
• Est. primary completion date: December 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Cannabis
• Cardiovascular Risk Factor
• Marijuana Abuse

Intervention

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

Locations

Country	Name	City	State
Canada	University of Guelph	Guelph	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Jamie Burr

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Aortic Stiffness From Baseline Following Cannabis Consumption	Assessed via carotid-femoral pulse wave velocity (PWV)	Baseline, Post-Intervention (<2 Hours)
Primary	Change in Brachial Artery Vascular Function From Baseline Following Cannabis Consumption	Assessed via brachial artery flow mediated dilation (FMD)	Baseline, Post-Intervention (<2 Hours)
Primary	Change in Sympathetic Nervous System Activity From Baseline Following Cannabis Consumption	Assessed via microneurographic recordings of the peroneal nerve	Baseline, Post-Intervention (<2 Hours)
Primary	Change in Cardiac Function From Baseline Following Cannabis Consumption	Measured by echocardiography	Baseline, Post-Intervention (<2 Hours)
Secondary	Exercise Capacity	Assessed by maximal average power attainable during 20 minutes of continuous cycling exercise	Baseline, Post-Intervention (<2 Hours)
Secondary	Heart Rate	Measured at rest and during exercise	Baseline, Post-Intervention (<2 Hours)
Secondary	Systolic Blood Pressure	Measured at rest and during exercise	Baseline, Post-Intervention (<2 Hours)
Secondary	Diastolic Blood Pressure	Measured at rest and during exercise	Baseline, Post-Intervention (<2 Hours)
Secondary	Perceived Exertion	Measured during exercise	Baseline, Post-Intervention (<2 Hours)
Secondary	Oxygen Consumption	Measure of metabolic activity	Baseline, Post-Intervention (<2 Hours)