Cannabis Inhalation: Effects on Cardiovascular Function During Rest and Exercise

NCT04693884 | Completed Early Phase 1

• 1 other identifier: UOG-HPL-CAN (REB# 18-11-013)
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

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.

Conditions

Cannabis; Cardiovascular Risk Factor

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (6)

• Exercise Capacity

  Baseline, Post-Intervention (<2 Hours)

• Heart Rate

  Baseline, Post-Intervention (<2 Hours)

• Systolic Blood Pressure

  Baseline, Post-Intervention (<2 Hours)

• Diastolic Blood Pressure

  Baseline, Post-Intervention (<2 Hours)

• Perceived Exertion

  Baseline, Post-Intervention (<2 Hours)

Study Arms (4)

High THC, Smoked

EXPERIMENTAL

Drug: Cannabis

High THC, Vaporized

EXPERIMENTAL

Drug: Cannabis

High CBD, Smoked

EXPERIMENTAL

Drug: Cannabis

High CBD, Vaporized

EXPERIMENTAL

Drug: Cannabis

Interventions

Cannabis DRUG

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

Also known as: High THC, Smoked

High THC, Smoked

Eligibility Criteria

• Age: 19 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Jamie Burr: lead

Study Sites (1)

University of Guelph

Guelph, Ontario, N1G2W1, Canada

Location

Related Publications (2)

• 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.

  PMID: 39575727 DERIVED

• 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.

  PMID: 36314198 DERIVED

MeSH Terms

Conditions

Marijuana Abuse

Interventions

nabiximols

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: November 3, 2020
• First Posted: January 5, 2021
• Study Start: September 1, 2021
• Primary Completion: April 16, 2025
• Study Completion: April 16, 2025
• Last Updated: April 18, 2025

Record last verified: 2025-04

Locations

CA (1)