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Completed

NCT Number: NCT04693884

Cannabis Inhalation: Effects on Cardiovascular Function During Rest and Exercise

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.

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Key information

Conditions

Cannabis Cardiovascular Risk Factor Chemically-Induced Disorders Marijuana Abuse Mental Disorders Substance-Related Disorders

Age range

19 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

University of Guelph

Guelph, Ontario, N1G2W1, Canada

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cannabis

Drug

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

Other names: High THC, Smoked

Primary outcomes

  1. Change in Aortic Stiffness From Baseline Following Cannabis Consumption

    Time frame: Baseline, Post-Intervention (<2 Hours)

    Assessed via carotid-femoral pulse wave velocity (PWV)

  2. 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)

  3. 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

  4. Change in Cardiac Function From Baseline Following Cannabis Consumption

    Time frame: Baseline, Post-Intervention (<2 Hours)

    Measured by echocardiography

Secondary outcomes

  1. Exercise Capacity

    Time frame: Baseline, Post-Intervention (<2 Hours)

    Assessed by maximal average power attainable during 20 minutes of continuous cycling exercise

  2. Heart Rate

    Time frame: Baseline, Post-Intervention (<2 Hours)

    Measured at rest and during exercise

  3. Systolic Blood Pressure

    Time frame: Baseline, Post-Intervention (<2 Hours)

    Measured at rest and during exercise

  4. Diastolic Blood Pressure

    Time frame: Baseline, Post-Intervention (<2 Hours)

    Measured at rest and during exercise

  5. Perceived Exertion

    Time frame: Baseline, Post-Intervention (<2 Hours)

    Measured during exercise

  6. Oxygen Consumption

    Time frame: Baseline, Post-Intervention (<2 Hours)

    Measure of metabolic activity

Sponsors and collaborators

Lead sponsor

Jamie Burr

Other

Registry information

Official study 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

Important dates

Study start
2021
Primary completion
2025
Study completion
2025
First posted
Jan 5, 2021
Registry last updated
Apr 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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