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Cannabis Inhalation: Effects on Cardiovascular Function During Rest and Exercise

Sponsor
Jamie Burr (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT04693884
Collaborator
(none)
20
Enrollment
1
Location
4
Arms
15
Anticipated Duration (Months)
1.3
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Early Phase 1

Study Design

Study Type:
Interventional
Anticipated Enrollment :
20 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
Single (Participant)
Primary Purpose:
Basic Science
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
Actual Study Start Date :
Sep 1, 2021
Anticipated Primary Completion Date :
Dec 1, 2022
Anticipated Study Completion Date :
Dec 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: High THC, Smoked

Drug: Cannabis
Cannabis of (~10% THC concentration <1% CBD concentration) will be smoked.
Other Names:
  • High THC, Smoked

    		•
    Experimental: High THC, Vaporized

    Drug: Cannabis
    Cannabis of (~10% THC concentration <1% CBD concentration) will be vaporized.
    Other Names:
  • High THC, Vaporized

    		•
    Experimental: High CBD, Smoked

    Drug: Cannabis
    Cannabis of (~10% CBD concentration <1% THC concentration) will be smoked.
    Other Names:
  • High CBD, Smoked

    		•
    Experimental: High CBD, Vaporized

    Drug: Cannabis
    Cannabis of (~10% CBD concentration <1% THC concentration) will be vaporized.
    Other Names:
  • High CBD, Vaporized

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Change in Aortic Stiffness From Baseline Following Cannabis Consumption [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 [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 [Baseline, Post-Intervention (<2 Hours)]

      Assessed via microneurographic recordings of the peroneal nerve

    4. Change in Cardiac Function From Baseline Following Cannabis Consumption [Baseline, Post-Intervention (<2 Hours)]

      Measured by echocardiography

    Secondary Outcome Measures

    1. Exercise Capacity [Baseline, Post-Intervention (<2 Hours)]

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

    2. Heart Rate [Baseline, Post-Intervention (<2 Hours)]

      Measured at rest and during exercise

    3. Systolic Blood Pressure [Baseline, Post-Intervention (<2 Hours)]

      Measured at rest and during exercise

    4. Diastolic Blood Pressure [Baseline, Post-Intervention (<2 Hours)]

      Measured at rest and during exercise

    5. Perceived Exertion [Baseline, Post-Intervention (<2 Hours)]

      Measured during exercise

    6. Oxygen Consumption [Baseline, Post-Intervention (<2 Hours)]

      Measure of metabolic activity

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    19 Years to 45 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Guelph Guelph Ontario Canada N1G2W1

    Sponsors and Collaborators

    • Jamie Burr

    Investigators

    None specified.

    Study Documents (Full-Text)

    More Information

    Publications

    None provided.
    Responsible Party:
    Jamie Burr, Associate Professor, University of Guelph
    ClinicalTrials.gov Identifier:
    NCT04693884
    Other Study ID Numbers:
    • UOG-HPL-CAN (REB# 18-11-013)
    First Posted:
    Jan 5, 2021
    Last Update Posted:
    Aug 24, 2022
    Last Verified:
    Aug 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    No
    Additional relevant MeSH terms:
    Marijuana Abuse

    Study Results

    No Results Posted as of Aug 24, 2022