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Cannabis Inhalation: Effects on Cardiovascular Function During Rest and Exercise

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ClinicalTrials.gov Identifier: NCT04693884
Recruitment Status : Not yet recruiting
First Posted : January 5, 2021
Last Update Posted : January 5, 2021
Sponsor:
Information provided by (Responsible Party):
Jamie Burr, University of Guelph

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
Cannabis Cardiovascular Risk Factor Drug: Cannabis Early Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated 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
Estimated Study Start Date : September 2021
Estimated Primary Completion Date : April 2022
Estimated Study Completion Date : September 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: High THC, Smoked Drug: Cannabis
Cannabis of (~10% THC concentration <1% CBD concentration) will be smoked.
Other Name: High THC, Smoked

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

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

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




Primary Outcome Measures :
  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 Outcome Measures :
  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



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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04693884


Contacts
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Contact: Jamie F Burr, PhD (519) 824-4120 ext 52591 burrj@uoguelph.ca
Contact: Christian P Cheung, MSc 6472058535 ccheun05@uoguelph.ca

Sponsors and Collaborators
Jamie Burr
  Study Documents (Full-Text)

Documents provided by Jamie Burr, University of Guelph:
Study Protocol  [PDF] August 11, 2020
Statistical Analysis Plan  [PDF] December 16, 2020

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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: January 5, 2021    Key Record Dates
Last Update Posted: January 5, 2021
Last Verified: December 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Marijuana Abuse
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders