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Cannabis Inhalation: Effects on Cardiovascular Function During Rest and Exercise

Primary Purpose

Cannabis, Cardiovascular Risk Factor

Status
Active
Phase
Early Phase 1
Locations
Canada
Study Type
Interventional
Intervention
Cannabis
Cannabis
Cannabis
Cannabis
Sponsored by
Jamie Burr
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Cannabis

Eligibility Criteria

19 Years - 45 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • University of Guelph

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

High THC, Smoked

High THC, Vaporized

High CBD, Smoked

High CBD, Vaporized

Arm Description

Outcomes

Primary Outcome Measures

Change in Aortic Stiffness From Baseline Following Cannabis Consumption
Assessed via carotid-femoral pulse wave velocity (PWV)
Change in Brachial Artery Vascular Function From Baseline Following Cannabis Consumption
Assessed via brachial artery flow mediated dilation (FMD)
Change in Sympathetic Nervous System Activity From Baseline Following Cannabis Consumption
Assessed via microneurographic recordings of the peroneal nerve
Change in Cardiac Function From Baseline Following Cannabis Consumption
Measured by echocardiography

Secondary Outcome Measures

Exercise Capacity
Assessed by maximal average power attainable during 20 minutes of continuous cycling exercise
Heart Rate
Measured at rest and during exercise
Systolic Blood Pressure
Measured at rest and during exercise
Diastolic Blood Pressure
Measured at rest and during exercise
Perceived Exertion
Measured during exercise
Oxygen Consumption
Measure of metabolic activity

Full Information

First Posted
November 3, 2020
Last Updated
August 19, 2022
Sponsor
Jamie Burr
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1. Study Identification

Unique Protocol Identification Number
NCT04693884
Brief Title
Cannabis Inhalation: Effects on Cardiovascular Function During Rest and Exercise
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
September 1, 2021 (Actual)
Primary Completion Date
December 2022 (Anticipated)
Study Completion Date
December 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Jamie Burr

4. Oversight

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

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cannabis, Cardiovascular Risk Factor

7. Study Design

Primary Purpose
Basic Science
Study Phase
Early Phase 1
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
High THC, Smoked
Arm Type
Experimental
Arm Title
High THC, Vaporized
Arm Type
Experimental
Arm Title
High CBD, Smoked
Arm Type
Experimental
Arm Title
High CBD, Vaporized
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Cannabis
Other Intervention Name(s)
High THC, Smoked
Intervention Description
Cannabis of (~10% THC concentration <1% CBD concentration) will be smoked.
Intervention Type
Drug
Intervention Name(s)
Cannabis
Other Intervention Name(s)
High THC, Vaporized
Intervention Description
Cannabis of (~10% THC concentration <1% CBD concentration) will be vaporized.
Intervention Type
Drug
Intervention Name(s)
Cannabis
Other Intervention Name(s)
High CBD, Smoked
Intervention Description
Cannabis of (~10% CBD concentration <1% THC concentration) will be smoked.
Intervention Type
Drug
Intervention Name(s)
Cannabis
Other Intervention Name(s)
High CBD, Vaporized
Intervention Description
Cannabis of (~10% CBD concentration <1% THC concentration) will be vaporized.
Primary Outcome Measure Information:
Title
Change in Aortic Stiffness From Baseline Following Cannabis Consumption
Description
Assessed via carotid-femoral pulse wave velocity (PWV)
Time Frame
Baseline, Post-Intervention (<2 Hours)
Title
Change in Brachial Artery Vascular Function From Baseline Following Cannabis Consumption
Description
Assessed via brachial artery flow mediated dilation (FMD)
Time Frame
Baseline, Post-Intervention (<2 Hours)
Title
Change in Sympathetic Nervous System Activity From Baseline Following Cannabis Consumption
Description
Assessed via microneurographic recordings of the peroneal nerve
Time Frame
Baseline, Post-Intervention (<2 Hours)
Title
Change in Cardiac Function From Baseline Following Cannabis Consumption
Description
Measured by echocardiography
Time Frame
Baseline, Post-Intervention (<2 Hours)
Secondary Outcome Measure Information:
Title
Exercise Capacity
Description
Assessed by maximal average power attainable during 20 minutes of continuous cycling exercise
Time Frame
Baseline, Post-Intervention (<2 Hours)
Title
Heart Rate
Description
Measured at rest and during exercise
Time Frame
Baseline, Post-Intervention (<2 Hours)
Title
Systolic Blood Pressure
Description
Measured at rest and during exercise
Time Frame
Baseline, Post-Intervention (<2 Hours)
Title
Diastolic Blood Pressure
Description
Measured at rest and during exercise
Time Frame
Baseline, Post-Intervention (<2 Hours)
Title
Perceived Exertion
Description
Measured during exercise
Time Frame
Baseline, Post-Intervention (<2 Hours)
Title
Oxygen Consumption
Description
Measure of metabolic activity
Time Frame
Baseline, Post-Intervention (<2 Hours)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
University of Guelph
City
Guelph
State/Province
Ontario
ZIP/Postal Code
N1G2W1
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Cannabis Inhalation: Effects on Cardiovascular Function During Rest and Exercise

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