SEC-V: Studying the Effects of Cannabis on Vasculature

Sponsor
Lawson Health Research Institute (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05581368
Collaborator
Academic Medical Organization of Southwestern Ontario (Other), Canadian Cardiovascular Society (Other)
100
12

Study Details

Study Description

Brief Summary

Cannabis is commonly used globally. It is associated with psychiatric problems, but the effects on the cardiovascular system are unclear. In this project, the investigators plan to study the effects of cannabis on the cardiovascular system. This will be done by using a non-invasive test to measure blood vessel function and by using blood samples to measure inflammation. As a control for this project, the investigators would like to test the blood vessel function and inflammation levels of participants who do not use cannabis. This study will provide important information on the long term cardiovascular effects of cannabis.

Condition or Disease Intervention/Treatment Phase
  • Other: Chronic Cannabis use

Detailed Description

Cannabis is the most commonly used illicit drug in the world, but the investigators do not know the long-term effects on the cardiovascular system in humans. The investigators have data from cell culture and small animal studies that cannabis is toxic to the cardiovascular system. Recently legalized in Canada, the long-term effects of cannabis use on the cardiovascular system may not be apparent for several decades. The purpose of this study is to test the effect of cannabis use on the vascular system. Using a non-invasive test of vascular function, the investigators would like to assess the effects of cannabis on chronic cannabis users. The investigators would also like to test if cannabis use by smoking and/or vaping causes adverse cardiovascular effects acutely. Lastly, the investigators would like to test blood from chronic cannabis users for inflammatory cytokines, which could further support our hypothesis that cannabis damages the cardiovascular system via inflammation.

Study Design

Study Type:
Observational
Anticipated Enrollment :
100 participants
Observational Model:
Case-Control
Time Perspective:
Prospective
Official Title:
Elucidating the Effects of Cannabis on Cardiovascular System
Anticipated Study Start Date :
Dec 1, 2022
Anticipated Primary Completion Date :
Jun 1, 2023
Anticipated Study Completion Date :
Dec 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Chronic Cannabis Cohort

For investigations on the effects of cannabis on the cardiovascular system, the investigators would like to recruit 50 participants with the following inclusion criteria: age: 19 to 80 males and females all ethnicities cannabis use at least 3-4 times per week or more in the past 6 months (50 volunteers, experimental group) no history of cardiovascular disease For investigations on the effects of cannabis on the cardiovascular system, the investigators will exclude cannabis users: that ingest cannabis containing cannabidiol (CBD) that are unable to provide a receipt for the cannabis product(s) they ingest that are unwilling to stop consuming soy products and/or genistein 48 hours prior to appointments.

Other: Chronic Cannabis use
The investigators will test levels of inflammation and vascular dysfunction in participants who chronically use cannabis.

Control Cohort

For investigations on the effects of cannabis on the cardiovascular system, the investigators would like to recruit 50 participants with the following inclusion criteria: age: 19 to 80 males and females all ethnicities patients who do not use cannabis no history of cardiovascular disease For investigations on the effects of cannabis on the cardiovascular system, the investigators will exclude participants: that ingest cannabis that are unwilling to stop consuming soy products and/or genistein 48 hours prior to appointments.

Outcome Measures

Primary Outcome Measures

  1. Inflammation [Baseline measurement.]

    The investigators will measure the concentration of inflammatory cytokines using an Olink for chronic cannabis users and the control group.

  2. Endothelial function [Baseline measurement.]

    The investigators will measure the reactive hyperaemia index (RHI) using an EndPAT device for both groups.

Secondary Outcome Measures

  1. Cholesterol Level [Baseline measurement.]

    The investigators will measure lipid profile (total cholesterol, LDL, HDL, ratio) for both groups.

  2. BMI [Baseline measurement.]

    The investigators will measure body-mass index or both groups.

  3. Blood pressure [Baseline measurement.]

    The investigators will measure baseline blood pressure for both groups.

Eligibility Criteria

Criteria

Ages Eligible for Study:
19 Years to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • age: 19 to 80

  • males and females

  • all ethnicities

  • cannabis use at least 3-4 times per week or more in the past 6 months (50 volunteers, experimental group)

  • patients who do not use cannabis (50 volunteers, control group)

  • no history of cardiovascular disease

Exclusion Criteria:
  • that ingest cannabis containing cannabidiol (CBD)

  • that are unable to provide a receipt for the cannabis product(s) they ingest

  • that are unwilling to stop consuming soy products and/or genistein 48 hours prior to appointments.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Lawson Health Research Institute
  • Academic Medical Organization of Southwestern Ontario
  • Canadian Cardiovascular Society

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Mark Chandy, Assistant Professor, Lawson Health Research Institute
ClinicalTrials.gov Identifier:
NCT05581368
Other Study ID Numbers:
  • WCVP0001
First Posted:
Oct 14, 2022
Last Update Posted:
Oct 18, 2022
Last Verified:
Oct 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
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 18, 2022