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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05581368
Other study ID # WCVP0001
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date December 1, 2023
Est. completion date December 2024

Study information

Verified date April 2024
Source Lawson Health Research Institute
Contact Mark Chandy, MD, PhD
Phone 5196612111
Email mark.chandy@lhsc.on.ca
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 100
Est. completion date December 2024
Est. primary completion date December 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 19 Years to 80 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Canada London Regional Health Science Centre London Ontario

Sponsors (3)

Lead Sponsor Collaborator
Lawson Health Research Institute Academic Medical Organization of Southwestern Ontario, Canadian Cardiovascular Society

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary Inflammation The investigators will measure the concentration of inflammatory cytokines using an Olink for chronic cannabis users and the control group. Baseline measurement.
Primary Endothelial function The investigators will measure the reactive hyperaemia index (RHI) using an EndPAT device for both groups. Baseline measurement.
Secondary Cholesterol Level The investigators will measure lipid profile (total cholesterol, LDL, HDL, ratio) for both groups. Baseline measurement.
Secondary BMI The investigators will measure body-mass index or both groups. Baseline measurement.
Secondary Blood pressure The investigators will measure baseline blood pressure for both groups. Baseline measurement.
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