Studying the Effects of Cannabis on Vasculature (SECV)

Elucidating the Effects of Cannabis on Cardiovascular System

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.

Study Overview

Status

Recruiting

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

    • Ontario
      • London, Ontario, Canada, N6A 5A5
        • Recruiting
        • London Regional Health Science Centre
        • Contact:
          • Mark Chandy, MD, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

15 years to 76 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Probability Sample

Study Population

The investigators plan to recruit participants from the London Health Sciences Centre HIV clinic and chronic pain clinic who use cannabis for medicinal purposes.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Inflammation
Time Frame: Baseline measurement.
The investigators will measure the concentration of inflammatory cytokines using an Olink for chronic cannabis users and the control group.
Baseline measurement.
Endothelial function
Time Frame: Baseline measurement.
The investigators will measure the reactive hyperaemia index (RHI) using an EndPAT device for both groups.
Baseline measurement.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cholesterol Level
Time Frame: Baseline measurement.
The investigators will measure lipid profile (total cholesterol, LDL, HDL, ratio) for both groups.
Baseline measurement.
BMI
Time Frame: Baseline measurement.
The investigators will measure body-mass index or both groups.
Baseline measurement.
Blood pressure
Time Frame: Baseline measurement.
The investigators will measure baseline blood pressure for both groups.
Baseline measurement.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2023

Primary Completion (Estimated)

June 30, 2025

Study Completion (Estimated)

December 30, 2025

Study Registration Dates

First Submitted

October 12, 2022

First Submitted That Met QC Criteria

October 12, 2022

First Posted (Actual)

October 14, 2022

Study Record Updates

Last Update Posted (Actual)

June 15, 2025

Last Update Submitted That Met QC Criteria

June 11, 2025

Last Verified

June 1, 2025

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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