Cardiovascular DiseasesSECVNCT05581368
Studying the Effects of Cannabis on Vasculature
An observational study of Cardiovascular Diseases and Inflammation, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 19 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Diseases, Inflammation, Atherosclerosis
- What is being tested?
- Chronic Cannabis use
- How many people
- 100 participants
- Where
- 1 siteCanada
- Study dates
- 1 Dec 2023to 30 Dec 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
London Regional Health Science Centre
London, Ontario, N6A 5A5
Mark Chandy, MD, PhD
About this study
Official title: 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.
Read the 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.
- Conditions
- Cardiovascular Diseases, Inflammation, Atherosclerosis
- Being tested
- Chronic Cannabis use
- Medical subject headings
- Cardiovascular Diseases, Inflammation, Atherosclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chronic Cannabis useOther
The investigators will test levels of inflammation and vascular dysfunction in participants who chronically use cannabis.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Chronic Cannabis use | |
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Inflammation
The investigators will measure the concentration of inflammatory cytokines using an Olink for chronic cannabis users and the control group.
Measured: Baseline measurement.
Endothelial function
The investigators will measure the reactive hyperaemia index (RHI) using an EndPAT device for both groups.
Measured: Baseline measurement.
Secondary outcomes (3)
Cholesterol Level
The investigators will measure lipid profile (total cholesterol, LDL, HDL, ratio) for both groups.
Measured: Baseline measurement.
BMI
The investigators will measure body-mass index or both groups.
Measured: Baseline measurement.
Blood pressure
The investigators will measure baseline blood pressure for both groups.
Measured: Baseline measurement.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2022
- Study start1 Dec 2023
- Primary completion30 Jun 2025 (estimated)
- Study completion30 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- More trials run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Sponsor type
- University, hospital or other
- Collaborators
- Academic Medical Organization of Southwestern Ontario, Canadian Cardiovascular Society, Stanford University, Greenstone Biosciences, Inc.
- Responsible party
- Principal investigator, Mark Chandy, London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05581368
- Sponsor's protocol ID
- WCVP0001
- Acronym
- SECV
- Status last verified
- Jun 2025
- First submitted
- 12 Oct 2022
- Last updated
- 15 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Elucidating the Effects of Cannabis on Cardiovascular System
- ClinicalTrials.gov ID
- NCT05581368
- Acronym / sponsor ID
- SECV / WCVP0001
- Conditions
- Cardiovascular Diseases, Inflammation, Atherosclerosis
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sUniversity, hospital or other
- Collaborators
- Academic Medical Organization of Southwestern Ontario, Canadian Cardiovascular Society, Stanford University, Greenstone Biosciences, Inc.
- Study start
- 1 Dec 2023 (actual)
- Primary completion
- 30 Jun 2025 (estimated)
- Study completion
- 30 Dec 2025 (estimated)
- First posted
- 14 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Chronic Cannabis Cohort | – | Other: Chronic Cannabis useFor 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. |
| 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. |
Who may qualify
- Ages
- 19 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (6 listed)
- 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)
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Chronic Cannabis useThe investigators will test levels of inflammation and vascular dysfunction in participants who chronically use cannabis. | Other | Chronic Cannabis Cohort |
Primary outcome
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.
Endothelial function
Time frame: Baseline measurement.
The investigators will measure the reactive hyperaemia index (RHI) using an EndPAT device for both groups.
3 secondary outcomes
Cholesterol Level
Time frame: Baseline measurement.
BMI
Time frame: Baseline measurement.
Blood pressure
Time frame: Baseline measurement.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiovascular Diseases and Inflammation, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mark Chandy, MD, PhD (5196612111, mark.chandy@lhsc.on.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Inflammation (time frame: Baseline measurement.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2025.