NCT05581368

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.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2023

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 12, 2022

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 14, 2022

Completed
1.1 years until next milestone

Study Start

First participant enrolled

December 1, 2023

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2025

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2025

Completed
Last Updated

June 15, 2025

Status Verified

June 1, 2025

Enrollment Period

1.6 years

First QC Date

October 12, 2022

Last Update Submit

June 11, 2025

Conditions

Outcome Measures

Primary Outcomes (2)

  • Inflammation

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

    Baseline measurement.

  • Endothelial function

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

    Baseline measurement.

Secondary Outcomes (3)

  • Cholesterol Level

    Baseline measurement.

  • BMI

    Baseline measurement.

  • Blood pressure

    Baseline measurement.

Study Arms (2)

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

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.

Interventions

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

Chronic Cannabis Cohort

Eligibility Criteria

Age19 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

London Regional Health Science Centre

London, Ontario, N6A 5A5, Canada

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

The investigators would like to test blood and vascular function of chronic cannabis users for signs of vascular dysfunction. The investigators e will obtain blood from a single blood draw using EDTA tubes. The investigators will separate into plasma, red blood cells, and white blood cells. The investigators will test the plasma from control and chronic cannabis users with a lipid panel, complete metabolic panel, HgbA1c, fasting glucose, and Olink inflammation panel. The investigators will retain unused plasma and peripheral blood mononuclear cells for future studies.

MeSH Terms

Conditions

Cardiovascular DiseasesInflammationAtherosclerosis

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Central Study Contacts

Mark Chandy, MD, PhD

CONTACT

Kerry-Ann Nakreiko, PhD

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

October 12, 2022

First Posted

October 14, 2022

Study Start

December 1, 2023

Primary Completion

June 30, 2025

Study Completion

December 30, 2025

Last Updated

June 15, 2025

Record last verified: 2025-06

Locations