Longitudinal Study of Xenon-129 MRI Imaging Effects of Cannabis Smoking

August 11, 2025 updated by: Western University, Canada

Longitudinal Study of Xenon-129 MRI Imaging of Effects of Cannabis Smoking on Lung Structure and Function

This is a longitudinal study of the long-term health impact of cannabis smoking on the lungs. Participants will be followed over a period of 3 years, and impacts of cannabis smoking on the lungs will be measured with magnetic resonance imaging (MRI) using hyperpolarized xenon-129 gas, pulmonary function tests, exercise capacity, computed tomography images and questionnaires.

Study Overview

Detailed Description

This is a longitudinal study of the long-term lung health impact of cannabis smoking in adults using xenon-129 (129Xe) MRI over three years.

Males and females between the ages of 18 to 85 years with a history of cannabis smoking will be screened, and those who satisfy all inclusion and exclusion criteria will undergo study visits for up to 3 years, with visits every 12 ± 3 months, for a total of up to four study visits. Each study visit will include collection of patient smoking history and vital signs. At Visit 1 and 4, 129-Xe MRI, spirometry, plethysmography for airways resistance (Raw) and lung volumes, forced oscillation technique (FOT) and multiple breath nitrogen washout (MBNW) for the lung clearance index (LCI) will all be performed pre- and post-bronchodilator. Blood will be drawn for blood eosinophil count, and sputum induction will be done to measure sputum eosinophils. A CT will also be done at Robarts Research Institute, or at University Hospital, London Health Sciences Centre next door to Robarts. Visit 2 will be a telephone call to complete questionnaires. Visit 3 will include spirometry and questionnaires only. Participants 35 years of age or older will complete a six minute walk test (6MWT) for the distance walked (6MWD), pre and post oxygen saturation, perceived dyspnea (Modified Borg Scale) and perceived exertion (Borg's rating of perceived exertion). These participants will complete the St. George's Respiratory Questionnaire (SGRQ).

Participants under the age of 35 will complete Cardio Pulmonary Exercise Testing to assess exercise capacity, and the American Thoracic Society Questionnaire (ATSQ).

Study Type

Observational

Enrollment (Estimated)

200

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

  • Name: Grace E Parraga, PhD
  • Phone Number: 519-931-5265
  • Email: gparraga@uwo.ca

Study Locations

    • Ontario
      • London, Ontario, Canada, N6A 5B7
        • Recruiting
        • Robarts Research Institute; The University of Western Ontario; London Health Sciences Centre
        • Contact:

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

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Probability Sample

Study Population

Current and former smokers of cannabis

Description

Inclusion Criteria:

  • Patient understands study procedures and is willing to participate in the study as indicated by the patient's signature
  • Provision of written, informed consent prior to any study specific procedures
  • Males and females aged 18-85
  • Current or former cannabis smoker (medicinal or recreational) with or without concurrent tobacco smoking history
  • Participant is able to perform reproducible pulmonary function testing (i.e. the 3 best acceptable spirograms have Forced Expiratory Volume in 1 second (FEV1) values that do not vary more than 150 millilitres)
  • Participant is able to perform a breathhold for 16s
  • FEV1 > 25% predicted
  • Forced Vital Capacity (FVC) > 25% predicted and >0.5 litres

Exclusion Criteria:

  • Participant is, in the opinion of the investigator, mentally or legally incapacitated, preventing informed consent from being obtained, or cannot read or understand written material
  • Participant is medically unstable in the opinion of the Principal Investigator
  • Participant has a daytime room air oxygen saturation <90% while lying supine
  • Participant is unable to perform spirometry or plethysmography maneuvers
  • Patient is pregnant at time of enrolment
  • In the opinion of the investigator, patient suffers from any physical, psychological or other condition(s) that might prevent performance of the MRI, such as severe claustrophobia
  • Patient has implanted mechanically, electrically or magnetically activated device or any metal in their body, which cannot be removed, including but not limited to pacemakers, neurostimulators, biostimulators, implanted insulin pumps, aneurysm clips, bioprosthesis, artificial limb, metallic fragment or foreign body, shunt, surgical staples (including clips or metallic sutures and/or ear implants) - at the discretion of the MRI Technologist.

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Cannabis Smoker
Participants in this group will be current or former cannabis smokers
Participants will be imaged using MRI using hyperpolarized xenon-129 gas as a contrast gas
Participants will undergo a CT scan of the thoracic cavity
Other Names:
  • CT
Participants will provide a sputum sample that will be analysed for eosinophils
Participants will have their blood drawn and analysed for eosinophil count.
Participants will have their lung function evaluated using PFTs
Other Names:
  • PFTs
Participants >35 years of age will perform the six minute walk test as a measure of exercise capacity
Other Names:
  • 6MWT
Participants <35 will perform cardiopulmonary exercise testing as a measure of exercise capacity
Other Names:
  • CPET

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in airways over time
Time Frame: 3 years
Measured using Xenon-129 (129-Xe) MRI
3 years
Changes in parenchyma over time
Time Frame: 3 years
Measured using Xenon-129 (129-Xe) MRI
3 years
Differences in lung ventilation in cannabis smokers compared to never-smokers and tobacco smokers
Time Frame: 3 years
Measured using 129-Xe MRI
3 years
Differences in perfusion in cannabis smokers compared to never-smokers and tobacco smokers
Time Frame: 3 years
Measured using 129-Xe MRI
3 years
Differences in parenchyma integrity in cannabis smokers compared to never-smokers and tobacco smokers
Time Frame: 3 years
Measured using 129-Xe MRI
3 years
Differences in airways between cannabis-only smokers and cannabis and tobacco smokers
Time Frame: 3 years
Measured using 129-Xe MRI
3 years
Differences in parenchyma between cannabis-only smokers and cannabis and tobacco smokers
Time Frame: 3 years
Measured using 129-Xe MRI
3 years
Dose-response of cannabis use to changes in airways over time
Time Frame: 3 years
Measured using 129-Xe MRI
3 years
Dose-response of cannabis use to changes in parenchyma over time
Time Frame: 3 years
Measured using 129-Xe MRI
3 years

Collaborators and Investigators

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

Investigators

  • Principal Investigator: Grace E Parraga, PhD, Robarts Research Institute, The University of Western Ontario

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)

June 1, 2022

Primary Completion (Estimated)

December 1, 2030

Study Completion (Estimated)

December 1, 2030

Study Registration Dates

First Submitted

March 25, 2019

First Submitted That Met QC Criteria

April 5, 2019

First Posted (Actual)

April 10, 2019

Study Record Updates

Last Update Posted (Estimated)

August 15, 2025

Last Update Submitted That Met QC Criteria

August 11, 2025

Last Verified

August 1, 2025

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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