Cannabis Use Clinical Trial
Official title:
Longitudinal Study of Xenon-129 MRI Imaging of Effects of Cannabis Smoking on Lung Structure and Function
NCT number | NCT03909477 |
Other study ID # | ROB0043 |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | June 1, 2022 |
Est. completion date | December 1, 2030 |
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.
Status | Recruiting |
Enrollment | 200 |
Est. completion date | December 1, 2030 |
Est. primary completion date | December 1, 2030 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 85 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Canada | Robarts Research Institute; The University of Western Ontario; London Health Sciences Centre | London | Ontario |
Lead Sponsor | Collaborator |
---|---|
Western University, Canada |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Changes in airways over time | Measured using Xenon-129 (129-Xe) MRI | 3 years | |
Primary | Changes in parenchyma over time | Measured using Xenon-129 (129-Xe) MRI | 3 years | |
Primary | Differences in lung ventilation in cannabis smokers compared to never-smokers and tobacco smokers | Measured using 129-Xe MRI | 3 years | |
Primary | Differences in perfusion in cannabis smokers compared to never-smokers and tobacco smokers | Measured using 129-Xe MRI | 3 years | |
Primary | Differences in parenchyma integrity in cannabis smokers compared to never-smokers and tobacco smokers | Measured using 129-Xe MRI | 3 years | |
Primary | Differences in airways between cannabis-only smokers and cannabis and tobacco smokers | Measured using 129-Xe MRI | 3 years | |
Primary | Differences in parenchyma between cannabis-only smokers and cannabis and tobacco smokers | Measured using 129-Xe MRI | 3 years | |
Primary | Dose-response of cannabis use to changes in airways over time | Measured using 129-Xe MRI | 3 years | |
Primary | Dose-response of cannabis use to changes in parenchyma over time | Measured using 129-Xe MRI | 3 years |
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