Robarts Research Institute; The University of Western Ontario; London Health Sciences Centre
London, Ontario, N6A 5B7, Canada
Location status: Recruiting
NCT Number: NCT03909477
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.
Interested in participating?
Request Info18 year–85 year
All sexes
Observational
London, Ontario, N6A 5B7, Canada
Location status: Recruiting
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).
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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 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
Participants will provide a sputum sample that will be analysed for eosinophils
Participants will have their blood drawn and analysed for eosinophil count.
Time frame: 3 years
Measured using Xenon-129 (129-Xe) MRI
Time frame: 3 years
Measured using Xenon-129 (129-Xe) MRI
Time frame: 3 years
Measured using 129-Xe MRI
Time frame: 3 years
Measured using 129-Xe MRI
Time frame: 3 years
Measured using 129-Xe MRI
Time frame: 3 years
Measured using 129-Xe MRI
Time frame: 3 years
Measured using 129-Xe MRI
Time frame: 3 years
Measured using 129-Xe MRI
Time frame: 3 years
Measured using 129-Xe MRI
Contact information is provided by the study sponsor or research team.
Western University, Canada
Other
Longitudinal Study of Xenon-129 MRI Imaging of Effects of Cannabis Smoking on Lung Structure and Function
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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