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Trial record 4 of 5 for:    Recruiting, Not yet recruiting, Available Studies | "Marijuana Use"

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

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ClinicalTrials.gov Identifier: NCT03909477
Recruitment Status : Not yet recruiting
First Posted : April 10, 2019
Last Update Posted : April 10, 2019
Sponsor:
Information provided by (Responsible Party):
Western University, Canada

Brief Summary:
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 10 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.

Condition or disease Intervention/treatment
Cannabis Use Cannabis Smoking Marijuana Smoking Marijuana Usage Diagnostic Test: Hyperpolarized Xenon-129 MRI of the lungs Diagnostic Test: Computed Tomography (CT) Diagnostic Test: Pulmonary Function Tests (PFTs) Diagnostic Test: Six Minute Walk Test (6MWT) Diagnostic Test: Cardiopulmonary exercise testing (CPET) Diagnostic Test: Sputum analysis Diagnostic Test: Blood analysis

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 ten 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 10 years, with visits every 24 ± 6 months, for a total of up to six study visits. Each study visit will include collection of patient smoking history and vital signs. 129Xe 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. At baseline, 6 year follow-up and 10 year follow-up, a CT will also be done at University Hospital, London Health Sciences Centre.

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).


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Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Longitudinal Study of Xenon-129 MRI Imaging of Effects of Cannabis Smoking on Lung Structure and Function
Estimated Study Start Date : May 1, 2019
Estimated Primary Completion Date : December 1, 2029
Estimated Study Completion Date : December 1, 2029

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Marijuana Smoking
Drug Information available for: Xenon

Group/Cohort Intervention/treatment
Cannabis Smoker
Participants in this group will be current or former cannabis smokers
Diagnostic Test: Hyperpolarized Xenon-129 MRI of the lungs
Participants will be imaged using MRI using hyperpolarized xenon-129 gas as a contrast gas

Diagnostic Test: Computed Tomography (CT)
Participants will undergo a CT scan of the thoracic cavity
Other Name: CT

Diagnostic Test: Pulmonary Function Tests (PFTs)
Participants will have their lung function evaluated using PFTs
Other Name: PFTs

Diagnostic Test: Six Minute Walk Test (6MWT)
Participants >35 years of age will perform the six minute walk test as a measure of exercise capacity
Other Name: 6MWT

Diagnostic Test: Cardiopulmonary exercise testing (CPET)
Participants <35 will perform cardiopulmonary exercise testing as a measure of exercise capacity
Other Name: CPET

Diagnostic Test: Sputum analysis
Participants will provide a sputum sample that will be analysed for eosinophils

Diagnostic Test: Blood analysis
Participants will have their blood drawn and analysed for eosinophil count.




Primary Outcome Measures :
  1. Changes in airways over time [ Time Frame: 10 years ]
    Measured using Xenon-129 (129-Xe) MRI

  2. Changes in parenchyma over time [ Time Frame: 10 years ]
    Measured using Xenon-129 (129-Xe) MRI

  3. Differences in lung ventilation in cannabis smokers compared to never-smokers and tobacco smokers [ Time Frame: 10 years ]
    Measured using 129-Xe MRI

  4. Differences in perfusion in cannabis smokers compared to never-smokers and tobacco smokers [ Time Frame: 10 years ]
    Measured using 129-Xe MRI

  5. Differences in parenchyma integrity in cannabis smokers compared to never-smokers and tobacco smokers [ Time Frame: 10 years ]
    Measured using 129-Xe MRI

  6. Differences in airways between cannabis-only smokers and cannabis and tobacco smokers [ Time Frame: 10 years ]
    Measured using 129-Xe MRI

  7. Differences in parenchyma between cannabis-only smokers and cannabis and tobacco smokers [ Time Frame: 10 years ]
    Measured using 129-Xe MRI

  8. Dose-response of cannabis use to changes in airways over time [ Time Frame: 10 years ]
    Measured using 129-Xe MRI

  9. Dose-response of cannabis use to changes in parenchyma over time [ Time Frame: 10 years ]
    Measured using 129-Xe MRI



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Current and former smokers of cannabis
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03909477


Contacts
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Contact: Grace E Parraga, PhD 519-931-5777 ext 24197 gparraga@robarts.ca
Contact: Danielle Knipping, RN 519-931-5777 ext 24197 dknipping@robarts.ca

Locations
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Canada, Ontario
Robarts Research Insitute; The University of Western Ontario; London Health Sciences Centre
London, Ontario, Canada, N6A 5B7
Sponsors and Collaborators
Western University, Canada
Investigators
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Principal Investigator: Grace E Parraga, PhD Robarts Research Institute, The University of Western Ontario

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Responsible Party: Western University, Canada
ClinicalTrials.gov Identifier: NCT03909477     History of Changes
Other Study ID Numbers: ROB0043
First Posted: April 10, 2019    Key Record Dates
Last Update Posted: April 10, 2019
Last Verified: March 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Marijuana Use
Marijuana Abuse
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Xenon
Anesthetics, Inhalation
Anesthetics, General
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs