NCT03909477 Longitudinal Study of Xenon-129 MRI Imaging Effects of Cannabis Smoking
| NCT ID | NCT03909477 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Western University, Canada |
| Condition | Cannabis Use |
| Study Type | OBSERVATIONAL |
| Enrollment | 200 participants |
| Start Date | 2022-06-01 |
| Primary Completion | 2030-12-01 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 200 participants in total. It began in 2022-06-01 with a primary completion date of 2030-12-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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.
Eligibility 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.
Contact & Investigator
Grace E Parraga, PhD
PRINCIPAL INVESTIGATOR
Robarts Research Institute, The University of Western Ontario
Frequently Asked Questions
Who can join the NCT03909477 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 85 Years, studying Cannabis Use. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT03909477 currently recruiting?
Yes, NCT03909477 is actively recruiting participants. Contact the research team at gparraga@uwo.ca for enrollment information.
Where is the NCT03909477 trial being conducted?
This trial is being conducted at London, Canada.
Who is sponsoring the NCT03909477 clinical trial?
NCT03909477 is sponsored by Western University, Canada. The principal investigator is Grace E Parraga, PhD at Robarts Research Institute, The University of Western Ontario. The trial plans to enroll 200 participants.