Real World Evidence on the Use of Medical Cannabis in Pediatrics
NCT ID: NCT05863910
Last Updated: 2023-11-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
500 participants
OBSERVATIONAL
2023-11-20
2027-12-31
Brief Summary
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Detailed Description
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Following screening, eligible participants will be contacted by the study coordinator. Following informed consent, study participants will record complete outcome measures on pain, sleep, mood (anxiety, depression and positive affect), behaviour, as well as report their cannabis use and indication-specific outcomes as applicable at 3, 6, 12, and 18 weeks, as well as 6, 12, 18 and 24-months.
Conditions
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Keywords
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Epilepsy Cohort
For children with epilepsy, the following tools will be added for data collection at each time point:
* Side effects: Pediatric Epilepsy Side Effects Questionnaire \[PESQ\]
* Seizure frequency/severity: Seizure Diary Data Questionnaire
Medical Cannabis
Any cannabis product that is available to participants through the Medical Cannabis Access Program is eligible to be included in this study.
Cancer Cohort
For children with cancer, the following tools will be added for data collection at each time point:
* Cancer symptom burden: Symptom Screening in Pediatrics Tool \[SSPedi\]
* Cachexia: Pediatric Functional Assessment of Anorexia/ Cachexia Treatment \[peds-FAACT\]
Medical Cannabis
Any cannabis product that is available to participants through the Medical Cannabis Access Program is eligible to be included in this study.
General Pediatrics Cohort
There are no specific outcome scales added for this cohort.
Medical Cannabis
Any cannabis product that is available to participants through the Medical Cannabis Access Program is eligible to be included in this study.
Interventions
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Medical Cannabis
Any cannabis product that is available to participants through the Medical Cannabis Access Program is eligible to be included in this study.
Eligibility Criteria
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Inclusion Criteria
* have a medical document provided by a prescribing health care practitioner (i.e. physician, nurse practitioner, etc.) for the use of medical cannabis
* medical cannabis is authorized for pain, sleep, mood, behaviour, seizures, cancer or cancer-treatment related symptom management
* ability to respond to electronic questionnaires in English
Exclusion Criteria
* those only using cannabis recreationally
3 Years
17 Years
ALL
No
Sponsors
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The Canadian Collaborative for Childhood Cannabinoid Therapeutics
UNKNOWN
Canadian Cancer Society (CCS)
OTHER
Canadian Institutes of Health Research (CIHR)
OTHER_GOV
University of Manitoba
OTHER
Responsible Party
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Principal Investigators
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Sapna Oberoi, MD
Role: PRINCIPAL_INVESTIGATOR
University of Manitoba
Taylor Lougheed, MD
Role: PRINCIPAL_INVESTIGATOR
Northern Ontario School of Medicine
Evan Lewis, MD
Role: PRINCIPAL_INVESTIGATOR
Neurology Centre of Toronto
Locations
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U Manitoba
Winnipeg, Manitoba, Canada
Countries
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Central Contacts
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Facility Contacts
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Lauren Kelly, PhD
Role: primary
Related Links
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For more information on our research team visit our website.
Other Identifiers
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CAN-RWE
Identifier Type: -
Identifier Source: org_study_id