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Trial Title:
Real World Evidence on the Use of Medical Cannabis in Pediatrics
NCT ID:
NCT05863910
Condition:
Cancer
Epilepsy
Neurodevelopmental Disorders
Conditions: Official terms:
Neurodevelopmental Disorders
Conditions: Keywords:
cannabinoids
cannabis
pediatrics
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Drug
Intervention name:
Medical Cannabis
Description:
Any cannabis product that is available to participants through the Medical Cannabis
Access Program is eligible to be included in this study.
Arm group label:
Cancer Cohort
Arm group label:
Epilepsy Cohort
Arm group label:
General Pediatrics Cohort
Summary:
CAN-RWE is an observational study that is following 500 children who have authorizations
for medical cannabis for two years from across Canada.
Detailed description:
Pediatric patients (3 to 17 years) using medical cannabis (MC) for pain, sleep, mood,
behaviour, seizures, treatment of cancer, or to manage symptoms related to cancer or
cancer-treatment are eligible to join this 24-month study if they have a valid MC
authorization.
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.
Criteria for eligibility:
Study pop:
Population includes children (3 to 17 years) who are cannabis-naïve or experienced with a
medical document provided by a prescribing health care practitioner (i.e. physician,
nurse practitioner, etc.) for the use o medical cannabis primarily for pain, sleep, mood,
behaviour, seizures, cancer or cancer-treatment related symptom management.
Sampling method:
Non-Probability Sample
Criteria:
Inclusion Criteria:
- 3 to 17 years
- 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:
- individuals using cannabis for medical purposes without a medical cannabis
authorization from a health care provider
- those only using cannabis recreationally
Gender:
All
Minimum age:
3 Years
Maximum age:
17 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
U Manitoba
Address:
City:
Winnipeg
Zip:
R3E0T6
Country:
Canada
Status:
Recruiting
Contact:
Last name:
Lauren Kelly, PhD
Phone:
2042723149
Email:
lauren.kelly@umanitoba.ca
Start date:
November 20, 2023
Completion date:
December 31, 2027
Lead sponsor:
Agency:
University of Manitoba
Agency class:
Other
Collaborator:
Agency:
The Canadian Collaborative for Childhood Cannabinoid Therapeutics
Agency class:
Other
Collaborator:
Agency:
Canadian Cancer Society (CCS)
Agency class:
Other
Collaborator:
Agency:
Canadian Institutes of Health Research (CIHR)
Agency class:
Other
Source:
University of Manitoba
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05863910
http://www.medcannkids.ca
