Clinical trial NCT05863910: Real World Evidence on the Use of Medical Cannabis in Pediatrics
Official title: Real World Evidence on the Use of Medical Cannabis in Pediatrics: A Prospective Observational Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cancer
Epilepsy
Neurodevelopmental Disorders
Keywords: cannabinoids
cannabis
pediatrics
Lead sponsor: University of Manitoba
Sponsor class: OTHER
Collaborators: name: The Canadian Collaborative for Childhood Cannabinoid Therapeutics
name: Canadian Cancer Society (CCS)
name: Canadian Institutes of Health Research (CIHR)
First posted: 2023-05-18
Enrollment: 500
Sex: ALL
Minimum age (years): 3
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

Brief 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.

Eligibility 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

Primary outcomes:
measure: Patterns of cannabis use (caregiver-reported)
timeFrame: baseline to 24-months
Secondary outcomes:
measure: Effectiveness in seizure cohort - seizure frequency
timeFrame: baseline to 24-months
measure: Effectiveness in seizure cohort - QOLCE
timeFrame: baseline to 24-months
measure: Effectiveness in oncology cohort - symptom burden
timeFrame: baseline to 24-months
measure: Effectiveness in oncology cohort - cachexia
timeFrame: baseline to 24-months
measure: Adverse events
timeFrame: baseline to 24-months
measure: Family related quality of life
timeFrame: baseline to 24-months
measure: Changes in mood - anxiety
timeFrame: baseline to 24-months
measure: Changes in mood - depression
timeFrame: baseline to 24-months
measure: Changes in mood - positive affect
timeFrame: baseline to 24-months
measure: Changes in sleep related impairment
timeFrame: baseline to 24-months
measure: Changes in pain interference
timeFrame: baseline to 24-months
measure: Parental overall impression of behaviour
timeFrame: baseline-24months
Other outcomes:
Locations:
city: Winnipeg
country: Canada
facility: U Manitoba
state: Manitoba
Study officials:
affiliation: University of Manitoba
name: Sapna Oberoi, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Northern Ontario School of Medicine
name: Taylor Lougheed, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Neurology Centre of Toronto
name: Evan Lewis, MD
role: PRINCIPAL_INVESTIGATOR
References: