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NCT Number: NCT05863910

Real World Evidence on the Use of Medical Cannabis in Pediatrics

CAN-RWE is an observational study that is following 500 children who have authorizations for medical cannabis for two years from across Canada.

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Key information

Conditions

Cancer Brain Diseases Central Nervous System Diseases Chemically-Induced Disorders Epilepsy Marijuana Abuse Mental Disorders Neoplasms Nervous System Diseases Neurodevelopmental Disorders Substance-Related Disorders

Age range

3 year–17 year

Sex eligibility

All sexes

Study type

Observational

Primary location

U Manitoba

Winnipeg, Manitoba, R3E0T6, Canada

Location status: Recruiting

Location contact

Lauren Kelly, PhD

CONTACT

[email protected]

2042723149

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Medical Cannabis

Drug

Any cannabis product that is available to participants through the Medical Cannabis Access Program is eligible to be included in this study.

Primary outcomes

  1. Patterns of cannabis use (caregiver-reported)

    Time frame: baseline to 24-months

    Describe patterns of cannabis use are described using a standard data collection form including dose and product type completed by caregivers at baseline, 3, 6, 12, and 18-weeks and 6, 12, 18 and 24-months

Secondary outcomes

  1. Effectiveness in seizure cohort - seizure frequency

    Time frame: baseline to 24-months

    Longitudinal assessment for benefit signals in epilepsy seizure frequency/severity measure by a seizure diary

  2. Effectiveness in seizure cohort - QOLCE

    Time frame: baseline to 24-months

    Longitudinal assessment for benefit signals including epilepsy related side effects measured using QOLCE

  3. Effectiveness in oncology cohort - symptom burden

    Time frame: baseline to 24-months

    Longitudinal assessment for benefit signals in caregiver reported changes in symptom burden assessed using mini-SSPEDI (under 8 yr) and SSPEDI scales

  4. Effectiveness in oncology cohort - cachexia

    Time frame: baseline to 24-months

    Longitudinal assessment of cachexia using Peds-FAACT

  5. Adverse events

    Time frame: baseline to 24-months

    Cannabis-related adverse events and serious adverse events reported by caregivers using a standard AE data collection tool and categorized according to CTCAE v5.0 at baseline, 3, 6, 12, and 18-weeks and 6, 12, 18 and 24-months

  6. Family related quality of life

    Time frame: baseline to 24-months

    Longitudinal assessment of cachexia using PedsQL

  7. Changes in mood - anxiety

    Time frame: baseline to 24-months

    PROMIS short form scales for pediatric anxiety symptoms 8a v2.0

  8. Changes in mood - depression

    Time frame: baseline to 24-months

    PROMIS short form scales for pediatric depression symptoms 8a v2.0

  9. Changes in mood - positive affect

    Time frame: baseline to 24-months

    PROMIS short form pediatric positive affect scale 8a v2.0

  10. Changes in sleep related impairment

    Time frame: baseline to 24-months

    PROMIS short form pediatric sleep related impairment scale 8a v2.0

  11. Changes in pain interference

    Time frame: baseline to 24-months

    PROMIS short form pediatric pain interference scale 8a v2.0

  12. Parental overall impression of behaviour

    Time frame: baseline-24months

    Parents/Caregivers will be asked to report on if their childs behaviour has improved or worsened and will have an open-ended text box to describe anything they want to tell us about changes in their child's behaviour.

Study contacts

Contact information is provided by the study sponsor or research team.

Lauren E Kelly, PhD

CONTACT

[email protected]

2042723149

Sponsors and collaborators

Lead sponsor

University of Manitoba

Other

Collaborators

  • Canadian Cancer Society (CCS)
  • Canadian Institutes of Health Research (CIHR)
  • The Canadian Collaborative for Childhood Cannabinoid Therapeutics

Registry information

Official study title

Real World Evidence on the Use of Medical Cannabis in Pediatrics: A Prospective Observational Study

Acronym: CAN-RWE

Important dates

Study start
2023
Primary completion
2027
Study completion
2027
First posted
May 18, 2023
Registry last updated
Nov 30, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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