Recruiting

Medical Cannabis

Sponsor:

University of Manitoba

Code:

NCT05863910

Conditions

Cancer

Epilepsy

Neurodevelopmental Disorders

Eligibility Criteria

Sex: All

Age: 3 - 17

Healthy Volunteers: Not accepted

Interventions

Medical Cannabis

Study Details

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.

Conditions

Cancer

Epilepsy

Neurodevelopmental Disorders

Study ID

NCT05863910

Start date

Nov 20, 2023

Status verified date

Nov, 2023

Completion date

Dec 31, 2027

Anticipated

Primary completion date

Dec 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 3 - 17

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

500 participants

Anticipated

Interventions and Outcome Measures

Arms

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

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 \[peds-FAACT\]

General Pediatrics Cohort

There are no specific outcome scales added for this cohort.

Interventions

Medical Cannabis

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

Primary outcome measure

  • Patterns of cannabis use (caregiver-reported) [ Time Frame: baseline to 24-months ]

Central Contacts and Locations

Central contacts

Lauren E Kelly, PhD

2042723149lauren.kelly@umanitoba.ca

Locations

U Manitoba

Recruiting

Winnipeg, Manitoba, Canada, R3E0T6

Contacts

Lauren Kelly, PhD

2042723149lauren.kelly@umanitoba.ca

More Information

Sponsor

University of Manitoba

Last update posted

Nov 30, 2023

Last verified

Nov, 2023

Keywords

  • cannabinoids
  • cannabis
  • pediatrics

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Manitoba on 2023-11-30.