Actively Recruiting
Cannabis for Chronic Headaches in Adolescents: the CAN-CHA Trial
Led by University of Manitoba · Updated on 2025-05-29
20
Participants Needed
3
Research Sites
63 weeks
Total Duration
On this page
Sponsors
U
University of Manitoba
Lead Sponsor
S
SickKids Foundation
Collaborating Sponsor
AI-Summary
What this Trial Is About
Chronic headaches are a major cause of disability among adolescents. Cannabis products have supported the management of headaches in adults and may play a role in pediatric chronic pain. We propose a multisite, open-label, tolerability study conducted across three centers in Canada of Cannabidiol-enriched Cannabis Herbal Extract in adolescents (ages 14 to 17 years old) with chronic headaches. The study includes a one month baseline assessment, four months of escalating treatment doses and a weaning period. Our primary outcome is tolerability defined as the number and severity of reported adverse events.
CONDITIONS
Official Title
Cannabis for Chronic Headaches in Adolescents: the CAN-CHA Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adolescents aged between 14-17 years at screening
- Diagnosed with Chronic Migraine: headaches occurring 15 or more days per month for over 3 months, with at least 8 days per month showing migraine features
- Failed at least two treatment options due to safety or effectiveness, including medications like antidepressants, magnesium, gabapentinoids, topiramate, or non-drug therapies
- Females who have started menstruating must have a negative pregnancy test at screening
- Willing to participate in psychology and physiotherapy during the trial
You will not qualify if you...
- Considered unsuitable by the investigator due to personal or medical reasons affecting study completion
- History of post-concussion headache or new daily persistent headache
- Diagnosis of medication overuse headache
- Presence of cardiac, kidney, or liver disease
- Diagnosis of complex regional pain syndrome-II
- Abnormal ECG results at baseline
- Use of opioids, antipsychotics, antimanic drugs, barbiturates, benzodiazepines, muscle relaxants, sedatives, or tramadol
- Developmental delay or impairments such as autism, cerebral palsy, or intellectual disability
- Personal or family history of schizophrenia or psychotic disorders
- Pregnant, breastfeeding, or planning pregnancy during or shortly after the study
- Unable to commit to contraception, avoiding recreational cannabis, and refraining from driving during the study
- Known allergy to cannabinoids or palm/coconut oil
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 3 locations
1
University of British Columbia
Vancouver, British Columbia, Canada, V6T1Z4
Not Yet Recruiting
2
Dalhousie University-
Halifax, Nova Scotia, Canada, B3K 6R8
Not Yet Recruiting
3
North Toronto Neurology
Toronto, Ontario, Canada
Actively Recruiting
Research Team
L
Lauren E Kelly, PhD
CONTACT
L
Lauren Kelly
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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