Status:
RECRUITING
Cannabis for Chronic Headaches in Adolescents: the CAN-CHA Trial
Lead Sponsor:
University of Manitoba
Collaborating Sponsors:
SickKids Foundation
Conditions:
Chronic Migraine
Eligibility:
All Genders
14-17 years
Phase:
PHASE2
Brief Summary
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 ...
Eligibility Criteria
Inclusion
- To be eligible to participate in this study, an individual must meet all of the following criteria:
- Adolescents aged between 14-17 years of age at the time of screening.
- Diagnosed with Chronic Migraine according to ICHD-3: headache (migraine-like or tension-type like) occurring on 15 or more days per month for more than 3 months which on at least 8 days per month have features of migraine headache. \[121\]
- Failed at least two treatment options on the grounds of safety (tolerability) and/or efficacy, including but not limited to antidepressant (tricyclic antidepressant or selective norepinephrine reuptake inhibitor), magnesium, gabapentinoids topiramate and/or non-pharmacological therapies.
- Females who have reached menarche should have a negative pregnancy test during screening.
- Must be willing to engage with psychology and physiotherapy throughout the trial as appropriate.
Exclusion
- As per the investigator judgement, the participant is not an ideal candidate due to a personal issue or medical condition that is likely to impede in the successful completion of the study
- Participants with a history of post-concussion headache or new daily persistent headache
- Participants with a diagnosis of medication overuse headache
- Participants with cardiac, renal or hepatic disease (assessed by the site investigator)
- Participants with complex regional pain syndrome-II
- Participants with abnormal ECG findings at baseline (as determined by the investigator)
- Participants who are on the following medications: opioids, antipsychotics, antimanic, barbiturates, benzodiazepines, muscle relaxants, sedatives, or tramadol.
- Participants with developmental delay or impairments including autism, cerebral palsy or intellectual disability.
- Participants with a personal or family history of schizophrenia or psychotic disorders
- Participants who are pregnant or breast/chest-feeding or plans to become pregnant within the study period or within three months of interventional product discontinuation
- Participants who cannot commit to using contraception and refraining from recreational cannabis use and driving throughout the study period
- Participants with known allergy to cannabinoids and/or palm/coconut oil
Key Trial Info
Start Date :
October 11 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2025
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT05337033
Start Date
October 11 2024
End Date
December 31 2025
Last Update
May 29 2025
Active Locations (3)
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1
University of British Columbia
Vancouver, British Columbia, Canada, V6T1Z4
2
Dalhousie University-
Halifax, Nova Scotia, Canada, B3K 6R8
3
North Toronto Neurology
Toronto, Ontario, Canada