Cannabis for Chronic Headaches in Adolescents: the CAN-CHA Trial
Eligible age
14–17 yrs
Accepts
All genders
Locations
0 states
Healthy volunteers
No
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About this study
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.
Sponsor: University of Manitoba
You may qualify if…
- ✓ To be eligible to participate in this study, an individual must meet all of the following criteria:
- ✓ 1. Adolescents aged between 14-17 years of age at the time of screening.
- ✓ 2. 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. \[121\]
- ✓ 3. 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.
- ✓ 4. Females who have reached menarche should have a negative pregnancy test during screening.
- ✓ 5. Must be willing to engage with psychology and physiotherapy throughout the trial as appropriate.
You may not qualify if…
- ✕ 1. 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
- ✕ 2. Participants with a history of post-concussion headache or new daily persistent headache
- ✕ 3. Participants with a diagnosis of medication overuse headache
- ✕ 4. Participants with cardiac, renal or hepatic disease (assessed by the site investigator)
- ✕ 5. Participants with complex regional pain syndrome-II
- ✕ 6. Participants with abnormal ECG findings at baseline (as determined by the investigator)
- ✕ 7. Participants who are on the following medications: opioids, antipsychotics, antimanic, barbiturates, benzodiazepines, muscle relaxants, sedatives, or tramadol.
- ✕ 8. Participants with developmental delay or impairments including autism, cerebral palsy or intellectual disability.
Source: ClinicalTrials.gov · NCT05337033 · last updated 2025-05-29