Cannabis for Chronic Headaches in Adolescents: the CAN-CHA Trial (NCT05337033) | Clinical Trial Compass
RecruitingPhase 2
Cannabis for Chronic Headaches in Adolescents: the CAN-CHA Trial
Canada20 participantsStarted 2024-10-11
Plain-language 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 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.
Who can participate
Age range
14 Years – 17 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion 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 criteria
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Cannabis-related adverse events
Timeframe: Reported daily through study completion, an average of 6 months
. 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.