NCT05337033 Cannabis for Chronic Headaches in Adolescents: the CAN-CHA Trial
| NCT ID | NCT05337033 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | University of Manitoba |
| Condition | Chronic Migraine |
| Study Type | INTERVENTIONAL |
| Enrollment | 20 participants |
| Start Date | 2024-10-11 |
| Primary Completion | 2025-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 20 participants in total. It began in 2024-10-11 with a primary completion date of 2025-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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.
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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. 9. Participants with a personal or family history of schizophrenia or psychotic disorders 10. 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 11. Participants who cannot commit to using contraception and refraining from recreational cannabis use and driving throughout the study period 12. Participants with known allergy to cannabinoids and/or palm/coconut oil
Contact & Investigator
Lauren E Kelly, PhD
PRINCIPAL INVESTIGATOR
University of Manitoba
Frequently Asked Questions
Who can join the NCT05337033 clinical trial?
This trial is open to participants of all sexes, aged 14 Years or older, up to 17 Years, studying Chronic Migraine. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05337033 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT05337033 currently recruiting?
Yes, NCT05337033 is actively recruiting participants. Contact the research team at lauren.kelly@umanitoba.ca for enrollment information.
Where is the NCT05337033 trial being conducted?
This trial is being conducted at Vancouver, Canada, Halifax, Canada, Toronto, Canada.
Who is sponsoring the NCT05337033 clinical trial?
NCT05337033 is sponsored by University of Manitoba. The principal investigator is Lauren E Kelly, PhD at University of Manitoba. The trial plans to enroll 20 participants.
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