Using cannabis to treat chronic headaches in teenagers

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This trial investigates the use of Cannabidiol-enriched Cannabis Herbal Extract for managing chronic migraines in adolescents aged 14 to 17. Conducted across three Canadian centers, the study involves a one-month baseline assessment followed by four months of escalating treatment doses and a weaning period. The primary focus is on the tolerability of the treatment, measured by the number and severity of reported adverse events. Participants will also engage with psychological and physiotherapy support throughout the trial.

Why it matters

Who can join: the full rules

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

Where it's running

• North Toronto Neurology
  Toronto, Ontario, Canada Recruiting
• University of British Columbia
  Vancouver, British Columbia, Canada Not yet recruiting
• Dalhousie University-
  Halifax, Nova Scotia, Canada Not yet recruiting

Study contacts

• Principal investigator: Lauren E Kelly, PhD — University of Manitoba
• Study coordinator: Lauren E Kelly, PhD
• Email: lauren.kelly@umanitoba.ca
• Phone: 2042723149

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.