Overview

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

Inclusion Criteria:

        To be eligible to participate in this study, an individual must meet all of the following
        criteria:
          1. Adolescents between 14-17 years of age at the time of screening
          2. Diagnosed with chronic migraine for more than three months
          3. Failed other treatment options on the grounds of safety (tolerability) or efficacy,
             including but not limited to antidepressants (tricyclic antidepressant or selective
             norepinephrine reuptake inhibitor), gabapentinoids or topiramate.
          4. Females who have reached menarche should have a negative serum pregnancy test during
             screening.
          5. Must be willing to engage with psychology and physiotherapy throughout the trial
        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