Using cannabis to treat chronic headaches in teenagers

A Multi-Centre, Tolerability Study of a Cannabidiol-enriched Cannabis Herbal Extract for Chronic Headaches in Adolescents: the CAN-CHA Trial

This study is testing if a special cannabis extract can help teenagers aged 14 to 17 with chronic headaches feel better and manage their pain.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 20 (estimated)
• Ages: 14 Years to 17 Years
• Sex: All
• Sponsor: University of Manitoba (Academic / other)
• Locations: 3 sites (Vancouver, British Columbia and 2 other locations)
• Trial ID: NCT05337033 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are adolescents aged 14 to 17 with a diagnosis of chronic migraine who have failed at least two previous treatment options.

Not a fit: Patients who have not been diagnosed with chronic migraines or those who have not failed previous treatments may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new option for adolescents suffering from chronic migraines who have not responded to traditional therapies.

How similar studies have performed: While cannabis has shown promise in managing headaches in adults, this specific approach in adolescents is relatively novel and has not been extensively tested.

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

Where this trial is running

Vancouver, British Columbia and 2 other locations

• University of British Columbia — Vancouver, British Columbia, Canada (Not_yet_recruiting)
• Dalhousie University- — Halifax, Nova Scotia, Canada (Not_yet_recruiting)
• North Toronto Neurology — Toronto, Ontario, Canada (Recruiting)

Study contacts

• Principal investigator: Lauren E Kelly, PhD — University of Manitoba
• Study coordinator: Lauren E Kelly, PhD

Conditions Chronic Migraine; Adolescents; Children; Cannabis; Migraine; Cannabidiol; Tetrahydrocannbinol