Cannabis for Chronic Headaches in Adolescents: the CAN-CHA Trial
Recruiting · NCT05337033 · Interventional (participants receive a specific treatment) · Lead sponsor: University of Manitoba
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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 take part
Inclusion criteria
- To be eligible to participate in this study, an individual must meet all of the following 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
- 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.
- Participants with a personal or family history of schizophrenia or psychotic disorders
- 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
- Participants who cannot commit to using contraception and refraining from recreational cannabis use and driving throughout the study period
- Participants with known allergy to cannabinoids and/or palm/coconut oil
Where it is running
3 locations listed.
- University of British Columbia - Vancouver, British Columbia, Canada
- Dalhousie University- - Halifax, Nova Scotia, Canada
- North Toronto Neurology - Toronto, Ontario, Canada