Cannabis for Chronic Headaches in Adolescents: the CAN-CHA Trial

Trial details

Who runs it

University of Manitoba

Trial code

NCT05337033

Record updated

29 May 2025

Original description

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.Read full original descriptionShow less

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

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.

Inclusion: 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: Participants with a diagnosis of medication overuse headache; Participants who are on the following medications: opioids, antipsychotics, antimanic, barbiturates, benzodiazepines, muscle relaxants, sedatives, or tramadol; 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 cardiac, renal or hepatic disease (assessed by the site investigator); Participants with complex regional pain syndrome-II; Participants with a personal or family history of schizophrenia or psychotic disorders; Participants with known allergy to cannabinoids and/or palm/coconut oil; Participants with abnormal ECG findings at baseline (as determined by the investigator); Participants with developmental delay or impairments including autism, cerebral palsy or intellectual disability; 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.

ClinicalTrials.gov NCT05337033