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

Launched by UNIVERSITY OF MANITOBA · Apr 14, 2022

Keywords

ClinConnect Summary

The CAN-CHA Trial is a clinical study looking at how a cannabis product, specifically Cannabidiol-enriched Cannabis Herbal Extract, can help adolescents aged 14 to 17 who suffer from chronic migraines. Chronic migraines are headaches that occur frequently and can significantly impact daily life. This study aims to see how well the product is tolerated by participants, meaning they will closely monitor any side effects or problems that may arise during treatment. The trial will last for about five months, including a month of assessments before starting the treatment, followed by four months of gradually increasing doses, and a period for tapering off the treatment.

To be eligible for this study, participants must be between 14 and 17 years old, have been diagnosed with chronic migraines for at least three months, and have not found relief from other treatments like certain medications. It's important for participants to be open to working with medical professionals, including psychologists and physiotherapists, throughout the trial. Participants will need to commit to not using recreational cannabis or driving during the study. This trial is currently recruiting, and it provides an opportunity for adolescents with chronic migraines to explore a new treatment option.

Gender

ALL

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