Study of CBD-enriched Cannabis Oil to Treat Chronic Migraines in Teens Aged 14 to 17

What this Trial Is About

Chronic headaches significantly impact adolescents daily lives, and cannabis products have shown potential in managing headaches in adults. This trial evaluates a cannabidiol-enriched cannabis herbal extract in adolescents aged 14 to 17 years with chronic migraines. The study is a multisite, open-label, phase 2 tolerability study conducted across three Canadian centers, focusing on assessing the safety and tolerability of this treatment in young patients. Participants will receive a medical cannabis oil called CBD50 plus, containing 2 mgml delta-9-THC and 50 mgml CBD. The treatment lasts four months, starting with low doses of cannabidiol and gradually increasing monthly from 0.2-0.4 mgkgday to 0.8-1 mgkgday. After treatment, participants will follow a weekly dose reduction plan. The study includes a one-month baseline period before treatment begins. During the approximately six-month study, participants will report daily on headache frequency, duration, pain intensity, sleep hours, and cannabis-related adverse events. Monthly reports will assess sleep quality, mood, depression, anxiety, and goal attainment. Participants will engage with psychology and physiotherapy as appropriate. The main measure is the number and severity of adverse events related to cannabis use, monitored throughout the study.

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