Plain-English translation of NCT05337033 on ClinicalTrials.gov ↗ · Source last updated · Translation generated · How we translate trials
Phase 2 — Testing in a bigger group (up to a few hundred people) to see if the treatment actually works and is still safe.
This trial is testing a medication called Cannabidiol-enriched Cannabis Herbal Extract (CBD50 plus) to see if it can help teenagers with chronic headaches that occur 15 or more days per month. The study is small (only 20 participants across three Canadian centers) and is designed primarily to check how well teenagers tolerate the medication and what side effects they experience. Researchers want to understand whether this treatment could be a helpful option for young people whose chronic headaches haven't improved with other treatments they've already tried.
Chronic headaches are a major source of disability for teenagers, and many young people don't get relief from standard treatments like antidepressants or supplements. Cannabis products have shown promise in helping adults manage headaches, but there is very little research on whether the medication is safe and tolerable in teenagers, which is why this study is needed.
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If you enroll, you would first have a one-month baseline period where researchers assess your current headaches without treatment. Then you would take gradually increasing doses of the medication over four months while attending visits at one of three Canadian centers to report how you're feeling and any side effects you experience. Finally, there would be a gradual weaning-off period where your dose is slowly decreased. Throughout the study, you'd also participate in psychology and physiotherapy as appropriate, and researchers would closely monitor your tolerability to the treatment.
AI-generated summary from trial data · Jun 1, 2026 · Not medical advice
Canada