NCT03972124

Cannabis for the Prophylactic Treatment of Migraine

Cannabis for the Prophylactic Treatment of Migraine: a Randomized Double-Blind Placebo-Controlled Clinical Trial

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: University of Calgary · Academic / Other
• Sex: All
• Age: 25 Years
• Healthy volunteers: Not accepted

Summary

This study will evaluate the efficacy and safety of cannabis for the treatment of chronic migraine headaches. Study subjects will be randomized to one of three groups: lower dose CBD, higher dose CBD or placebo.

Detailed description

Migraine is a neurological disorder characterized by recurrent attacks of moderate to severe headache, often accompanied by sensory sensitivity and nausea. Migraine can be very disabling and often interferes with social and occupational functioning. Given the high prevalence of migraine and the significant burden it places on the individual and society, it is an important condition to study and manage optimally. This is especially true because current migraine treatments often result in only marginal improvement and are frequently associated with intolerable side effects. For this reason, there is a need for new migraine treatments. The endocannabinoid system is an important potential treatment target as it is involved in pain processing and overlaps with some mechanisms of migraine pathophysiology. Cannabis was legalized in Canada on October 17th, 2018. As a result, the consumption of cannabis products for migraine treatment may increase. However, at this time there is limited evidence for the safety and efficacy of cannabis for the treatment of migraine. As a result, there is a need for further study and research in this area. Thus, we propose a randomized, double-blind, placebo-controlled clinical trial to study cannabis (specifically cannabidiol) as a preventative therapy for patients with chronic migraine.

Conditions

• Chronic Migraine

Interventions

Type	Name	Description
DRUG	CBD 100 mg OD	CBD oil - purified to \<1% THC in soft-gel capsules
DRUG	CBD 200 mg OD	CBD oil - purified to \<1% THC in soft-gel capsules
DRUG	Placebo	Soft-gel capsules containing placebo

Timeline

• Start date: 2024-06-01
• Primary completion: 2026-06-01
• Completion: 2026-06-01
• First posted: 2019-06-03
• Last updated: 2023-05-16