Mechanistic Studies of Psilocybin in Headache Disorders

This interventional trial (n=50) will explore the mechanisms of psilocybin in headache disorders, focusing on migraine sufferers and healthy controls.

Conducted by Yale University, the study aims to understand the effects of psilocybin on brain function and inflammation. Participants will be administered either 10 mg of psilocybin or a placebo, with brain imaging (fMRI and PET), actigraphy, and sleep EEG assessments before and after the drug administration. The study will also monitor changes in peripheral inflammation markers and circadian rhythms.

The primary goal is to investigate how psilocybin influences brain connectivity and inflammation in migraine patients compared to healthy controls. This research is expected to provide insights into the therapeutic potential of psilocybin for headache disorders.

Trial Details

In previous clinical trial work, the investigators observed lasting reductions in headache burden after limited dosing of psilocybin. This purpose of this study is to examine potential sources for this observed effect. This study will measure brain resting state functional connectivity (fMRI), central synaptic density (SV2A PET), peripheral markers of inflammation, circadian rhythm (actigraphy), and sleep (sleep EEG) in both migraine and healthy control participants before and one week after the administration of psilocybin or an active control agent.

NCT Number NCT06464367

Data attribution

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