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Mechanistic Studies of Psilocybin in Headache Disorders
Sponsor: Yale University
Summary
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.
Key Details
Gender
All
Age Range
21 Years - 70 Years
Study Type
INTERVENTIONAL
Enrollment
50
Start Date
2025-05-19
Completion Date
2026-12-31
Last Updated
2025-07-24
Healthy Volunteers
Yes
Conditions
Interventions
Psilocybin
synthetic psilocybin 10 mg (oral)
Placebo
synthetic THC 2.5 mg (oral)
Locations (1)
VA Connecticut Healthcare System
West Haven, Connecticut, United States