Mechanistic Studies of Psilocybin in Headache Disorders
Eligible age
21–70 yrs
Accepts
All genders
Locations
1 state
Healthy volunteers
Yes
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About this study
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.
Sponsor: Yale University
You may qualify if…
- ✓ Age 21 to 70 (inclusive)
- ✓ Migraine disease per ICHD-3 criteria (for migraine participants) OR Healthy control patient
- ✓ Exclusion criterion
- ✓ Unstable medical condition or serious nervous system pathology
- ✓ Pregnant, breastfeeding, lack of adequate birth control
- ✓ Psychotic or manic disorder
- ✓ Substance abuse in the prior 3 months
- ✓ Use of classic psychedelics (e.g., psilocybin, LSD, mescaline) in the past 6 months
Where it's recruiting
West Haven
Source: ClinicalTrials.gov · NCT06464367 · last updated 2025-07-24