Mechanistic Studies of Psilocybin in Headache Disorders

ConditionMigraine
Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age21-70
SponsorYale University

About this trial

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.

Eligibility criteria

Qualifiers

Age 21 to 70 (inclusive)

Migraine disease per ICHD-3 criteria (for migraine participants) OR Healthy control patient

Unstable medical condition or serious nervous system pathology

Pregnant, breastfeeding, lack of adequate birth control

Disqualifiers

None

Trial design

Treatments tested in this trial

  • Psilocybin
  • Placebo

Treatment groups

50 Participants
are divided into 4 treatment groups

Sponsors and collaborators

Yale University

Lead sponsor

The Wallace Foundation

Collaborator