Mechanistic Studies of Psilocybin in Headache Disorders

Description

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.

Conditions

Migraine

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Study Overview

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Study Details

Study overview

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.

Mechanistic Studies of Psilocybin in Headache Disorders

Mechanistic Studies of Psilocybin in Headache Disorders

Condition
Migraine
Intervention / Treatment

-

Contacts and Locations

West Haven

VA Connecticut Healthcare System, West Haven, Connecticut, United States, 06516

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * 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
  • * 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
  • * Use of cannabis or other THC products in the prior 2 weeks
  • * Urine toxicology positive to drugs of abuse
  • * The use of triptans (e.g., sumatriptan) or ditans (e.g., lasmiditan) more than twice weekly on average
  • * Use of serotonergic preventive therapies (i.e., taken chronically; amitriptyline, fluoxetine, imipramine, cyproheptadine) in the past 6 weeks
  • * Use of preventive or transitional treatments that produce spikes and waning of symptom relief (e.g., botulinum toxin, calcitonin gene-related peptide system targeting antibodies, peripheral nerve or ganglion blocks, chiropractic manipulation)
  • * History of a bleeding disorder or are currently taking anticoagulants (e.g., warfarin, enoxaparin, dabigatran, apixaban).
  • * Use of non-steroidal anti-inflammatory drugs (NSAIDs; e.g., ibuprofen, naproxen) in the 7 days before PET scan and 7 days after PET scan.

Ages Eligible for Study

21 Years to 70 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

Yes

Collaborators and Investigators

Yale University,

Study Record Dates

2026-12-31