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RecruitingAccepts healthy volunteersEarly Phase 1

Mechanistic Studies of Psilocybin in Headache Disorders

Yale University · with The Wallace Foundation · NCT06464367

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 21–70 · All sexes
Healthy volunteers
Accepted
Study type
Interventional · Early Phase 1
Target enrollment
50
US sites recruiting
1
Study start
May 19, 2025
Record last updated
July 13, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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.

Being studied: Psilocybin; Placebo

Conditions: Migraine

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full criteria

Inclusion criteria

  • 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
  • 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.

Recruiting US locations

  • VA Connecticut Healthcare System

    West Haven, CT 06516

    Site contact: Erik Zorrilla, PhD · 203-932-5711 · erik.zorrilla@yale.edu

Study contacts (from the official record)

  • Erik Zorrilla, PhD · 203-932-5711 · erik.zorrilla@yale.edu
  • Emmanuelle Schindler, MD, PhD · 203-932-5711 · emmanuelle.schindler@yale.edu
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Mechanistic Studies of Psilocybin in Headache Disorders (NCT06464367) | Bored Studies