Mechanistic Studies of Psilocybin in Headache Disorders
Yale University · with The Wallace Foundation · NCT06464367
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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