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RecruitingEarly Phase 1

Mechanistic Studies of Psilocybin in Headache Disorders

NCT06464367 · Yale University

Recruiting
Status
Accepting participants
Early Phase 1
Phase
50
Target enrolment
1
Study sites
1 US states

What it is testing

Summary

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.

Summary as written by the trial’s own sponsor and published on ClinicalTrials.gov API v2. It is the sponsor’s description, reproduced unedited, not an assessment by this site.

What counts as success

Primary outcome measures

  • Baseline SV2A PET

    Measured over from date of randomization until the date of first PET scan, assessed up to 6 months

  • Baseline RSFC

    Measured over from date of randomization until the date of first MRI, assessed up to 6 months

  • Change in SV2A PET after drug administration

    Measured over from date of first PET scan to the date of second PET scan, assessed up to 6 months

  • Change in resting state functional connectivity (RSFC) after drug administration

    Measured over from date of first MRI to the date of second MRI, assessed up to 6 months

A trial succeeds or fails on its primary outcome, declared in advance. Everything else it reports is secondary by definition.

Who can take part

Eligibility, as published

21 Years to 70 Years
Ages
All
Sex
Accepted
Healthy volunteers
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.

Where

1 study site

FacilityCityRegionCountry
VA Connecticut Healthcare SystemWest HavenConnecticutUnited States

On the registry

Contact the trial directly

This site does not enrol anyone and is not involved in this trial. To ask about taking part, use the sponsor’s own contact details on the official registry record, which is also where the most current version of everything above lives.

Before you do, the preparation checklist lists what a site will ask you on a first call and what is worth asking them. It is free and collects nothing.

NCT06464367 on ClinicalTrials.gov →

Last updated in the registry 2026-07-13. Registry records change; this page reflects the data build of 2026-08-25.

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Where this trial sits

Substance

Indication

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