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Study of Psilocybin for Migraine Headaches

This study is investigating how psilocybin might help people with migraine headaches. Researchers previously saw that psilocybin reduced headache burden and now want to understand why. You could be eligible if you are between 21 and 70 years old and have migraines, or if you are a healthy volunteer. The study will compare synthetic psilocybin (10 mg) to a placebo (synthetic THC 2.5 mg). Researchers will measure changes in brain activity (using fMRI and PET scans) and other body markers before and after receiving the study drug. The main goals are to see how psilocybin affects brain connections and a specific brain protein (SV2A) up to 6 months after the first scan. The study plans to enroll 50 participants, but its current status is unclear.

Study design
This is an interventional study planning to enroll 50 participants. It compares synthetic psilocybin to a placebo.
What's involved
Participants will undergo brain scans (PET and MRI), and have measurements taken for inflammation, circadian rhythm, and sleep before and one week after receiving the study drug.
Compensation
Not stated in the trial record.
Follow-up
Participants will be assessed for changes in brain activity (SV2A PET and RSFC) for up to 6 months after the first scan.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06464367

Mechanistic Studies of Psilocybin in Headache Disorders

Recruiting
EARLY_PHASE1Ages 21–70Interventional
Yale University
~50 participants
Updated 2026-07-13 on ClinicalTrials.gov
What's tested:PsilocybinPlacebo

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Baseline SV2A PET
Measured over from date of randomization until the date of first PET scan, assessed up to 6 months
+3 more outcomes measured

Conditions

Migraine

Explore related trials

Healthy ControlMigraine

Where it's being run

1 sites across 1 states
Connecticut1

Who to contact

Erik Zorrilla, PhD
[email protected]
203-932-5711 · ext. 14335
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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.

What this trial measures

  • Baseline SV2A PETfrom date of randomization until the date of first PET scan, assessed up to 6 months

    Comparing initial SV2A PET between migraine and HC

  • Baseline RSFCfrom date of randomization until the date of first MRI, assessed up to 6 months

    Comparing initial RSFC between migraine and HC

  • Change in SV2A PET after drug administrationfrom date of first PET scan to the date of second PET scan, assessed up to 6 months

    Comparing change in SV2A PET after drug between psilocybin/THC and migraine/HC

  • Change in resting state functional connectivity (RSFC) after drug administrationfrom date of first MRI to the date of second MRI, assessed up to 6 months

    Comparing change in RSFC after drug between psilocybin/THC and migraine/HC