Tests psilocybin's effects on brain and sleep in people with migraine
Tests psilocybin against a placebo in adults with migraine and healthy volunteers.
Key facts
- Who runs it
- Yale University
- Where
- West Haven, United StatesSee the site
- Trial code
- Registry title
- Mechanistic Studies of Psilocybin in Headache Disorders
- Status
- Recruiting
- Phase
- Early phase 1
- People taking part
- 50 people, planned
- Started
- 19 May 2025
- Expected to end
- 31 Dec 2027
- Type of study
- Interventional, 4 groupsOne group gets a placebo (a dummy treatment), for comparison.
- Treatments tested
- Psilocybin
- Placebo
- Record updated
- 13 July 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with migraine and healthy adults without migraine. It studies how psilocybin may change the brain, inflammation, sleep and daily rhythm.
- Age
- 21 to 70 years
- Sex
- All sexes can join.
- Disease stage
- Migraine disease as defined by the ICHD-3 criteria (for the migraine group). Healthy volunteers can also join as a control group.
- Earlier treatment
- Cannot join if: classic psychedelics (psilocybin, LSD, mescaline) in the past 6 months; cannabis or THC products in the past 2 weeks; serotonergic preventive therapies in the past 6 weeks; triptans or ditans more than twice weekly on average.
Main reasons for not taking part
- Unstable medical condition or serious nervous system disease
- Pregnant, breastfeeding, or not using adequate birth control
- Psychotic or manic disorder
- Substance abuse in the past 3 months, or a urine drug test positive for drugs of abuse
- Bleeding disorder or taking anticoagulants
The registry criteria, word for word
Show all 14 criteriaShow less
Who can take part
- 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
Check if you might fit
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 21 and 70 years old?
Where in United States
- VA Connecticut Healthcare SystemWest Haven, United StatesContact: Erik Zorrilla, PhDTaking people
About the trial
What the trial wants to find out
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.
The 4 groups in the trial
- Migraine psilocybinTreatment being tested
Migraine participants randomized to receive 10 mg psilocybin (oral)
Treatment: Psilocybin
- Migraine placeboPlacebo, for comparison
Migraine participants randomized to receive 2.5 mg THC (oral)
Treatment: Placebo
- Healthy control psilocybinTreatment being tested
Healthy control participants randomized to receive 10 mg psilocybin (oral)
Treatment: Psilocybin
- Healthy control placeboPlacebo, for comparison
Healthy control participants randomized to receive 2.5 mg THC
Treatment: Placebo
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Mechanistic Studies of Psilocybin in Headache Disorders
- Plain-language title
- Tests psilocybin's effects on brain and sleep in people with migraineGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Fit questions
- Built from NCT06464367, who can take part
- Record updated
- 13 July 2026