Actively Recruiting
Mechanistic Studies of Psilocybin in Headache Disorders
Led by Yale University · Updated on 2025-07-24
50
Participants Needed
1
Research Sites
84 weeks
Total Duration
On this page
Sponsors
Y
Yale University
Lead Sponsor
T
The Wallace Foundation
Collaborating Sponsor
AI-Summary
What this Trial 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.
CONDITIONS
Official Title
Mechanistic Studies of Psilocybin in Headache Disorders
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 21 to 70 years inclusive
- Diagnosis of migraine disease per ICHD-3 criteria for migraine participants or healthy control status
You will not qualify if you...
- Unstable medical condition or serious nervous system pathology
- Pregnant or breastfeeding, or lacking adequate birth control
- History of psychotic or manic disorder
- Substance abuse in the prior 3 months
- Use of classic psychedelics (psilocybin, LSD, mescaline) in the past 6 months
- Use of cannabis or other THC products in the prior 2 weeks
- Positive urine toxicology for drugs of abuse
- Use of triptans or ditans more than twice weekly on average
- Use of serotonergic preventive therapies chronically in past 6 weeks
- Use of preventive or transitional treatments causing symptom relief fluctuations
- History of bleeding disorder or current use of anticoagulants
- Use of NSAIDs within 7 days before and after PET scan
AI-Screening
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Trial Site Locations
Total: 1 location
1
VA Connecticut Healthcare System
West Haven, Connecticut, United States, 06516
Actively Recruiting
Research Team
S
Sarah Anthony, MSc
CONTACT
E
Emmanuelle Schindler, MD, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
OTHER
Number of Arms
4
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