NCT06464367RecruitingEarly phase 1
Mechanistic Studies of Psilocybin in Headache Disorders
Source: ClinicalTrials.gov · Last updated 13 Jul 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Early phase 1
- Study type
- Interventional
- Enrollment
- 50 (estimated)
- First submitted
- 8 Jun 2024
- Start date
- 19 May 2025
- Primary completion date
- 31 Dec 2027
- Lead sponsor
- Yale University
- Diseases
- Migraine
- NCT number
- NCT06464367
What you commit to
- Study type: Interventional · Early phase 1
- Planned participants: 50
- From 19 May 2025 to the primary completion date, 31 Dec 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Who the study is looking for
- 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.
Age in the registry: 21 years to 70 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| VA Connecticut Healthcare System Coordinator of this site? Confirm its status | West Haven | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.