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NCT06464367 · ClinicalTrials.gov registry record · Early Phase 1
Mechanistic Studies of Psilocybin in Headache Disorders
A Early Phase 1 study of Migraine, sponsored by Yale University.
- Recruiting
- Registry status
- Early Phase 1
- Development phase
- 50
- Enrollment target
- 1
- Study location
NCT06464367: Recruiting Early Phase 1 study of Migraine, sponsored by Yale University.
NCT06464367 is a Early Phase 1 study of Migraine that is actively recruiting participants, run by Yale University. The registered enrollment target is 50 participants, below the 358-participant average among 102 other Migraine trials with a reported enrollment target (86% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06464367, a Early Phase 1 study of Migraine, is actively recruiting participants, sponsored by Yale University.
- RECRUITING
- Registry status
- Early Phase 1
- Development phase
- 50 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
Comparing initial SV2A PET between migraine and HC
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Psilocybin
Study Locations (1)
Connecticut
- VA Connecticut Healthcare System - West Haven
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 50 participants |
| Start Date | 2025-05-19 |
| Est. Completion | 2026-12-31 |
| Phase | Early Phase 1 |
What NCT06464367 shows while recruiting
NCT06464367 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 50 participants, a relatively small participant target, below the 358-participant average among 102 other Migraine trials with a reported enrollment target (86% lower).
The record links to 1 condition, with Migraine appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT06464367 reports a single indexed study location in Connecticut.
Frequently Asked Questions
What is clinical trial NCT06464367 about?
NCT06464367 is a clinical study titled "Mechanistic Studies of Psilocybin in Headache Disorders". 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), centr...
What is the current status of trial NCT06464367?
This trial is currently recruiting. It is a Early Phase 1 study. The enrollment target is 50 participants. The study started on 2025-05-19. Estimated completion is 2026-12-31.
What conditions does trial NCT06464367 study?
This clinical trial studies the following conditions: Migraine.
What interventions are being tested in trial NCT06464367?
The interventions under investigation include: Placebo (DRUG), Psilocybin (DRUG).
Who is sponsoring clinical trial NCT06464367?
This trial is sponsored by Yale University, which has 1,492 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06464367 being conducted?
This trial has 1 study location across Connecticut. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Migraine
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06464367's enrollment target sits among peer trials
50 82nd of 102 higher than 19 of 102 other Migraine trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Migraine trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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