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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 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.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06464367
The ClinicalTrials.gov registry entry for NCT06464367 describes a study currently listed as recruiting, categorized as Early Phase 1. The registered enrollment target is 50 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 358-participant average among 102 other Migraine trials with a reported enrollment target (86% lower). The listed sponsor is Yale University, which has 1,492 total studies on file at ClinicalTrials.gov.
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 1 study location spanning 1 distinct geographic area - top geographies include 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.
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Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.