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RECRUITING
NCT06464367
EARLY_PHASE1

Mechanistic Studies of Psilocybin in Headache Disorders

Sponsor: Yale University

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

21 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

50

Start Date

2025-05-19

Completion Date

2026-12-31

Last Updated

2025-07-24

Healthy Volunteers

Yes

Conditions

Interventions

DRUG

Psilocybin

synthetic psilocybin 10 mg (oral)

DRUG

Placebo

synthetic THC 2.5 mg (oral)

Locations (1)

VA Connecticut Healthcare System

West Haven, Connecticut, United States