Thinking of joining a study?

Register your interest

Become a volunteer?

NCT06464367 | RECRUITING | Migraine

Mechanistic Studies of Psilocybin in Headache Disorders
Sponsor:

Yale University

Information provided by (Responsible Party):

Emmanuelle Schindler

Brief 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.

Condition or disease

Migraine

Intervention/treatment

Psilocybin

Placebo

Phase

EARLY_PHASE1

Study Type : INTERVENTIONAL
Estimated Enrollment : 50 participants
Masking : QUADRUPLE
Primary Purpose : OTHER
Official Title : Mechanistic Studies of Psilocybin in Headache Disorders
Actual Study Start Date : 2025-05-19
Estimated Primary Completion Date : 2026-12-31
Estimated Study Completion Date : 2026-12-31

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 21 Years to 70 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: 1
Criteria
Inclusion criteria
  • * 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.
Mechanistic Studies of Psilocybin in Headache Disorders

Location Details

NCT06464367

Please Choose a site

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

United States, Connecticut

VA Connecticut Healthcare System

West Haven, Connecticut, United States, 06516