RECRUITING

Mechanistic Studies of Psilocybin in Headache Disorders

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Mechanistic Studies of Psilocybin in Headache Disorders

Quick Facts

Study Start:2024-12-01
Study Completion:2026-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06464367

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:21 Years to 70 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Age 21 to 70 (inclusive)
  2. * Migraine disease per ICHD-3 criteria (for migraine participants) OR Healthy control patient
  3. * Unstable medical condition or serious nervous system pathology
  4. * Pregnant, breastfeeding, lack of adequate birth control
  5. * Psychotic or manic disorder
  6. * Substance abuse in the prior 3 months
  7. * Use of classic psychedelics (e.g., psilocybin, LSD, mescaline) in the past 6 months
  8. * Use of cannabis or other THC products in the prior 2 weeks
  9. * Urine toxicology positive to drugs of abuse
  10. * The use of triptans (e.g., sumatriptan) or ditans (e.g., lasmiditan) more than twice weekly on average
  11. * Use of serotonergic preventive therapies (i.e., taken chronically; amitriptyline, fluoxetine, imipramine, cyproheptadine) in the past 6 weeks
  12. * 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)
  13. * History of a bleeding disorder or are currently taking anticoagulants (e.g., warfarin, enoxaparin, dabigatran, apixaban).
  14. * 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.
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Study Contact

Sarah Anthony, MSc
CONTACT
203-932-5711
sarah.anthony@yale.edu
Emmanuelle Schindler, MD, PhD
CONTACT
203-932-5711
emmanuelle.schindler@yale.edu

Study Locations (Sites)

VA Connecticut Healthcare System
West Haven, Connecticut, 06516
United States

Collaborators and Investigators

Sponsor: Yale University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-12-01
Study Completion Date2026-12-31

Study Record Updates

Study Start Date2024-12-01
Study Completion Date2026-12-31

Terms related to this study

Keywords Provided by Researchers

  • psilocybin
  • resting state functional connectivity
  • synaptic density
  • synaptic vessel glycoprotein 2A (SV2A)
  • circadian rhythm
  • sleep
  • inflammation

Additional Relevant MeSH Terms

  • Migraine