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RecruitingEarly Phase 1

Mechanistic Studies of Psilocybin in Headache Disorders

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
21 Years to 70 Years
Sex
All sexes
Healthy volunteers
Accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study looks at why psilocybin may reduce headaches over time. Adults with migraine and healthy adults will get psilocybin or another drug used for comparison. Researchers will measure brain activity, brain cell connections, inflammation, daily body rhythms, and sleep before treatment and one week after.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Age 21 to 70.
  • Have migraine that meets standard diagnosis rules, or be a healthy adult.

Who can't join

  • An unstable health condition or serious disease of the brain or nerves.
  • Pregnant, breastfeeding, or not using enough birth control to prevent pregnancy.
  • A disorder involving psychosis (trouble knowing what is real) or mania (extreme high energy or mood).
  • Substance abuse in the past 3 months, psychedelic drug use in the past 6 months, cannabis or THC use in the past 2 weeks, or a positive urine test for drugs of abuse.
  • Use of triptans or ditans, such as sumatriptan or lasmiditan, for headaches more than twice a week on average.
  • Use of daily preventive drugs that affect serotonin in the past 6 weeks, such as amitriptyline or fluoxetine. Also excluded are treatments with relief that rises and fades, such as Botox, CGRP antibody drugs, nerve blocks, or chiropractic adjustments.
  • A history of a bleeding disorder, or current use of blood thinners such as warfarin or apixaban.
  • Use of anti-inflammatory pain drugs, such as ibuprofen or naproxen, in the 7 days before or 7 days after the PET brain scan.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility 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.

Study sites (1)

CT