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Recruiting NCT06464367

Mechanistic Studies of Psilocybin in Headache Disorders

Early Phase I Interventional Migraine

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Psilocybin, Placebo.
Who it may be relevant to
Registry conditions: Migraine. Basic parameters: 21 years — 70 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Overview

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.

Interventions

  • Drug Psilocybin
    synthetic psilocybin 10 mg (oral)
  • Drug Placebo
    synthetic THC 2.5 mg (oral)

Primary outcome measures

  • Baseline SV2A PET [Time frame: from date of randomization until the date of first PET scan, assessed up to 6 months]
  • Baseline RSFC [Time frame: from date of randomization until the date of first MRI, assessed up to 6 months]
  • Change in SV2A PET after drug administration [Time frame: from date of first PET scan to the date of second PET scan, assessed up to 6 months]
  • Change in resting state functional connectivity (RSFC) after drug administration [Time frame: from date of first MRI to the date of second MRI, assessed up to 6 months]
Secondary outcome measures (12)
  • Change in TNF-alpha [Time frame: from screening to 7 days after drug administration]
  • Change in IL-1beta [Time frame: from screening to 7 days after drug administration]
  • Change in IL-6 [Time frame: from screening to 7 days after drug administration]
  • Change in calcitonin gene-related peptide (CGRP) [Time frame: from screening to 7 days after drug administration]
  • Change in pituitary adenylate cyclase activating polypeptide (PACAP) [Time frame: from screening to 7 days after drug administration]
  • Change in bedtime (via actigraphy) [Time frame: from screening through 14 days after drug administration]
  • Change in get-up time (via actigraphy) [Time frame: from screening through 14 days after drug administration]
  • Change in daily active period (via actigraphy) [Time frame: from screening through 14 days after drug administration]
  • Change in daily rest period (via actigraphy) [Time frame: from screening through 14 days after drug administration]
  • Change in REM latency (via sleep electroencephalography) [Time frame: from screening to 7 days after drug administration]
  • Change in percent REM (via sleep electroencephalography) [Time frame: from screening to 7 days after drug administration]
  • Change in sleep efficiency (via sleep electroencephalography) [Time frame: from screening to 7 days after drug administration]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Other

Study locations

United States · 1 center
  • VA Connecticut Healthcare System — West Haven

Identifiers

NCT: NCT06464367 · 2000034634 · ES0006

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗