Mechanistic Studies of Psilocybin in Headache Disorders
Recruiting · NCT06464367 · Interventional (participants receive a specific treatment) · Lead sponsor: Yale University
View the official record on ClinicalTrials.gov →Interventions studied
PlaceboPsilocybin
What this trial is about
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.
Who can take part
Age range
21 Years to 70 Years
Sex
All (male and female)
Healthy volunteers
Yes - healthy volunteers may be accepted
Phase
Early Phase 1
Study type
Interventional (participants receive a specific treatment)
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.
Where it is running
1 location listed across 1 US state.
- VA Connecticut Healthcare System - West Haven, Connecticut, United States