Mechanistic Studies of Psilocybin in Headache Disorders

Launched by YALE UNIVERSITY · Jun 12, 2024

Keywords

ClinConnect Summary

This clinical trial is exploring how psilocybin, a naturally occurring compound found in certain mushrooms, may help reduce migraine headaches. Previous studies have shown that some people experienced fewer headaches after taking psilocybin, and this research aims to understand why that happens. Researchers will look at various factors, including brain activity, inflammation, sleep patterns, and other health markers, by comparing migraine sufferers with healthy participants.

To be eligible for this study, participants need to be between 21 and 70 years old and either have migraines or be healthy controls. Certain health conditions and recent use of specific medications or substances may prevent someone from joining the trial. Participants can expect to undergo brain scans and other assessments before and after receiving either psilocybin or a control treatment. This study is currently looking for volunteers, and if you or someone you know is interested, it could be a valuable opportunity to contribute to understanding migraine treatment.

Gender

ALL

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.