Repeat Dosing of Psilocybin in Migraine Headache

  • STATUS
    Recruiting
  • End date
    Jul 15, 2024
  • participants needed
    24
  • sponsor
    Yale University
Updated on 7 October 2022
headache
triptan

Summary

In seeking to understand the capacity for psilocybin to reduce migraine headache burden, this study will investigate single and repeated dosing of psilocybin up to two doses. In seeking to identify an underlying mechanism in psilocybin's effects, neuroinflammatory markers for migraine headache will be measured.

Description

Migraine headache is a common medical condition and a top cause of disability worldwide. Treatment options for migraine headache are many and varied, though an approximated 10% of migraineurs is refractory to medication and thus, there is a need to develop alternative treatments. There is anecdotal evidence supporting lasting therapeutic effects after limited dosing of psilocybin and related compounds in headache disorders. The cause of this unique effect remains unknown, though the drug class has demonstrable anti-inflammatory activity, a biological process relevant to migraine and other headache disorders. In seeking to understand the capacity for psilocybin to reduce migraine headache burden, this study will investigate single and repeated dosing of psilocybin up to two doses. In seeking to identify an underlying mechanism in psilocybin's effects, neuroinflammatory markers for migraine headache will be measured. The results from this study will serve in the development of larger investigations seeking to understand the effects of psilocybin and related compounds in headache disorders.

Details
Condition Migraine Headache
Treatment Placebo, Psilocybin
Clinical Study IdentifierNCT04218539
SponsorYale University
Last Modified on7 October 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Diagnosis of migraine headache per ICHD-3 criteria
Typical pattern of migraine attacks with approximately two migraines or more weekly
Attacks are managed by means involving no more than twice weekly triptan use

Exclusion Criteria

Axis I psychotic or manic disorder (e.g., schizophrenia, bipolar I, depression with psychosis)
Axis I psychotic or manic disorder in first degree relative
Unstable medical condition; severe renal, cardiac, or hepatic disease; pacemaker; or serious central nervous system pathology
Pregnant, breastfeeding, lack of adequate birth control
History of intolerance to psilocybin, lysergic acid diethylamide (LSD), or related compounds
Drug abuse within the past 3 months (excluding tobacco)
Urine toxicology positive to drugs of abuse
Alcohol use of >21 drinks per week (males); >14 drinks per week (females; NIAAA guidelines)
Use of alcohol in the week prior to the first test day
Use of vasoconstrictive medications (i.e., sumatriptan, pseudoephedrine, midodrine) within 5 half-lives of test days
Use of serotonergic antiemetics (i.e., ondansetron) in the past 2 weeks
Use of antidepressant medication (i.e., TCA, MAOI, SSRI) in the past 6 weeks
Use of steroids or certain other immunomodulatory agents (i.e., azathioprine) in the past 2 weeks
Use of migraine onabotulinum toxin (i.e., Botox) or monoclonal antibodies against CGRP or its receptor (i.e., erenumab) in the past month or while therapeutic effects are still present
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