Repeat Dosing of Psilocybin in Migraine Headache

• Status: Recruiting
• Trial end date: 2023-07-15
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Yale University
• Collaborator: Wallace Research Foundation
• Treatments: Psilocybin

Criteria

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