Status:
COMPLETED
Psilocybin for the Treatment of Migraine Headache
Lead Sponsor:
Yale University
Collaborating Sponsors:
Ceruvia Lifesciences
Conditions:
Migraine Headache
Eligibility:
All Genders
21-65 years
Phase:
PHASE1
Brief Summary
The purpose of this study is to investigate the effects of oral psilocybin in migraine headache. Subjects will each receive a dose of placebo and a dose of psilocybin approximately 14 days apart. Subj...
Detailed Description
The number of arms reflects the design of the enhanced blinding method. The final enrollment number reflects the number of subjects participating in study procedures.
Eligibility Criteria
Inclusion
- Diagnosis of migraine headache per ICHD-3beta 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
- Age 21 to 65
Exclusion
- Axis I psychotic disorder (e.g. schizophrenia, bipolar I, depression with psychosis)
- Axis I psychotic 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, LSD, or related compounds
- Drug or alcohol abuse within the past 3 months (excluding tobacco)
- Urine toxicology positive to drugs of abuse
- 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
Key Trial Info
Start Date :
November 1 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 31 2021
Estimated Enrollment :
14 Patients enrolled
Trial Details
Trial ID
NCT03341689
Start Date
November 1 2017
End Date
October 31 2021
Last Update
October 12 2023
Active Locations (1)
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1
VA Connecticut Healthcare System, West Haven Campus
West Haven, Connecticut, United States, 06516