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Psilocybin for the Treatment of Migraine Headache

Phase 1
Waitlist Available
Research Sponsored by Yale University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from two weeks before first session to three months after second session using a headache diary

Summary

This trial is testing whether a substance from 'magic mushrooms' called psilocybin can help people who suffer from migraines. Participants will take psilocybin to see if it reduces their headache frequency and intensity. The study will help understand if psilocybin can be an effective treatment for migraines. Psilocybin is a well-characterized classic hallucinogen with a long history of religious use by indigenous cultures and has shown potential in treating cluster headaches and chronic pain.

Eligible Conditions
  • Migraine

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from two weeks before first session to two weeks after second session using a headache diary
This trial's timeline: 3 weeks for screening, Varies for treatment, and from two weeks before first session to two weeks after second session using a headache diary for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Nausea
Change in intensity of phonophobia
Change in intensity of photophobia
+5 more
Secondary study objectives
Change in blood pressure
Change in heart rate
Change in peripheral oxygenation
+5 more

Trial Design

4Treatment groups
Experimental Treatment
Group I: Placebo/Low Dose PsilocybinExperimental Treatment2 Interventions
Subjects in this arm receive placebo in the first session and low dose psilocybin in the second session.
Group II: Placebo/High Dose PsilocybinExperimental Treatment2 Interventions
Subjects in this arm receive placebo in the first session and high dose psilocybin in the second session.
Group III: Low Dose Psilocybin/PlaceboExperimental Treatment2 Interventions
Subjects in this arm receive low dose psilocybin in the first session and placebo in the second session.
Group IV: High Dose Psilocybin/PlaceboExperimental Treatment2 Interventions
Subjects in this arm receive high dose psilocybin in the first session and placebo in the second session.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Low Dose Psilocybin
2017
Completed Phase 1
~20
Placebo
1995
Completed Phase 3
~2670
High Dose Psilocybin
2017
Completed Phase 1
~20

Find a Location

Who is running the clinical trial?

Yale UniversityLead Sponsor
1,930 Previous Clinical Trials
3,033,460 Total Patients Enrolled
3 Trials studying Migraine
268 Patients Enrolled for Migraine
Ceruvia LifesciencesUNKNOWN
1 Previous Clinical Trials
25 Total Patients Enrolled
~2 spots leftby Dec 2025
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