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Low Dose Psilocybin for Migraine

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
Awards & highlights

Study Summary

This trial will test the effects of psilocybin on migraine headaches. Subjects will keep a headache diary before, during, and after treatment.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Nausea
Change in intensity of phonophobia
Change in intensity of photophobia
+5 more
Secondary outcome measures
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
1,848 Previous Clinical Trials
2,737,804 Total Patients Enrolled
1 Trials studying Migraine
18 Patients Enrolled for Migraine
Ceruvia LifesciencesUNKNOWN
1 Previous Clinical Trials
25 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Who else is applying?

What state do they live in?
New Jersey
New York
Connecticut
Other
How old are they?
65+
18 - 65
What site did they apply to?
VA Connecticut Healthcare System, West Haven Campus
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
Recent research and studies
NeurotherapeuticsJournal
Exploratory Controlled Study of the Migraine-suppressing Effects of Psilocybin
Schindler, Emmanuelle A. D., R. Andrew Sewell, Christopher H. Gottschalk, Christina Luddy, L. Taylor Flynn, Hayley Lindsey, Brian P. Pittman, Nicholas V. Cozzi, and Deepak C. D’Souza. 2020. “Exploratory Controlled Study of the Migraine-suppressing Effects of Psilocybin”. Neurotherapeutics. Springer Science and Business Media LLC. doi:10.1007/s13311-020-00962-y.
clinicaltrials.govStudy
Psilocybin for the Treatment of Migraine Headache
Deepak C. D'Souza 2017. "Psilocybin for the Treatment of Migraine Headache". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03341689.
~2 spots leftby Apr 2025
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