Low Dose Psilocybin for Migraine

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Migraine+2 More
Low Dose Psilocybin - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

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

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

8 Primary · 8 Secondary · Reporting Duration: From two weeks before first session to three months after second session using a headache diary

From the day of each session until two weeks after each test session
Time to first migraine attack
Migraine Disorders
From two weeks before first session to three months after second session using a headache diary
Quality of life using the Centers for Disease Control (CDC) Health-Related Quality of Life Scale: Healthy Days Symptoms Module
From two weeks before first session to two weeks after second session using a headache diary
Nausea
Change in intensity of phonophobia
Change in intensity of photophobia
Change in migraine attack duration
Change in migraine attack frequency
Change in migraine attack-related functional disability
Change in migraine headache days
Change in pain intensity of migraine attacks
Change in the use of abortive/rescue medication
Hour 6
Change in heart rate
Change in peripheral oxygenation
Hour 6
Change in blood pressure
Hour 6
Psychedelic effects using the 5-Dimensional Altered States of Consciousness (5D-ASC) scale

Trial Safety

Trial Design

4 Treatment Groups

Low Dose Psilocybin/Placebo
1 of 4
High Dose Psilocybin/Placebo
1 of 4
Placebo/Low Dose Psilocybin
1 of 4
Placebo/High Dose Psilocybin
1 of 4

Experimental Treatment

24 Total Participants · 4 Treatment Groups

Primary Treatment: Low Dose Psilocybin · Has Placebo Group · Phase 1

Low Dose Psilocybin/PlaceboExperimental Group · 2 Interventions: Low Dose Psilocybin, Placebo · Intervention Types: Drug, Drug
High Dose Psilocybin/PlaceboExperimental Group · 2 Interventions: Placebo, High Dose Psilocybin · Intervention Types: Drug, Drug
Placebo/Low Dose PsilocybinExperimental Group · 2 Interventions: Low Dose Psilocybin, Placebo · Intervention Types: Drug, Drug
Placebo/High Dose PsilocybinExperimental Group · 2 Interventions: Placebo, High Dose Psilocybin · Intervention Types: Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Placebo
1995
Completed Phase 3
~2670

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: from two weeks before first session to three months after second session using a headache diary

Who is running the clinical trial?

Yale UniversityLead Sponsor
1,667 Previous Clinical Trials
21,074,684 Total Patients Enrolled
1 Trials studying Migraine
24 Patients Enrolled for Migraine

Eligibility Criteria

Age 18+ · All Participants · 4 Total Inclusion Criteria

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About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 1st, 2021

Last Reviewed: November 22nd, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.

Who else is applying?

What state do they live in?
New Jersey20.0%
New York20.0%
California10.0%
Other50.0%
How old are they?
18 - 6580.0%
65+20.0%
What site did they apply to?
VA Connecticut Healthcare System, West Haven Campus100.0%
What portion of applicants met pre-screening criteria?
Met criteria80.0%
Did not meet criteria20.0%