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Psychedelic

High Dose Psilocybin for Post-Traumatic 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 two weeks after second session using a headache diary

Summary

This trial tests if psilocybin pills can help people with headaches caused by head injuries. Psilocybin may reduce headache frequency and severity by changing brain activity and reducing inflammation. Psilocybin has a long history of use by indigenous cultures and has shown potential in treating headaches and chronic pain in recent studies.

Eligible Conditions
  • Post-Traumatic Headache

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~two weeks following each test session
This trial's timeline: 3 weeks for screening, Varies for treatment, and two weeks following each test session for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Acute change in functional disability
Acute change in nausea/vomiting
Acute change in pain intensity
+11 more
Secondary study objectives
Change in blood pressure
Change in heart rate
Change in peripheral levels of calcitonin gene-related peptide (CGRP)
+8 more

Trial Design

6Treatment 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: Low Dose Psilocybin/High Dose PsilocybinExperimental Treatment2 Interventions
Subjects in this arm receive low dose psilocybin in the first session and high dose psilocybin in the second session.
Group V: High Dose Psilocybin/PlaceboExperimental Treatment2 Interventions
Subjects in this arm receive high dose psilocybin in the first session and placebo in the second session.
Group VI: High Dose Psilocybin/Low Dose PsilocybinExperimental Treatment2 Interventions
Subjects in this arm receive high dose psilocybin in the first session and low dose psilocybin in the second session.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
High Dose Psilocybin
2017
Completed Phase 1
~20
Placebo oral capsule
2010
Completed Phase 4
~2380
Low Dose Psilocybin
2017
Completed Phase 1
~20

Find a Location

Who is running the clinical trial?

Yale UniversityLead Sponsor
1,919 Previous Clinical Trials
3,040,343 Total Patients Enrolled
1 Trials studying Post-Traumatic Headache
12 Patients Enrolled for Post-Traumatic Headache
~2 spots leftby Nov 2025
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