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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
Awards & highlights

Study Summary

This trial is testing whether psilocybin can help relieve post-traumatic headaches, by either reducing frequency or intensity.

Eligible Conditions
  • Post-Traumatic Headache

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
Acute change in functional disability
Acute change in nausea/vomiting
Acute change in pain intensity
+11 more
Secondary outcome measures
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
1,847 Previous Clinical Trials
2,736,516 Total Patients Enrolled
1 Trials studying Post-Traumatic Headache
12 Patients Enrolled for Post-Traumatic Headache

Frequently Asked Questions

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

Would I qualify to participate in this research experiment?

"This clinical trial has an enrolment of 24 people suffering from cervicogenic headaches and between the ages 21-65. Essential inclusion criteria include that any medication used to treat the condition cannot be taken more than twice a week with triptans."

Answered by AI

Is the minimum age of eligibility for this clinical trial twenty years or older?

"This clinical trial's inclusion criteria necessitates that all patients are between 21 and 65 years of age. Conversely, there exist 19 trials specifically for minors under 18 and 120 studies dedicated to elderly individuals over the age of 65."

Answered by AI

Has the FDA sanctioned High Dose Psilocybin for therapeutic use?

"In view of sparse clinical data, the safety rating for High Dose Psilocybin was conservatively estimated as a 1."

Answered by AI

Are there still opportunities to participate in this research trial?

"According to information available on clinicaltrials.gov, this research trial is currently enlisting participants. It was initially posted on March 28th 2019 and recently amended on July 27th 2022."

Answered by AI

How many participants are engaged in the experiment?

"Affirmative, the information on clinicaltrials.gov demonstrates that this research is currently accommodating patient recruitment. This study was first posted on March 28th 2019 and most recently updated on July 27th 2022; with 24 patients needed from a single medical centre."

Answered by AI

What is the goal of this medical exploration?

"This clinical trial's primary endpoint is a modification in the intensity of phonophobia during headaches. Secondary endpoints are shifts from baseline levels of pituitary adenylate cyclase-activating peptide (PACAP), heart rate, and suicide hazard as measured by Columbia Suicide Severity Rating Scale(CSSRS). These data points will be recorded at 0, 1, 2, 4 hours after drug administration plus 24 hours posttreatment."

Answered by AI

What other exploratory trials have been implemented with High Dose Psilocybin?

"Currently, 33 clinical investigations are ongoing that focus on the effects of High Dose Psilocybin. Of these, none have reached Phase 3 yet. Centres running trials for this particular treatment span 36 different locales with a concentration in Vancouver and Washington State."

Answered by AI

Who else is applying?

What state do they live in?
Michigan
Florida
California
Other
How old are they?
65+
18 - 65
What site did they apply to?
VA Connecticut Healthcare System
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
3+

How responsive is this trial?

Typically responds via
Email
Most responsive sites:
  1. VA Connecticut Healthcare System: < 48 hours
Average response time
  • < 2 Days
~2 spots leftby Apr 2025