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Psychedelic

Psilocybin for the Treatment of Cluster 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 six months following the completion of pulse regimen (after completion of experimental sessions 1, 2, and 3)

Summary

This trial tests if taking psilocybin pills can help people with severe cluster headaches. Participants will take different doses of psilocybin and keep a diary of their headache experiences. The goal is to see if psilocybin can make these headaches less frequent and less intense. Psilocybin is a well-known substance with a long history of use by indigenous cultures and has shown potential in treating headache disorders.

Eligible Conditions
  • Cluster Headache

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~two months following the completion of pulse regimen (after completion of experimental sessions 1, 2, and 3)
This trial's timeline: 3 weeks for screening, Varies for treatment, and two months following the completion of pulse regimen (after completion of experimental sessions 1, 2, and 3) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in cluster period duration compared to typical cluster period (episodic subjects only)
Change in duration of attacks
Change in frequency of attacks
+6 more
Secondary study objectives
Attack-free time
Change in blood pressure
Change in heart rate
+4 more

Trial Design

3Treatment groups
Active Control
Placebo Group
Group I: Psilocybin High DoseActive Control1 Intervention
Group II: Psilocybin Low DoseActive Control1 Intervention
Group III: PlaceboPlacebo Group1 Intervention

Find a Location

Who is running the clinical trial?

Yale UniversityLead Sponsor
1,927 Previous Clinical Trials
3,031,707 Total Patients Enrolled
Heffter Research InstituteOTHER
14 Previous Clinical Trials
494 Total Patients Enrolled
Ceruvia LifesciencesUNKNOWN
1 Previous Clinical Trials
14 Total Patients Enrolled
CH TAC LLCUNKNOWN
Cluster Headache-Trigeminal Autonomic Cephalalgia (CH-TAC), LLCUNKNOWN

Media Library

Cluster Headache Research Study Groups: Psilocybin High Dose, Psilocybin Low Dose, Placebo
~3 spots leftby Dec 2025
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