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Psychedelic

Psilocybin High Dose for 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)
Awards & highlights

Study Summary

This trial is testing whether psilocybin, a compound found in some mushrooms, can help treat cluster headaches. People with cluster headaches will be given either a placebo or psilocybin in three sessions, separated by 5 days. They will keep a headache diary before, during, and after the sessions. After at least 6 months from the last session, they may be invited back for a second round of the trial.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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 outcome measures
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
1,863 Previous Clinical Trials
2,742,556 Total Patients Enrolled
Heffter Research InstituteOTHER
13 Previous Clinical Trials
474 Total Patients Enrolled
Ceruvia LifesciencesUNKNOWN
1 Previous Clinical Trials
14 Total Patients Enrolled

Media Library

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