Overview

Psilocybin for the Treatment of Cluster Headache

Status:
Active, not recruiting
Trial end date:
2022-06-01
Target enrollment:
Participant gender:
Summary
The purpose of this study is to investigate the effects of an oral psilocybin pulse regimen in cluster headache. Subjects will be randomized to receive oral placebo, low dose psilocybin, or high dose psilocybin in three experimental sessions, each separated by 5 days. Subjects will maintain a headache diary prior to, during, and after the pulse regimen in order to document headache frequency and intensity before, during, and after the pulse regimen. After at least 6 months from the last experimental session, subjects may be invited for a second round, in which they will be randomized to receive either low dose or high dose psilocybin.
Phase:
Phase 1
Details
Lead Sponsor:
Yale University
Collaborators:
Cluster Headache-Trigeminal Autonomic Cephalalgia (CH-TAC), LLC
Heffter Research Institute
Treatments:
Psilocybin
Psilocybine