NCT02981173

Psilocybin for the Treatment of Cluster Headache

Safety and Efficacy of Psilocybin for the Treatment of Headache Disorders

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 25 (actual)
• Sponsor: Yale University · Academic / Other
• Sex: All
• Age: 21 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Cluster Headache

Interventions

Type	Name	Description
DRUG	0.143 mg/kg Psilocybin or 10 mg Psilocybin	0.143 mg/kg psilocybin capsule (weight-based option) or 10 mg psilocybin capsule (fixed-dose option) ingested on each of three test days (5 days apart +/- 1-2 days)
DRUG	0.0143 mg/kg Psilocybin or 1 mg Psilocybin	0.0143 mg/kg psilocybin capsule (weight-based option) or 1 mg psilocybin (fixed-dose option) ingested on each of three test days (5 days apart +/- 1-2 days)
DRUG	Placebo	Microcrystalline cellulose capsule ingested on each of three test days (5 days apart +/- 1-2 days)

Timeline

• Start date: 2016-12-05
• Primary completion: 2022-06-30
• Completion: 2022-10-21
• First posted: 2016-12-05
• Last updated: 2023-12-15

Locations

1 site across 1 country: United States