Psilocybin for the Treatment of Cluster Headache

PHASE1CompletedINTERVENTIONAL
Enrollment

25

Participants

Timeline

Start Date

December 5, 2016

Primary Completion Date

June 30, 2022

Study Completion Date

October 21, 2022

Conditions
Cluster Headache
Interventions
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)

Trial Locations (1)

06516

VA Connecticut Healthcare System, West Haven

All Listed Sponsors
collaborator

Heffter Research Institute

OTHER

collaborator

Ceruvia Lifesciences

UNKNOWN

collaborator

CH TAC LLC

UNKNOWN

lead

Yale University

OTHER