Open-label, single-group pilot study (n=10) assessing prophylactic effects of low-dose psilocybin (0.14 mg/kg oral) given in three weekly sessions for chronic cluster headache with fMRI and psilocin sampling.
Prospective open-label pilot evaluating whether three low-dose psilocybin administrations (0.14 mg/kg p.o., one week apart) reduce attack frequency, intensity and duration in people with chronic cluster headache.
Participants complete a headache diary over a 10-week period including a 4-week baseline, three dosing weeks and a 4-week follow-up; acute treatments are permitted and recorded, prophylactic medications must be washed out prior to inclusion.
Outcomes include change in headache frequency, duration and intensity, correlation of clinical response with plasma psilocin and estimated 5-HT2A receptor occupancy, and pre/post fMRI measures of brain network connectivity; participants contacted at 3, 6 and 12 months for remission data.
Low-dose psilocybin administered in three outpatient sessions spaced one week apart for prophylaxis of chronic cluster headache.
Blood sampling for psilocin during first session; fMRI before first and after last dose.