Randomised, triple-blind, crossover Phase I study (n=25 actual) testing three oral sessions of placebo, low-dose or high-dose psilocybin (three sessions 5 days apart) for cluster headache.
Randomised, triple-masked crossover study in participants with cluster headache comparing three-session pulse regimens of high-dose, low-dose and placebo psilocybin; sessions occur approximately 5 days apart.
Participants maintain a headache diary before, during and after the pulse regimen to document frequency and intensity; participants may be invited for a second round after at least six months and will be randomised to low or high dose.
High-dose psilocybin (weight-based or fixed-dose) given on each of three test days in a crossover design.
Weight-based option 0.143 mg/kg or fixed 10 mg option.
Low-dose psilocybin (weight-based or fixed-dose) given on each of three test days in a crossover design.
Weight-based option 0.0143 mg/kg or fixed 1 mg option.
Placebo capsule given on each of three test days in crossover.
Microcrystalline cellulose capsule.