drugset / Trial / NCT03341689

Psilocybin for the Treatment of Migraine Headache

NCT03341689

Phase 1 Completed 14 enrolled Yale University Ceruvia Lifesciences · collab
RandomizedCrossoverDouble-blindTreatment

Summary

The purpose of this study is to investigate the effects of oral psilocybin in migraine headache. Subjects will each receive a dose of placebo and a dose of psilocybin approximately 14 days apart. Subjects will be randomized to the order of treatment and they will be randomized to receive either low or high dose psilocybin. Subjects will maintain a headache diary prior to, during, and after the treatments in order to document headache frequency and intensity, as well as associated symptoms. This preliminary study will inform on the basic effects of psilocybin in migraine headache and inform on the design of larger, more definitive studies.

Timeline

Start
2017-11-01
Primary completion
2021-04-30
Completion
2021-10-31

Drugs

EvaluationDrugModalityDoseRoute
Subject Psilocybin Other / unclassified 0.0143 mg/kg Oral
Subject Psilocybin Other / unclassified 0.143 mg/kg Oral

Indications