drugset / Trial / NCT03806985

Effects of Psilocybin in Concussion Headache

NCT03806985

Phase 1 Terminated 12 enrolled Yale University
RandomizedCrossoverDouble-blindTreatment

Summary

The purpose of this study is to investigate the effects of oral psilocybin in post-traumatic headache. Subjects will be randomized to receive placebo, low dose psilocybin, or high dose psilocybin on two separate test days approximately 14 days apart. 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. Blood samples will be drawn at various timepoints to measure levels of inflammatory peptides.

Timeline

Start
2019-03-28
Primary completion
2023-06-27
Completion
2023-06-27

Drugs

EvaluationDrugModalityDoseRoute
Subject Psilocybin Other / unclassified 0.0143 mg/kg Oral
Subject Psilocybin Other / unclassified 0.143 mg/kg Oral
Subject Psilocybin Other / unclassified 1 mg Oral
Subject Psilocybin Other / unclassified 10 mg Oral