NCT03806985

Effects of Psilocybin in Concussion Headache

Safety and Efficacy of Psilocybin for the Treatment of Headache Disorders: Sub-Study II

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: Yale University · Academic / Other
• Sex: All
• Age: 21 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Post-Traumatic Headache

Interventions

Type	Name	Description
DRUG	Placebo oral capsule	microcrystalline cellulose capsule
DRUG	Low Dose Psilocybin	0.0143 mg/kg psilocybin capsule (weight-based option) or 1 mg psilocybin capsule (fixed-dose option)
DRUG	High Dose Psilocybin	0.143 mg/kg psilocybin capsule (weight-based option) or 10 mg psilocybin capsule (fixed-dose option)

Timeline

• Start date: 2019-03-28
• Primary completion: 2023-06-27
• Completion: 2023-06-27
• First posted: 2019-01-16
• Last updated: 2023-10-12

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study