NCT03341689

Psilocybin for the Treatment of Migraine Headache

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 14 (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 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.

Detailed description

The number of arms reflects the design of the enhanced blinding method. The final enrollment number reflects the number of subjects participating in study procedures.

Conditions

• Migraine Headache

Interventions

Type	Name	Description
DRUG	High Dose Psilocybin	0.143 mg/kg psilocybin capsule
DRUG	Low Dose Psilocybin	0.0143 mg/kg psilocybin capsule
DRUG	Placebo	microcrystalline cellulose capsule

Timeline

• Start date: 2017-11-01
• Primary completion: 2021-04-30
• Completion: 2021-10-31
• First posted: 2017-11-14
• Last updated: 2023-10-12

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study