Repeat Dosing of Psilocybin in Migraine Headache

Summary

In seeking to understand the capacity for psilocybin to reduce migraine headache burden, this study will investigate single and repeated dosing of psilocybin up to two doses. In seeking to identify an underlying mechanism in psilocybin's effects, neuroinflammatory markers for migraine headache will be measured.

Timeline

Start

2021-08-10

Primary completion

2023-11-05

Completion

2023-11-05

Outcome

Missed primary endpoint

paper the change from baseline in migraine days/week was not significantly different among groups PMID 41459830 ↗

paper Χ2 (2) = 4.56, p = 0.102 PMID 41459830 ↗

Publications

• Schindler EAD, Gottschalk CH, Pittman BP, D'Souza DC. Comparing single- and repeat-dose psilocybin with active placebo for migraine prevention in an exploratory randomized controlled clinical trial. Headache. 2026 Apr;66(4):885-895. doi: 10.1111/head.70024. Epub 2025 Dec 29.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Psilocybin	Other / unclassified	10 mg	—

Indications