NCT03341689

Psilocybin for the Treatment of Migraine Headache

Completed Phase 1 Last updated 12 October 2023

What this trial tests

Phase 1 trial testing High Dose Psilocybin in Migraine Headache in 14 participants. Completed in 31 October 2021.

Timeline

1 November 2017

Primary endpoint
30 April 2021

31 October 2021

Quick facts

Lead sponsor	Yale University
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	double
Primary purpose	treatment
Enrollment	14
Start date	1 November 2017
Primary completion	30 April 2021
Estimated completion	31 October 2021
Sites	1 location across United States

Drugs / interventions tested

• High Dose Psilocybin — full drug profile →
• Low Dose Psilocybin
• Placebo

Conditions studied

• Migraine Headache — all drugs for Migraine Headache →

Sponsor

Yale University

Who can join

Adults 21 to 65, any sex, with Migraine Headache. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

6 peer-reviewed publications reference this trial (live from Europe PMC):

1. Exploratory Controlled Study of the Migraine-Suppressing Effects of Psilocybin.
   Schindler EAD, Sewell RA, Gottschalk CH, Luddy C, et al · · 2021 · cited 87× · PMID 33184743 · DOI 10.1007/s13311-020-00962-y
2. Psychedelic Therapy's Transdiagnostic Effects: A Research Domain Criteria (RDoC) Perspective.
   Kelly JR, Gillan CM, Prenderville J, Kelly C, et al · · 2021 · cited 36× · PMID 34975593 · DOI 10.3389/fpsyt.2021.800072
3. Psychedelic therapies reconsidered: compounds, clinical indications, and cautious optimism.
   Mitchell JM, Anderson BT. · · 2024 · cited 32× · PMID 37479859 · DOI 10.1038/s41386-023-01656-7
4. The Use of Psychedelics in the Treatment of Medical Conditions: An Analysis of Currently Registered Psychedelics Studies in the American Drug Trial Registry.
   Kurtz JS, Patel NA, Gendreau JL, Yang C, et al · · 2022 · cited 19× · PMID 36259015 · DOI 10.7759/cureus.29167
5. Classic Psychedelics in Pain Modulation: Mechanisms, Clinical Evidence, and Future Perspectives.
   Czopek A, Jończyk J, Fryc M, Kluzik D, et al · · 2025 · cited 3× · PMID 40474592 · DOI 10.1021/acschemneuro.5c00152
6. Exploring the Therapeutic Potential of Psychedelics in Chronic Pain Management: A New Frontier in Medicine.
   Lin C, Wang X, Wang X. · · 2025 · cited 2× · PMID 39832122 · DOI 10.1007/s12264-025-01351-1