Exploratory Controlled Study of the Migraine-Suppressing Effects of Psilocybin
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ORIGINAL ARTICLE
Exploratory Controlled Study of the Migraine-Suppressing Effects of Psilocybin Emmanuelle A. D. Schindler 1,2,3 & R. Andrew Sewell 4,5 & Christopher H. Gottschalk 3 & Christina Luddy 4,5 & L. Taylor Flynn 4,5 & Hayley Lindsey 1,2,3 & Brian P. Pittman 4 & Nicholas V. Cozzi 6,7 & Deepak C. D’Souza 4,5 Accepted: 27 October 2020 # Copyright line is: This is a U.S. government work and not under copyright protection in the U.S.; foreign copyright protection may apply. 2020
Abstract While anecdotal evidence suggests that select 5-hydroxytryptamine 2A (5-HT2A) receptor ligands, including psilocybin, may have long-lasting therapeutic effects after limited dosing in headache disorders, controlled investigations are lacking. In an exploratory double-blind, placebo-controlled, cross-over study, adults with migraine received oral placebo and psilocybin (0.143 mg/kg) in 2 test sessions spaced 2 weeks apart. Subjects maintained headache diaries starting 2 weeks before the first session until 2 weeks after the second session. Physiological and psychological drug effects were monitored during sessions and several follow-up contacts with subjects were carried out to assure safety of study procedures. Ten subjects were included in the final analysis. Over the 2-week period measured after single administration, the reduction in weekly migraine days from baseline was significantly greater after psilocybin (mean, − 1.65 (95% CI: − 2.53 to − 0.77) days/week) than after placebo (− 0.15 (− 1.13 to 0.83) days/week; p = 0.003, t(9) = 4.11). Changes in migraine frequency in the 2 weeks after psilocybin were not correlated with the intensity of acute psychotropic effects during drug administration. Psilocybin was well-tolerated; there were no unexpected or serious adverse events or withdrawals due to adverse events. This exploratory study suggests there is an enduring therapeutic effect in migraine headache after a single administration of psilocybin. The separation of acute psychotropic effects and lasting therapeutic effects is an important finding, urging further investigation into the mechanism underlying the clinical effects of select 5-HT2A receptor compounds in migraine, as well as other neuropsychiatric conditions. Clinicaltrials.gov: NCT03341689 Key Words Migraine . headache . preventive treatment . psilocybin . psychedelics
R. Andrew Sewell, posthumous (RAS passed away in 2013) * Emmanuelle A. D. Schindler [email protected] 1
Department of Neurology, Yale School of Medicine, New Haven, CT, USA
2
Neurology Service, Veterans Affairs Connecticut Healthcare System, MS 127, 950 Campbell Avenue, West Haven, CT 06516, USA
3
Veterans Affairs Headache Center of Excellence, West Haven, CT, USA
4
Department of Psychiatry, Yale School of Medicine, New Haven, CT, USA
5
Psychiatry Service, Veterans Affairs Connecticut Healthcare System, West Haven, CT, USA
6
Neuropharmacology Laboratory, University of Wisconsin School of Medicine and Public Health, Madison, WI, USA
7
Alexander Shulgin Research Institute
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