Exploratory Controlled Study of the Migraine-Suppressing Effects of Psilocybin.

Autor: Schindler EAD; Department of Neurology, Yale School of Medicine, New Haven, CT, USA. emmanuelle.schindler@yale.edu.; Neurology Service, Veterans Affairs Connecticut Healthcare System, MS 127, 950 Campbell Avenue, West Haven, CT, 06516, USA. emmanuelle.schindler@yale.edu.; Veterans Affairs Headache Center of Excellence, West Haven, CT, USA. emmanuelle.schindler@yale.edu., Sewell RA; Department of Psychiatry, Yale School of Medicine, New Haven, CT, USA.; Psychiatry Service, Veterans Affairs Connecticut Healthcare System, West Haven, CT, USA., Gottschalk CH; Veterans Affairs Headache Center of Excellence, West Haven, CT, USA., Luddy C; Department of Psychiatry, Yale School of Medicine, New Haven, CT, USA.; Psychiatry Service, Veterans Affairs Connecticut Healthcare System, West Haven, CT, USA., Flynn LT; Department of Psychiatry, Yale School of Medicine, New Haven, CT, USA.; Psychiatry Service, Veterans Affairs Connecticut Healthcare System, West Haven, CT, USA., Lindsey H; Department of Neurology, Yale School of Medicine, New Haven, CT, USA.; Neurology Service, Veterans Affairs Connecticut Healthcare System, MS 127, 950 Campbell Avenue, West Haven, CT, 06516, USA.; Veterans Affairs Headache Center of Excellence, West Haven, CT, USA., Pittman BP; Department of Psychiatry, Yale School of Medicine, New Haven, CT, USA., Cozzi NV; Neuropharmacology Laboratory, University of Wisconsin School of Medicine and Public Health, Madison, WI, USA.; Alexander Shulgin Research Institute, Lafayette, CA, USA., D'Souza DC; Department of Psychiatry, Yale School of Medicine, New Haven, CT, USA.; Psychiatry Service, Veterans Affairs Connecticut Healthcare System, West Haven, CT, USA.
Jazyk: angličtina
Zdroj: Neurotherapeutics : the journal of the American Society for Experimental NeuroTherapeutics [Neurotherapeutics] 2021 Jan; Vol. 18 (1), pp. 534-543. Date of Electronic Publication: 2020 Nov 12.
DOI: 10.1007/s13311-020-00962-y
Abstrakt: While anecdotal evidence suggests that select 5-hydroxytryptamine 2A (5-HT 2A ) 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-HT 2A receptor compounds in migraine, as well as other neuropsychiatric conditions. Clinicaltrials.gov : NCT03341689.
Databáze: MEDLINE
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