Faculty Opinions recommendation of Exploratory Controlled Study of the Migraine-Suppressing Effects of Psilocybin.
Faculty Opinions – Post-Publication Peer Review of the Biomedical Literature – June 28, 2021
Source: OpenAlex
Summary
A single psilocybin dose significantly reduced migraine frequency. In a double-blind clinical trial, ten adults experienced 1.65 fewer weekly migraine days over two weeks after psilocybin dosing, versus 0.15 with placebo. This hallucinogen medicine had no serious adverse effect. Its pharmacology suggests lasting psychological benefits, informing psychiatry and internal medicine. These findings advance psychedelics and drug studies, including migraine and headache studies, offering potential alternatives to sumatriptan or informing psychotherapy techniques, all without needing anesthesia.
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. PMID: 33184743 Funding information This work was supported by: NCATS NIH HHS, United States Grant ID: UL1 TR001863