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Can psilocybin be safely administered under medical supervision? A systematic review of adverse event reporting in clinical trials

Jeremy Roscoe, Olivia Lozy

Drug Science Policy and Law 2022 DOI: 10.1177/20503245221085222 (opens in new tab)

Study at a glance

AI-extracted from the abstract
Characteristics Systematic review Peer reviewed
Sample size 52
Population Clinical trials of psilocybin administered by a medical professional
Topics Psilocybin
Keywords Clinical trial Adverse effect Tolerability Hallucinogen Pharmacology
Citations 30
Key findings None of the 52 included clinical trials reported psilocybin to be unsafe, and 27 suggested it is safe to administer under proper medical supervision.

Abstract

This systematic review investigates whether clinical trials of psilocybin support criterion number three of the drug's schedule I designation: There is a lack of accepted safety for use of the drug or other substance under medical supervision. Data were collected by using the PubMed database and conducting a search on November 24, 2021, with the search term psilocybin and applying the clinical trial filter. Only primary reports on the sole administration of psilocybin by a medical professional were included for analysis, excluding trials wherein psilocybin was not administered, trials wherein psilocybin was exclusively co-administered with other drugs, articles that were not clinical trials, and articles that were repeat analyses of already included trials. 52 included publications were closely examined for reports of adverse events, drug tolerability, and drug safety. Zero of these articles reported psilocybin to be unsafe, while 27 of the included trials suggested that psilocybin is safe to administer under proper medical supervision.

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