Commentary: A framework for assessment of adverse events in psychedelic research.

A commentary responds to a proposed framework for assessing adverse events in psychedelic-assisted therapies, which includes spiritual, existential, religious, and theological impacts. The authors argue that adverse event assessment in psychedelic clinical trials should match the rigor and standards of other research areas, and emphasize the need for transparency and accessibility in reporting. The commentary discusses the framework's feasibility and various assessment methods, focusing on ensuring systematic and unbiased evaluation of adverse events.

Study at a glance

Abstract

Recent discussions about the methodological rigor of psychedelic clinical trials have focused on potential underreporting or misreporting of adverse events (AEs), with many calling for their systematic assessment to help mitigate these issues. In their recent paper, Palitsky et al. offer a comprehensive framework for the assessment of AEs in psychedelic-assisted therapies, with consideration of the spiritual, existential, religious, and theological impacts that psychedelics can have. In this commentary, we respond to Palitsky et al.'s proposal, discussing the framework, its feasibility, and various assessment methods. We emphasize the need to ensure that AE assessment in psychedelic clinical trials is held to the same rigor and standard as research in other areas, in addition to maintaining and improving transparency and accessibility in AE reporting.