Commentary: A framework for assessment of adverse events in psychedelic research.
Journal of psychopharmacology (Oxford, England) – May 01, 2025
Source: PubMed
Summary
Psychedelic therapy research faces a unique challenge: how do we accurately track both positive outcomes and potential adverse events? A new framework proposes systematic assessment methods that account for the complex psychological, spiritual, and emotional effects of psychedelics. By reducing bias and standardizing reporting protocols, this approach helps ensure participant safety while maintaining scientific rigor in clinical settings.
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.