Commentary: A framework for assessment of adverse events in psychedelic research.
Katherine Cheung, Rebecca Ehrenkranz, Jared T. Hinkle, David B. Yaden
Journal of psychopharmacology (Oxford, England) May 1, 2025 DOI: 10.1177/02698811241309623 (opens in new tab)
Study at a glance
AI-extracted from the abstract| Characteristics | Commentary Peer reviewed |
|---|---|
| Keywords | Psychedelics Adverse events Bias Systematic assessment Psychedelic-therapy Clinical-safety-protocols Research-methodology Adverse-event-monitoring Assessment-frameworks |
| Citations | 1 |
| Key points | Argues that adverse event assessment in psychedelic clinical trials must be held to the same rigor and standards as other research areas, while maintaining transparency and accessibility in reporting. |
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.