An international Delphi consensus for reporting of setting in psychedelic clinical trials

作者：Chloé Pronovost-Morgan, Kyle T. Greenway, Leor Roseman, The ReSPCT Experts, Jacob S. Aday, Gabrielle Agin-Liebes, Kirran Ahmad, Helena Aicher, Marc Aixalà, Simon Amar, Dráulio Barros de Araújo, Frederick S. Barrett, Alexander Belser, Marc G. Blainey, Michael Bourne, R.W. Bowman, Joost J. Breeksema, Kayla Breelove Carter, Jacqueline Bussey, Cesar Camara, Nicholas K. Canby, Jimena Chalchi, James Close, Tonie Cox, Pedram Daraeizadeh, Alan K. Davis, Sara de la Salle, Neşe Devenot, Erika Dyck, David Erritzøe, Houman Farzin, Phoebe Friesen, Nicolas Garel, Josephine Giblin, Tasha L. Golden, George Greer, Natalie Gukasyan, Jeffrey Guss, Emma Hapke, Ido Hartogsohn, Friederike Holze, Hannes Kettner, Adam Knowles, Nicolas Langlitz, Alexandre Lehmann, Michael Lifshitz, Philippe Lucas, Katherine A. MacLean, Orla Mallon, Olivia Marcus, Jerónimo Mazarrasa, Rosalind McAlpine, Francisco Moreno, Logan Neitzke‐Spruill, Tehseen Noorani, Peter Oehen, Genís Oña, Fernanda Palhano-Fontes, Ryan Patchett-Marble, Gail Peekeekoot, Daniel Perkins, Katrin H. Preller, Johannes G. Ramaekers, Sara Reed, Dimitris Repantis, Brian D. Richards, William A. Richards, Sally Risby, Jessica Rochester, Ian Roullier, James Rucker, Simon Ruffell, James W. Sanders, L. Schneider, Thomas Shutte, Balázs Szigeti, Sayali Tadwalkar, Julien Thibault Lévesque, Christopher Timmermann, Keren Tzarfaty, H. Bradley Wells, Keith Williams · 发表于：Nature Medicine · 年份：2025 · DOI：10.1038/s41591-025-03685-9 · 被引用次数：33 · 研究领域：Psychedelics and Drug Studies、Olfactory and Sensory Function Studies、Pharmaceutical industry and healthcare

Psychedelic substances exhibit complex interactions with the 'set and setting' of use, that is, the mental state of the user and the environment in which a psychedelic experience takes place. Despite these contextual variables' known importance, psychedelic research has lacked methodological rigor in reporting extra-pharmacological factors. This study aimed to generate consensus-based guidelines for reporting settings in psychedelic clinical research, according to an international group of psychedelic researchers, clinicians and past trial participants. We conducted a Delphi consensus study composed of four iterative rounds of quasi-anonymous online surveys. A total of 89 experts from 17 countries independently listed potentially important psychedelic setting variables. There were 770 responses, synthesized into 49 distinct items that were subsequently rated, debated and refined. The process yielded 30 extra-pharmacological variables reaching predefined consensus ratings:i.e., 'important' or 'very important' for ≥70% of experts. These items compose the Reporting of Setting in Psychedelic Clinical Trials (ReSPCT) guidelines, categorized into physical environment, dosing session procedure, therapeutic framework and protocol, and subjective experiences. Emergent findings reveal significant ambiguities in current conceptualizations of set and setting. The ReSPCT guidelines and accompanying explanatory document provide a new standard for the design and documentation of extra-pharm...