An international Delphi consensus for reporting of setting in psychedelic clinical trials.
Chloé Pronovost-Morgan, Kyle T. Greenway, Leor Roseman, Jacob S. Aday, Gabrielle Agin-Liebes, Kirran Ahmad, Helena Aicher, Marc Aixalà, Simon Amar, Draulio B. De Araujo, Frederick S. Barrett, Alexander Belser, Marc Blainey, Michael Bourne, Ronald Bowman, Joost Breeksema, Kayla Breelove Carter, Jacqueline Bussey, Cesar Camara, Nicholas 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 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 Maclean, Orla Mallon, Olivia Marcus, Jerónimo Mazarrasa, Rosalind McAlpine, Francisco Moreno, Logan Neitzke-Spruill, Tehseen Noorani, Peter Oehen, Genís Ona, Fernanda Palhano-Fontes, Ryan Patchett-Marble, Gail Peekeekoot, Daniel Perkins, Katrin H. Preller, Johannes G. Ramaekers, Sara Reed, Dimitris Repantis, Brian Richards, William Richards, Sally Risby, Jessica Rochester, Ian Roullier, James Rucker, Simon Ruffell, James W. Sanders, Leonie Schneider, Thomas Shutte, Balázs Szigeti, Sayali Tadwalkar, Julien Thibault Lévesque, Christopher Timmermann, Keren Tzarfaty, Hattie Wells, Keith Williams
Nature medicine June 3, 2025 DOI: 10.1038/s41591-025-03685-9 via PubMed
Summary
AI-generated from the abstractA Delphi consensus study with 89 experts from 17 countries identified 30 extra-pharmacological variables that are important or very important for reporting the setting in psychedelic clinical trials. These variables, forming the ReSPCT guidelines, cover physical environment, dosing session procedure, therapeutic framework and protocol, and subjective experiences. The findings reveal significant ambiguities in current conceptualizations of set and setting. The guidelines provide a new standard for designing and documenting contextual factors in psychedelic research.
Study at a glance
| Characteristics | Delphi consensus study Peer reviewed |
|---|---|
| Sample size | 89 |
| Population | International group of psychedelic researchers, clinicians and past trial participants |
| Duration | Four iterative rounds of quasi-anonymous online surveys |
| Topics | Psychedelic-assisted therapy |
| Keywords | Therapeutic protocols Clinical guidelines Mental health treatment Psychedelic research |
| Citations | 26 |
| Key finding | The Delphi process yielded 30 extra-pharmacological variables that reached consensus as important or very important for reporting settings in psychedelic clinical trials, forming the ReSPCT guidelines. |
Abstract
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-pharmacological variables in psychedelic clinical research.