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

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.

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Publication Details

Journal
Nature Medicine
Published
2025-06-03
DOI
https://doi.org/10.1038/s41591-025-03685-9
Citations
18
Primary Topic
Psychedelics and Drug Studies
Type
article
Field-Weighted Citation Impact
41.52

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article

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

Fernanda Palhano-Fontes, Emma Hapke, Francisco Moreno, Tehseen Noorani et al.
18 citations
Nature Medicine
Psychedelics and Drug Studies
41.52
article

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

Fernanda Palhano-Fontes, Emma Hapke, Francisco Moreno, Tehseen Noorani, James W. Sanders, Frederick S. Barrett, Sayali Tadwalkar, Dráulio Barros de Araújo, Logan Neitzke‐Spruill, Orla Mallon, James Close, Dimitris Repantis, Nicolas Langlitz, Nicholas K. Canby, Leor Roseman, Erika Dyck, Johannes G. Ramaekers, Peter Oehen, Jacob S. Aday, Jeffrey Guss, Friederike Holze, Olivia Marcus, Helena Aicher, Tasha L. Golden, Brian D. Richards, Carmen Cámara, Philippe Lucas, Rosalind McAlpine, Kayla Breelove Carter, Alan K. Davis, William A. Richards, Houman Farzin, Katrin H. Preller, Ido Hartogsohn, Phoebe Friesen, Gabrielle Agin-Liebes, James Rucker, David Erritzøe, Natalie Gukasyan, Jessica Rochester, Daniel Perkins, Michael Lifshitz, Sara de la Salle, Christopher Timmermann, Hannes Kettner, Keith Williams, George Greer, Michelle Bourne, R.W. Bowman, Timothy C. Cox, Genís Oña, Alexandre Lehmann, Simon Amar, Julien Thibault Lévesque, Ryan Patchett-Marble, L. Schneider, Simon Ruffell, Alexander Belser, Balázs Szigeti, Neşe Devenot, Nicolas Garel, Kyle T. Greenway, Marc G. Blainey, Joost J. Breeksema, Keren Tzarfaty, Chloé Pronovost-Morgan, Marc Aixalà, Kirran Ahmad, H. Bradley Wells, Sara Reed, Katherine A. MacLean, Jacqueline Bussey, Jimena Chalchi, Pedram Daraeizadeh, Josephine Giblin, Adam Knowles, Jerónimo Mazarrasa, Gail Peekeekoot, Sally Risby, Ian Roullier, Thomas Shutte
article en
18 citations

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.

Nature MedicineVol. 31(7)
The New School (US), Twitter (United States) (US), Hospital Sant Joan de Déu Barcelona (ES), Santa Fe Institute (US), Gladstone Institutes (US), University Health Network (CA), University Medical Center Groningen (NL), University of Arizona (US), Bar-Ilan University (IL), Johns Hopkins University (US), University of Auckland (NZ), The University of Melbourne (AU), University of California, San Francisco (US), Baylor College of Medicine (US), King's College London (GB), South London and Maudsley NHS Foundation Trust (GB), University of Zurich (CH), University of Exeter (GB), Brown University (US), University of Michigan (US), Toronto Western Hospital (CA), Columbia University Irving Medical Center (US), Canadian Armed Forces (CA), McGill University Health Centre (CA), Jewish General Hospital (CA), Heffter Research Institute (US), University Hospital of Basel (CH), International Council for the Exploration of the Sea (DK), Vancouver Island University (CA), University of Saskatchewan (CA), Yale University (US), University of Florida (US), Maastricht University (NL), Universidade Federal do Rio Grande do Norte (BR), Hammersmith Medicines Research (GB), Sunset Laboratory (United States) (US), Multidisciplinary Association for Psychedelic Studies (US), Ciência Viva (PT), Michigan Medicine (US), Fluent (United States) (US), Department of Biomedicine Basel (CH), Southerners on New Ground (US), Hôtel-Dieu de Montréal (CA), Library Am Guisanplatz (CH), Melbourne Health (AU), Roche (Israel) (IL), International Laboratory for Brain, Music and Sound Research (CA), New York State Psychiatric Institute, University College London (GB), Imperial College London (GB), McGill University (CA), The Ohio State University (US), Monash University (AU), New York University (US), Université de Montréal (CA), Open University of the Netherlands (NL), Charité - Universitätsmedizin Berlin (DE), NOSM University (CA), Athabasca University (CA), Birkbeck, University of London (GB)
National Science Foundation, Strong, National Institute for Health and Care Research, Imperial College London, King's College London, Schweizerischer Nationalfonds zur Förderung der Wissenschaftlichen Forschung, National Institutes of Health
Openalex Percentile: Top 0%
Psychedelics and Drug Studies
41.52
DOIOpen Access PDFOpenAlex
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