This Delphi consensus study (n=89) involved psychedelic researchers, clinicians, and past trial participants across 17 countries to develop reporting standards for extra-pharmacological variables in psychedelic clinical trials. It resulted in the ReSPCT guidelines, a 30-item framework covering physical environment, session procedures, therapeutic protocol, and subjective experiences, aiming to standardise how “set and setting” are documented in future research.
Abstract of 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.“
Authors: Chloé Pronovost-Morgan, Kyle T. Greenway & Leor Roseman
Summary of An international Delphi consensus for reporting of setting in psychedelic clinical trials
Psychedelic drugs such as MDMA, DMT, ayahuasca, ketamine and others are known to interact deeply with what is termed “set and setting”—the psychological state of the user (set) and the environment in which the drug is taken (setting). This idea, foundational in psychedelic science, explains why the same substance can lead to dramatically different experiences depending on context. However, despite its recognised importance, clinical trials involving psychedelics often do not adequately report these contextual factors.
Prior reviews have revealed significant gaps and inconsistencies in the reporting of extra-pharmacological elements, such as details about physical environments or interactions during the dosing process. This lack of standardisation undermines the reproducibility, transparency and interpretability of psychedelic research. To address this, Pronovost-Morgan, Greenway, Roseman and colleagues aimed to develop a consensus-driven set of reporting guidelines for psychedelic clinical trials. These would be rooted in the collective expertise of researchers, clinicians, and former trial participants and focused on the setting-related aspects of trial design and reporting.
Methods
Study Design and Recruitment
The study used the Delphi method, a structured process that gathers expert consensus through multiple rounds of surveys. A total of 183 experts were invited, and 89 from 17 countries agreed to participate in the first round. These included psychedelic researchers, clinicians, and participants in previous clinical trials. Recruitment ensured diversity across age, gender, ethnicity, education, and professional backgrounds.
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An international Delphi consensus for reporting of setting in psychedelic clinical trials
https://doi.org/10.1038/s41591-025-03685-9
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Cite this paper (APA)
Pronovost-Morgan, C., Greenway, K. T., & Roseman, L. (2025). An international Delphi consensus for reporting of setting in psychedelic clinical trials. Nature Medicine, 1-10.