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.

迷幻物质表现出与使用的 “设置和设置”的复杂相互作用，即使用者的精神状态和迷幻体验发生的环境。尽管这些背景变量已知重要性，但迷幻药研究在报告药外因素方面缺乏方法论的严谨性。根据一个由迷幻药研究人员、临床医生和过去的试验参与者组成的国际小组的说法，这项研究旨在为迷幻药临床研究的报告环境生成基于共识的指南。我们进行了一项 Delphi 共识研究，该研究由四轮迭代的准匿名在线调查组成。共有来自 89 个国家的 17 名专家独立列出了可能重要的迷幻药设置变量。有 770 个回复，被综合成 49 个不同的项目，随后进行评分、辩论和提炼。该过程产生了 30 个药理学外变量，达到了预定义的共识评级：即 ≥70% 的专家认为是“重要”或“非常重要”。这些项目构成了迷幻药临床试验环境报告 （ReSPCT） 指南，分为物理环境、给药程序、治疗框架和方案以及主观体验。紧急发现揭示了当前 set 和 setting 概念化中的重大歧义。ReSPCT 指南和随附的解释性文件为迷幻药临床研究中药外变量的设计和记录提供了新标准。