J Psychopharmacol
June 30, 2023
Chloé Pronovost-Morgan, Ido Hartogsohn, Johannes G Ramaekers
33 citations
The randomized controlled trial (RCT) design assumes a drug's specific effect can be separated from nonspecific context and person effects, but ample evidence shows that physical, social, and cultural variables not only add to but also shape drug effects. Harnessing these placebo effects for patient benefit is challenging due to conceptual and normative obstacles. A new framework inspired by psychedelic science's 'set and setting' concept acknowledges that drug and nondrug factors interact synergistically, suggesting ways to reintegrate nondrug variables into biomedical practice to ethically use placebo effects for improved clinical care.
Nature medicine
June 3, 2025
Chloé Pronovost-Morgan, Kyle T. Greenway, Leor Roseman et al.
26 citations
A 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.
Research Square
November 18, 2024
Chloé Pronovost-Morgan, Kyle T. Greenway, Leor Roseman
2 citations
A large international Delphi consensus study with 89 experts from 17 countries developed guidelines for reporting the setting in psychedelic clinical trials. The process identified 770 potential setting variables, synthesized into 49 items, and refined through four rounds of surveys and debates. Thirty extra-pharmacological variables reached consensus as important or very important for reporting, forming the ReSPCT guidelines. These 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, and the guidelines aim to improve methodological rigor in psychedelic research.
Universität Zürich, ZORA
July 1, 2025
Chloé Pronovost-Morgan, Kyle T. Greenway, Leor Roseman et al.
An international Delphi consensus study involving 89 experts from 17 countries generated guidelines for reporting contextual variables in psychedelic clinical research. Over four rounds, 770 responses were synthesized into 49 items, with 30 reaching consensus as important or very important for at least 70% of experts. These items form the Reporting of Setting in Psychedelic Clinical Trials (ReSPCT) guidelines, covering physical environment, dosing session procedure, therapeutic framework and protocol, and subjective experiences. The findings reveal significant ambiguities in current conceptualizations of set and setting, and the guidelines provide a new standard for documenting extra-pharmacological factors in psychedelic research.