BibTex format
@article{Pronovost-Morgan:2025:10.1038/s41591-025-03685-9,
author = {Pronovost-Morgan, C and Greenway, KT and Roseman, L and Aday, JS and Agin-Liebes, G and Ahmad, K and Aicher, H and Aixalà, M and Amar, S and de, Araujo DB and Barrett, FS and Belser, A and Blainey, M and Bourne, M and Bowman, R and Breeksema, J and Carter, KB and Bussey, J and Camara, C and Canby, N and Chalchi, J and Close, J and Cox, T and Daraeizadeh, P and Davis, AK and de, la Salle S and Devenot, N and Dyck, E and Erritzoe, D and Farzin, H and Friesen, P and Garel, N and Giblin, J and Golden, T and Greer, G and Gukasyan, N and Guss, J and Hapke, E and Hartogsohn, I and Holze, F and Kettner, H and Knowles, A and Langlitz, N and Lehmann, A and Lifshitz, M and Lucas, P and MacLean, K and Mallon, O and Marcus, O and Mazarrasa, J and McAlpine, R and Moreno, F and Neitzke-Spruill, L and Noorani, T and Oehen, P and Ona, G and Palhano-Fontes, F and Patchett-Marble, R and Peekeekoot, G and Perkins, D and Preller, KH and Ramaekers, JG and Reed, S and Repantis, D and Richards, B and Richards},
doi = {10.1038/s41591-025-03685-9},
journal = {Nature Medicine},
pages = {2186--2195},
title = {An international Delphi consensus for reporting of setting in psychedelic clinical trials},
url = {http://dx.doi.org/10.1038/s41591-025-03685-9},
volume = {31},
year = {2025}
}
RIS format (EndNote, RefMan)
TY - JOUR
AB - 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.
AU - Pronovost-Morgan,C
AU - Greenway,KT
AU - Roseman,L
AU - Aday,JS
AU - Agin-Liebes,G
AU - Ahmad,K
AU - Aicher,H
AU - Aixalà,M
AU - Amar,S
AU - de,Araujo DB
AU - Barrett,FS
AU - Belser,A
AU - Blainey,M
AU - Bourne,M
AU - Bowman,R
AU - Breeksema,J
AU - Carter,KB
AU - Bussey,J
AU - Camara,C
AU - Canby,N
AU - Chalchi,J
AU - Close,J
AU - Cox,T
AU - Daraeizadeh,P
AU - Davis,AK
AU - de,la Salle S
AU - Devenot,N
AU - Dyck,E
AU - Erritzoe,D
AU - Farzin,H
AU - Friesen,P
AU - Garel,N
AU - Giblin,J
AU - Golden,T
AU - Greer,G
AU - Gukasyan,N
AU - Guss,J
AU - Hapke,E
AU - Hartogsohn,I
AU - Holze,F
AU - Kettner,H
AU - Knowles,A
AU - Langlitz,N
AU - Lehmann,A
AU - Lifshitz,M
AU - Lucas,P
AU - MacLean,K
AU - Mallon,O
AU - Marcus,O
AU - Mazarrasa,J
AU - McAlpine,R
AU - Moreno,F
AU - Neitzke-Spruill,L
AU - Noorani,T
AU - Oehen,P
AU - Ona,G
AU - Palhano-Fontes,F
AU - Patchett-Marble,R
AU - Peekeekoot,G
AU - Perkins,D
AU - Preller,KH
AU - Ramaekers,JG
AU - Reed,S
AU - Repantis,D
AU - Richards,B
AU - Richards,W
AU - Risby,S
AU - Rochester,J
AU - Roullier,I
AU - Rucker,J
AU - Ruffell,S
AU - Sanders,JW
AU - Schneider,L
AU - Shutte,T
AU - Szigeti,B
AU - Tadwalkar,S
AU - Lévesque,JT
AU - Timmermann,C
AU - Tzarfaty,K
AU - Wells,H
AU - Williams,K
DO - 10.1038/s41591-025-03685-9
EP - 2195
PY - 2025///
SN - 1078-8956
SP - 2186
TI - An international Delphi consensus for reporting of setting in psychedelic clinical trials
T2 - Nature Medicine
UR - http://dx.doi.org/10.1038/s41591-025-03685-9
UR - https://doi.org/10.1038/s41591-025-03685-9
VL - 31
ER -
