Evidence map›Paper›PMID 40461819›Full record

ArticleNature medicine2025

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

Chloé Pronovost-Morgan, Kyle T Greenway, Leor Roseman, ReSPCT Experts

Abstract readConsensus Statement
In one paragraph

Article in Nature medicine, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 24 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
24citing papers in PubMed, 3 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

24 citing papers in PubMed, 3 syntheses or guidelines pooled it.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Trial
  5. Article
  6. Review
  7. Article
  8. Review
  9. Ten practical suggestions for setting up a psychedelic study.Journal of psychopharmacology (Oxford, England) · 2026
    Article
  10. Article
  11. Article
  12. Review
  13. Article
  14. Article
  15. Article
  16. Article
  17. Review
  18. Psychedelic therapy and postpartum depression: priorities and prospects.Therapeutic advances in psychopharmacology · 2026
    Review
  19. Article
  20. Concomitant use of antidepressants and classic psychedelics: A scoping review.Journal of psychopharmacology (Oxford, England) · 2025
    Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

4 authors.

Chloé Pronovost-MorganFaculty of Medicine and Health Sciences, McGill University, Montreal, Quebec, Canada. chloe.pronovost-morgan@mail.mcgill.ca.ORCID http://orcid.org/0000-0002-8386-4925
Kyle T GreenwayCentre for Psychedelic Research, Department of Brain Sciences, Imperial College London, London, UK. kyle.greenway@mcgill.ca.ORCID http://orcid.org/0000-0002-7829-493X
Leor RosemanCentre for Psychedelic Research, Department of Brain Sciences, Imperial College London, London, UK. l.roseman@exeter.ac.uk.ORCID http://orcid.org/0000-0001-9990-6029
ReSPCT Experts

Funding

Substance Use Disorders Treatment/Services Research Training ProgramT32DA007250 · NIDA · UNIVERSITY OF CALIFORNIA, SAN FRANCISCO · PI Derek D Satre, Janice Y Tsoh · 1991 to 2026
$7.4M
TRAINING OF ARTHRITIS RESEARCH SCIENTISTST32AR007080 · NIAMS · UNIVERSITY OF MICHIGAN AT ANN ARBOR · PI Jason Knight · 1986 to 2026
$6.3M
Bundesministerium für Bildung und Forschung (Federal Ministry of Education and Research) 01GGP2214DBundesministerium für Bildung und Forschung (Federal Ministry of Education and Research) 01GP2214ADH | National Institute for Health Research (NIHR) CS-2017-17-007Foundation for the National Institutes of Health (Foundation for the National Institutes of Health, Inc.) T32DA007250Mind and Life Institute Varela awardNIAMS NIH HHS T32 AR007080NIDA NIH HHS T32 DA007250Schweizerischer Nationalfonds zur Förderung der Wissenschaftlichen Forschung (Swiss National Science Foundation) P500PM_210867U.S. Department of Health & Human Services | NIH | National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) T32AR007080-44S1
6 · The paper itself

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.

Indexed as

Clinical Trials as TopicDelphi TechniqueHallucinogensHumansResearch DesignHallucinogens

Identifiers

PMID40461819
PMCPMC12283393

What OpenQuestion holds

Textmetadata
LicenceCC BY
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Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.