How to set up a psychedelic study: Unique considerations for research involving human participants
Marcus J. Glennon, Catherine Bird, Prateek Yadav, Patrick Kleine, Shayam Suseelan, Christina Boman-Markaki, Vasileia Kotoula, Matt Butler, Robert Leech, Leor Roseman, David Erritzøe, Deepak P. Srivastava, Celia J. A. Morgan, Christopher Timmermann, Greg Cooper, Jeremy I Skipper, James Rucker, Sunjeev K. Kamboj, Mitul A. Mehta, Ravi Das, Anjali Bhat
arXiv Preprint Archive March 28, 2025 preprint
Study at a glance
AI-extracted from the abstract| Characteristics | Review |
|---|---|
| Keywords | Q-bio.nc Psychedelic research Psychedelic trials Psychedelic studies Psychedelic science Research methodology Clinical trial design Research guidelines Best practices Research protocols Psychopharmacology Drug development Compound research Healthcare policy Regulatory guidelines Research policy Medical policy |
| Key findings | The paper provides a practical, experience-based guide for setting up psychedelic research studies, identifying unique challenges and areas of debate. |
Abstract
Setting up a psychedelic study can be a long, arduous, and kafkaesque process. This rapidly-developing field poses several unique challenges for researchers, necessitating a range of considerations that have not yet been standardised. Many of the complexities inherent to psychedelic research also challenge existing assumptions around, for example, approaches to psychiatric prescribing, the conceptual framing of the placebo effect, and definitions of selfhood. This review paper brings together several of the major psychedelic research teams across the United Kingdom to formalise these unique considerations, identify continuing areas of debate, and provide a practical, experience-based guide, with recommendations for policymakers and future researchers intending to set up a psychedelic research study or clinical trial. We approach this such that the paper can either be read end to end, or treated as a manual: readers can dip into relevant sections as needed.