Ten practical suggestions for setting up a psychedelic study.
Alice Caulfield, Matthew Butler, Mitul A. Mehta
Journal of psychopharmacology (Oxford, England) June 16, 2026 DOI: 10.1177/02698811261458350 (opens in new tab)
Study at a glance
AI-extracted from the abstract| Characteristics | Review Peer reviewed |
|---|---|
| Keywords | Schedule 1 Mechanistic study Non-ctimp Psychedelic Study design |
| Key findings | The article provides practical guidance for navigating challenges in setting up human psychedelic studies, including study design, legislation, and drug sourcing. |
Abstract
The therapeutic potential of psychedelics is currently being explored in a range of neuropsychiatric conditions. Nevertheless, their designation as Schedule 1 substances causes substantial regulatory and economic barriers to research. Rigorous human mechanistic studies are required to address the critical knowledge gaps surrounding the mechanisms underlying the putative treatment effects of psychedelics. This article presents practical guidance for navigating challenges relating to study design, legislation, and drug sourcing, to assist researchers in navigating the complex process of setting up human psychedelic studies, drawing on our experience of setting up non-clinical studies in the United Kingdom, while acknowledging that some of the content will be relevant for investigator-initiated studies more broadly.