Ten practical suggestions for setting up a psychedelic study.
Alice Caulfield, Matthew Butler, Mitul A Mehta
Journal of psychopharmacology (Oxford, England) June 16, 2026 Peer reviewed DOI: 10.1177/02698811261458350 via PubMed
Summary
The article discusses the challenges and considerations involved in conducting human mechanistic studies on psychedelics, which have potential therapeutic effects for neuropsychiatric conditions. It emphasizes the regulatory and economic barriers due to their Schedule 1 designation and provides practical guidance for researchers on study design, legislation, and drug sourcing based on experiences from non-clinical studies in the UK.
Study at a glance
| Design | mechanistic study |
|---|---|
| Key finding | The article highlights the need for rigorous human mechanistic studies to understand the treatment effects of psychedelics. |
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.