Ten practical suggestions for setting up a psychedelic study

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.