Ten practical suggestions for setting up a psychedelic study.

Psychedelics show promise for treating neuropsychiatric conditions, but their Schedule 1 status creates regulatory and economic hurdles for research. Rigorous human mechanistic studies are needed to understand how psychedelics produce therapeutic effects. This article offers practical guidance on study design, legislation, and drug sourcing, based on the authors' experience setting up non-clinical studies in the UK. The guidance aims to help researchers navigate the complex process of establishing human psychedelic studies, with some content applicable to investigator-initiated studies more broadly.

Study at a glance

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.