Validation of the Swiss Psychedelic Side Effects Inventory: Standardized assessment of adverse effects in studies of psychedelics and MDMA

A new standardized tool, the Swiss Psychedelic Side Effects Inventory (SPSI), was developed to systematically record side effects of psychedelics and MDMA in clinical studies. The SPSI includes 32 side effects with follow-up questions on severity, duration, impact, and treatment-relatedness. It was pilot tested in 145 participants from three studies and refined with expert feedback. The tool is designed for any study design and can be used as an interview or self-report at any time after treatment. Its systematic approach aims to improve clinical decisions, informed consent, and patient safety by providing consistent side effect data.

Study at a glance

Abstract

Introduction: Studies of psychedelic-assisted therapy with LSD, psilocybin, MDMA, and related substances show clinical promise but inadequately assess side effects. Measuring side effects is challenging because they are not always easily differentiated from treatment effects or disease symptoms and show high heterogeneity, variable duration and impact, and sensitivity to context. A systematic questionnaire describing important characteristics of side effects of psychedelics and MDMA would greatly improve on previous methods. We aimed to create a standardized tool for recording clinically relevant side effects of psychedelics and MDMA, including their severity, duration, impact, and treatment-relatedness.Methods: We constructed the Swiss Psychedelic Side Effects Inventory (SPSI) based on insights from previous research. It was pilot tested in 145 participants from three studies. Structured feedback from an expert panel was used to improve validity and feasibility. Results: The final SPSI contains 32 side effects and standardized follow-up questions about their severity, impact, treatment-relatedness, and duration. It is compatible with any study design and can be administered as an interview or self-report at any timepoint after treatment with psychedelics or MDMA.Limitations: The SPSI omits relatively unimportant side effects for brevity’s sake, though space for additional symptoms is given. Future studies are needed to confirm its validity in different contexts.Conclusions: The SPSI is available in English and German for collecting systematic data on side effects from psychedelics and MDMA. This information is vital for improving clinical decisions, informed consent, and patient safety.