Validation of the Swiss Psychedelic Side Effects Inventory: Standardized assessment of adverse effects in studies of psychedelics and MDMA.
Abigail E. Calder, Gregor Hasler
Journal of Affective Disorders November 15, 2024 DOI: 10.1016/j.jad.2024.08.091 (opens in new tab)
Study at a glance
AI-extracted from the abstract| Characteristics | Questionnaire development and pilot testing Peer reviewed |
|---|---|
| Sample size | 145 |
| Population | Participants from three studies of psychedelic-assisted therapy |
| Topics | MDMA |
| Keywords | Adverse effects Psychedelics Safety Side effects Psychedelic medicine Adverse drug reactions Clinical assessment tools MDMA Therapy Patient monitoring |
| Citations | 20 |
| Key points | The Swiss Psychedelic Side Effects Inventory (SPSI) is a standardized 32-item tool for recording side effects of psychedelics and MDMA, including severity, duration, impact, and treatment-relatedness. |
Abstract
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. 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. 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. 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. 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.
Comparable studies
Other cross-sectional and survey studies on MDMA, most cited first.
| Study | Year | Design | Participants |
|---|---|---|---|
| Recreational MDMA use in Sydney: a profile of ‘Ecstasy’ users and their experiences with the drug Recreational Ecstasy users recruited via snowball peer network | 1992 | Cross-sectional survey | n = 100 |
| Reducedin vivobinding to the serotonin transporter in the cerebral cortex of MDMA (‘ecstasy’) users Male regular ecstasy users and well-matched controls | 1999 | Cross-sectional association study | n = 20 |
| Patterns of simultaneous polysubstance use in drug using university students Drug-using university students | 2006 | Cross-sectional survey | n = 149 |
| Patterns of recreational drug use at dance events in Edinburgh, Scotland Drug users at dance events in Edinburgh, Scotland, UK, aged 16-47, 80% between 18 and... | 2001 | Cross-sectional survey | n = 122 |
| Acute, sub‐acute and long‐term subjective consequences of ‘ecstasy’ (MDMA) consumption in 430 regular users Regular MDMA users | 2003 | Cross-sectional study | n = 466 |
Citations in the library
Cited by 22
- Psychedelic‐assisted treatment for substance use disorder: A narrative systematic review Addiction January 30, 2025
- On Minimizing Risk and Harm in the Use of Psychedelics. Psychiatric Research and Clinical Practice February 11, 2025
- Naturalistic psychedelic therapy: The role of relaxation and subjective drug effects in antidepressant response Journal of Psychopharmacology September 20, 2024
- Emerging Medications for Treatment-Resistant Depression: A Review with Perspective on Mechanisms and Challenges Brain Sciences February 6, 2025
- Traumatic Psychedelic Experiences. Current Topics in Behavioral Neurosciences April 29, 2025
and 17 more in the library
Cites 25
- Human hallucinogen research: guidelines for safety. Journal of Psychopharmacology July 1, 2008
- Psychedelics and the essential importance of context. Journal of Psychopharmacology February 15, 2018
- Survey study of challenging experiences after ingesting psilocybin mushrooms: Acute and enduring positive and negative consequences Journal of Psychopharmacology August 31, 2016
- LSD-assisted psychotherapy for anxiety associated with a life-threatening disease: A qualitative study of acute and sustained subjective effects Journal of Psychopharmacology November 11, 2014
- The Challenging Experience Questionnaire: Characterization of challenging experiences with psilocybin mushrooms Journal of Psychopharmacology November 18, 2016
and 20 more in the library