Psychedelic-assisted psychotherapy: The need to monitor adverse events.
Krj Schruers, N K Leibold
Journal of Psychopharmacology May 21, 2025 DOI: 10.1177/02698811251340929 (opens in new tab)
Study at a glance
AI-extracted from the abstract| Characteristics | Review Peer reviewed |
|---|---|
| Topics | Psychedelic-assisted therapy |
| Keywords | Adverse events Hallucinogenic therapy Clinical safety Treatment safety Psychedelic-assisted treatment Vital signs monitoring Patient observation |
| Key findings | More rigorous assessment of adverse effects in psychedelic-assisted therapies is needed to promote safe use and clinical implementation. |
Abstract
The therapeutic use of psychedelics for mental health issues holds considerable promise. However, systematic assessment of adverse events associated with these substances has received relatively little attention. Here, we discuss several considerations concerning the assessment of adverse events in psychedelic-assisted therapies. We discuss the preference for using the term "adverse effects" over "side effects", as well as the ongoing debate regarding which substances are classified as psychedelic. We also provide recommendations on when and how to assess adverse effects, for example the importance to study them in any kind of therapy involving psychedelics, and using comprehensive monitoring of a wide range of physical parameters in combination with behavioral outcomes and the individual's experience, at baseline and throughout the study. Also, sex-specific differences should be considered. Furthermore, we highlight several significant studies that have addressed these aspects. In summary, psychedelics offer great promise as a potential treatment (add-on) option in psychiatry, but more rigorous assessment of adverse effects is needed to promote safe use and implementation in clinical practice.
Comparable studies
Other narrative reviews on psychedelic-assisted therapy, most cited first.
Citations in the library
Cites 27
- Single-Dose Psilocybin for a Treatment-Resistant Episode of Major Depression. New England Journal of Medicine November 3, 2022
- Psilocybin induces schizophrenia-like psychosis in humans via a serotonin-2 agonist action Neuroreport December 1, 1998
- Psilocybin with psychological support for treatment-resistant depression: six-month follow-up. Psychopharmacology November 8, 2017
- MDMA-assisted therapy for severe PTSD: a randomized, double-blind, placebo-controlled phase 3 study. Nature Medicine June 1, 2021
- Acute Effects of Lysergic Acid Diethylamide in Healthy Subjects Biological Psychiatry November 29, 2014
and 22 more in the library