The safety of psilocybin-assisted psychotherapy: A systematic review
Rosana Freitas, Efstathia Stephanie Gotsis, Alexander T. Gallo, Bernadette M. Fitzgibbon, Neil W. Bailey, Paul B. Fitzgerald
Australian & New Zealand Journal of Psychiatry December 13, 2024 DOI: 10.1177/00048674241289024 (opens in new tab)
Study at a glance
AI-extracted from the abstract| Characteristics | Systematic review Peer reviewed |
|---|---|
| Intervention | psilocybin-assisted psychotherapy |
| Topics | Psilocybin Psychedelic-assisted therapy |
| Keywords | Adverse effect Suicidal ideation Clinical trial Systematic review Psychotherapist Clinical psychology Hallucinogen |
| Citations | 14 |
| Key findings | Psilocybin-assisted psychotherapy shows a generally supported safety profile, but adverse event reporting varies widely across trials, and suicidal ideation or behavior, though infrequent, occurs mainly in those with prior suicidality history. |
Abstract
Introduction: Psilocybin, a classical psychedelic, has been rescheduled for use in psilocybin-assisted psychotherapy for treatment-resistant depression in Australia. While evidence for its use is promising, understanding the associated risks is crucial. Accordingly, this review aims to collate adverse event data from psilocybin-assisted psychotherapy clinical trials and evaluate its definition, way of measurement and reporting.
Methods: A systematic method was employed to identify clinical trials related to the use of psilocybin-assisted psychotherapy in clinical populations that reported on adverse events. The quality assessment focused on relevant criteria related to adverse event definition, monitoring and reporting methods.
Results: A total of 24 articles were included. The studies reported heterogeneous psilocybin doses, study designs and indications. Physical and psychological adverse events during and after psilocybin sessions were examined, revealing variations in measuring, reporting methods and occurrences. The most common adverse events during and after sessions included elevated blood pressure, headaches, nausea, vomiting, fatigue and anxiety. In addition, both suicidal ideation and behaviour were observed infrequently and mainly in participants with a history of suicidal ideation or suicide attempt(s).
Conclusion: The review highlights the need to standardise the defintion of an adverse event, including how they are measured and reported, in psychedelic clinical trials to ensure consistent reporting across studies. In addition, screening participants for suicidality history and ongoing monitoring remains important, given the potential risk identified in the literature. However, based on the available data, the safety of psilocybin-assisted psychotherapy is generally supported, and no deaths were attributed to psilocybin. Nevertheless, cautious optimism is needed due to the preliminary nature and heterogeneity of the safety data.
Comparable studies
Other systematic reviews and meta-analyses on psilocybin and psychedelic-assisted therapy, most cited first.
| Study | Year | Design | Participants |
|---|---|---|---|
| A Meta-Analysis of Placebo-Controlled Trials of Psychedelic-Assisted Therapy | 2020 | Systematic review | |
| Psychedelic therapy for depressive symptoms: A systematic review and meta-analysis. Participants in studies of psychedelic therapy for depressive symptoms (Major... | 2023 | Systematic review with meta-analysis | n = 14 |
| Psilocybin-assisted therapy for depression: A systematic review and meta-analysis. Patients diagnosed with life-threatening illnesses or major depressive disorder | 2023 | Systematic review and meta-analysis | n = 686 |
| United States National Institutes of Health grant funding for psychedelic-assisted therapy clinical trials from 2006-2020. | 2022 | Systematic review | |
| Safety and risk assessment of psychedelic psychotherapy: A meta-analysis and systematic review. Human subjects in studies of psychedelic-assisted psychotherapy | 2024 | Systematic review and meta-analysis | n = 30 |