Can psilocybin be safely administered under medical supervision? A systematic review of adverse event reporting in clinical trials
Drug Science, Policy and Law 2022 DOI: 10.1177/20503245221085222 (opens in new tab)
Study at a glance
AI-extracted from the abstract| Characteristics | Systematic review Peer reviewed |
|---|---|
| Sample size | 52 |
| Population | Clinical trials of psilocybin administered by a medical professional |
| Topics | Psilocybin |
| Keywords | Clinical trial Adverse effect Tolerability Hallucinogen Pharmacology |
| Citations | 30 |
| Key findings | None of the 52 included clinical trials reported psilocybin to be unsafe, and 27 suggested it is safe to administer under proper medical supervision. |
Abstract
This systematic review investigates whether clinical trials of psilocybin support criterion number three of the drug's schedule I designation: There is a lack of accepted safety for use of the drug or other substance under medical supervision. Data were collected by using the PubMed database and conducting a search on November 24, 2021, with the search term psilocybin and applying the clinical trial filter. Only primary reports on the sole administration of psilocybin by a medical professional were included for analysis, excluding trials wherein psilocybin was not administered, trials wherein psilocybin was exclusively co-administered with other drugs, articles that were not clinical trials, and articles that were repeat analyses of already included trials. 52 included publications were closely examined for reports of adverse events, drug tolerability, and drug safety. Zero of these articles reported psilocybin to be unsafe, while 27 of the included trials suggested that psilocybin is safe to administer under proper medical supervision.
Comparable studies
Other systematic reviews and meta-analyses on psilocybin, most cited first.
| Study | Year | Design | Participants |
|---|---|---|---|
| Therapeutic effects of classic serotonergic psychedelics: A systematic review of modern‐era clinical studies Patients with cancer- or illness-related anxiety and depression, major depressive... | 2020 | Systematic review | n = 188 |
| Blinding and expectancy confounds in psychedelic randomized controlled trials | 2021 | Systematic review | |
| Antidepressive, anxiolytic, and antiaddictive effects of ayahuasca, psilocybin and lysergic acid diethylamide (LSD): a systematic review of clinical trials published in the last 25 years Patients from included clinical trials | 2016 | Systematic review | |
| The experimental effects of psilocybin on symptoms of anxiety and depression: A meta-analysis People with elevated symptoms of anxiety and depression | 2020 | Meta-analysis | n = 117 |
| Default Mode Network Modulation by Psychedelics: A Systematic Review Participants from included studies | 2022 | Systematic review |
Citations in the library
Cited by 29
- Psilocybin-assisted therapy for depression: A systematic review and meta-analysis. Psychiatry Research November 1, 2023
- Adolescent Psychedelic Use and Psychotic or Manic Symptoms JAMA Psychiatry March 13, 2024
- Psychedelic use and psychiatric risks. Psychopharmacology July 1, 2025
- Giving consent to the ineffable Neuroethics February 15, 2024
- Assessing the risk of symptom worsening in psilocybin-assisted therapy for depression: A systematic review and individual participant data meta-analysis Psychiatry Research July 23, 2023
and 24 more in the library
Cites 53
- Psilocybin produces substantial and sustained decreases in depression and anxiety in patients with life-threatening cancer: A randomized double-blind trial Journal of Psychopharmacology November 30, 2016
- Rapid and sustained symptom reduction following psilocybin treatment for anxiety and depression in patients with life-threatening cancer: a randomized controlled trial Journal of Psychopharmacology November 30, 2016
- Psilocybin can occasion mystical-type experiences having substantial and sustained personal meaning and spiritual significance Psychopharmacology July 7, 2006
- Trial of Psilocybin versus Escitalopram for Depression New England Journal of Medicine April 14, 2021
- Effects of Psilocybin-Assisted Therapy on Major Depressive Disorder JAMA Psychiatry November 4, 2020
and 48 more in the library