A total of 598 unique patients were included in a review of associated with psychedelics and MDMA.
The review encompassed 44 articles, consisting of 34 quantitative and 10 qualitative studies.
Commonly reported acute adverse events included nausea, headaches, and anxiety across various diagnoses and substances.
Late adverse events reported involved headaches, fatigue, low mood, and anxiety, particularly with MDMA.
One serious adverse event, an increase in premature ventricular contractions, required brief hospitalization during MDMA treatment.
There is a possibility that psychologically challenging experiences during treatment could have therapeutic benefits.
Adverse events are likely underreported due to inadequate assessment methods and study design.
Simplified
INTRODUCTION: Small-scale clinical studies with psychedelic drugs have shown promising results for the treatment of several mental disorders. Before psychedelics become registered medicines, it is important to know the full range of (AEs) for making balanced treatment decisions.
OBJECTIVE: To systematically review the presence of AEs during and after administration of serotonergic psychedelics and 3,4-methyenedioxymethamphetamine (MDMA) in clinical studies.
METHODS: We systematically searched PubMed, PsycINFO, Embase, and ClinicalTrials.gov for clinical trials with psychedelics since 2000 describing the results of quantitative and qualitative studies.
RESULTS: We included 44 articles (34 quantitative + 10 qualitative), describing treatments with MDMA and serotonergic psychedelics (psilocybin, lysergic acid diethylamide, and ayahuasca) in 598 unique patients. In many studies, AEs were not systematically assessed. Despite this limitation, treatments seemed to be overall well tolerated. Nausea, headaches, and anxiety were commonly reported acute AEs across diagnoses and compounds. Late AEs included headaches (psilocybin, MDMA), fatigue, low mood, and anxiety (MDMA). One serious AE occurred during MDMA administration (increase in premature ventricular contractions requiring brief hospitalization); no other AEs required medical intervention. Qualitative studies suggested that psychologically challenging experiences may also be therapeutically beneficial. Except for ayahuasca, a large proportion of patients had prior experience with psychedelic drugs before entering studies.
CONCLUSIONS: AEs are poorly defined in the context of psychedelic treatments and are probably underreported in the literature due to study design (lack of systematic assessment of AEs) and sample selection. Acute challenging experiences may be therapeutically meaningful, but a better understanding of AEs in the context of psychedelic treatments requires systematic and detailed reporting.
Key numbers
44
Total Studies
Total number of studies analyzed for .
598
Unique Patients
Total unique patients treated with psychedelics or MDMA.
56%
Prior Experience
Percentage of patients with prior psychedelic use in MDMA studies.
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The authors declared the following potential conflicts of interest with respect to the research, authorship, and/or publication of this article: RS received a research grant from the Netherlands Organization Health Research and Development for a clinical study on oral esketamine, and is the co-investigator of a clinical study on psilocybin funded by Compass Pathways. He has also received an educational grant from Janssen, Pharmaceutical Companies of Johnson and Johnson, and honorarium from Clexio Biosciences. EV is the principal investigator of a clinical trial on MDMA funded by the Multidisciplinary Association for Psychedelic Studies. WvdB has been a consultant for Janssen Netherlands and is a member of the Scientific Advisory Board of Clearmind. JJB, BK and JK declare no conflicts of interest.
