Anxiety DisordersHeadache Disorders (Cluster & Migraine)Safety & Risk ManagementChronic PainAyahuascaLSDMDMAPsilocybin

Adverse events in clinical treatments with serotonergic psychedelics and MDMA: A mixed-methods systematic review

This mixed-methods systematic review of 44 clinical studies (598 patients) found serotonergic psychedelics and MDMA to be generally well tolerated but noted that adverse events were poorly defined and likely underreported. Common acute AEs were nausea, headache and anxiety, late AEs included fatigue and low mood, one serious MDMA-related cardiac event occurred, and qualitative data suggest challenging psychological experiences can also have therapeutic value, underlining the need for systematic, detailed AE assessment in future trials.

Authors

  • Robert Schoevers
  • Jeanine Kamphuis
  • Eric Vermetten

Published

Journal of Psychopharmacology
meta Study

Abstract

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 adverse events (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.

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Research Summary of 'Adverse events in clinical treatments with serotonergic psychedelics and MDMA: A mixed-methods systematic review'

Introduction

Clinical research into serotonergic psychedelics and MDMA has reported promising therapeutic effects for a range of mental disorders, but much of the evidence comes from small, selective samples. Earlier literature described adverse reactions after non-medical use (for example panic reactions, transient psychoses and flashbacks) and reviews up to 1984 characterised harms along a continuum from acute, time-limited reactions to more persistent problems. As clinical trials expand and Phase III studies approach completion, determining the full spectrum of adverse events (AEs) that may occur during or after medically supervised psychedelic treatments is critical for balanced benefit–risk assessments and for identifying patients who may be at greater risk of harm. Breeksema and colleagues set out to systematically review AEs reported in clinical studies of classic/serotonergic hallucinogens (psilocybin, LSD, ayahuasca) and the entactogen MDMA in patients with diagnosed mental disorders. The review sought both quantitative and qualitative evidence on acute (during or on the day of dosing) and late (after the dosing day) AEs, using an exploratory mixed-methods approach to capture the range, timing and contextual interpretation of adverse reactions in clinical settings.

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Study Details

References (83)

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