Evidence map›Paper›PMID 36017784›Full record

SynthesisJournal of psychopharmacology (Oxford, England)2022

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

Joost J Breeksema, Bouwe W Kuin, Jeanine Kamphuis, Wim van den Brink, Eric Vermetten, Robert A Schoevers

Open access · greenAbstract readSystematic Review
In one paragraph

Synthesis in Journal of psychopharmacology (Oxford, England), 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 69 papers, 7 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
69citing papers in PubMed, 7 pooled it
29.7field-weighted citation impact, top 1% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

69 citing papers in PubMed, 7 syntheses or guidelines pooled it, 162 citations in OpenAlex.

  1. Pooled it
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  5. Side-effects of mdma-assisted psychotherapy: a systematic review and meta-analysis.Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology · 2024
    Pooled it
  6. Pooled it
  7. Pooled it
  8. Psilocybin therapy for mood dysfunction in Parkinson's disease: an open-label pilot trial.Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology · 2025
    Trial
  9. Psilocybin-assisted neurofeedback for the improvement of executive functions: a randomized semi-naturalistic-lab feasibility study.Philosophical transactions of the Royal Society of London. Series B, Biological sciences · 2024
    Trial
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  14. A contemporary exploration of motivations and practices of psychedelic use among emerging adult cannabis users in the United States: A qualitative analysis.Psychology of addictive behaviors : journal of the Society of Psychologists in Addictive Behaviors · 2026
    Article
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  16. Article
  17. Review
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  20. Article

9 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

6 authors at 3 institutions in 1 country.

Joost J BreeksemaDepartment of Psychiatry, University of Groningen, University Medical Center Groningen, Groningen, The Netherlands.ORCID 0000-0002-8787-4610
Bouwe W KuinDepartment of Psychiatry, University of Groningen, University Medical Center Groningen, Groningen, The Netherlands.
Jeanine KamphuisDepartment of Psychiatry, University of Groningen, University Medical Center Groningen, Groningen, The Netherlands.
Wim van den BrinkDepartment of Psychiatry, Amsterdam University Medical Center, Amsterdam, The Netherlands.
Eric VermettenDepartment of Psychiatry, Leiden University Medical Center, Leiden, The Netherlands.ORCID 0000-0003-0579-4404
Robert A SchoeversDepartment of Psychiatry, University of Groningen, University Medical Center Groningen, Groningen, The Netherlands.
University Medical Center Groningen · NLAmsterdam University Medical Centers · NLLeiden University Medical Center · NL

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionSmall-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.

objectiveTo systematically review the presence of AEs during and after administration of serotonergic psychedelics and 3,4-methyenedioxymethamphetamine (MDMA) in clinical studies.

methodsWe systematically searched PubMed, PsycINFO, Embase, and ClinicalTrials.gov for clinical trials with psychedelics since 2000 describing the results of quantitative and qualitative studies.

resultsWe 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.

conclusionsAEs 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.

Indexed as

BanisteriopsisHallucinogensN-Methyl-3,4-methylenedioxyamphetamineHeadacheHumansLysergic Acid DiethylamidePsilocybinHallucinogensLysergic Acid DiethylamideN-Methyl-3,4-methylenedioxyamphetaminePsilocybinadverse effectsadverse eventsayahuascaLSDMDMApsilocybinPsychedelics

Identifiers

PMID36017784
PMCPMC9548934
OpenAlexW4293194637

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.