PMID- 36017784
OWN - NLM
STAT- MEDLINE
DCOM- 20221010
LR  - 20221120
IS  - 1461-7285 (Electronic)
IS  - 0269-8811 (Print)
IS  - 0269-8811 (Linking)
VI  - 36
IP  - 10
DP  - 2022 Oct
TI  - Adverse events in clinical treatments with serotonergic psychedelics and MDMA: A 
      mixed-methods systematic review.
PG  - 1100-1117
LID - 10.1177/02698811221116926 [doi]
AB  - 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.
FAU - Breeksema, Joost J
AU  - Breeksema JJ
AUID- ORCID: 0000-0002-8787-4610
AD  - Department of Psychiatry, University of Groningen, University Medical Center 
      Groningen, Groningen, The Netherlands.
AD  - Department of Psychiatry, Leiden University Medical Center, Leiden, The 
      Netherlands.
AD  - OPEN Foundation, Amsterdam, The Netherlands.
FAU - Kuin, Bouwe W
AU  - Kuin BW
AD  - Department of Psychiatry, University of Groningen, University Medical Center 
      Groningen, Groningen, The Netherlands.
FAU - Kamphuis, Jeanine
AU  - Kamphuis J
AD  - Department of Psychiatry, University of Groningen, University Medical Center 
      Groningen, Groningen, The Netherlands.
FAU - van den Brink, Wim
AU  - van den Brink W
AD  - Department of Psychiatry, Amsterdam University Medical Center, Amsterdam, The 
      Netherlands.
FAU - Vermetten, Eric
AU  - Vermetten E
AUID- ORCID: 0000-0003-0579-4404
AD  - Department of Psychiatry, Leiden University Medical Center, Leiden, The 
      Netherlands.
FAU - Schoevers, Robert A
AU  - Schoevers RA
AD  - Department of Psychiatry, University of Groningen, University Medical Center 
      Groningen, Groningen, The Netherlands.
LA  - eng
PT  - Journal Article
PT  - Review
PT  - Systematic Review
DEP - 20220826
PL  - United States
TA  - J Psychopharmacol
JT  - Journal of psychopharmacology (Oxford, England)
JID - 8907828
RN  - 0 (Hallucinogens)
RN  - 2RV7212BP0 (Psilocybin)
RN  - 8NA5SWF92O (Lysergic Acid Diethylamide)
RN  - KE1SEN21RM (N-Methyl-3,4-methylenedioxyamphetamine)
SB  - IM
MH  - *Banisteriopsis
MH  - *Hallucinogens
MH  - Headache/chemically induced
MH  - Humans
MH  - Lysergic Acid Diethylamide
MH  - *N-Methyl-3,4-methylenedioxyamphetamine/adverse effects
MH  - Psilocybin/therapeutic use
PMC - PMC9548934
OTO - NOTNLM
OT  - LSD
OT  - MDMA
OT  - Psychedelics
OT  - adverse effects
OT  - adverse events
OT  - ayahuasca
OT  - psilocybin
COIS- 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.
EDAT- 2022/08/27 06:00
MHDA- 2022/10/12 06:00
PMCR- 2022/10/10
CRDT- 2022/08/26 06:02
PHST- 2022/08/27 06:00 [pubmed]
PHST- 2022/10/12 06:00 [medline]
PHST- 2022/08/26 06:02 [entrez]
PHST- 2022/10/10 00:00 [pmc-release]
AID - 10.1177_02698811221116926 [pii]
AID - 10.1177/02698811221116926 [doi]
PST - ppublish
SO  - J Psychopharmacol. 2022 Oct;36(10):1100-1117. doi: 10.1177/02698811221116926. 
      Epub 2022 Aug 26.