PMID- 35301934 OWN - NLM STAT- MEDLINE DCOM- 20220725 LR - 20220727 IS - 1744-764X (Electronic) IS - 1474-0338 (Linking) VI - 21 IP - 6 DP - 2022 Jun TI - Ayahuasca, a potentially rapid acting antidepressant: focus on safety and tolerability. PG - 789-801 LID - 10.1080/14740338.2022.2054988 [doi] AB - INTRODUCTION: Ayahuasca is a psychedelic brew originally used by Amazonian indigenous groups and in religious rituals. Pre-clinical and observational studies have demonstrated its possible potential as an antidepressant, and open- and placebo-controlled clinical trials corroborated these results. For it to become an approved treatment for depression, its safety and tolerability need to be assessed and documented. AREAS COVERED: We have gathered data regarding the occurrence of adverse events (AEs) in all reported randomized, placebo-controlled trials with healthy and clinical populations involving ayahuasca administration (n = 108 ayahuasca administrations). We systematically categorized these results, recorded their prevalence, and discussed the possible mechanisms related to their emergence. EXPERT OPINION: There were no reports of serious AEs, indicating a relative safety of ayahuasca administration in controlled settings. Most common AEs included nausea, vomiting, headaches, and transient increases in cardiovascular measurements. Ayahuasca research is still in its infancy, especially concerning the absence of large and robust clinical trials to verify its antidepressant effects. Dose standardization, legal prohibition of the possession of its alkaloids and how traditional communities will be compensated if ayahuasca becomes an approved medicine are the biggest obstacles to overcome for its future use in the therapeutic context. FAU - Rossi, Giordano Novak AU - Rossi GN AUID- ORCID: 0000-0002-1952-1207 AD - Department of Neurosciences and Behavior, Ribeirao Preto Medical School, University of Sao Paulo, Ribeirao Preto, Brazil. FAU - Dias, Isabella Caroline da Silva AU - Dias ICDS AD - Department of Neurosciences and Behavior, Ribeirao Preto Medical School, University of Sao Paulo, Ribeirao Preto, Brazil. FAU - Baker, Glen AU - Baker G AD - National Institute for Translational Medicine (INCT-TM) CNPq, Brazil. AD - Department of Psychiatry (Neurochemical Research Unit) and Neuroscience & Mental Health Institute, University of Alberta, Edmonton, Alberta, Canada. FAU - Bouso Saiz, Jose Carlos AU - Bouso Saiz JC AUID- ORCID: 0000-0003-1115-9407 AD - Department of Neurosciences and Behavior, Ribeirao Preto Medical School, University of Sao Paulo, Ribeirao Preto, Brazil. AD - International Center for Ethnobotanical Education, Research and Services, ICEERS,Barcelona, Spain. AD - Medical Anthropology Research Center (MARC), Universitat Rovira i Virgili, Tarragona, Spain. FAU - Dursun, Serdar M AU - Dursun SM AD - National Institute for Translational Medicine (INCT-TM) CNPq, Brazil. AD - Department of Psychiatry (Neurochemical Research Unit) and Neuroscience & Mental Health Institute, University of Alberta, Edmonton, Alberta, Canada. FAU - Hallak, Jaime E C AU - Hallak JEC AD - Department of Neurosciences and Behavior, Ribeirao Preto Medical School, University of Sao Paulo, Ribeirao Preto, Brazil. AD - National Institute for Translational Medicine (INCT-TM) CNPq, Brazil. AD - Department of Psychiatry (Neurochemical Research Unit) and Neuroscience & Mental Health Institute, University of Alberta, Edmonton, Alberta, Canada. FAU - Dos Santos, Rafael G AU - Dos Santos RG AUID- ORCID: 0000-0003-2388-4745 AD - Department of Neurosciences and Behavior, Ribeirao Preto Medical School, University of Sao Paulo, Ribeirao Preto, Brazil. AD - National Institute for Translational Medicine (INCT-TM) CNPq, Brazil. AD - International Center for Ethnobotanical Education, Research and Services, ICEERS,Barcelona, Spain. LA - eng PT - Journal Article DEP - 20220323 PL - England TA - Expert Opin Drug Saf JT - Expert opinion on drug safety JID - 101163027 RN - 0 (Antidepressive Agents) SB - IM MH - *Antidepressive Agents/adverse effects MH - *Banisteriopsis/adverse effects MH - Humans MH - Randomized Controlled Trials as Topic OTO - NOTNLM OT - adverse events OT - antidepressant OT - ayahuasca OT - safety EDAT- 2022/03/19 06:00 MHDA- 2022/07/26 06:00 CRDT- 2022/03/18 08:39 PHST- 2022/03/19 06:00 [pubmed] PHST- 2022/07/26 06:00 [medline] PHST- 2022/03/18 08:39 [entrez] AID - 10.1080/14740338.2022.2054988 [doi] PST - ppublish SO - Expert Opin Drug Saf. 2022 Jun;21(6):789-801. doi: 10.1080/14740338.2022.2054988. Epub 2022 Mar 23.