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SYSTEMATIC REVIEW article
Front. Psychiatry
Sec. Psychopharmacology
Volume 15 - 2024 |
doi: 10.3389/fpsyt.2024.1477996
This article is part of the Research Topic Safety and Side Effects of Psychotropic Medications, volume III View all 6 articles
Short-term safety and tolerability profile of 5-methoxy-N,N-dimethyltryptamine (5-MeO-DMT) in human subjects: a systematic review of clinical trials
Provisionally accepted- Medical University of Gdansk, Gdańsk, Poland
Introduction: Psychedelic agents have regained the attention of pharmaceutical companies as promising treatments for depressive episodes. 5-Methoxy-N,N-dimethyltryptamine (5-MeO-DMT), an atypical psychedelic, is emerging as a potentially effective, novel rapid-acting antidepressant. In this systematic review, we analyze the safety and tolerability evidence from clinical trials. Methods: Following the Preferred Reporting Items for Systematic Reviews and Meta-analyses (PRISMA) guidelines, electronic databases (PubMed, SCOPUS, Web of Science, EMBASE, and EBSCO) were searched from inception until 15 May 2024 to identify clinical trials (regardless of phase) reporting on short-term safety and tolerability profile of 5-MeO-DMT using the following keywords in various combinations: 5-methoxy-N, N-dimethyltryptamine, 5-MeO-DMT, safety, adverse, adverse reaction, side effects, tolerability, dropout, healthy volunteer, healthy participant, depression, major depressive disorder. Only studies written in English were considered. Results: Initial search yielded 100 records, out of which 3 met the inclusion criteria. These studies reported on the results from clinical trial phases I and I/II, with a total of 78 participants included; two studies involved healthy volunteers, and one included patients with treatment-resistant depression. Although the data is limited, it confirms a good short-term safety and tolerability profile for 5-MeO-DMT, with no serious adverse events (SAEs) reported. Furthermore, no drop-outs were reported. Conclusion: 5-MeO-DMT administration in human subjects presents favorable short-term safety and tolerability profile. Importantly, no SAEs have been documented, and no adverse events led to participant withdrawal from the studies There is a need for future randomized, double-blind, placebo-controlled trials with larger samples and follow-up to assess potential chronic adverse events.
Keywords: 5-methoxy-N,N-dimethyltryptamine, 5-MeO-DMT, Safety, tolerability, adverse events, side effects
Received: 08 Aug 2024; Accepted: 30 Aug 2024.
Copyright: © 2024 Kwaśny, Wilkowska and Cubała. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) or licensor are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.
* Correspondence:
Aleksander Kwaśny, Medical University of Gdansk, Gdańsk, Poland
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