This systematic review and meta-analysis (2024) examined the side effects of MDMA-assisted psychotherapy (MDMA-AP) across Phase II and III studies. Thirteen studies were included, with most showing an increase in side effects during medication sessions and the following week compared to control conditions. Despite these findings, the overall certainty of evidence was rated as very low to moderate, and the quality of side effects reporting was generally poor, suggesting further research is needed to fully understand the safety profile of MDMA-AP.
Abstract of Side-effects of mdma-assisted psychotherapy: a systematic review and meta-analysis
“Evidence suggests that MDMA-assisted psychotherapy (MDMA-AP) has therapeutic potential for treatment of psychiatric illness. We conducted the first comprehensive systematic review and meta-analysis of the side effects of MDMA-AP across indications. We also assessed the quality of side effects-reporting in published trials of MDMA-AP. PubMed, EMBASE, PsycINFO, MEDLINE and Cochrane Central Register of Controlled Trials (CENTRAL) were systematically searched. Phase 2 and 3 MDMA-AP studies were included; Phase 1 studies, which assessed MDMA without psychotherapy, were not. Quality of side effects-reporting was assessed against the CONSORT Harms 2022 guidelines. We also compared numbers of adverse events reported in publications to those recorded in ClinicalTrial.gov registers. Thirteen studies were included, with eight contributing to the meta-analysis. In Phase 2 studies, MDMA-AP was associated with increased odds of any side effect during medication sessions (OR = 1.67, 95%CI (1.12, 2.49)) and in the 7 days following (OR = 1.59, 95%CI (1.12, 2.24)) relative to control conditions. In Phase 3 studies, MDMA-AP was associated with increased odds of any adverse event during the treatment period relative to placebo-assisted psychotherapy (OR = 3.51, 95%CI (2.76, 4.46)). The majority of RCTs were rated as having high risk of bias. Certainty of the evidence was rated as very low to moderate according to the GRADE framework. No included RCT had adequate adherence to the CONSORT Harms 2022 recommendations and reporting rates were also low. Compared to placebo, MDMA-AP was associated with increased odds of side effects, which were largely transient and mild or moderate in severity. However, identified limitations in existing evidence indicate that further investigation is needed to better characterize the safety profile of MDMA-AP and guide implementation.”
Authors: Julia Colcott, Alexandre A. Guerin, Olivia Carter, Sally Meikle & Gillinder Bedi
Summary of Side-effects of mdma-assisted psychotherapy: a systematic review and meta-analysis
Introduction
In the past decade, research has gathered pace on the therapeutic use of 3,4-methylenedioxymethamphetamine (MDMA) in psychotherapy. While concerns exist about the unique potential for substances like MDMA – when combined with psychotherapy – to cause harm, several clinical trials are planned or ongoing.
A systematic review and meta-analysis of studies on the safety and tolerability of MDMA-AP was conducted. The study included the most recent Phase 3 study of MDMA-AP, and addressed concerns about the adequacy of safety reporting in this research.
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Side-effects of mdma-assisted psychotherapy: a systematic review and meta-analysis
https://doi.org/10.1038/s41386-024-01865-8
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Cite this paper (APA)
Colcott, J., Guerin, A. A., Carter, O., Meikle, S., & Bedi, G. (2024). Side-effects of MDMA-assisted Psychotherapy: A Systematic Review and Meta-analysis. Neuropsychopharmacology, 1-19.