MDMA-assisted psychotherapy for post-traumatic stress disorder: The devil is in the detail

Recent years have seen escalating media, public and scientific interest in psychedelic medicine. Australia and New Zealand have been late to this research; however, in the past 2 years, rapid developments suggest that this is changing. Here, we argue for the need to critically review existing evidence in this field to guide future directions. We focus on (+/-)3,4-methylenedioxymethamphetamine-assisted psychotherapy for post-traumatic stress disorder, currently the most advanced area of clinical psychedelic research. Food and Drug Administration approval of this approach is likely in 2023, based on a series of promising findings. We provide a detailed overview of Phase 2 and 3 studies published to date. We identify several concerns related to this body of evidence, including methodological/design limitations and broader factors - such as robust involvement of advocacy groups in research and reliance on non-government financing leading to simplistic public messaging - that compound the methodological issues identified. We propose steps for future improvement, including the need for large, high-quality, independent efficacy trials with design enhancements, effectiveness trials and for researchers to consider their own engagement with media and public messaging around these modalities. We argue that, notwithstanding promising findings to date, rigorous and dispassionate science is needed to move the field forward and safeguard the welfare of participants.

Automated summary

Recent years have seen increased interest in psychedelic medicine globally, although Australia and New Zealand have been slower to join this research. However, rapid developments in the past 2 years suggest a changing landscape in these countries. This article argues for a critical review of existing evidence in this field, particularly focusing on the most advanced area of clinical psychedelic research, MDMA-assisted psychotherapy for post-traumatic stress disorder. The article highlights concerns regarding methodological/design limitations, as well as broader issues such as the involvement of advocacy groups and reliance on non-government financing leading to simplified public messaging.