MDMA-assisted psychotherapy for post-traumatic stress disorder: The devil is in the detail.
Gillinder Bedi, Susan M Cotton, Alexandre A Guerin, Henry J Jackson
The Australian and New Zealand journal of psychiatry April 1, 2023 Peer reviewed DOI: 10.1177/00048674221127186 via PubMed
Summary
MDMA-assisted psychotherapy for post-traumatic stress disorder is an advanced area of clinical psychedelic research, with FDA approval anticipated in 2023 due to promising findings. However, existing studies have methodological limitations and concerns related to advocacy group involvement and public messaging. To improve future research, large independent efficacy trials and careful engagement with media are recommended, emphasizing the need for rigorous science despite encouraging results.
Study at a glance
| Key finding | There are methodological limitations in existing studies on MDMA-assisted psychotherapy for PTSD, despite promising findings. |
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Abstract
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.