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 DOI: 10.1177/00048674221127186 via PubMed
Summary
AI-generated from the abstractMedia, public, and scientific interest in psychedelic medicine has grown rapidly, and Australia and New Zealand are now catching up. This paper critically reviews existing evidence, focusing on MDMA-assisted psychotherapy for post-traumatic stress disorder, the most advanced area of clinical psychedelic research. The authors detail Phase 2 and 3 studies and identify methodological and design limitations, as well as broader issues such as advocacy-group involvement in research and reliance on non-government financing that lead to simplistic public messaging. They call for large, high-quality, independent efficacy trials with design enhancements, effectiveness trials, and careful researcher engagement with media and public messaging to ensure rigorous, dispassionate science and safeguard participant welfare.
Study at a glance
| Characteristics | Review Peer reviewed |
|---|---|
| Intervention | MDMA-assisted psychotherapy |
| Topics | PTSD |
| Keywords | MDMA-Assisted Psychotherapy Clinical trials Methodology Psychedelic medicine |
| Citations | 17 |
| Key finding | The authors argue that despite promising findings, the evidence base for MDMA-assisted psychotherapy for PTSD has methodological and design limitations, compounded by advocacy-group involvement and non-government financing, and that rigorous, independent trials are needed. |
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.