Development of an Australian Clinical Practice Guideline on methylenedioxymethamphetamine (MDMA)-assisted Psychotherapy for Post-traumatic Stress Disorder
Alene Sze Jing Yong, Sue Brennan, Suzie Bratuskins, Aimee Freeburn, Gillinder Bedi, Rimona Burke, Terry Haines, Mary Hollick, Kim Jones, Andrew J. Lawrence, Yong Yi Lee, Alexander C. Mcfarlane, Stephen Parker, Nicholas Procter, Liam Spicer, Andrew A. Somogyi, Simon Stafrace, Stacey Watts, Clare Walton, Kay Wilson, J. Simon Bell
medRxiv February 21, 2025 preprint DOI: 10.1101/2025.02.18.25322184 via OpenAlex
Summary
The Australian Therapeutic Goods Administration has allowed the prescribing of MDMA for PTSD as of July 2023. This manuscript outlines the development of a Clinical Practice Guideline for MDMA-assisted psychotherapy (MDMA-AP) for PTSD, utilizing the GRADE process to evaluate benefits and harms compared to other treatments. The guideline will incorporate systematic reviews and consider various factors such as patient preferences and feasibility, with plans for dissemination through multiple platforms.
Study at a glance
| Population | people with PTSD |
|---|---|
| Key finding | The Australian Clinical Practice Guideline on MDMA-assisted psychotherapy for PTSD will assess the treatment's benefits and harms compared to other options. |
Abstract
Abstract Introduction Despite recent clinical and research interest, medical use of psychedelics has not been legalised in most jurisdictions. The Australian Therapeutic Goods Administration rescheduled methylenedioxymethamphetamine (MDMA) in July 2023 to permit authorised prescribing of MDMA for Post-traumatic Stress Disorder (PTSD) outside of the clinical trial setting. Objective This manuscript describes the development of the Australian Clinical Practice Guideline on MDMA-assisted psychotherapy (MDMA-AP) for PTSD. Methods The Guideline will be developed using the Grading of Recommendations, Assessment, Development, and Evaluations (GRADE) process. The Guideline will consider the benefits and harms of MDMA-AP compared to other treatments in people with PTSD. High quality systematic reviews identified via an overview of systematic reviews will be used as index and supplementary reviews. Using the GRADE Evidence-to-Decision framework, the multidisciplinary Guideline Development Group (GDG) will consider treatment benefits and harms, certainty of evidence, patient preferences and values, resources, equity, acceptability and feasibility. The GDG will be supported by a Stakeholder Group, Expert Group, Conflict of Interest Oversight Committee, and Evidence Review Team. The Guideline will be developed using an integrated knowledge translation approach, emphasising the co-production of knowledge through active participation and shared decision-making with end-users. Conclusion The Guideline will be published on the digital platform MAGICapp and disseminated in peer-reviewed publications, professional conferences and via specific stakeholder groups. A Companion Guide will be developed for people living with PTSD and their carers, family members, and supports.