Development of an Australian Clinical Practice Guideline on methylenedioxymethamphetamine (MDMA)-assisted Psychotherapy for Post-traumatic Stress Disorder.

Australia's Therapeutic Goods Administration rescheduled MDMA in July 2023, permitting authorized prescribing for PTSD outside clinical trials. This manuscript describes development of an Australian Clinical Practice Guideline on MDMA-assisted psychotherapy for PTSD using the GRADE process. The guideline will compare benefits and harms of MDMA-assisted psychotherapy against other treatments, drawing on high-quality systematic reviews. A multidisciplinary Guideline Development Group will consider evidence certainty, patient values, resources, equity, acceptability, and feasibility. The guideline will be published on MAGICapp and disseminated through peer-reviewed publications and conferences. A Companion Guide will be created for people with PTSD and their carers.

Study at a glance

Abstract

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. This manuscript describes the development of the Australian Clinical Practice Guideline on MDMA-assisted psychotherapy (MDMA-AP) for PTSD. 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. 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.