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.
Australia's Therapeutic Goods Administration rescheduled MDMA in July 2023, allowing its prescription for PTSD outside clinical trials. This manuscript outlines the development of an Australian Clinical Practice Guideline on MDMA-assisted psychotherapy for PTSD, using the GRADE process to weigh benefits and harms against other treatments. A multidisciplinary Guideline Development Group, supported by stakeholder and expert groups, will consider evidence certainty, patient values, resources, equity, acceptability, and feasibility. The guideline will be published on MAGICapp and in peer-reviewed outlets, with a companion guide for people with PTSD and their carers.