Development of an Australian Clinical Practice Guideline on methylenedioxymethamphetamine (MDMA)-assisted Psychotherapy for Post-traumatic Stress Disorder.
Alene Sze Jing Yong, Sue E Brennan, Suzie Bratuskins, Aimee Freeburn, Gillinder Bedi, Rimona Burke, Mary Hollick, Kimberley Ann 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
Journal of Affective Disorders July 17, 2025 DOI: 10.1016/j.jad.2025.119866 (opens in new tab)
Study at a glance
AI-extracted from the abstract| Characteristics | Theoretical or philosophical paper Peer reviewed |
|---|---|
| Population | People with post-traumatic stress disorder |
| Intervention | MDMA-assisted psychotherapy |
| Topics | MDMA Psychedelic-assisted therapy PTSD |
| Keywords | Evidence-based treatment Therapeutic guidelines Psychedelic therapy: ecstasy MDMA-Assisted Psychotherapy PTSD Treatment: PTSD Authorized prescribing Protocols Evidence-based medicine: evidence-based Rigorous Carefully considered |
| Citations | 3 |
| Key points | Proposes a process for developing an Australian Clinical Practice Guideline on MDMA-assisted psychotherapy for PTSD, using the GRADE framework and integrated knowledge translation. |
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.
Comparable studies
Other theoretical and historical papers on MDMA and psychedelic-assisted therapy, most cited first.
| Study | Year | Design | Participants |
|---|---|---|---|
| The potential use of N-methyl-3,4-methylenedioxyamphetamine (MDMA) assisted psychotherapy in the treatment of eating disorders comorbid with PTSD. | 2021 | Theoretical or philosophical paper | |
| MDMA-assisted psychotherapy for PTSD in adolescents: rationale, potential, risks, and considerations. Adolescents with PTSD | 2024 | Theoretical or philosophical paper | |
| Couple Therapy With MDMA-Proposed Pathways of Action. | 2021 | Theoretical or philosophical paper | |
| Informed Consent in Psychedelic-Assisted Therapy. | 2024 | Theoretical or philosophical paper | |
| The “Third” Eye: Ethics of Video Recording in the Context of Psychedelic-Assisted Therapy | 2023 | Theoretical or philosophical paper |
Citations in the library
Cited by 4
- “You can only take your clients as far as you’ve been yourself”: examining the intersections between psychedelic-assisted therapy, lived-living experience, and clinical practice Drugs Education Prevention and Policy March 22, 2026
- Efficacy and risks of psychedelics in treatment of posttraumatic stress disorder: A systematic review American Journal of Health-System Pharmacy March 4, 2026
- Experiences of Australian clinicians, researchers, and patients with MDMA-assisted psychotherapy for post-traumatic stress disorder: A framework-guided qualitative analysis. Journal of Affective Disorders February 2, 2026
- Methodological fragmentation and integration priorities in psychedelic-assisted therapy assessment: a scoping review Frontiers in Psychiatry August 6, 2026
Cites 15
- MDMA-assisted therapy for severe PTSD: a randomized, double-blind, placebo-controlled phase 3 study. Nature Medicine June 1, 2021
- MDMA-assisted therapy for moderate to severe PTSD: a randomized, placebo-controlled phase 3 trial. Nature Medicine October 1, 2023
- Psychedelic Drug Legislative Reform and Legalization in the US JAMA Psychiatry December 7, 2022
- A Survey of American Psychiatrists' Attitudes Toward Classic Hallucinogens The Journal of Nervous and Mental Disease May 17, 2018
- Using a MDMA- and LSD-Group Therapy Model in Clinical Practice in Switzerland and Highlighting the Treatment of Trauma-Related Disorders Frontiers in Psychiatry April 25, 2022
and 10 more in the library