Development of an Australian Clinical Practice Guideline on methylenedioxymethamphetamine (MDMA)-assisted Psychotherapy for Post-traumatic Stress Disorder.
Gespeichert in:
| Titel: | Development of an Australian Clinical Practice Guideline on methylenedioxymethamphetamine (MDMA)-assisted Psychotherapy for Post-traumatic Stress Disorder. |
|---|---|
| Autoren: | Yong ASJ; Centre for Medicine Use and Safety, Faculty of Pharmacy and Pharmaceutical Sciences, Monash University, Parkville, VIC, Australia., Brennan SE; School of Public Health and Preventive Medicine, Faculty of Medicine, Nursing and Health Sciences, Monash University, Melbourne, VIC, Australia., Bratuskins S; Neuromedicines Discovery Centre, Monash Institute of Pharmaceutical Sciences, Monash University, Parkville, VIC, Australia., Freeburn A; Neuromedicines Discovery Centre, Monash Institute of Pharmaceutical Sciences, Monash University, Parkville, VIC, Australia., Bedi G; Centre for Youth Mental Health, The University of Melbourne, and Orygen, Melbourne, Australia., Burke R; Paddington Family Practice, Paddington, NSW, Australia., Haines T; School of Primary and Allied Health Care, Monash University, Melbourne, Victoria, Australia., Hollick M; Grampians Interim Regional Body, Mental Health and Wellbeing Division Department, VIC, Australia., Jones KA; Indigenous Health Equity Unit, Onemda, Melbourne School of Population and Global Health, The University of Melbourne, Melbourne, VIC, Australia., Lawrence AJ; The Florey Institute of Neuroscience and Mental Health, The University of Melbourne, VIC, Australia., Lee YY; Health Economics Group, School of Public Health and Preventive Medicine, Monash University, Melbourne, Australia; School of Public Health, The University of Queensland, Herston, QLD, Australia; Queensland Centre for Mental Health Research, Brisbane, QLD, Australia., McFarlane AC; The University of Adelaide, Adelaide, SA, Australia., Parker S; Faculty of Medicine, The University of Queensland, Brisbane, QLD, Australia; Metro North Mental Health, Royal Brisbane and Women's Hospital, Herston, QLD, Australia; Faculty of Medicine, Griffith University, Brisbane, QLD, Australia., Procter N; Clinical and Health Sciences, The University of South Australia, Adelaide, South Australia, Australia., Spicer L; The Cairnmillar Institute, Melbourne, VIC, Australia., Somogyi AA; Faculty of Health and Medical Sciences, The University of Adelaide, Adelaide, Australia., Stafrace S; Alfred Mental and Addiction Health, Alfred Health, Melbourne, Victoria, Australia; Faculty of Medicine, Nursing and Health Sciences, Monash University, Melbourne, VIC, Australia., Watts S; Faculty of Education, Monash University, Melbourne, VIC, Australia., Walton C; The University of Melbourne, Melbourne, VIC, Australia., Wilson K; Melbourne Law School, The University of Melbourne, Australia., Bell JS; Centre for Medicine Use and Safety, Faculty of Pharmacy and Pharmaceutical Sciences, Monash University, Parkville, VIC, Australia. Electronic address: simon.bell2@monash.edu. |
| Quelle: | Journal of affective disorders [J Affect Disord] 2025 Dec 15; Vol. 391, pp. 119866. Date of Electronic Publication: 2025 Jul 17. |
| Publikationsart: | Journal Article |
| Sprache: | English |
| Info zur Zeitschrift: | Publisher: Elsevier/North-Holland Biomedical Press Country of Publication: Netherlands NLM ID: 7906073 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1573-2517 (Electronic) Linking ISSN: 01650327 NLM ISO Abbreviation: J Affect Disord Subsets: MEDLINE |
| Imprint Name(s): | Original Publication: Amsterdam, Elsevier/North-Holland Biomedical Press. |
| MeSH-Schlagworte: | Stress Disorders, Post-Traumatic*/therapy , Stress Disorders, Post-Traumatic*/drug therapy , Psychotherapy*/methods , N-Methyl-3,4-methylenedioxyamphetamine*/therapeutic use , Practice Guidelines as Topic* , Hallucinogens*/therapeutic use, Humans ; Australia |
| Abstract: | Competing Interests: Declaration of competing interest The author(s) disclosed receipt of the following financial support for the research, authorship, and/or publication of this article: NP currently receives funding from SA Health, Victorian Foundation for Survivors of Torture Inc., Sonder, Mates in Construction, and Overseas Services to Survivors of Torture and Trauma. All funds are paid to the employing institution. JSB has received grant funding or consulting funds from the National Health and Medical Research Council, Victorian Government Department of Health and Human Services, Dementia Australia Research Foundation, Yulgilbar Foundation, Aged Care Quality and Safety Commission, Dementia Centre for Research Collaboration, Pharmaceutical Society of Australia, Society of Hospital Pharmacists of Australia, GlaxoSmithKline Supported Studies Programme, Amgen, and several aged care provider organisations unrelated to this work. All grants and consulting funds were paid to the employing institution. GB has received grant funding from the US National Institute of Drug Abuse, the Medical Research Future Fund, Victorian Government Department of Health and Human Services, the National Centre for Clinical Research on Emerging Drugs, the Youth Support and Advocacy Service, and several philanthropic organisations unrelated to this work. All the other authors declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article. 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. (Copyright © 2025 The Authors. Published by Elsevier B.V. All rights reserved.) |
| Contributed Indexing: | Keywords: Ecstasy; Evidence-based treatment; PTSD; Psychedelic; Psychedelic-assisted therapy; Therapeutic guidelines |
| Substance Nomenclature: | KE1SEN21RM (N-Methyl-3,4-methylenedioxyamphetamine) 0 (Hallucinogens) |
| Entry Date(s): | Date Created: 20250719 Date Completed: 20250915 Latest Revision: 20250915 |
| Update Code: | 20250916 |
| DOI: | 10.1016/j.jad.2025.119866 |
| PMID: | 40683535 |
| Datenbank: | MEDLINE |
Full Text Finder 
Nájsť tento článok vo Web of Science | Abstract: | Competing Interests: Declaration of competing interest The author(s) disclosed receipt of the following financial support for the research, authorship, and/or publication of this article: NP currently receives funding from SA Health, Victorian Foundation for Survivors of Torture Inc., Sonder, Mates in Construction, and Overseas Services to Survivors of Torture and Trauma. All funds are paid to the employing institution. JSB has received grant funding or consulting funds from the National Health and Medical Research Council, Victorian Government Department of Health and Human Services, Dementia Australia Research Foundation, Yulgilbar Foundation, Aged Care Quality and Safety Commission, Dementia Centre for Research Collaboration, Pharmaceutical Society of Australia, Society of Hospital Pharmacists of Australia, GlaxoSmithKline Supported Studies Programme, Amgen, and several aged care provider organisations unrelated to this work. All grants and consulting funds were paid to the employing institution. GB has received grant funding from the US National Institute of Drug Abuse, the Medical Research Future Fund, Victorian Government Department of Health and Human Services, the National Centre for Clinical Research on Emerging Drugs, the Youth Support and Advocacy Service, and several philanthropic organisations unrelated to this work. All the other authors declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.<br />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.<br />Objective: This manuscript describes the development of the Australian Clinical Practice Guideline on MDMA-assisted psychotherapy (MDMA-AP) for PTSD.<br />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.<br />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.<br /> (Copyright © 2025 The Authors. Published by Elsevier B.V. All rights reserved.) |
|---|---|
| ISSN: | 1573-2517 |
| DOI: | 10.1016/j.jad.2025.119866 |