New study to inform Australia’s first psychedelics clinical guideline

5 March 2025

Australia’s first clinical practice guideline on the appropriate use of methylenedioxymethamphetamine-assisted psychotherapy (MDMA-AP) to treat post-traumatic stress disorder (PTSD) is a step closer following the publication of a new Monash-led study.

The study - published in the Australian & New Zealand Journal of Psychiatry (ANZJP) - assessed the current evidence regarding the safety and efficacy of MDMA-AP compared to psychotherapy alone among adults with PTSD.

The researchers will use findings from the study, combined with the Grading of Recommendations, Assessment, Development, and Evaluations (GRADE) process, to develop the Australian Clinical Practice Guideline on MDMA-AP for PTSD.

In 2023, Australia became the first country to reschedule MDMA and psilocybin from Prohibited Substances (Schedule 9) to Controlled Substances (Schedule 8). This has allowed authorised prescribers to administer MDMA and psilocybin for the treatment of PTSD and treatment-resistant depression outside of clinical trials, respectively.

The ANZJP study found that despite improvement in PTSD outcomes following MDMA-AP, the evidence is of low to very-low certainty.

The researchers analysed 14 systematic reviews, of which four were considered high-quality. All 14 reviews included studies of one-to-three sessions of 50-125mg MDMA-AP (some with supplemental dosage) compared to either 25-40mg of MDMA or inactive placebo with psychotherapy.

The study’s lead author and Research Fellow at Monash’s Centre for Medicine Use and Safety (CMUS) within the Monash Institute of Pharmaceutical Sciences, Dr Alene Sze Jing Yong, said while the reviews showed a substantial overall improvement in PTSD symptoms, based on the four high-quality reviews the evidence presented was insufficient or low-certainty due to several factors.

Read the full article here.