NHMRC GRADE Guideline for MDMA‑Assisted Psychotherapy: Reporting Summary

An NHMRC-approved guideline has been published to define the appropriate use of MDMA-assisted psychotherapy for post-traumatic stress disorder (PTSD).

The document was developed using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) method and is presented as a clinical practice guideline focused on MDMA-assisted psychotherapy (MDMA‑AP) in PTSD. It describes inclusion criteria for MDMA‑AP and identifies patient groups for whom the guideline recommends against its use.

Monash University’s Center for Medicine Use and Safety (CMUS) and Neuromedicines Discovery Center (NDC) developed the guideline, with the stated aim of supporting clinicians and people living with PTSD in decision-making about MDMA‑AP. The document’s contents include: four formal recommendations, 21 Good Practice Statements, and 15 research recommendations. In terms of the development methods, the groups focused on explicit consideration of benefits and harms, certainty of evidence, patient values and preferences, resources, equity, acceptability, and feasibility.

The guideline describes a limited set of patient-selection criteria for considering MDMA‑AP in PTSD. It states that eligibility is restricted to adults (≥18 years) and that PTSD symptoms should have been present for at least six months post-diagnosis, with symptoms described as moderate or severe in the past month. Together, these elements frame a time- and severity-bounded population rather than an open-ended indication.

Additionally, the use of MDMA‑AP should be limited to people who have received an adequate trial of first-line evidence-based treatments and who are at low risk of re-exposure to the index trauma during treatment. The guideline also “strongly recommends against” using MDMA‑assisted psychotherapy (MDMA‑AP) in patient groups excluded from existing clinical trials for safety reasons, listing examples that include pregnant or breastfeeding people; those with cardiovascular disease; psychotic disorder; suicide-related distress (defined as current suicidal thoughts and/or behavior); and people using medications that may interact with MDMA.

Key Takeaways:

• An NHMRC-approved, GRADE-based clinical practice guideline for MDMA‑AP in PTSD is reported, and it includes formal recommendations, Good Practice Statements, and research recommendations.
• The guideline describes eligibility boundaries limited to adults and further constrained by symptom duration post-diagnosis and recent symptom severity.
• The guideline also describes prerequisites (including prior first-line treatment trials and low re-exposure risk) and a “strongly recommends against” exclusion list.