An Open-Label Feasibility Study to Assess the Safety and Effect of Manualised MDMA-Assisted Psychotherapy for the Treatment of Severe Posttraumatic Stress Disorder among Four Australians

The trial (n=4) aims to determine whether an Australian treatment team can safely deliver MDMA-assisted psychotherapy to patients with treatment-refractory PTSD.

The study follows the Multidisciplinary Association for Psychedelic Studies (MAPS) MDMA-assisted psychotherapy treatment protocol over approximately 12 weeks. The treatment involves 15 psychotherapy sessions administered by male/female co-therapy teams, with three preparation sessions before the first MDMA session. Each MDMA session consists of two doses administered orally in capsules, followed by overnight stays and integrative psychotherapy sessions. Lifestyle modifications are required, and participants must agree to video recording of study visits.

The primary outcome measures include adherence to the treatment protocol and changes in PTSD severity. Secondary outcomes include functional impairment and safety measures such as monitoring heart rate, blood pressure, and suicidality.

The trial, conducted at Edith Cowan University, aims to assess the feasibility of providing MDMA-assisted psychotherapy in Australia. Data sharing will be available upon request, with individual participant data accessible until January 2028.

Topic PTSD
Compound MDMA
Country Australia
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