A study to investigate the safety and feasibility of delivering MDMA-assisted psychotherapy to patients with posttraumatic stress disorder

This open-label study (n=5) investigates the safety and feasibility of delivering MDMA-assisted psychotherapy to patients with posttraumatic stress disorder (PTSD).

Participants undergo three treatment cycles over 12 weeks, with preparatory and integration sessions. Each treatment cycle includes an initial dose of 87mg of MDMA with a supplemental half-dose, accompanied by psychotherapy.

Safety and feasibility are assessed through adverse events, treatment costs, and resource requirements. Secondary outcomes include changes in PTSD symptomatology, anxiety, depression, quality of life, workplace productivity, healthcare utilization, patient and clinician impressions of change, and the impact of secondary traumatic stressors.

Key inclusion criteria involve providing a support person, having a PTSD diagnosis, being an active patient at the study site, and having tried at least two conventional treatments. Exclusion criteria include certain medical conditions, substance use disorder, and current suicide risk.

The study is conducted in Australia and funded by Emyria Ltd.

Topic PTSD
Compound MDMA
Country Australia
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Trial Details



Trial Number

Sponsors & Collaborators

Emyria
Emyria Limited is a company focused on developing data-backed drug treatments and clinical care solutions, with a significant emphasis on mental health innovation. The company's operations span across conducting clinical trials, developing novel drug compounds, and establishing purpose-built clinics for drug-assisted therapies.

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