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
Visit trial
Status Recruiting
Results Published No
Start date 06 July 2023
End date 27 June 2025
Phase Phase II
Design Open
Type Interventional
Generation First
Participants 5
Sex All
Age 18- 70
Therapy Yes

Trial Details

Posttraumatic stress disorder (PTSD) is a serious debilitating disorder that negatively impacts a person’s daily life, and can result in diminished cognitive and psychosocial functioning, fractured relationships, inability to maintain employment, substance abuse, high-cost healthcare utilisation, increased depression and other mental and physical health co-morbidities. MDMA-assisted therapy has shown to be effective for the treatment of PTSD as it reduces defenses and fear of emotional injury, enhances communication, and increase empathy and compassion. The subjective effects of MDMA create a productive psychological state that enhances the therapeutic process. The purpose of this study is to investigate the safety and feasibility of delivering MDMA-assisted psychotherapy to patients with PTSD.

NCT Number ACTRN12623000838617

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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