This interventional trial (n=30) will assess the efficacy and safety of Psychedelic Therapy for Post Traumatic Stress Disorder (PTSD) using MDMA.
Participants will receive MDMA medicines orally in capsule form once in the morning on specific medicine days, alongside psychotherapy sessions. The treatment regimen involves three preparatory sessions, a dosing session lasting approximately 6-7 hours, and three integration sessions, all conducted over several weeks. The therapy sessions will be led by HREC approved psychologists/psychotherapists and a psychiatrist.
The study aims to evaluate changes in clinician-rated PTSD symptoms, trauma, adverse events, personality disorder symptoms, disability, connection, relationships, mystical experiences, alcohol use, drug use, suicidal ideation, depression, eating attitudes, disordered eating, and eating disorder symptomology from baseline to 2 weeks post-treatment.
The trial is recruiting participants in New South Wales, Australia, with a target of 30 participants. It is funded by self-funding and is led by Prof Dr Ranil Gunewardene. For further information, individuals can contact Dr Ranil Gunewardene at Mindlife Clinic Northern Beaches Hospital.
Trial Details
We intend to measure the effectiveness of psychedelic assisted medicines (methylene dioxy methamphetamine - MDMA) when combined with talking therapy; for the treatment of Post Traumatic Stress Disorder in real world patient groups We will test how effective MDMA is for PTSD and treat patients who have had limited benefits with existing treatments for these hard to treat conditions.NCT Number ACTRN12624000041550