Pedram Dara
MDMA Therapy Trial Participant

Improving the Impact of MDMA-assisted Therapy for PTSD: Participant Perspectives 4 Years After Open-Label Phase 2 Trials.

Post-traumatic stress disorder (PTSD) is a debilitating mental health condition that not only causes suffering for individuals but also poses a significant public health challenge. Despite available solutions, the efficacy of current treatments is often limited. However, MDMA-assisted psychotherapy has shown promising results as a potential treatment for PTSD and is currently in the final phase of research, with plans for FDA approval in the U.S. in 2024, followed by approvals in Canada, Israel, and Europe. This presentation is based on an in-depth understanding of MDMA-assisted therapy for PTSD, gained from personal experience as a participant in an open-label phase 2 clinical trial in Canada in 2019. Through self-reflection and consultation with other study participants and experts, the presentation highlights the most effective components of the treatment and identifies areas for improvement. Despite encouraging results, the pool of MDMA therapy participants is limited. Fewer than 500 people globally have received the treatment, including in the largest phase 3 clinical trials. There is a lack of qualitative long-term follow-up studies that go beyond 2-4 years post-treatment.

Currently, the majority of positive results published are based on 2-month follow-up after final MDMA sessions, causing uncertainty about the durability of the positive effects and the risk of relapse, and need for ongoing treatment. The current MAPS protocol may not fully address the needs of patients due to lack of comprehensive measurement of progress and sufficient therapist training. Moreover, it may overlook important personal factors, such as socio-economic status, race, and culture. The protocol also lacks practical tools for patients to apply in daily life and tackle long-term challenges after treatment. Improving the protocol with a participant-centric approach could reduce adverse effects and increase treatment efficacy, leading to better long-term outcomes. The inclusion of patients' perspectives at conferences is crucial for humanising participants and providing qualitative insights to supplement quantified research results. Despite limitations in participant pool, long-term follow-up, and MAPS protocol, the aim of this presentation is to offer valuable feedback while recognising the potential of this therapy where current treatments fall short, and to enhance the quality of care and ultimately patients' quality of life.

Pedram Dara is a passionate advocate for the potential of psychedelics in mental healthcare, with a deep understanding honed through personal experience. As a participant in a Phase 2 clinical trial of MDMA-assisted psychotherapy for PTSD through MAPS, he embarked on a transformative healing journey. Using this experience as a catalyst, Pedram has shared his ongoing story and insights at various conferences, trainings, and meetings, including at the European Parliament, alongside prominent researchers in the field such as David Nutt, Matthew Johnson, Bill Richards, Rick Doblin, and Michael Mithoefer.

His participation in the Interdisciplinary Conference on Psychedelic Research (ICPR) in 2020 led to him joining the leadership team of the OPEN Foundation to further advance psychedelic science and therapies. At ICPR 2022, he organised the world's first dedicated panel for participant perspectives in clinical trials at a major psychedelic science conference, which was well received and provided a platform to amplify the voices of research participants and mental health patients. Dedicated to research participant safety and wellbeing, Pedram is committed to ensuring that safe, beneficial, and accessible applications of psychedelics are ethically and responsibly integrated into science, healthcare, and society. He is well aware of the potential benefits and risks associated with psychedelics and is constantly working towards effectively communicating and addressing them.