MDMA-Assisted Therapy for PTSD: Real-World Insights for Clinicians of First Responders
Tracks
Monarch - In-Person Only
| Tuesday, March 4, 2025 |
| 2:15 PM - 2:35 PM |
| Monarch Room |
Overview
Dr Michael Winlo and Dr Jon Laugharne, Empax Centre
Presenter
Dr Jon Laugharne
Lead Psychiatrist
Empax Centre
MDMA-Assisted Therapy for PTSD: Real-World Insights for Clinicians of First Responders
Presentation Overview
MDMA-Assisted Therapy for PTSD: Insights and Innovations from the Front Lines in Western Australia
Background: In July 2023, the Therapeutic Goods Administration (TGA) established a legal framework for psychedelic-assisted therapy, making Australia the only country where MDMA-assisted therapy is legally available. Our service commenced offering MDMA-assisted therapy for PTSD in October 2023, within this framework. As a specialist psychological trauma treatment centre, the Empax centre has been uniquely positioned to assess whether the promising Phase 3 clinical trial data on MDMA-assisted therapy can be generalised to our patient population. Given that the FDA has not yet approved MDMA as a treatment, Australia continues to hold a unique opportunity to advance the field globally.
Method: We carefully select and closely monitor all patients at our service in a controlled clinical environment. Our assessment process utilises a range of validated clinical tools, including the PCL-5, QIDS SR-16, WHODAS 2.0, ReQoL 10, CGI, and PGI, to rigorously measure patient outcomes. Our clinical governance framework is also designed to navigate the complexities of state laws, GMP drug supply requirements, and the Authorised Prescriber process, ensuring both compliance and sustainability.
Results: Early clinical outcomes have shown significant improvements in mental health metrics and overall quality of life for our patients. We have also gained critical insights into navigating regulatory frameworks, optimising the therapeutic environment, and managing treatment costs. Patient safety profiles have been positive, with no serious adverse events reported.
Conclusion: MDMA-assisted therapy represents a promising and emerging advancement in psychiatric treatment, offering substantial therapeutic potential amid significant logistical challenges. Australia’s unique legal standing provides a rare perspective and opportunity to lead in this emerging field. This presentation will share our model, early clinical outcomes, and key lessons for implementation, offering valuable insights for future directions.
Presentation Key Learnings:
1. Understand the comprehensive setup and operational requirements for initiating MDMA-assisted therapy in a clinical setting, including adherence to state laws and the Authorised Prescriber process.
2. Appreciate the importance of employing a broad array of clinical assessments to monitor and report patient progress.
3. Discuss the practical challenges and future research directions in the broader application of MDMA-assisted therapy.
Background: In July 2023, the Therapeutic Goods Administration (TGA) established a legal framework for psychedelic-assisted therapy, making Australia the only country where MDMA-assisted therapy is legally available. Our service commenced offering MDMA-assisted therapy for PTSD in October 2023, within this framework. As a specialist psychological trauma treatment centre, the Empax centre has been uniquely positioned to assess whether the promising Phase 3 clinical trial data on MDMA-assisted therapy can be generalised to our patient population. Given that the FDA has not yet approved MDMA as a treatment, Australia continues to hold a unique opportunity to advance the field globally.
Method: We carefully select and closely monitor all patients at our service in a controlled clinical environment. Our assessment process utilises a range of validated clinical tools, including the PCL-5, QIDS SR-16, WHODAS 2.0, ReQoL 10, CGI, and PGI, to rigorously measure patient outcomes. Our clinical governance framework is also designed to navigate the complexities of state laws, GMP drug supply requirements, and the Authorised Prescriber process, ensuring both compliance and sustainability.
Results: Early clinical outcomes have shown significant improvements in mental health metrics and overall quality of life for our patients. We have also gained critical insights into navigating regulatory frameworks, optimising the therapeutic environment, and managing treatment costs. Patient safety profiles have been positive, with no serious adverse events reported.
Conclusion: MDMA-assisted therapy represents a promising and emerging advancement in psychiatric treatment, offering substantial therapeutic potential amid significant logistical challenges. Australia’s unique legal standing provides a rare perspective and opportunity to lead in this emerging field. This presentation will share our model, early clinical outcomes, and key lessons for implementation, offering valuable insights for future directions.
Presentation Key Learnings:
1. Understand the comprehensive setup and operational requirements for initiating MDMA-assisted therapy in a clinical setting, including adherence to state laws and the Authorised Prescriber process.
2. Appreciate the importance of employing a broad array of clinical assessments to monitor and report patient progress.
3. Discuss the practical challenges and future research directions in the broader application of MDMA-assisted therapy.
Biography
Dr. Jon Laugharne, a Psychiatrist in Perth, has over 20 years of experience in trauma-focused mental health care. He has pioneered treatments like Eye Movement Desensitisation and Reprocessing (EMDR) and developed Mind Body Reprogramming (MBR). He is also a Clinical Senior Lecturer in Psychiatry at the University of Western Australia, focused on trauma and post-traumatic stress.
Dr Michael Winlo
CEO
Empax Centre
MDMA-Assisted Therapy for PTSD: Real-World Insights for Clinicians of First Responders
Presentation Overview
MDMA-Assisted Therapy for PTSD: Insights and Innovations from the Front Lines in Western Australia
Background: In July 2023, the Therapeutic Goods Administration (TGA) established a legal framework for psychedelic-assisted therapy, making Australia the only country where MDMA-assisted therapy is legally available. Our service commenced offering MDMA-assisted therapy for PTSD in October 2023, within this framework. As a specialist psychological trauma treatment centre, the Empax centre has been uniquely positioned to assess whether the promising Phase 3 clinical trial data on MDMA-assisted therapy can be generalised to our patient population. Given that the FDA has not yet approved MDMA as a treatment, Australia continues to hold a unique opportunity to advance the field globally.
Method: We carefully select and closely monitor all patients at our service in a controlled clinical environment. Our assessment process utilises a range of validated clinical tools, including the PCL-5, QIDS SR-16, WHODAS 2.0, ReQoL 10, CGI, and PGI, to rigorously measure patient outcomes. Our clinical governance framework is also designed to navigate the complexities of state laws, GMP drug supply requirements, and the Authorised Prescriber process, ensuring both compliance and sustainability.
Results: Early clinical outcomes have shown significant improvements in mental health metrics and overall quality of life for our patients. We have also gained critical insights into navigating regulatory frameworks, optimising the therapeutic environment, and managing treatment costs. Patient safety profiles have been positive, with no serious adverse events reported.
Conclusion: MDMA-assisted therapy represents a promising and emerging advancement in psychiatric treatment, offering substantial therapeutic potential amid significant logistical challenges. Australia’s unique legal standing provides a rare perspective and opportunity to lead in this emerging field. This presentation will share our model, early clinical outcomes, and key lessons for implementation, offering valuable insights for future directions.
Presentation Key Learnings:
1. Understand the comprehensive setup and operational requirements for initiating MDMA-assisted therapy in a clinical setting, including adherence to state laws and the Authorised Prescriber process.
2. Appreciate the importance of employing a broad array of clinical assessments to monitor and report patient progress.
3. Discuss the practical challenges and future research directions in the broader application of MDMA-assisted therapy.
Background: In July 2023, the Therapeutic Goods Administration (TGA) established a legal framework for psychedelic-assisted therapy, making Australia the only country where MDMA-assisted therapy is legally available. Our service commenced offering MDMA-assisted therapy for PTSD in October 2023, within this framework. As a specialist psychological trauma treatment centre, the Empax centre has been uniquely positioned to assess whether the promising Phase 3 clinical trial data on MDMA-assisted therapy can be generalised to our patient population. Given that the FDA has not yet approved MDMA as a treatment, Australia continues to hold a unique opportunity to advance the field globally.
Method: We carefully select and closely monitor all patients at our service in a controlled clinical environment. Our assessment process utilises a range of validated clinical tools, including the PCL-5, QIDS SR-16, WHODAS 2.0, ReQoL 10, CGI, and PGI, to rigorously measure patient outcomes. Our clinical governance framework is also designed to navigate the complexities of state laws, GMP drug supply requirements, and the Authorised Prescriber process, ensuring both compliance and sustainability.
Results: Early clinical outcomes have shown significant improvements in mental health metrics and overall quality of life for our patients. We have also gained critical insights into navigating regulatory frameworks, optimising the therapeutic environment, and managing treatment costs. Patient safety profiles have been positive, with no serious adverse events reported.
Conclusion: MDMA-assisted therapy represents a promising and emerging advancement in psychiatric treatment, offering substantial therapeutic potential amid significant logistical challenges. Australia’s unique legal standing provides a rare perspective and opportunity to lead in this emerging field. This presentation will share our model, early clinical outcomes, and key lessons for implementation, offering valuable insights for future directions.
Presentation Key Learnings:
1. Understand the comprehensive setup and operational requirements for initiating MDMA-assisted therapy in a clinical setting, including adherence to state laws and the Authorised Prescriber process.
2. Appreciate the importance of employing a broad array of clinical assessments to monitor and report patient progress.
3. Discuss the practical challenges and future research directions in the broader application of MDMA-assisted therapy.
Biography
Michael, CEO of Emyria, a company developing and improving MDMA-assisted therapy programs for PTSD, combining clinical services with innovative drug development. With a background in medicine, an MBA from Stanford, and experience leading Palantir’s Health team, he brings expertise in data-driven healthcare solutions.
