This survey (n=68) of researchers and clinicians involved in MDMA-assisted therapy (MDMA-AT) examines opinions on clinical practices, training, and regulation. The study finds broad support for training standardization and highlights challenges in the national (European) approval process. Experts emphasize the importance of science-informed policy, active regulatory involvement, and international cooperation to integrate MDMA-AT into the European mental healthcare system, particularly for treating PTSD.
Abstract of Expert opinions on implementation of MDMA-assisted therapy in Europe
“Introduction: The positive results of MDMA from Phase 2 and 3 clinical trials in MDMA-assisted therapy (MDMA-AT) for the treatment of post-traumatic stress disorder (PTSD) call for a critical evaluation of its regulatory status within the European mental healthcare system. This is driven by the recent submission of MDMA-AT for FDA approval in the United States. Unless coordinated efforts in the European regulatory landscape start, there may be potential divergences in national regulatory strategies. Gaining insights from researchers and clinicians involved in the application of MDMA-AT may be useful in guiding the discussion of factors involved in its implementation.
Method: A comprehensive invitation-only survey was sent to researchers and clinicians involved in MDMA-AT clinical trials and contributors to the scientific literature on MDMA-AT from around the globe. This study aimed to collect opinions on clinical practices, training, and regulation worldwide, examining the global best practices and pitfalls to outline strategies for possible European implementation of MDMA-AT.
Results: The survey, which included responses from 68 experts, yielded a range of opinions where a large majority endorsed the need for training and standardization, emphasizing equity and access, stressing impediments in the national approval processes, and reflecting critically on anticipated spill-over effects of MDMA-AT in clinical settings.
Conclusion: The experts highlight the need for science-informed policy development, active regulatory involvement, and international cooperation to incorporate MDMA-AT into the European mental healthcare system in general and the treatment of PTSD in particular. The study emphasizes the importance of ongoing research, open professional discourse, and collaborative engagement to facilitate MDMA-AT’s ethical and effective implementation.”
Authors: Jerome Herpers, Natalie Maximets, Noah N. N. van Dongen, Josjan Zijlmans, Eric Vermetten
Summary of Expert opinions on implementation of MDMA-assisted therapy in Europe
The prevalence and debilitating nature of Post-Traumatic Stress Disorder pose significant challenges for clinical research, as current treatments often fail to provide adequate relief for many patients. There is currently no standardized method for assessing the outcomes of prior treatments for patients with treatment-resistant PTSD.
Despite current treatment options, a substantial percentage of patients do not attain remission, regardless of the treatment regimen employed. MDMA-assisted therapy has been shown to have promising results in the treatment of PTSD, but the regulation of MDMA and implementation of MDMA-AT in mental health care is facing substantial challenges.
While the safety, long-term efficacy, and mechanisms of action of MDMA-AT are more thoroughly comprehended, there are still questions driving new research studies. Some methodological concerns have been raised regarding the research on MDMA-AT and other forms of psychedelic psychotherapy. Scientists respond to the evidence report published by The Institute for Clinical and Economic Review by claiming that two Phase 3 trials indicate a positive benefitrisk ratio for MDMA-AT in patients with PTSD, and advocate for further research.
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https://doi.org/10.1080/20008066.2024.2378651
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Herpers, J., Maximets, N., van Dongen, N. N. N., Zijlmans, J., & Vermetten, E. (2024). Expert opinions on implementation of MDMA-assisted therapy in Europe: Critical appraisal towards training, clinical practice, and regulation. European Journal of Psychotraumatology, 15(1)
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