Expert opinions on implementation of MDMA-assisted therapy in Europe: critical appraisal towards training, clinical practice, and regulation.
Jerome Herpers, Natalie Maximets, Noah N N van Dongen, Josjan Zijlmans, Eric Vermetten
European Journal of Psychotraumatology 2024 DOI: 10.1080/20008066.2024.2378651 (opens in new tab)
Study at a glance
AI-extracted from the abstract| Characteristics | Survey Peer reviewed |
|---|---|
| Sample size | 68 |
| Population | Researchers and clinicians involved in MDMA-AT clinical trials and contributors to the scientific literature on MDMA-AT |
| Topics | MDMA Psychedelic-assisted therapy PTSD |
| Keywords | Investigación Policy Política Regulación Regulation MDMA Treatment Mental healthcare systems PTSD Treatment Tept Trauma therapy |
| Citations | 7 |
| Key findings | Experts emphasize the need for training, standardization, equity, and access, and highlight impediments in national approval processes and anticipated spill-over effects of MDMA-assisted therapy. |
Abstract
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.
Comparable studies
Other cross-sectional and survey studies on MDMA and psychedelic-assisted therapy, most cited first.
| Study | Year | Design | Participants |
|---|---|---|---|
| Assessing the quality of publicly available videos on MDMA‐assisted psychotherapy for PTSD Videos on YouTube about MDMA-assisted psychotherapy for PTSD | 2022 | Cross-sectional study | n = 100 |
| Attitudes toward psychedelics and psychedelic-assisted therapy among potential mental health service users and the general population in Australia. Australians, including individuals with and without self-identified mental illness | 2024 | Cross-sectional survey | n = 502 |
| Knowledge, attitudes, and concerns about psilocybin and MDMA as novel therapies among U.S. healthcare professionals. U.S. healthcare professionals | 2024 | Cross-sectional survey | n = 879 |
| Psychedelic-assisted therapy: a survey on the clinical methods of Swiss physicians. Physicians providing psychedelic-assisted therapy under Swiss Federal Office of Public... | 2026 | Survey | n = 41 |
| Oncology Providers' Perspectives on Psychedelic-Assisted Therapy. Healthcare professionals involved in oncology across academic and nonacademic... | 2026 | Cross-sectional survey | n = 385 |