Expert opinions on implementation of MDMA-assisted therapy in Europe: critical appraisal towards training, clinical practice, and regulation

Post-traumatic stress disorder (PTSD) remains a substantial clinical problem because many patients do not achieve remission with existing psychotherapeutic or pharmacological treatments, and there is no consensus definition or standardised assessment for treatment-resistant PTSD (TR-PTSD). Van Dongen and colleagues note that despite established options such as trauma-focused cognitive behavioural therapy, EMDR, interpersonal therapy and antidepressants, around 33–60% of patients fail to remit, which has focused attention on novel approaches including MDMA-assisted therapy (MDMA-AT). Recent Phase II and Phase III trials report large treatment effects for MDMA-AT in PTSD, but methodological concerns (for example limited long-term follow-up, possible unblinding and expectancy effects), unclear mechanisms, and questions about safety, access and regulation remain. This study set out to gather expert opinion from clinicians and researchers familiar with MDMA-AT in order to inform how MDMA-AT might be implemented within European mental healthcare. Using an invitation-only online survey, the investigators sought views on regulation, training and standardisation, programme access models, equity and likely spill-over effects, aiming to identify global best practices and pitfalls to guide policy and clinical integration in Europe.

The study used an invitation-only online survey targeted at clinicians, therapists, researchers, educators and advocates with experience or involvement in MDMA-AT. Potential respondents were identified through the authors' professional contacts, an association of Dutch psychiatrists, clinicaltrials.gov entries for ongoing or planned MDMA-AT studies (with requests to forward to colleagues listed on those trials), and authorship of relevant academic publications. Inclusion required a professional role related to MDMA-AT and familiarity with the therapy; regulators and respondents unfamiliar with MDMA-AT were excluded. The questionnaire focussed on six thematic areas: regulation, training and standardisation, programme preferences (routes of access), perceived impact and implications, equity and access alongside research and regulatory gaps, and potential spill-over effects to non-official or recreational use. The survey was open for three weeks between 9 October and 23 October 2023. A total of 108 contacts were invited, 75 respondents completed the survey, and five were excluded for being governmental regulators, yielding 68 experts for analysis. Analysis was descriptive. Categorical responses were displayed using stacked bar graphs with percentages reported. Open-ended replies were summarised using ChatGPT 4 Data Analyst. Demographic information collected and reported included age bands (reported as equally represented), primary affiliations (research institutions, academia, non-profits, pharmaceutical companies and clinical roles), country distribution (predominantly the Netherlands and the UK, with some respondents from North America and Israel), and self-reported familiarity and roles in MDMA-AT (therapist, researcher, psychiatrist being most common).

Sixty-eight experts contributed to the analysed dataset. Respondents were mostly familiar with MDMA-AT (all but two) and worked primarily as therapists, researchers or psychiatrists in a range of institutional settings across several countries. Regulation: Nearly half of respondents judged the current regulatory status of MDMA-AT to be misaligned with the available scientific evidence, while only 15% considered it moderately to highly aligned. The leading perceived barriers to regulatory approval in Europe were political or public perception (54%), stigma (47%), lack of an industry partner for Europe (37%), safety concerns (35%), interpretation of trial data (21%) and ethical considerations (12%). A clear information gap identified by respondents was long-term follow-up data, rated essential or very important by 71% of participants; comparative studies and more robust trial data were also noted as lacking. Training and standardisation: Strong support emerged for mandatory specialised training for therapists delivering MDMA-AT (88%). Respondents ranked psychological integration techniques highest for inclusion in training (93%), followed by medical considerations and safety protocols (88%), ethical guidelines (78%), and session structuring and patient communication (71%). Open comments suggested inclusion of therapist self-experience, adverse event reporting and involvement of patients' social networks. Seventy-one percent favoured standardised protocols, and preferences for training providers included MAPS (62%), national institutions (57%) and other organisations (39%). Ongoing supervision was recommended, with 38% selecting it as the preferred ongoing support mechanism. Programme preferences: While MDMA-AT remains unregistered in respondents' countries, the most favoured interim access route was 'Expanded Access' (43%), followed by 'Special Access' (29%). Smaller proportions supported off-label use (11%), compassionate use (7%) or other approaches (7%), with an overall view that these are stopgap measures pending formal approval. Perceived impact: Most experts predicted a positive effect on the mental health landscape (88%), seeing the greatest benefit in treatment-resistant PTSD (87%) and considering MDMA-AT as a potential new paradigm in mental healthcare (78%). Fifty-six percent expected it could reduce long-term reliance on medications. Chief risks identified included insufficient therapist training (79%), difficulties in standardising treatment (38%) and potential for misuse or abuse (29%). Public attitudes were reported as mixed by 47% and positive by 38%, while 69% perceived regulatory and medical bodies as cautiously open. Equity and access: Only 15% reported active efforts to enhance access for underserved communities, 26% said access was limited to specific patient profiles, 32% reported no particular focus on equity, and 26% were unsure. Respondents highlighted research gaps including testing MDMA-AT in conditions beyond PTSD (for example addiction, depression, chronic pain, eating disorders, personality disorders), assessing diverse populations (race-based trauma, refugees), examining group or couple therapy formats, and studying post-session integration and therapist variables. Most (88%) reported no recent national legal changes or were unsure; legal changes were cited by 9% of respondents in the USA and Canada. Spill-over effects: Opinions were mixed on whether regulated MDMA-AT would increase non-official treatments such as retreats or underground therapy: 44% considered it possible, 26% found it likely or very likely, and 22% thought it unlikely or very unlikely. With respect to recreational MDMA use, 41% believed regulation was unlikely to boost recreational use and 26% believed it very unlikely; 7% considered an increase likely and 22% possible. Final thoughts: Respondents were divided on whether extra regulatory measures are necessary for safe and ethical provision—49% supported additional measures while 51% did not. Those in favour urged legal clarity for therapists' self-experience, specialised training, certification and accreditation, stringent clinician oversight, medical monitoring, clear treatment guidelines, specialised centres with trained staff, and safeguards for ethical issues such as informed consent, therapeutic touch and therapist integrity. Some suggested measures for monitoring clinicians (for example video recording) and guidance for therapists operating outside formal systems.

Van Dongen and colleagues interpret the survey findings as indicating a generally favourable expert view of MDMA-AT's therapeutic potential for treatment-resistant PTSD, coupled with concern that current European regulatory frameworks do not align with the clinical evidence. The respondents viewed MDMA-AT as likely to have a very positive impact on mental healthcare but stressed the need for more real-world, long-term safety and efficacy data to underpin regulatory approval in Europe. The authors position these results against broader developments in psychedelic-assisted therapies and regulatory precedent, noting parallels with psilocybin-AT and ketamine-AT while emphasising MDMA-AT's particular regulatory challenges because it combines pharmacological effects with structured psychotherapy. They report that experts highlighted risks requiring attention—potential neurotoxicity, cardiovascular effects, misuse, and the need for rigorous safety protocols—and reiterated ethical concerns such as the importance of robust informed consent, managing heightened vulnerability and suggestibility during sessions, avoiding abuse of power (including careful rules on therapeutic touch) and preserving confidentiality except where disclosure is legally or ethically required. Acknowledged limitations include the constrained survey design (notably a single-choice item for ethical concerns), potential selection or funding bias among respondents (for example some invitees’ affiliations with organisations that may benefit from approval), and the inherent subjectivity of expert opinion. The investigators note that although some upward bias is possible, they consider it likely minimal given the mix of contacts and sponsorship statuses. They also stress that the survey captures opinions rather than empirical outcome data. For implementation, the study team recommends collaborative, cross-national efforts involving governmental regulators and professional psychiatric, psychological and nursing bodies to develop training, safety protocols, ethical guidelines and accreditation processes. They suggest regulatory strategies to limit uncontrolled proliferation of unregulated medical and non-medical MDMA use and recommend engaging with the European Medicines Agency (EMA) to consider whether additional interventional or 'real world' studies are required or whether extant Phase III evidence could be accepted, while negotiating supplementary post-approval data collection where appropriate.

Respondents expect that regulated medical use of MDMA will have a positive impact on mental healthcare, particularly for treatment-resistant PTSD, but generally judge current regulatory frameworks as not aligned with the scientific evidence. The authors therefore recommend informed policy development, active cross-national regulatory engagement and international cooperation to integrate MDMA-AT into European mental healthcare in a manner that balances access with safety, training, standardisation and ethical oversight.