Access to MDMA-Assisted Therapy
April 6, 2025Last month, the Dutch State Commission on MDMA released its report advising the Government to allow access to MDMA-Assisted Therapy (MDMA-AT) for people living with PTSD. The report has now been translated into English.
The Netherlands’ history with MDMA stretches back decades, with over 550,000 people in the country having taken MDMA recreationally at least once in 2022.
Its extensive use in raves and clubs has led to criminal gang operations and industrial-scale production of the compound in the country, igniting calls for its regulation to stop this criminal activity.
However, outside of this recreational use, recent years have seen increasing research demonstrating MDMA’s potential as a treatment for PTSD in combination with psychotherapy.
In light of these developments, the independent State Commission was established by the Dutch Parliament in 2023 to research the legal status of MDMA and provide advice on its medical use.
Highlighting that Dutch drug policy dates from 1995 and has not been reviewed since 2009, the report emphasises that there is an urgent need for a thorough review and update on the basis of scientific evidence and not “emotions”.
While the MDMA: Beyond Ecstasy report does not review the entire Dutch drug policy, it maps out the historical, legal, policy-related, public health science and therapeutic aspects of MDMA, includes recommendations for policy and the use of MDMA in medical settings, and concludes there is sufficient evidence for MDMA’s medical application.
Speaking to Psychedelic Health, Sergio Pérez Rosal, MD, Associate at the Faculty of Psychedelic Studies at University of Ottawa, commented: “The recent publication of the “MDMA: Beyond Ecstasy” report by the Dutch State Commission on MDMA marks a significant step forward in the evolving understanding of MDMA’s role in both recreational and therapeutic contexts.
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“This detailed report provides a balanced view of MDMA, exploring its historical use, current policy challenges, and future possibilities, particularly in the realm of mental health treatment.”
Recommendations on MDMA
Advising on the pros and cons of the medicinal use of MDMA for the treatment of PTSD, the committee recommends in the report that the Netherlands develops a regulatory framework for the medical use of MDMA as quickly as possible.
Notably, the report found that the health effects of MDMA appear to justify its transfer from a Schedule I substance to a Schedule II substance, and that evidence exists that demonstrates MDMA-assisted therapy for PTSD offered in a clinical, controlled setting is “not only effective, but also relatively safe”.
The report reads: “A possible move to another schedule to the UN Convention may, however, be considered in the international context. The Netherlands could, for this purpose, ask the WHO to reassess its inclusion of MDMA in Schedule I to the 1971 UN Convention. This would promote the taking of steps in the international context and the Netherlands could play a guiding role in this connection.”
The report also explores alternative routes for access in the country, however, highlights that many of them are not financially viable.
Recommendations for the government include:
- For the medical use of MDMA to treat PTSD be developed in the Netherlands as soon as possible and that its implementation be facilitated.
- Lay down clear frameworks and preconditions to prevent the risky or harmful use of MDMA-AT.
- Set up naturalist research to make MDMA-AT available as soon as possible.
- Explore whether existing psychedelic substances require a different registration approach than ‘normal’ medication does. New legal frameworks may have to be set up for unregistered substances with a known medical use that are already available on the illegal market.
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Recommendations to professional associations include:
- The professional associations must draw up guidelines for the treatment
of PTSD using MDMA-AT.
- Develop special training courses for providing MDMA-AT.
Recommendations to treating physicians and/or organisations:
- Raise realistic expectations in communications with patients.
- Use MDMA of pharmaceutical quality in order to guarantee the correct dosage and purity of the MDMA.
The suggested multi-year, large-scale naturalist study would MDMA-AT available to specially selected patients and investigate aspects such as the feasibility and cost-effectiveness of MDMA-AT in the Netherlands.
“One of the key takeaways from the report is the Commission’s strong endorsement of MDMA-assisted therapy (MDMA-AT) for PTSD. The report highlights compelling evidence from recent studies indicating that MDMA-AT can be exceptionally effective for PTSD patients, especially those who have not found relief through traditional therapies,” said Perez Rosal.
“The Commission’s recommendation to initiate a large-scale naturalistic study in the Netherlands to facilitate the use of MDMA-AT underscores a proactive approach to addressing mental health challenges.”
Uncertainty for MDMA in the US
The report and its recommendations were published just days following the U.S. Food and Drug Administration’s (FDA) advice on Lykos Therapeutics MDMA-assisted therapy New Drug Application (NDA), which voted that there was not enough data to confirm its therapeutic efficacy and safety.
While the final decision on the matter is not expected until 11 August 2024, the advice has been a major blow to the advancement of psychedelic therapy in the US.
Perez Rosal added: “This decision has generated significant debate among researchers and mental health professionals, many of whom argue that the therapeutic potential of MDMA should not be overlooked despite the committee’s concerns about study design and data integrity.
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“The Dutch State Commission’s report calls for an updated and evidence-based drug policy that reflects the current scientific understanding of MDMA. By focusing on both the recreational and therapeutic aspects of MDMA, the report advocates for a nuanced approach that prioritises public health while also recognising the potential benefits of MDMA in treating severe mental health conditions.
“As discussions continue globally, the Dutch report sets a thoughtful and forward-looking example of how to navigate the complexities surrounding MDMA. It highlights the importance of grounding policy decisions in scientific evidence and balancing the potential risks and benefits of MDMA use.
“The “MDMA: Beyond Ecstasy” report by the Dutch State Commission is a landmark document that could pave the way for innovative mental health treatments and more informed drug policies. It invites a necessary dialogue on how best to harness the potential of MDMA in a safe and effective manner, offering hope for improved therapeutic options for those suffering from PTSD and other mental health disorders.”
To read the report in full and see the complete recommendations, please visit: https://www.government.nl/documents/reports/2024/05/31/mdma-beyond-ecstasy
