Drug Science and University College London (UCL) are pleased to announce their strategic collaboration aimed at advancing our understanding of MDMA-assisted psychotherapy. This partnership seeks to address concerns that the ‘psychotherapy’ aspect of MDMA-assisted psychotherapy – which expert opinion considers to be crucial to long-term success involving MDMA as a psychotherapeutic agent – is not yet well understood and may be suboptimal.
This collaboration therefore seeks to update our understanding of the interplay between successful; MDMA-assisted therapy treatment results and the nature of the psychotherapeutic component involved
By investigating competing therapeutic modalities to assess the nature of their compatibility with MDMA;
Discerning more clearly than ever before the features of the psychotherapeutic model for MDMA-assisted psychotherapy which are most inextricably linked to its treatment potential.
For over three decades, the Multidisciplinary Association for Psychedelic Studies (MAPS) has been pioneering the development of MDMA as a novel therapeutic tool. Administered in three doses over a 14-week psychotherapy course, MDMA-assisted therapy has demonstrated significant clinical efficacy in six phase 2 trials and two large phase 3 trials. These promising results led the US Food and Drug Administration (FDA) to grant breakthrough therapy status for MDMA as a treatment, prompting the establishment of Lykos to facilitate its medical use. Lykos submitted a comprehensive clinical efficacy and safety dossier to the FDA, with a decision announced in August 2024.
In early June 2024, the FDA's public advisory committee nearly unanimously rejected the evidence of efficacy and benefit-risk profile for MDMA-assisted therapy as presented by Lykos. Unfortunately, this decision was later endorsed by the FDA, highlighting their need for further research before allowing MDMA to continue through the fast-track approval pathway. The FDA raised several concerns. These included the regulation of combination therapy, blinding issues, potential for misuse, therapist training and generalisability, the risk of therapist misconduct, long-term benefits, and a potentially negative benefit-risk ratio if the treatment proved ineffective.
In addition to these regulatory concerns, some critics of MDMA-assisted psychotherapy - and psychedelic-assisted psychotherapy more generally - note that the complex interactions between the drug and the ‘psychotherapy’ components is poorly understood. A more refined understanding of this interaction may require a shift away from the traditional methods of evaluation typically used in neuroscience and psychopharmacology.
Drug Science and UCL are undertaking novel research using a bold alternative approach to understanding how MDMA works. The researchers aim to begin recruiting study participants in 2025.
The result will be a set of applied, practical understandings that can be directly implemented in a standardised way, to advance the safety and efficacy of psychotherapeutic healing with MDMA.
Professor David Nutt, Founder of Drug Science had this to say: “MDMA-assisted therapy has shown great promise, but the recent decision by the FDA highlights the necessity for further research. Our collaboration with UCL aims to address the specific concerns raised, particularly around the regulation of combination therapy and therapist training. This partnership is crucial for developing a more refined and evidence-based understanding of MDMA’s therapeutic potential.”
Prof Sunjeev Kamboj, Professor of Translational Clinical Psychology at UCL added that “Modern neuroscience and pharmacological experiments have been pivotal in driving our understanding of MDMA and psychedelics. But we’re now at an impasse in understanding of how these drugs work at a high level. This is why we are taking an unusual, more qualitative approach to tackling this issue by testing the effects of MDMA in psychotherapists who have a strong foundation in theories of psychopathology. We think this will be a critical step in advancing our understanding of the psychological, rather than neurobiological, mechanisms of action of MDMA”.
Drug Science is committed to advancing the scientific understanding and clinical application of MDMA-assisted therapy and ensuring rigorous standards and addressing regulatory requirements to pave the way for its mainstream acceptance.
About Drug Science
Drug Science is the only completely independent, science-led drugs charity in the UK, uniquely bringing together leading drugs experts from a wide range of specialisms to carry out ground-breaking research into drug harms and effects. Drug Science works to provide an evidence base free from political or commercial influence, creating the foundation for sensible and effective drug laws, and equipping the public, media and policy makers with the knowledge and resources to enact positive change.
About University College London
Founded in 1826 in the heart of London, UCL is London's leading multidisciplinary university, with more than 16,000 staff and 50,000 students from over 150 different countries.
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