717. Clinical trials, ethical dimensions, and the pathway of MDMA-assisted therapy in PTSD

Abstract

Abstract Background MDMA-assisted therapy (MDMA-AT) has shown promise for treatment-resistant post-traumatic stress disorder (PTSD), leveraging unique affective effects such as enhanced trust, empathy, and social connectedness. Despite preliminary efficacy, ethical challenges in clinical trials may directly affect regulatory approval and future clinical implementation. Aims & Objectives The presentation examines ethical issues specific to MDMA clinical trials, including risks to the therapeutic relationship, epistemic harms, and informed consent, and considers how these challenges may shape the translational pathway of MDMA-AT. Method A literature review focused on clinical trial reports, regulatory documentation, and scholarly analyses of MDMA-AT ethics. Key domains included therapist–patient interactions, affective modulation, memory processing, and clinical trial implications. Results Ethical concerns arise from MDMA’s affective and cognitive effects, which may influence vulnerability in the patient–therapist relationship, the emergence of memory and belief changes, and participants’ understanding of the intervention, as well as therapist's implicit and explicit therapy models. These challenges intersect with trial design and regulatory requirements, shaping safety monitoring, consent processes, and the integration of therapy, also as part of post-trial obligations. Discussion & Conclusions MDMA-AT trials raise distinctive ethical issues with implications for both clinical practice and regulatory evaluation. Systematic attention to consent, therapist training, boundary management, and risk monitoring is essential to support the safe and responsible translation.