Reply to: Caution at psychiatry’s psychedelic frontier and Challenges with benchmarking of MDMA-assisted psychotherapy.

This is a helpful further free full-text part of the discussion of the key phase 3 trial of MDMA-assisted therapy for PTSD. The authors write: "We are delighted that our recent publication has kindled such active discourse. We thank the journal for inviting this discussion, as we believe that it is through open and inclusive dialogue that the fields of science and medicine move forward with speed and precision. In our publication on 3,4-methylenedioxymethamphetamine (MDMA)-assisted therapy for post-tramautic stress disorder (PTSD), we report on a new, combined psychotherapy and pharmacotherapy approach to treatment of severe, chronic PTSD. As the study was designed as a pivotal phase 3 trial intended for an application for marketing authorization, the sponsor obtained agreement with the regulatory agencies on study design through a ‘special protocol assessment’ with the US Food and Drug Administration (FDA) (maps.org/ SPA) and a ‘scientific advice’ process with the European Medicines Agency (EMA), to ensure the study design met regulatory standards for marketing. With this in mind, several comments were presented in Halvorsen et al. and Burke et al., which we address below. Halvorsen et al. espouse the benefits of trauma-focused psychotherapies such as prolonged exposure therapy (PE) and cognitive behavioral therapy (CBT), and we agree on the value of these approaches. However, it should be noted that the overwhelming majority of our trial participants had previously engaged in at least one psychological intervention and still met eligibility criteria for severe PTSD. Despite the availability and accessibility of trauma-focused therapies, a countless number of people still suffer from severe and chronic PTSD and are unwilling or unable to engage in available treatments. We therefore echo our previous assertion that the current treatment options are insufficient and that new treatments, including those integrating psychotherapy and pharmacotherapy, are needed."

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