MDMA assisted therapy is submitted to the FDA by MAPS

The Multidisciplinary Association of Psychedelic Studies (MAPS) submitted their studies for psychedelic assisted psychotherapy for the treatment of Post Traumatic Stress Disorder (PTSD) Tuesday (December 12, 2023). The current mainstays of PTSD treatment, including Selective Serotonin Reuptake Inhibitors (SSRIs) and various forms of psychotherapy, often fall short, with a considerable number of patients either not responding adequately or discontinuing treatment. This significant treatment gap underscores the critical need for innovative and effective therapeutic approaches, especially as PTSD presents a significant global health challenge affecting millions each year with profound social and economic implications. I’ll discuss the landmark study from Nature that will be presented to the FDA.

The MAPS PTSD treatment research has brought MDMA (3,4-methylenedioxymethamphetamine), typically associated with recreational use as Ecstasy or Molly, into focus as a promising therapeutic agent. MDMA’s mechanism of action, particularly its ability to induce serotonin release and modulate fear memory processes, positions it as a potential groundbreaking treatment for PTSD. Recognizing its therapeutic potential, the FDA has granted MDMA-assisted therapy a Breakthrough Therapy designation, indicating its potential to offer substantial improvements over existing treatments. The MAPS study aims at granting FDA approval for MDMA assisted psychotherapy, which after review, could be approved in six to ten months.

The landmark MAPS study conducted between November 2018 and August 2020 provides robust evidence supporting the effectiveness of MDMA-assisted therapy in treating severe PTSD. The study involved 131 participants who were rigorously selected and randomized to receive either MDMA or a placebo, alongside structured therapy sessions. The findings from this study are not just promising; they are groundbreaking.

Participants who underwent MDMA-assisted therapy showed a remarkable reduction in the severity of PTSD symptoms and associated functional impairment. These improvements were quantitatively measured using the CAPS-5 scale for PTSD symptoms and the SDS scale for functional impairment. Notably, MDMA therapy also significantly alleviated depressive symptoms, a common comorbidity in PTSD sufferers.

One of the most significant findings of the study was the efficacy of MDMA therapy in participants with comorbid conditions such as depression, and dissociation. These groups are typically considered challenging to treat with conventional therapies, underscoring the potential of MDMA to address a critical unmet need in PTSD treatment.

In the MDMA group, an impressive 67% of participants no longer met the criteria for a PTSD diagnosis following the treatment, compared to just 32% in the placebo group. Additionally, 33% of participants in the MDMA group achieved remission. These results underscore the profound impact that MDMA-assisted therapy could have on PTSD treatment.

In terms of safety, the treatment was generally well-tolerated, with most adverse events being mild to moderate and transient. Crucially, the study observed no significant increase in suicidality-related adverse events in the MDMA group, an essential consideration given the heightened risk of suicidal ideation among individuals with PTSD.

The study’s discussion delves into MDMA’s potential mechanisms of action in treating PTSD. The drug’s effect on serotonergic function and fear-based behavior regulation is central to its therapeutic impact. By potentially creating a ‘window of tolerance’, MDMA, in conjunction with therapy, could enable patients to process traumatic memories more effectively, without being overwhelmed. The acute prosocial effects of MDMA might also enhance the therapeutic alliance, a crucial factor in the success of PTSD treatment.

The study, however, acknowledges certain limitations. The participant pool was smaller than initially planned, partly due to the COVID-19 pandemic, and lacked sufficient racial and ethnic diversity. Additionally, the study’s relatively short duration calls for extended follow-up to ascertain the long-term efficacy and safety of MDMA-assisted therapy.

Psychedelic-assisted psychotherapy represents a significant advancement in the field of PTSD treatment. Its rapid and robust efficacy, even in severe and complex cases of PTSD, positions it as a potentially transformative treatment modality. The MAPS study advocates for expedited clinical evaluation and broader implementation of MDMA-assisted therapy, suggesting its potential to dramatically change the current approach to PTSD treatment. As the global community continues to grapple with the escalating burden of PTSD, exacerbated by events such as the COVID-19 pandemic, MDMA-assisted therapy shines as a beacon of hope, offering a new pathway to recovery and improved quality of life for those afflicted by this debilitating disorder.

The study itself can be found here.