MDMA Archives - Green Market Report

Julie AitchesonMay 5, 2021
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5min16090

The Multidisciplinary Association of Psychedelic Studies (MAPS) has worked for the last 35 years to shift the perception around psychedelics as a treatment tool for mental health issues. Now, with the release of data from its Phase III trial with the FDA for the use of MDMA (ecstasy) to treat PTSD, MAPS’ work has coalesced into findings that could change the mental health treatment landscape as we know it. 

MDMA is on the cusp of FDA approval to treat PTSD, not just for military veterans, but for an array of people who have suffered from abuse and other trauma-inducing events. In 2017, the FDA granted MDMA “breakthrough therapy status” in anticipation of approving it as a medication for mental health, and the release of MAPS’ latest statistically significant findings constitutes a huge leap towards legalization. 

The conversation around the legalization of psychedelic drugs is not new to the mental health community. Trials testing the efficacy of psychedelics such as LSD for mental illness began as early as the 1950s. By the 1960s more than 1,000 papers had been published about LSD as a treatment for depression, alcoholism, schizophrenia, and as an adjunct to psychotherapy. These trials lacked the scientific rigor necessary for legitimacy in the eyes of the FDA, but due in no small part to the work of MAPS, legitimacy is no longer the stumbling block it once was.

 MDMA showed efficacy for treating PTSD in six MAPS Phase II trials, providing a cost-saving and clinically beneficial treatment for those with severe or extreme chronic PTSD resulting from any cause. The Phase III trial is the first of any psychedelic-assisted therapy. It was a randomized, blinded study designed under an FDA-approved Special Protocol Assessment. 90 patients with severe, chronic PTSD were enrolled in the trial and randomized to receive either MDMA or a placebo. The results, according to the lead author of the paper, Jennifer Mitchell, Ph.D., were significant. “People with the most difficult-to-treat diagnosis, often considered intractable, respond just as well to this novel treatment as other participants. In fact, participants diagnosed with the dissociative type of PTSD experienced a greater reduction in symptoms than those without the dissociative subtype.”

The Phase III trial data revealed that 67% of the group who received MDMA no longer qualified for a PTSD diagnosis after three treatment sessions (compared to 32% of the placebo group). 88% of participants in the MDMA sessions experienced a clinically significant reduction in symptoms, as opposed to 60% of the placebo group who received therapy alone. Mitchell attributes MDMA’s effectiveness to its role as a catalyst in therapy, which often involves recalling, and frequently reactivating, previous trauma. “The unique ability of MDMA to raise compassion and understanding while tamping down fear is likely what enables it to be so effective.”

Researchers are currently enrolling participants in a second Phase III trial and MAPS is formulating plans for additional studies to evaluate MDMA’s efficacy for mental health conditions not yet explored, as well as other protocols beyond one-on-one sessions, including group therapy and cognitive behavioral therapy focused on couples. The fact that MDMA is currently classified as a Schedule I drug and defined as having “no medical benefit” means that the only way to receive MDMA-assisted therapy right now is through clinical trials. However, the FDA has given its blessing to an expanded access program so that 50 patients can access MDMA-assisted therapy before it is approved and MAPS has committed to confronting accessibility and equity issues from its own side of the table. While not a sure thing, with MAPS’ latest data and continued efforts in alignment with FDA requirements the hoped-for 2023 FDA approval of MDMA-assisted therapy for PTSD is closer to becoming a reality than ever before.


StaffOctober 15, 2020
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A peer-reviewed study published in the research journal PLOS ONE demonstrates that MDMA-assisted psychotherapy is remarkably cost-effective when compared to currently available treatments for posttraumatic stress disorder (PTSD). It is estimated that a public healthcare payer or private insurer making MDMA-assisted psychotherapy available to 1,000 patients with PTSD would reduce general and mental health care costs by $103.2 million over 30 years. This treatment has not yet been approved by the FDA, does not work for everyone, and carries risks even in therapeutic settings.

Lead author Elliot Marseille, Dr.P.H., M.P.P., said, “MDMA-assisted psychotherapy is conducted by a licensed psychologist and trained clinician over the course of twelve sessions with three sessions lasting six or more hours. The cost of that time is not inconsiderable, but in just over three years, healthcare providers will break even on the costs of mental health and general medical care. These estimates are promising yet likely too conservative: the study did not measure the value of increased productivity or lower disability payments as patients recover from PTSD and is constrained by the limited availability of data on the long-term trajectory of PTSD. Further research will be needed to determine the full financial, personal, and societal benefits of MDMA-assisted psychotherapy for PTSD.”

Berra Yazar-Klosinski, Ph.D., Deputy Director and Head of Research Development and Regulatory Affairs for MAPS Public Benefit Corporation and co-author, developed the treatment manuals governing MDMA-assisted psychotherapy. She notes, “A growing body of evidence suggests that MDMA-assisted psychotherapy is often more effective than currently available treatments for PTSD, a notoriously difficult-to-treat condition. Previous research has focused on safety and efficacy and indicates statistically significant improvements over currently available treatments with a reduction in symptoms for 82% of participants. This study should compel healthcare providers to include MDMA-assisted psychotherapy as a covered treatment for PTSD following FDA approval.”

Rick Doblin, Ph.D., Executive Director of MAPS and a study co-author, states,  “The profound personal toll of PTSD can include a deterioration in physical health, relationships, and ability to participate in social activities along with the anxiety, insomnia, and suicidal ideation that mark the condition. By demonstrating a return of an average of 5.5 quality-adjusted life-years over 30 years, we have shown that MDMA-assisted psychotherapy has the potential to reduce more than the personal burden of PTSD, contributing to improved health outcomes and reduced healthcare burdens for payers and providers.”

The cost-effectiveness of MDMA-assisted psychotherapy from the U.S. healthcare payers’ perspective was constructed with a decision-analytic Markov model to portray the costs and health benefits of treating patients with chronic, severe, or extreme, treatment-resistant PTSD. Efficacy was based on the pooled results of six randomized controlled trials with the 105 subjects who participated in Phase 2 trials and a four-year follow-up of 19 of those subjects. Other inputs were based on published literature and on assumptions when data were unavailable. Results are modeled over a 30-year analytic horizon and conducted extensive sensitivity analyses. The model calculates expected medical costs, mortality, quality-adjusted life-years, and incremental cost-effectiveness ratio.

 


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