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MDMA-assisted Therapy Can Successfully Treat PTSD, Study Finds

By Alexander Beadle

Published: Jun 02, 2021   
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The use of MDMA-assisted therapy for post-traumatic stress disorder (PTSD) has now proven itself in its first phase 3 clinical trial.

Results from the trial published in Nature Medicine report that 67 percent of participants who received three MDMA-assisted therapy sessions no longer qualified for a PTSD diagnosis by the trial’s end. While in the control group, which received a placebo during identical therapy sessions, only 32 percent no longer met the definition for PTSD diagnosis by this endpoint.

A second phase 3 trial is already enrolling participants and the researchers are hopeful that MDMA-assisted therapy for PTSD will be approved by the US Food and Drug Administration (FDA) by 2023.

Nearly 90 percent of participants show significant improvement

The new phase 3 trial was designed under a special protocol assessment with the FDA and included 90 participants with severe PTSD diagnoses. All participants went through three talk therapy sessions with specially-trained, licensed therapists, with half of the participants given MDMA during the therapy. The other half received a placebo, but participants were blinded as to which drug they received during treatment.

The effect of the therapy on the participants’ PTSD symptoms was measured using the clinician-administered PTSD Scale for DSM-5 (CAPS-5), which covers a 30-item list of symptoms corresponding to the DSM-5 diagnosis for PTSD. Participants were also asked about improvements to functional impairment in their work/school, social, and family life.

By the endpoint of the trial, 67 percent of the participants who received the MDMA-assisted therapy sessions no longer qualified for a PTSD diagnosis. The majority of this group (88 percent) even reported a “clinically meaningful” reduction in symptoms. This is compared to the 32 percent and 60 percent of patients, respectively, who just received the talk therapy with placebo.

“MDMA is an experiential therapeutic and therefore necessitates the appropriate set and setting to truly guide change and recovery. While many forms of PTSD therapy involve recalling 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,” said lead author Jennifer Mitchell in a statement.

“People with the most difficult-to-treat diagnoses, often considered intractable, respond just as well to this novel treatment as other study participants. In fact, participants diagnosed with the dissociative subtype of PTSD experienced a greater reduction in symptoms than those without the dissociative subtype.”

A notable strength of the study was its inclusion of a broad range of patients, reporting PTSD caused by combat-related events, accidents, abuse, and sexual harm. Eighty-four percent of participants also had a history of developmental trauma, speaking to the broad effectiveness of MDMA-assisted talk therapy.

No significant safety issues were seen in the MDMA-receiving group, with only minor adverse events being reported. These – most commonly an increased pulse, decreased appetite, nausea, and sweating – all lasted for only a short while after the end of each session. This is consistent with the findings of earlier phase 2 trials and other clinical studies.

The potential of psychedelic-assisted psychotherapy

This phase 3 trial was funded by the Multidisciplinary Association of Psychedelic Studies (MAPS) and conducted by researchers from the MAPS Public Benefit Corporation (MAPS PBC), which is a subsidiary of MAPS.

“MAPS Public Benefit Corporation is establishing a new paradigm in drug research, development, and commercialization in which we center our efforts wholly on the beneficiaries of our healing modality rather than shareholders,” explained MAPS PBC CEO Amy Emerson, in a statement.

“This approach commits us to open science and open books as we research best practices for psychedelic-assisted therapy. Ultimately, any proceeds from our work will be reinvested to generate more research, more training, and more affordable options for treatment.”

MAPS is not the only body interested in psychedelic-assisted therapies though. Recent research from the Center for Psychedelic and Consciousness Research at Johns Hopkins University has found psilocybin-assisted psychotherapy to be around four-times more effective at treating major depressive disorder than traditional antidepressants. LSD has also been used historically in conjunction with therapy to treat PTSD and alcoholism.

For MDMA-assisted psychotherapy, the next hurdle will be to have the treatment officially approved by the FDA. The drug is still a Schedule 1 substance in the United States, and so is formally considered to have “no currently accepted medical use” in the eyes of the federal government.

Last year, the FDA agreed to allow an Expanded Access Program for MDMA-assisted psychotherapy in PTSD, which will allow around 50 patients with severe PTSD who do not qualify for phase 3 clinical trials the chance to access the treatment before FDA approval. But for the majority of those with severe PTSD, it will only be possible to access this treatment once approval has been granted. In their public statement on the phase 3 trial findings, MAPS anticipates “the hopeful approval in 2023” for MDMA-assisted therapy for PTSD.

“As a result of this study and through the persistent and consistent application of scientific rigor, we have demonstrated that MDMA-assisted therapy is likely to provide relief for people diagnosed with PTSD,” commented MAPS executive director Rick Doblin. “Far from having no medical benefit, MDMA, when combined with talk therapy in this protocol, has the potential to catalyze the therapeutic process and generate positive mental health outcomes.”

Michael Mithoefer, who is the senior medical director for Medical Affairs, Training, and Supervision at MAPS PBC, also added: “The success of this pivotal study is a major step toward regulatory approval, and we hope these results will attract many more researchers and clinicians to join the effort to further explore and deliver MDMA-assisted therapy so we can together address our national – and global – mental health crisis.”


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