MDMA-Assisted Therapy Is One Step Closer to FDA Approval

MDMA-Assisted Therapy Is Closer to FDA ApprovalGetty Images

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People suffering from post-traumatic stress disorder (PTSD) may be a step closer to harnessing psychedelics to heal their trauma. According to a groundbreaking new study, MDMA-assisted therapy appears to be effective in easing the symptoms of moderate to severe PTSD.

This is a huge breakthrough for PTSD sufferers—a notoriously difficult-to-treat condition— as well as for people with any number of other mental disorders. It’s estimated that 3.6 percent of American adults have had PTSD in the past year, a third of whom suffered from a serious form of the disorder. “It’s quite clear that our outcomes for all mental disorders—whether anxiety, depression, PTSD, eating disorders, or addictions—are very poor compared to the rest of medicine,” says Ben Sessa, a consultant psychiatrist who has spent 20 years in the field of psychedelic research. (Sessa was not involved in the study.) “We’ve got 60 percent treatment resistance in PTSD. That means that 60 percent of patients, even with the very best that modern medicine throws at them, have chronic, unremitting PTSD for life. After a hundred years of modern psychiatry, that’s not good enough. But psychedelics represent the most innovative new form of technology that psychiatry has had for a century. These kinds of treatments are long overdue.”

In the study, participants were given three eight-hour sessions combining talk therapy with MDMA, also known as ecstacy or molly. The results speak for themselves—86.5 percent of participants had a reduction in symptoms, and almost three quarters of participants no longer fit the criteria for a formal PTSD diagnosis. “We were able to show that in something that’s thought of as chronic and treatment-resistant, we could decrease the severity of symptoms and also improve the quality of life for those who are really suffering,” says Amy Emerson, the CEO of MAPS Public Benefit Corporation, which conducted the trials.

Research into exactly how psychedelics impact the brain is ongoing. But it seems that a major factor in the drugs’ positive effects stem from their ability to encourage neuroplasticity, as new connections forge between neurons. MAPS Public Benefits Corporation, a drug-developing subsidiary of the Multidisciplinary Association for Psychedelic Studies (MAPS) founded by Rick Doblin, plans to submit a drug-approval application to the FDA later this year. If granted, MDMA-assisted therapy (a combination of the psychedelic drug and talk therapy) could be available as a PTSD treatment as early as winter 2024.

MDMA has been illegal in the U.S. since 1985, but in 2017, the FDA granted the drug “breakthrough therapy” status as a treatment for PTSD, opening up a host of promising research opportunities. In June, Australia became the first country in the world to approve MDMA-assisted therapy as a treatment for PTSD, and to approve psilocybin (magic mushrooms) to treat depression.

Currently, the most common first-line treatment for PTSD is prolonged exposure therapy, in which sufferers relive their trauma-related memories over and over, often in excruciating detail. Theoretically, MDMA-assisted therapy takes some of the pain out of recalling these experiences. “This is the holy grail for psychotherapy,” says Sessa, who is also an MDMA-, psilocybin-, and ketamine-trained psychotherapist. “MDMA’s pharmacological effect is that it switches off the amygdala, a part of the brain that responds to stress and fear. People understandably avoid stressful and fearful memories, and that’s why they can’t engage in typical psychotherapy. For a rape victim, just the word rape is enough to make them flee and drop out of treatment. But with the amygdala switched off, you ask someone to talk about their trauma and they are amazed to suddenly be able to talk about it, sometimes after 30 years. The MDMA acts like a bulletproof vest that allows you to go into battle with your trauma memories, and talk about them for the first time in your life.”

Notably, the study was relatively diverse: Thirty-four percent of participants and 28 percent of therapists were of color. “It's important that diverse populations are included in all research, especially as mental illness is over-represented in people of color,” says Sessa. “There are also more mental health problems for people facing unemployment, racism, and exclusion.”

Some scientists and researchers in the field have expressed frustration that MDMA has been off the table as a treatment option for decades, despite having been used successfully by therapists before the ban in the ’80s. But Emerson thinks that the slow process of research has been vital to allow for rigorous science. “The FDA regulations are there for the safety of people, and it’s important that we go through a process of ensuring we follow the science,” she says. “Plus, it also took a cultural change—there has long been a stigma about using psychedelics for treatment. In some ways, we can also only move as quickly as the world is ready for.”

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