In 2017, the U.S. Food and Drug Administration (FDA) designated MDMA-assisted psychotherapy as a breakthrough treatment for post-traumatic stress disorder (PTSD). MDMA (often referred to as ecstasy or molly) itself is not officially legal or approved for clinical use, but phase III trials are underway, and expanded access status was granted in January 2020 in the United States and Israel. The results of preliminary clinical studies have been extremely promising, and the FDA could approve MDMA-assisted psychotherapy for PTSD as early as 2022.
Mount Sinai’s new Center for Psychedelic Psychotherapy and Trauma Research is one of a handful of research centers nationwide focused on studying unconventional treatment methods such as MDMA-assisted psychotherapy for PTSD, depression, anxiety, and other stress-related problems in veterans and civilians. “For those who have suffered through chronic and extreme trauma MDMA could be a game-changer. This treatment doesn't just dampen symptom severity, in most cases it results in the patient no longer having PTSD,” said Rachel Yehuda, PhD, Director of the Center and Vice Chair for Veteran Affairs for the Department of Psychiatry. “As mental health professionals, we’re not used to seeing individuals with PTSD cleared of their diagnoses within a 3-4-month course of treatment with either psychotherapy or medication.”
The Center is initially focusing on MDMA-assisted psychotherapy but will expand to studying other psychedelic-assisted psychotherapies with compounds such as psilocybin. Using computational genetics, molecular biology, and neuroimaging, Dr. Yehuda hopes to accelerate understanding of how treatments like MDMA work.
As part of the Center’s ramp-up, the Department of Psychiatry sponsored a Multidisciplinary Association for Psychedelic Studies training in July 2020 that trained and is in the process of certifying 30 therapists to treat patients with MDMA-assisted psychotherapy. These skills can be used in research protocols, and when the treatment receives FDA approval for PTSD, these therapists will be allowed to access the medication for use with patients.
Dr. Yehuda recently participated in an FDA-approved protocol that put her in the role of patient. This involved ingesting 125+ 65 mg of MDMA and undergoing an intense and searching daylong session with psychotherapists. “It was one of the most amazing experiences I’ve had in recent memory, allowing me to explore things in a way I never could before,” she said. “Most importantly, it allowed me to put myself in the shoes of someone who might have a very deep trauma to process, and it helped me understand that this is the kindest, gentlest way to effect real change.
MDMA-assisted psychotherapy involves much more than a single eight-hour session, however. Patients generally receive two or three sessions with MDMA over three months, but before and after each session, there are three 90-minute sessions to help prepare for the sessions and process the material that arose. The clinical evidence, to date, shows that unlike most other therapies for PTSD, symptom reduction is maintained after a single course of treatment. In fact, more than two-thirds of patients were found to be virtually symptom-free one year after treatment with MDMA. “Instead of just blunting symptoms, the MDMA-assisted psychotherapy enables patients to talk in a different way about their emotional injuries and traumatic experiences,” said Dr. Yehuda. “The MDMA helps increase levels of introspection and intrapersonal trust so they can work through the issues with their therapists.”
The pharmacologic effects of MDMA result from the release of neurotransmitters such as serotonin, dopamine, and norepinephrine, with a subsequent increased secretion of such hormones as oxytocin, prolactin, cortisol, and vasopressin. “These properties don’t fully explain the sense of empathy toward oneself and the openness to engage in self-reflection,” Dr. Yehuda said. “MDMA seems to put trauma survivors in a state of mind that is most conducive to processing their past experiences; they are less self-critical and fearful, and more open and forgiving toward themselves. They experience a sense of well-being, empathy toward self and the therapists, and, often, sensory pleasure. These are optimal conditions to engage in the processing of difficult or traumatic material.”
In making PTSD the centerpiece of her research for the past 30 years, Dr. Yehuda has been at the forefront of identifying molecular processes involved in risk, susceptibility, resilience, and recovery from this debilitating disease. “I’m hopeful, excited, and optimistic about what lies ahead,” she said. “I also recognize that there is so much work to be done to try to understand who can benefit from this treatment, how to scale and operationalize the treatment for use in clinical settings, how to train and support therapists in this new way of working with patients, and how to better understand for whom the treatment may be contraindicated. We now have to give the scientific, medical, and academic communities the chance to do the rigorous research that can answer these questions. That’s why we created the Center.”
To learn more about Dr. Yehuda’s work, listen to this Road to Resilience podcast, "PTSD Meet MDMA."
Rachel Yehuda, PhD
Director of the Center for Psychedelic Psychotherapy and Trauma Research, and Vice Chair for Veteran Affairs, Department of Psychiatry