But new research has also revealed its potential to serve a higher purpose. A pivotal study of MDMA-assisted therapy revealed the treatment to be significantly safe and effective in treating individuals with severe, chronic post-traumatic stress disorder. These findings can be added to the growing body of research in support of the therapeutic potential of psychedelic compounds.
The Research
Presenting significant challenges to both patients and medical professionals, PTSD affects the lives of millions of U.S. adults through a variety of symptoms following exposure to a traumatic event. This poses a major threat to public health, as currently available treatments are only modestly effective. However, the first Phase 3 trial of MDMA-assisted therapy presents evidence that it could be an effective and cost-saving treatment for this debilitating mental health condition. The study’s findings, published in Nature Medicine, showed that 67% of participants who received MDMA-assisted therapy sessions no longer qualified for a PTSD diagnosis, and 88% experienced a clinically meaningful reduction in symptoms. Participants were 90 individuals with severe, chronic PTSD caused by abuse, accidents, combat-related events, or sexual harm, who had been living with PTSD for an average of 14 years. They were randomized to receive three sessions of either placebo or MDMA paired with identical talk therapy. After 18 weeks, patients were assessed for PTSD severity, as well as average change in functional impairment in work/school, family and social life. No serious safety or tolerability issues were observed in the MDMA group. While this research piggybacks off of previous trials, the specific intention of this Phase 3 trial is to show the FDA that MDMA is safe and effective in the treatment of PTSD so that it can be moved forward and approved as a therapeutic, says the study’s lead researcher Jennifer Mitchell, PhD. As a therapist and psychedelic researcher, Devon Christie, MD, medical and therapeutic services director with Numinus Wellness, views these findings as a landmark achievement for the study and treatment of PTSD. “Not only are the results indisputably positive…they also demonstrate robust safety and tolerability, and the response to treatment was the same even for dissociative-subtype PTSD which is notoriously more challenging to treat through conventional treatments,” Christie says.
MDMA and the Brain
While MDMA is currently listed as a Schedule I drug, defined as effectively illegal in the U.S. and having no currently accepted medical use, the FDA granted MDMA-assisted therapy “breakthrough therapy” status following Phase 2 trials. This distinguished it as a treatment for a life-threatening condition while demonstrating the potential to be more beneficial than currently available treatments. So, what exactly makes it so effective? “MDMA is classified as an empathogen, which speaks to its ability to generate states of empathy and increase positive emotions, while lowering the intensity of negative emotions and memories,” Christie says. “Psychedelics in general share an underlying mechanism of enhanced psychological flexibility and neuroplasticity that allows for the relaxation of strongly conditioned negative cognitions and biases, while enabling new insights and perceptions to arise.” These effects make MDMA-assisted therapy uniquely effective. Whereas other FDA-approved treatments for PTSD involve taking pharmaceutical drugs or engaging in a long process of psychotherapy, an MDMA-centered treatment combines the two, Christie points out. “The presence of the drug makes the impossible, possible in therapy,” she says. Each modality complements the other: MDMA calms the brain’s fear centers and enhances feelings of trust and compassion in a therapeutic environment, allowing the patient to access and discuss trauma, while psychotherapy allows the patient to process and release those painful emotions and memories. While the exact neurological effects of the drug have only been studied in animal models, Mitchell explains that MDMA appears to reopen a critical period for social and emotional learning. “This suggests that perhaps there is a type of social and emotional openness that is less easy to attain after a trauma, and that MDMA allows that to be re-actualized," she says. “In that place, it’s easier to revisit really traumatic, emotionally evocative stuff.” For these reasons, researchers consider MDMA-assisted therapy a potential breakthrough treatment that deserves expedited clinical evaluation, especially in the interest of patients who have yet to see success in treating their symptoms. “We’re really hoping it provides a new tool in the toolbox of providers who are dealing with patients with truly intractable, severe PTSD,” Mitchell says. “People living with comorbidities like childhood trauma, depression, dissociative PTSD, are considered to be treatment-resistant. MDMA could change that.”
