MDMA One Step Closer to FDA-Approval: Treatment Shows Powerful Results in Clinical Trial (NYT)

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by Steven Rowe

MDMA, sometimes known as molly or ecstasy, has just passed an important hurdle in becoming FDA approved for therapeutic use, according to a recent article by The New York Times. In a phase three clinical trial, researchers paired talk therapy with three doses of the drug and saw powerful results in treating chronic posttraumatic stress disorder (PTSD).

In the study, a cohort of 90 individuals with PTSD were given 18 weeks of therapy that included three, 8-hour “experimental” sessions. During these experimental sessions, half of participants were given an inactive placebo, and half were given MDMA—everything else about the treatment was the same. Two months after the treatment was over, 67% of the group that received MDMA no longer qualified for a diagnosis of PTSD, while only 32% of the placebo group. This is in contrast to antidepressants (the current first-line medication for PTSD), which don’t work for 40-60% of patients, and common psychotherapy treatments (e.g., CPT, prolonged exposure) that fail to resolve PTSD in up to 72% of patients. The treatment was tolerated well by participants, and the worst side effects reported were nausea and loss of appetite. The full results of the research were published in Nature Medicine this month.

The next step for this promising treatment, replicating these stellar results in a second phase three clinical trial, is currently underway. If the findings are similar, then treatment like what was conducted in the study could get the green light by the FDA to become available to the public as early as 2023. However, PTSD and MDMA treatment is only the beginning of what researchers and clinicians hope to do with psychedelic-assisted therapy. Early-stage research has already been done suggesting MDMA might have therapeutic potential to treat many other mental health disorders, including substance abuse, depression, OCD, eating disorders, end-of-life anxiety, and more. Other psychedelics like LSD and psilocybin are also showing encouraging potential for therapeutic use.

MDMA-assisted therapy for PTSD is unique in that its goal isn’t to manage the symptoms of the disorder, like traditional pharmaceuticals. The mechanism that researchers believe to be helpful here is how MDMA allows people with this disorder to feel emotionally and physically safe enough to process their traumatic memories faster, and more effectively. Although, the exact neurological process for how this happens in the brain is not fully understood. MDMA causes an increase in serotonin in the synapses of the brain, as well as elevated levels of oxytocin, dopamine, and other neurotransmitters. This combination produces feelings of empathy, trust, compassion, and forgiveness, while reducing fear and anxiety.

Scientists also theorize that a possible therapeutic effect may come from the drug’s ability to reopen what is called the “critical period”, a window people go through in childhood where the brain has an increased ability to create and store new memories. Having a glance into this window as an adult may allow people to revisit their traumatic memories and make peace with them.

One participant in the study described how the MDMA therapy allowed him to work through PTSD surrounding a traumatic event that happened when he was four years old. “This allowed me to accept myself and recognize who I am,” he said. He goes on to say how he has since experienced less anger and has an easier time enjoying the moment.

Here at SoundMind, we are laying the groundwork to provide MDMA-assisted psychotherapy and other psychedelic-assisted therapies as they become legal and FDA-approved. We are committed to making these vital and groundbreaking treatments accessible to all Philadelphians, especially BIPOC and low-income individuals in our local West Philadelphia community. In addition to clinical services, we also create free mental health and wellness programming and create tech and media to enhance the efficacy and safety of psychedelic-assisted psychotherapy for all people.

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