Summary: Forbes reports on the progress of Phase 3 clinical trials of MDMA-assisted psychotherapy for PTSD. The article highlights promising results from Phase 2 trials, the Food and Drug Administration (FDA) granting Breakthrough Therapy Designation to MDMA-assisted psychotherapy, and the potential mechanisms for MDMA’s therapeutic attributes when combined with psychotherapy. “If you look at what MDMA and other psychedelics do, they’re encouraging neuroplasticity. So they encourage neurons to make new connections, to get out of the old connections and to make new ones,” explains Brad Burge of MAPS.
Originally appearing here.
Jonathan Lubecky was truly at the end of his rope. The former Army Sergeant, who’d served in Iraq and was later plagued by the violent events he’d witnessed in war, says he had already attempted suicide five times.
“I drank a bottle of vodka, loaded a Beretta 9mm, put it to my temple and pulled the trigger,” he told WRAL.com in Raleigh, North Carolina. “And the gun malfunctioned.”
After many years of experiencing severe post-traumatic stress disorder (PTSD) – including near-constant anxiety and depression – Lubecky now credits a clinical drug trial he’d embarked upon several years ago with altering his life forever. Because of those experimental drug trials, he no longer feels the overwhelming burden of PTSD.
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Known universally as the nightclub drug Ecstasy or Molly – and chemically identified as MDMA – prescription versions of the substance are currently being tested on patients with severe PTSD in experimental settings across the U.S. in conjunction with psychotherapy sessions. And the results are proving to be astoundingly positive.
The pioneering clinical trials are sponsored by the non-profit Multidisciplinary Association for Psychedelic Studies (MAPS), which since 1986 has created awareness around psychedelics as a healing modality. The organization has raised over $70 million developing such groundbreaking therapies – with more than half of that amount going specifically to MDMA-assisted PTSD work, currently in Phase 3 trials.
Phase 3 trials are a pretty big deal for drug makers seeking approval from the Food and Drug Administration (FDA) – particularly for drugs like MDMA, which at present is illegal and designated by the U.S. government as a Schedule 1 drug alongside heroin. It means that MAPS has already jumped through the hoops of initial Phase 1 and Phase 2 trials and reported encouraging results to the FDA that are significant enough to move on to Phase 3 final trials.
MAPS notes that in their Phase 2 trials of 107 people, 61% of participants no longer qualified for PTSD after just three sessions of MDMA-assisted psychotherapy two months following treatment. At the 12-month follow-up, that number jumped to 68% no longer experiencing PTSD. Prior to the therapies, all participants had “chronic, treatment-resistant PTSD and had suffered for an average of 17.8 years.”
What MDMA-assisted psychotherapy is doing for people suffering from PTSD is nothing short of amazing. Effectively helping to rewire impaired circuitry in the brain, which can often lock individuals into repeatedly reliving traumatic events, MDMA is helping to correct distressed neurological pathways.
Brad Burge, director of strategic communications at MAPS, says, “We’re literally rewiring neural connections in the brain. If you look at what MDMA and other psychedelics do, they’re encouraging neuroplasticity. So they encourage neurons to make new connections, to get out of the old connections and to make new ones.”
The mechanism behind MDMA also helps to lower activity in the amygdala, a region of the brain responsible for the perception of emotions including fear and anger. The amygdala is great at storing memories of certain key events and emotions so that an individual can recognize similar threats in the future and react accordingly. In the case of people with PTSD, systems go awry, and fear and aggression responses get recycled into seemingly endless negative loops.
Associate Social Worker Ashley Booth, who works as a co-therapist on the Phase 3 team for MAPS’ MDMA-assisted psychotherapy, says that patients with PTSD who are undergoing therapies can have a truer sense of themselves on the medication.
“It’s common for people who’ve had a trauma to take on responsibilities, like ‘I shouldn’t have walked down that alley, or talked to that person,’” says Booth. “MDMA has psychoactive properties that lower activity in the amygdala, which is the fear center of the brain, and allows people to look at themselves from a more empathetic perspective.”
Booth, who is also co-founder of the California Center for Psychedelic Therapy in Los Angeles, says patients experiencing MDMA-assisted therapy are “better able to look at trauma in their lives without being re-traumatized.”
Results were so positive early on that in 2017 the FDA granted MAPS’ trials a “breakthrough therapy designation,” which is a process designed by the FDA to expedite the development and review of drugs that are intended to treat a serious condition, when preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over available therapies. Burge says that at the same time that year, the trials also received what’s called a special protocol assessment (SPA). It’s an important piece of the puzzle that could accelerate the use of MDMA as a widespread medicine.
“The SPA says that if we get a certain level of statistical efficacy and the Phase 3 trials are conducted per protocol – the protocol that was approved – then the FDA has agreed in writing to approve the drug,” he says.
Burge notes that for-profit pharmaceutical companies are not interested in developing MDMA into a medicine because the patent for MDMA has expired. The concept of using MDMA to assist psychotherapy of any kind for any specific clinical indication has long been in the public domain. Still, MAPS is currently the only organization in the world funding clinical trials of MDMA-assisted psychotherapy specifically for PTSD and is driving to have the drug FDA approved as a prescription medicine by 2021.
Clinical trials are currently being conducted in 15 research sites, including Boston, Montreal, Charleston, San Francisco, and Tel Aviv. After the first quarter of 2020, MAPS plans to do an interim analysis of trial data and assess the statistical efficacy of the trials, based on what the FDA is going to require.
Army veteran Lubecky, who is living proof of that data, already personally knows the efficacy of MDMA as a viable treatment.
“We can heal PTSD like a broken bone,” he says. “If it can help someone like me heal from mental injury, then people should absolutely have access to it.”