Party Drug Potential for PTSD

Ecstasy is in final clinical trials for treating the disorder

Many people, especially those who have had horrific war experiences, suffer from severe post-traumatic stress disorder (PTSD) that includes constant anxiety and depression and may trigger suicide. A familiar drug in an unfamiliar role may help to change that.

The nightclub drug Ecstasy or Molly, which is chemically identified as MDMA, is now available in a prescription version and is being tested on patients with severe PTSD in clinical trial settings in various locations across the U.S., along with psychotherapy sessions. The results are said to be “astoundingly positive,” according to an article by David Carpenter in Forbes.

The non-profit Multidisciplinary Association for Psychedelic Studies (MAPS) is sponsoring the clinical trials. MAPS, which has created awareness of psychedelics as a healing modality since 1986, has raised more than $70 million developing such groundbreaking therapies. More than half is aimed at MDMA-assisted PTSD work, currently in Phase 3 trials.

As Carpenter said, “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.” Thus, MAPS has already met the challenges of initial Phase 1 and Phase 2 trials and given the FDA enough significant results to be able to move on to Phase 3 final trials.

In the Phase 2 trials of 107 people, 61 percent of participants no longer qualified for PTSD after just three sessions of MDMA-assisted psychotherapy two months after treatment. At the 12-month follow-up, that number was up to 68 percent. Before the therapies, all participants had “chronic, treatment-resistant PTSD and had suffered for an average of 17.8 years.” MAPS believes that MDMA is correcting distressed neurological pathways.

According to Brad Burge, director of strategic communications at MAPS, “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.”

MDMA also helps to lower activity in the amygdala, a brain region responsible for the perception of emotions including fear and anger. The amygdala stores memories of certain key events and emotions, enabling an individual to recognize similar threats in the future and react accordingly. People with PTSD have systems that go awry, and “fear and aggression responses get recycled into seemingly endless negative loops,” Burge said.

Associate Social Worker Ashley Booth, a co-therapist on the Phase 3 team for MAPS’ MDMA-assisted psychotherapy, said, “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. 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, co-founder of the California Center for Psychedelic Therapy in Los Angeles, said patients experiencing MDMA-assisted therapy are “better able to look at trauma in their lives without being re-traumatized.”

In 2017 the FDA granted MAPS’ trials a “breakthrough therapy designation,” 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. The trials also received a special protocol assessment (SPA) that could accelerate the use of MDMA as a widespread medicine. If there is a certain level of statistical efficacy and the Phase 3 trials are conducted per protocol, the FDA has agreed in writing to approve the drug.

For-profit pharmaceutical companies are not interested in developing MDMA into a medicine, because the patent has expired. MAPS is the only organization funding clinical trials of MDMA-assisted psychotherapy specifically for PTSD and is trying to have the drug FDA approved as a prescription medicine by 2021.

Clinical trials are currently being conducted in 15 research sites. After the first quarter of 2020, MAPS plans to do an interim analysis of trial data and assess the statistical efficacy of the trials.