The Post and Courier: After Successful Trials in SC, FDA Expands Access to Ecstasy to Help Veterans With PTSD

Summary:The Post and Courier reports on the expansion of MDMA-assisted psychotherapy for PTSD through the Food and Drug Administration’s Expanded Access program and touches on the history of MAPS-sponsored research in South Carolina. “The resurgence of research into using drugs such as MDMA to catalyze psychotherapy is the most promising and exciting development I’ve seen in my psychiatric career,” explains Dr. Michael Mithoefer, the Acting Medical Director for MAPS Public Benefit Corporation who has conducted clinical trials of MDMA-assisted psychotherapy for PTSD at his office in South Carolina since 2004.

Originally appearing here.

Veterans battling severe post-traumatic stress disorder could soon have access to ecstasy-guided therapy because of successful medical trials done in Mount Pleasant. 

Ecstasy, scientifically called MDMA, is an illegal psychoactive drug culturally associated with rave culture, dance parties and music festivals. But last week, after years of successful trials in South Carolina, the Food and Drug Administration announced the expansion of the study to help firefighters, police officers and soldiers trying to combat long-standing trauma. 

“The resurgence of research into using drugs such as MDMA to catalyze psychotherapy is the most promising and exciting development I’ve seen in my psychiatric career,” said Michael Mithoefer, a Mount Pleasant therapist who has conducted trials at his office since 2004. 

The research has already helped dozens of veterans, including Army Sgt. C.J. Hardin. The West Ashley resident served in Iraq and Afghanistan for eight years. The stress of war paired with memories from his childhood haunted him. 

He said he turned to heavy drinking and intense self-medicating with marijuana to feel “numb.” He shut himself off from human contact and felt like he was becoming a hermit. 

“It was a culmination of events in my life but it got more intense during my deployment,” Hardin said. “There was this general feeling of not feeling safe at anytime. The sounds of rockets and mortars and knowing that at any moment a bomb could come in on you.” 

The Multidisciplinary Association for Psychedelic Studies, a nonprofit that Mithoefer serves as the acting director of, got the green light from the FDA to offer it outside of clinical trials to those with “a serious or life-threatening condition for whom currently available treatments have not worked,” according to the organization. 

PTSD plagues many active-duty service members and veterans. The Department of Veterans Affairs estimates 11 to 20 percent of veterans who served in the wars in Iraq and Afghanistan have PTSD, compared with about 7 to 8 percent of the general U.S. population.

The government has not been an advocate of ecstasy. On July 1, 1985, the Drug Enforcement Agency listed MDMA as a Schedule I substance that “has high abuse potential, no accepted medical use and no accepted safety for use.″

Mithoefer said the stigma about MDMA isn’t easy to combat. 

“It has been a problem,” he said. “We’re using it very carefully by screening people first and preparing them for the experience. There’s a lot that goes into the safety and efficacy of it.”

It’s an involved process. Participants in Mount Pleasant are selected and coached about what to expect from the treatment, consisting of three, 24-hour individual sessions spaced a month apart.

Patients take a pure form of the drug provided by the FDA, or a placebo, and are given eye shades and music to listen to. Following overnight observation to make sure the patient is safe, therapists will follow up with multiple sessions to discuss emotions before the next dose is administered. 

The drug decreases activity in the amygdala, the brain’s fear center, while it increases activity in the prefrontal cortex, the higher processing center. This allows patients struggling with overwhelming anxiety to feel more open in talking about their trauma.

A Phase 2 trial resulted in 68 percent of participants no longer showing PTSD symptoms. Of the 26 participants in that study, 22 were veterans.

In 2017, the FDA allowed researchers to proceed to Phase 3 clinical trials. It’s only one step away before the agency considers approving the drug for use in a medical setting. The Phase 3 trials are expected to be completed in 2021, meaning that the FDA could approve the treatment as early as 2022.

So far, Mithoefer said 56 participants have gone through the trials. Hardin said he’s grateful that he was one of them. He’s not sure he’d be alive today if it wasn’t for it. 

“Before, I was unemployable,” Hardin said. “After the therapy, I went back to school and now I’m an aviation mechanic. It took me from just living day to day to having a good job and a career that I’m proud of.”