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'It saved my life.' Mount Pleasant therapists' use of psychedelic drug to treat PTSD puts FDA closer to approving it

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Mount Pleasant-based psychiatrist Michael Mithoefer and his wife Annie Mithoefer, a nurse, have used the psychedelic drug MDMA to treat patients with post-traumatic stress disorder. File/Staff

Ed Thompson had tried practically everything, conventional and not-so-conventional. He went through therapy sessions, tried all sorts of prescription drugs. Sometimes, he mixed the powerful pills with alcohol when nothing else could block out the pain of his post-traumatic stress disorder.

He nearly killed himself that way a few times.

At his lowest point, the retired Charleston firefighter went down to the Medical University of South Carolina’s Institute of Psychiatry. He called his therapist and told her he was checking himself in.

“She said, ‘Wait… I have an idea,’” Thompson said.

Moments later, she called back with a phone number for Dr. Michael Mithoefer, a therapist who has conducted clinical trials with his wife Annie in their Mount Pleasant office since 2004. They’re testing whether the psychedelic drug MDMA, the illegal substance known as Ecstasy, can help patients recover from PTSD when administered during intensive psychotherapy sessions.

Standing in the psych ward’s waiting room, Thompson dialed the number. Mithoefer told him there was a spot for him in their next trial.

“It saved my life,” Thompson said. “I’m so much more myself now. It’s hard to even put words to. I’m better than I was before, honestly.”

Thompson’s success, repeated by many other participants in studies of MDMA-assisted psychotherapy, led the U.S. Food & Drug Administration in November to grant researchers to proceed to Phase 3 clinical trials. It’s the final step before the agency considers approving the drug for use in a medical setting.

If that happens, and Dr. Mithoefer is optimistic it will in 2021, he and his wife will be credited with creating the protocols of the treatment with their nonprofit sponsor, Multidisciplinary Association for Psychedelic Studies.

Their effort is narrowly aimed at allowing MDMA to be used in psychotherapy, the way anesthesia is used in operating rooms.

“This is not something people would take every day. They take it only three times, a month apart. That’s it,” Mithoefer said. “It’s the idea that the drug catalyzes the therapeutic process, so then you don’t keep needing the drug. It helps people get at the root cause of the PTSD and process it successfully.”

'One of the most striking things'

The Mithoefers moved to Charleston in 1973, shortly after they married. He went to medical school at MUSC, where she also earned her nursing degree. After 10 years as an emergency room doctor, he went back to school for psychiatry.

Dr. Mithoefer opened his own practice in Mount Pleasant in 1991, and his wife became involved in much of the treatment. Now, they’re an inseparable team, along with their therapy dog Flynn, a small terrier mix who’s become a fixture of most of their sessions.

“Flynn’s the best therapist in the building,” Dr. Mithoefer joked last week from the sunny room where they treat their patients.

The Mithoefers completed the first-ever Phase 2 clinical trial there from 2004-2009, studying people with PTSD who had been victims of sexual abuse. It set the mold for the methods they’ve used in recent studies.

Those participants, who were selected because of their failure to respond to other types of treatment, reported a 56 percent decrease in symptoms after three months. Two-thirds met the criteria for no longer having PTSD at the end of the study, and none reported experiencing any harm.

In a follow-up three years later, many participants reported they had improved even more since, suggesting that the treatment had led to long-term recovery.

“That’s one of the most striking things,” Dr. Mithoefer said. “It seems to act as a catalyst to a process that keeps unfolding in a useful way for most people.”

Thompson was among 26 military veterans, firefighters and police officers with PTSD who the Mithoefers studied in their second round of Phase 2 clinical trials. Those trials recently ended and will be reported soon in a peer-reviewed publication. The couple's work already has been profiled in The New York Times, on "PBS NewsHour" and in other international media.

The Mithoefers said results from that trial were just as promising as the first, and they have a few theories as to why MDMA, used on the streets as a party drug, can help PTSD patients reach a breakthrough that isn’t possible otherwise.

A drug, a futon, then follow up

After participants are selected and coached about what to expect from the treatment, each is scheduled for three, 24-hour individual sessions for MDMA-assisted therapy, spaced a month apart.

Patients typically arrive at the Mithoefers’ office mid-morning and take the drug, which is a pure form of MDMA provided by the Drug Enforcement Administraton.

To calm patients’ nerves about taking the potent substance, the Mithoefers sit on either side of them on a futon as the drug kicks in (although some participants are given a placebo). They monitor their patient's vital signs throughout the session.

The patients have headphones to listen to music, as well as eye shades. 

“We encourage people just to go inside and see what comes up, and talk to us about it when they’re ready,” Dr. Mithoefer said. “It’s a nondirective process. It’s not like we say, ‘OK, now it’s time to talk about the trauma.’”

The intensive therapy lasts eight hours, then an attendant monitors the patient overnight before they’re released the next day. Most patients have a sort of breakthrough the first time they take the drug.

“We’re trusting that they are going to revisit the places they need to, and the trauma. We’re not instructing them to go back to places,” Annie said.

Patients then go to regular therapy without MDMA, called “integration” sessions, in the month-long periods between the drug-assisted sessions.

“The integration is very important. People actually keep improving after the session. It’s not at all limited to just the period of MDMA effect,” Dr. Mithoefer said.

‘Inner healing intelligence’

Recent participants went to MUSC to do brain-imaging scans before and after their treatment, and although those results aren’t yet available, Dr. Mithoefer said other imaging studies might help explain why MDMA works for people with PTSD.

The drug decreases activity in the amygdala, the brain's fear center, while it increases activity in the prefrontal cortex, the higher processing center. PTSD patients often struggle with overwhelming anxiety, which prevents them from talking about their trauma.

“You can see why, if you can temporarily have the fear center less active, and the higher processing center more active, that might be a good opportunity to make a breakthrough in therapy,” he said.

But the Mithoefers have another theory, too. It stems from a concept they call the body’s “inner healing intelligence.”

“The body has an inherent wisdom to close the wound and heal itself. If it doesn’t do that, it’s because there are obstacles still in the way — infection,” Annie said, explaining that’s when medicine comes in to help.

If PTSD is the infection, then MDMA is the medicine that intervenes and clears it up so the mind can move on to heal itself, Dr. Mithoefer said.

“It’s as if something has blocked them (people with PTSD) from being able to successfully process and resolve their traumatic experience. And the MDMA seems to remove that blockage,” he said. “It helps people feel their emotions more, but also with a sense of not being overwhelmed by them.”

Thompson's problems began at age 18, when as a volunteer firefighter, he responded to his friends' serious car accidents. Later, he responded to the Sofa Super Store fire in 2007, when nine firefighters perished. He even has responded to an emergency call at his home involving his twin daughters.

After suffering from PTSD for more than a year and trying so many other drugs and treatments, Thompson said MDMA helped him look at his issues from an entirely new perspective. 

“I felt this huge weight lifted off of my shoulder, finally being able to truly talk to someone about it. I couldn’t do that before, I wasn’t letting myself, and I wasn’t able to,” he said. “These sessions are the beginning to a journey to continually get better.”

Reach Abigail Darlington at 843-937-5906 and follow her on Twitter @A_Big_Gail.

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