13News Now Investigates: FDA trial uses Ecstasy to treat PTSD

Many people in Hampton Roads know the tragic reality: Post-traumatic stress disorder (PTSD) can result in suicide attempts and deaths. The disorder is difficult to treat. Right now, the only drugs approved don't actually heal the patients.

“We’ve known for a long time that although some medications can help decrease the symptoms, they aren't curative,” psychiatrist Michael Mithoefer told 13News Now.

Dr. Mithoefer and his wife, Annie, who is a nurse, have used therapy for years to help people with PTSD.

“The treatment involves revisiting the trauma and processing and bringing understanding to what's happened,” explained Mithoefer.

While psychotherapy has produced some positive results, the treatment, in and of itself, can be traumatic. For some veterans, revisiting the harsh realities of war causes overwhelming anxiety. For others who've shut down much of their emotions, the therapy isn't effective.

The Mithoefers, who lead the Charleston study site for the federal trial, said MDMA has been successful with this patient population.

“It gives people a period of time when there's less fear,” Mithoefer stated.

The drug decreases activity in the fear center of the brain and increases activity in the brain's processing center. As a result, the people don't feel the fear, which normally prohibits them from facing their memories. At the same time, they are able to process what happened more clearly.

Mithoefer and Annie took us through how the study (which the nonprofit group MAPS spearheads) works.

In addition to regular psychotherapy sessions, there are three times when participants randomly are given MDMA or a placebo during their inpatient therapy session. The patient doesn't know which one he/she received.

Participants are monitored at the study site for a full day during those sessions. The drug sessions are spaced three to five weeks apart, with regular therapy scheduled between the sessions. It's spread over the course of 12 weeks.

“After one MDMA session, we've had a number of people say they could sleep through the night, and before that they could not,” Annie said.

In the initial phases of the clinical trial, about 65 out of 107 patients (61 percent) no longer registered on the PTSD scale. At the one-year follow-up, that number increased to 73 (68 percent.)

Using a Schedule I substance for treatment is not without stigma or concern. Skeptics claim it's an excuse to legalize MDMA. Doctors said participants need to be monitored closely so the drug doesn't affect their blood pressure. There also could be psychological risks if participants are not supported properly by trained therapists.

“Neither the FDA nor any of us think it should be a take-home medicine, where you can pick it up at the pharmacy,” Mithoefer said. “We think it will only be licensed in licensed clinics that are set up to give it to people only under direct supervision.”

MDMA-assisted Psychotherapy for PTSD Phase 3 Clinical Trials by 13News Now on Scribd

There are certain things about which you just don't talk. It's not because you don't want to talk about them; oftentimes, it's because you can't.

“I avoid a lot of things that remind me of Iraq,” said Sgt. Jonathan Lubecky whose memories of his time overseas can replay over and over again. “Knowing it was the right decision and having to live with it are two different things."

Medical experts believe if you don't talk about a traumatic experience, you don't process it, and it lives with you every moment of every day.

“There's one in particular that will bother me for the rest of my life,” Lubecky stated, recalling a moment from the Marine Corps and Army veteran's time in Iraq. It's one of many moments about which you won't find the designated marksman or shooter talking to his Army buddies.

It only came up during an MDMA-assisted psychotherapy session. The drug is the reason Lubecky was able to talk about the memory and others. He gave 13News Now permission to view and share video of that session in order to give a more complete picture of the clinical trial.

“It's where I know it was the right decision,” he told counselors on the video. “I know what he was about to do.”

Lubecky and his wife, Olivia, sat down with us to explain how destructive the psychological effects of those memories were. Lubecky was diagnosed with PTSD and tried to kill himself five times. The scars on his wrists are constant reminders of the internal torment, which took over the couple's lives.

“You go from being in the military and being able to conquer the word, to not being able to leave your house,” he said.

“Reliving how horrible it was, I mean, like, you feel all alone,” Olivia shared, sobbing.

Lubecky tried just about every treatment available through the VA. At one point, he was taking 42 pills a day. When the couple learned about the clinical trial that combined MDMA with therapy to treat post-traumatic stress disorder, they didn't hesitate to sign up.

“I started talking about things I'd never told anybody before that happened over there, because I was that comfortable and that relaxed, and once the floodgates open, they open,” explained Lubecky.

According to his experience, once you can talk about the trauma, you can understand it and you get your life back.

“I literally went from being in a mental health facility, which she had to check me into, to working on a presidential campaign on the national level,” he told 13News Now.

Lubecky realizes the treatment is unconventional and believes trained counselors are needed for this kind of process.

“From when you take it until 24 hours later, you're under direct supervision,” he stated, addressing concerns of critics. “The only time I was ever in possession was when I took it off the plate and put it in my mouth. So, this is a lot like going into a surgical suite.”

The Lubeckys hope the strict controls in the clinical trial will lead to FDA approval. The agency will have more evidence to consider as 200 to 300 people soon will be enrolled in the Phase 3 trials starting this spring. Advocates with MAPS believe there will be a lot more veterans.

While that government approval process drags on, The Lubeckys share their story with the belief that their experience and the trial can help veterans tormented by PTSD and encourage veterans to hold onto hope.

“Get your spouse or significant other into the treatment because it makes a world of difference,” Olivia said. “It really does. You can live again. They can live again.”

Researchers are looking for participants for this next trial phase. Applications and more information will be available online soon.