Stars and Stripes: FDA Expands Access to Ecstasy Drug for PTSD Therapy
Summary: Stars and Stripes reports on the U.S. Food and Drug Administration’s (FDA) agreement to an Expanded Access program for MDMA-assisted psychotherapy for PTSD while highlighting previous clinical trial results, and speaks with Army SGT (R) Jon Lubecky about his experience participating in a MAPS-sponsored clinical trial.
Originally appearing here.
WASHINGTON – Iraq War veteran Jonathan Lubecky was deployed to Balad Air Base in 2006, where mortar attacks became part of daily life.
During one enemy strike, Lubecky was knocked unconscious, suffering a traumatic brain injury. His overall combat experience resulted in post-traumatic stress disorder.
After leaving the Army in 2009, he tried many treatments, including exposure therapy, cognitive behavioral therapy and several types of antidepressants – but nothing lessened his symptoms of PTSD. The pain became so overwhelming, Lubecky attempted suicide five times in eight years. He said when he wasn’t attempting to kill himself, he was thinking about it.
In 2014, Lubecky tried something new. He volunteered for a clinical trial of MDMA, the illegal psychedelic drug commonly known as molly or ecstasy. The U.S. Food and Drug Administration in 2017 designated MDMA as a “breakthrough therapy” to treat PTSD and last week said it would allow more people to access the treatment.
“I already had five suicide attempts. I put a gun to my head twice and pulled the trigger,” Lubecky said. “I figured I was going to die anyway, that I might as well try ecstasy. And then it worked.”
Lubecky, a retired sergeant, took a dose of ecstasy, and then was guided through eight hours of intensive psychotherapy. He repeated the process two more times. The drug, which enhances feelings of empathy and euphoria while blocking the brain’s ability to process fear, “broke down the barriers” that previously prevented Lubecky from opening up to therapists, he said. During those 24 hours of therapy, he talked about all of his traumas: his combat experience, divorce and multiple suicide attempts, among other things.
After the first session, Lubecky said he had fewer suicidal thoughts. He eventually went one full day without thinking of killing himself, then two. Five years after he completed the clinical trial, Lubecky no longer meets the qualifications for a PTSD diagnosis.
“The MDMA puts the mind, body and spirit in a place it needs to be in order to heal,” he said. “It’s like doing therapy while being hugged by everyone who loves you in a bathtub full of puppies licking your face. That’s the best way I’ve been able to describe it.”
The study is sponsored by the Multidisciplinary Association for Psychedelic Studies, or MAPS, a nonprofit that formed in 1986 to fund research of the drug after MDMA was made illegal.
The group announced Friday that MDMA-assisted psychotherapy will soon be available to more people. The FDA granted expanded access for the treatment, meaning patients outside of the clinical trials will be able to receive it.
Also known as “compassionate use,” expanded access allows people facing a serious or life-threatening condition to undergo experimental therapies that could help them. In this case, the treatment will be made available to an additional 50 people at 10 sites across the country. The sites will be announced in the next few months.
MAPS has already received 120 applications from sites that want to offer the treatment.
At the same time, MAPS stands up the expanded access program, it’s continuing with Phase 3 of the clinical trials at 15 sites in the United States, Canada and Israel. The trials are expected to be completed in 2021, and the FDA could approve the treatment in 2022.
The study has so far shown positive results. A Phase 2 trial near Charleston, S.C., of which Lubecky was part, resulted in 68 percent of participants no longer showing PTSD symptoms after their second session. Of the 26 participants in that study, 22 were veterans.
The veteran population experiences PTSD at a higher rate than the rest of the population. The VA estimates between 11 and 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.
No longer experiencing PTSD symptoms, Lubecky dedicates his time to advocating for the treatment, getting more veterans involved and changing the way society talks about mental illness.
He works for MAPS as a veterans and government affairs liaison and often speaks about his experience with the MDMA-assisted psychotherapy. Instead of a lifelong illness, he wants people to think of PTSD as a mental injury that can be healed.
“We’ve all been told this is a chronic, lifelong mental illness, that our symptoms can be addressed but we can’t make it go away,” Lubecky said. “MAPS and this MDMA therapy have shown that we can heal it.”
If he hadn’t participated in the trial, Lubecky believes he would have died by suicide.
“I’d be in Arlington cemetery,” he said. “The biggest impact on this has been my stepson. It’s the reason he has a father instead of a folded flag.”
Anyone interested in applying for expanded access to MDMA therapy can learn more at mapspublicbenefit.com.
Always use the online HTML Editor to compose the content for your website easily.