Summary: Stars and Stripes speaks to MAPS-sponsored MDMA researcher Michael Mithoefer, M.D., about the results of Phase 2 clinical trials of MDMA-assisted psychotherapy for PTSD, how receiving Breakthrough Therapy Designation ensures that the FDA will work closely with MAPS to complete upcoming Phase 3 trials, and veterans study participants in the trials. “One of the things we’ve been struck by with this group of veterans is how much they’re dedicated to trying to help out other vets,” explains Mithoefer. “Many have said this needs to be available to everyone. Some have said things like, ‘We were taught not to leave anybody behind.’ They want to get the word out.”
“Some people don’t respond to therapy because they find it so upsetting to face the trauma. Conversely, some are prone to emotional numbing and are so emotionally cut off that therapy doesn’t work,” explains Mithoefer. “So the idea with MDMA is, it seems to help people face the trauma without being overwhelmed by anxiety. It helps them to look clearly at what’s happened and their feelings with it, rather than having to avoid it as much.”
Originally appearing here.
WASHINGTON — The U.S. Food and Drug Administration designated the illegal psychedelic drug MDMA, commonly known to partygoers as Ecstasy, as a “breakthrough therapy” to treat post-traumatic stress disorder.
The designation was announced Saturday and provides a fast-track for possible approval of MDMA as a prescription drug. It’s the result of years of trials sponsored by the Multidisciplinary Association for Psychedelic Studies, or MAPS, that have included veterans since 2010.
“It doesn’t mean anything is approved or guaranteed, but it does mean this gets special attention from the FDA and allows it to move through the regulatory process more quickly,” said Michael Mithoefer, a clinical investigator who’s involved in the study of MDMA-assisted psychotherapy.
During the trials, participants took a dose of MDMA, and Mithoefer or another clinician guided them through eight hours of intensive psychotherapy. The process repeated two more times, each session one month apart.
The goal, Mithoefer said, was to get to the root cause of someone’s PTSD, and not just treat the symptoms, like other drugs do.
The Department of Veterans Affairs in 2014 issued guidance on therapy, not medication, as a frontline treatment for PTSD. MDMA makes that therapy more effective, Mithoefer said.
“Some people don’t respond to therapy because they find it so upsetting to face the trauma. Conversely, some are prone to emotional numbing and are so emotionally cut off that therapy doesn’t work,” Mithoefer said. “So the idea with MDMA is, it seems to help people face the trauma without being overwhelmed by anxiety. It helps them to look clearly at what’s happened and their feelings with it, rather than having to avoid it as much.”
The idea has seen positive results so far, according to MAPS.
The 107 people involved in Phase 2 trials had chronic PTSD that was severe enough to resist treatment from traditional methods. Two months after they completed three sessions of MDMA-assisted psychotherapy, 61 percent of them no longer qualified for a PTSD diagnosis, according to MAPS statistics.
Mithoefer recently completed a trial in Charleston, South Carolina, that tested the method on 22 veterans with service-related PTSD. Most of them had served in Iraq and Afghanistan, and a few of them were diagnosed with Military Sexual Trauma.
The results from the trial haven’t been published yet, but Mithoefer said veterans had “very strong results,” falling in line with the outcomes of other participants.
The veteran population experiences PTSD at a higher rate than the rest of the country. The VA estimates between 11 and 20 percent of veterans who served in the Iraq and Afghanistan wars have PTSD in a given year. About 7-8 percent of the U.S. population will suffer with PTSD at some point in their lives.
“One of the things we’ve been struck by with this group of veterans is how much they’re dedicated to trying to help out other vets,” Mithoefer said. “Many have said this needs to be available to everyone. Some have said things like, ‘We were taught not to leave anybody behind.’ They want to get the word out.”
The FDA will work with MAPS to complete Phase 3 trials. The trials are expected to start in 2018 and involve more than 200 participants at sites in the United States, Canada and Israel. MAPS set the goal of having MDMA approved as a prescription medication by 2021.
