Summary: Stars and Stripes covers MAPS’ MDMA-assisted psychotherapy for PTSD Phase 2 clinical trial results from study site in Charleston, South Carolina. “These results are further evidence that MDMA, used just two times at monthly intervals, can make psychotherapy much more effective and better tolerated,” explains Principal Investigator Michael Mithoefer, M.D.
Originally appearing here.
WASHINGTON — Study results published Tuesday show MDMA, commonly known as ecstasy, was effective in reducing symptoms of post-traumatic stress disorder for some veterans – boosting evidence to make the psychedelic drug an approved treatment.
The study, conducted by clinical investigator Michael Mithoefer and sponsored by the Multidisciplinary Association for Psychedelic Studies, was published in The Lancet, a peer-reviewed journal. It was one of six MAPS-sponsored studies during their Phase 2 trials of MDMA-assisted psychotherapy.
During the trials, participants took a dose of MDMA, and a clinician guided them through hours of intensive psychotherapy. Of the participants who received a full dose of MDMA in Mithoefer’s study, 68 percent no longer met the qualifications for a PTSD diagnosis one month after their second session.
The study had 26 participants, 22 of which were veterans. Three were firefighters, and one was a police officer. All of them had chronic PTSD that was severe enough to resist treatment from traditional methods.
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 participant in Mithoefer’s study was a Marine Corps veteran who served two tours in Iraq. He received treatment for PTSD at the Department of Veterans Affairs but continued to have severe symptoms, including fits of “uncontrollable rage,” during which he would yell at his wife and punch holes in the wall, according to the study.
During the psychotherapy, the veteran thought of the part of himself that’s full of rage.
“I realized I have that part of me locked up in jail,” he is quoted as saying in the study. “I went and opened the door and hugged him, and his evil eyes faded away.”
After his first session, his wife confirmed the veteran’s rage attacks stopped. Other symptoms improved over the following weeks, according to the study.
“These results are further evidence that MDMA, used just two times at monthly intervals, can make psychotherapy much more effective and better tolerated,” Mithoefer said.
As a result of the MAPS trials, the U.S. Food and Drug Administration recently designated MDMA as a “breakthrough therapy” to treat PTSD.
The designation provides a fast-track for possible approval of MDMA as a prescription drug.
MAPS will soon begin Phase 3 trials — the final step before the FDA could make a decision on the treatment.
MAPS is planning to enroll 200 to 300 participants at 16 sites in the United States, Canada and Israel. Participants must be 18 and older with severe PTSD. The trials will cost about $25 million, and MAPS is still attempting to raise $12.5 million.
According to MAPS, if Phase 3 trials demonstrate “significant efficacy and an acceptable safety profile,” the FDA is expected to approve MDMA-assisted psychotherapy as a PTSD treatment by 2021.
“I’m excited that Phase 3 trials will soon confirm whether this therapy can be approved for widespread use in a few years,” Mithoefer said.