A Phase 3 clinical trial of 90 people with severe post-traumatic stress disorder (PTSD) found that combining MDMA, the illegal psychedelic drug also known as ecstasy or Molly, with talk therapy significantly relieved symptoms, The New York Times reports. Two months after participating in the trial, 67 percent of the combat veterans, first responders, and survivors of sexual assault, childhood trauma, mass shootings, and domestic violence who were given MDMA no longer qualified for a PTSD diagnosis, versus 32 percent given a placebo with their talk therapy.
The study, awaiting likely publication in the journal Nature Medicine later this month, found no serious adverse reactions from the clinical doses of MDMA. If a second Phase 3 trial underway with 100 subjects shows similarly promising results and safety, the Food and Drug Administration could approve MDMA-assisted therapy for therapeutic use as soon as 2023, the Times reports.
“This is about as excited as I can get about a clinical trial,” Johns Hopkins neuroscientist Gul Dolen, who was not involved in the research, told the Times. “There is nothing like this in clinical trial results for a neuropsychiatric disease.” Jennifer Mitchell, the U.C. San Francisco neuroscientist who is lead author of the study, said she’s excited “people are suddenly willing to consider these substances as therapeutics again, which hasn’t happened in 50 years.”
MDMA was invented by Merck pharmacists in 1912 and revived in 1976 by psychedelic chemist Alexander Shulgin. From 1977 to 1985, hundreds of therapists and other practitioners experimented with using MDMA, some reporting thrilling successes. But after the drug “escaped the clinic to the dance floor” in the 1980s, the Times says, the Drug Enforcement Administration criminalized MDMA and the clinical research dried up. MDMA without talk therapy isn’t effective against PTSD, researchers caution, and recreational ecstasy or Molly is sometimes adulterated with dangerous substances.
An estimated 7 percent of Americans — and 13 percent of combat veterans — will experience PTSD, and a significant portion of them don’t respond to current medications. Mental health experts also expressed hope that this first Phase 3 trial on psychedelic-assisted therapy could pave the way for research on other banned psychedelics — including LSD, mescaline, and psilocybin (mushrooms) — or the use of MDMA on other intractable mental health conditions. Read more about the research at The New York Times. Peter Weber