The first Phase 3 Clinical Trial Results for MDMA-assisted therapy just got pre-announced by the NYT.
TLDR; “Two months after treatment, 𝟔𝟕% of participants in the MDMA group no longer qualified for a diagnosis of PTSD” after having suffered from severe PTSD for an average of 14 years prior.
“Expected to be published later this month in Nature Medicine, those who received MDMA during therapy experienced a significantly greater reduction in the severity of their symptoms compared with those who received therapy and an inactive placebo. MDMA produced no serious adverse side effects.
“This is about as excited as I can get about a clinical trial,” said Gul Dolen, a neuroscientist at Johns Hopkins University School of Medicine, who was not involved in the research. “There is nothing like this in clinical trial results for a neuropsychiatric disease.”
Mental health experts say that this research — the first Phase 3 trial conducted on psychedelic-assisted therapy — could pave the way for further studies on MDMA’s potential to help address other difficult-to-treat mental health conditions, including substance abuse, obsessive compulsive disorder, phobias, eating disorders, depression, end-of-life anxiety and social anxiety in autistic adults.
And, mental health researchers say, these studies could also encourage additional research on other banned psychedelics, including psilocybin, LSD and mescaline.
“This is a wonderful, fruitful time for discovery, because people are suddenly willing to consider these substances as therapeutics again, which hasn’t happened in 50 years,” said Jennifer Mitchell, a neuroscientist at the University of California, San Francisco, and lead author of the new study.
Unlike traditional pharmaceuticals, MDMA does not act as a band-aid that tries to blunt symptoms of PTSD. Instead, in people with PTSD, MDMA combined with therapy seems to allow the brain to process painful memories and heal itself, Dr. Mitchell said.
Critically, MDMA taken in isolation, without therapy, does not automatically produce a beneficial effect.
In 2018, the U.S. Department of Veterans Affairs spent $17 billion on disability payments for over one million veterans with PTSD. For the approximately half to one-third of people who do not find relief through treatment, PTSD can become chronic, lasting years or even a lifetime.
The Phase 3 trial included combat veterans, first responders and victims of sexual assault, mass shootings, domestic violence or childhood trauma. All had severe PTSD and had been diagnosed, on average, for more than 14 years, and 90 percent had considered suicide.
Albert Garcia-Romeu, a psychopharmacology researcher at Johns Hopkins University School of Medicine, who was not involved in the study, said the findings “make a clear case for medical approval,” something that “represents a sea change that could revolutionize health care.”
— NYT: https://www.nytimes.com/2021/05/03/health/mdma-approval.html
FD: this work is being done by the non-profit https://MAPS.org and we are supporters https://flic.kr/p/2jykyQ8
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