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MDMA (Ecstasy) passes Phase 3 clinical trial

Posted by Hugh on May 4, 2021, at 15:18:25

May 3, 2021

In an important step toward medical approval, MDMA, the illegal drug popularly known as Ecstasy or Molly, was shown to bring relief to those suffering from severe post-traumatic stress disorder when paired with talk therapy.

Of the 90 people who took part in the new study, which is 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. Two months after treatment, 67 percent of participants in the MDMA group no longer qualified for a diagnosis of PTSD, compared with 32 percent in the placebo group.

MDMA produced no serious adverse side effects. Some participants temporarily experienced mild symptoms like nausea and loss of appetite.

"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."

Before MDMA-assisted therapy can be approved for therapeutic use, the Food and Drug Administration needs a second positive Phase 3 trial, which is currently underway with 100 participants. Approval could come as early as 2023.

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.

Scott Ostrom, who participated in the study, had suffered from PTSD since returning home from his second deployment in Iraq in 2007. For more than a decade, he experienced debilitating nightmares. "Bullets would dribble out of the end of my gun, or I'd get separated from my team and be lost in a town where insurgents were watching me," he said.

Mr. Ostrom's days were punctuated by panic attacks, and he dropped out of college. He pushed friends and family away, and got into an unhealthy romantic relationship. He was charged with assault and attempted suicide. Therapy and medication did not help.

But after participating in the trial, he no longer has nightmares. "Literally, I'm a different person," he said.

During his first of three sessions in early 2019, lying on a couch with eye shades, and in a lucid dreamlike state, Mr. Ostrom encountered a spinning, oily black ball. Like an onion, the ball had many layers, each one a memory. At the center, Mr. Ostrom relived the moment in Iraq, he said, that "I became the person I needed to be to survive that combat deployment." Over the next two sessions, Mr. Ostrom engaged with "the bully," as he calls his PTSD alter ego, and asked permission for Scott to return.

Mr. Ostrom, 36, now works steadily as an HVAC specialist and owns a home near Boulder, Colo., which he shares with his girlfriend, Jamie Ehrenkranz, and his service dog, an English lab named Tim.

"The reason I like calling this medicine is it stimulated my own consciousness's ability for self-healing," Mr. Ostrom said. "You understand why it's OK to experience unconditional love for yourself."


Complete article:

https://www.nytimes.com/2021/05/03/health/mdma-approval.html


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poster:Hugh thread:1114875
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