In a crucial step in medical approval, MDMA, an illicit drug known as ecstasy or molly, has been shown to provide relief to people suffering from severe post-traumatic stress disorder when paired with speech therapy. talk
Of the 90 people enrolled in the new study, expected to be published later this month in the journal Nature Medicine, those who received MDMA during therapy experienced a significant decrease in symptom severity compared to those who took it. Who have received treatment and Inactive placebo Two months after treatment, 67% of participants in the MDMA group were no longer qualified to diagnose PTSD, compared with 32% in the placebo group.
MDMA does not have serious side effects. Some participants experienced mild symptoms such as nausea and loss of appetite.
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“This is as exciting as I can get about clinical trials,” said Gul Dolen, a neuroscientist at the Johns Hopkins University School of Medicine who was not involved in the research. Results of clinical trials for psychiatric neurosis “
Before MDMA therapy can be approved for therapeutic use, the Food and Drug Administration needs a second positive phase III trial, which is currently underway with 100 participants. Approval may take place as early as 2023.
Mental health experts say this research, the first Phase III trial conducted on psychedelic therapy, could pave the way for further studies of MDMA’s potential to help manage mental health conditions that are associated with psychedelics. Other difficult to treat include substance abuse, obsessive-compulsive disorder, phobias, eating disorders, depression, late-life anxiety, and social anxiety in adults with Is autistic
And mental health researchers say these studies could also spur more research into other banned psychedelics, such as psilocybin, LSD, and mescaline.
“This is a wonderful and fruitful moment for discoveries because people are suddenly willing to consider these substances as another therapy that hasn’t happened in 50 years,” said Jennifer Mitchell, a neuroscientist at the University of California. University of California, San Francisco, and Lead author of the new study
But some mental health experts called for restraint. Allen James Frances, professor emeritus and former chair of psychiatry at Duke University who was not involved in the new study, cautioned that the new treatment “was never as wonderful as the first time.”
“All new therapies in medicine often have a temporary effect on the basis of newness and promise to give more than they can afford,” Frances said.
Unlike conventional pharmaceuticals, MDMA does not act as a Band-Aid that tries to blunt the symptoms of PTSD. But in people with PTSD, MDMA, in combination with therapy, appears to help the brain process painful memories and heal itself, Mitchell said.
Importantly, MDMA separated without treatment would not automatically produce a benefit.
“It’s not a drug, it’s a drug-enhanced therapy,” said Rick Doblin, the study’s senior author and director. Multidisciplinary Association for Psychedelic Studies, a not-for-profit research group that supports and funds clinical trials.
For this process to work, individuals need to be prepared to be involved with their injuries. First, the participants attend preparations with two trained therapists. Then, in three eight-hour sessions, spaced one month apart, they were given a placebo or inactive MDMA. Neither the participant nor the therapist knew. While most of the participants correctly guessed they had taken a placebo or MDMA, this did not ruin the results of the study or its methods, which were pre-agreed upon by the FDA.
Scott Ostrom, a study participant, has suffered from PTSD since returning home from a second installation in Iraq in 2007. He has experienced a devastating nightmare for more than a decade. Me or I will be separated from my team and get lost in a city where insurgents are watching me, ”he said.
Ostrom’s days were punctuated by panic attacks, and he dropped out of college. He pushed away friends and family and was in an unhealthy romantic relationship. He has been charged with assault and attempted suicide. Therapy and medication did not help.
But after attending the trial, he was no longer having nightmares. “Indeed, I am a different person,” he said.
In the first of three sessions in early 2019, lying on a couch with eye shades and in a clear dreamlike state, Ostrom was met with a swirling black ball. Like onions, the ball has several layers, each with a memory layer. In the center of Ostrom, reminiscent of his time in Iraq, he said, “I became the person I needed to survive that battle.” In the next two sessions, Ostrom joined the “bully” as he. Called his PTSD alter ego and asked Scott to return.
Ostrom, 36, continues to work as an HVAC specialist and owns a home near Boulder, Colorado, which he shares with his girlfriend Jamie Ehrencranz and his service dog, an English lab. Tim name
“The reason I like to call this drug is that it stimulates my own conscious self-healing abilities,” says Ostrom. “You understand why it is normal to experience unconditional love. For yourself “
Merck pharmacists invented MDMA, which stands for 3,4-methylenedioxy-N-methylamphetamine, in 1912, but the compound was largely forgotten until 1976, when Alexander Shulgin, a well-known psychedelic chemist, synthesized MDMA and Try yourself Realizing his findings may have therapeutic value, Shulgin shared MDMA in 1977 with Leo Zeff, a psychotherapist who recommended it to other mental health professionals over the next eight years. Hundreds of people and others gave approximately half a million doses of MDMA. Some people report that with just a few uses of the drug, the patient experiences massive advances, usually over several years.
However, in the early 1980s, MDMA fled the clinic to the dance floor, where it was known as ecstasy. In 1985, the Drug Enforcement Administration designated MDMA as a Schedule I substance, which defines it. “There is no recognized medical use currently available and there is a high probability of misuse.”
Some mental health professionals continue to offer MDMA therapy underground, but most have stopped. The number of scientists following MDMA studies has also dropped. But few individuals continue to make a big push on behalf of MDMA research, including Doblin, who founded his association in 1986 to focus on the development of MDMA and other psychedelic drugs into well-tolerated drugs. It took nearly two decades to get FDA approval to overcome panic claims about the dangers of ecstasy, including that it eventually devours the user’s brain to get approval to begin the study. Animal and human research confirmed that MDMA did not induce neuroprotective effects in clinical trials.
On the other hand, ecstasy or Molly can be adulterated with other hazardous substances and users may use higher doses of the drug than is safe.In 2011, MDMA accounted for 1.8% of drug-related emergency department visits. All in the United States, according to a database maintained until that year by the European Substance Abuse and Mental Health Services Administration, MDMA is responsible for 8% of drug-related emergency visits to 16 of the major hospitals in the United States. 10 countries from 2013 to 2014
Scientists do not yet fully understand the origins of MDMA’s therapeutic effects. It binds to a protein that regulates serotonin, a mood-lifting neurotransmitter. Antidepressants like Prozac bind to the same protein and block the reuse of serotonin, but MDMA continues this process, causing the protein to pump serotonin to the synapse. The chemical signal strengthened.
MDMA also raises levels of oxytocin, dopamine and other chemicals, causing feelings of empathy, trust and empathy.
But its primary therapeutic effect may come from its ability to open up what neuroscientists refer to as the “critical” window of childhood, when the brain has a superior ability to make new memories and store new memories. hold Evidence from a mouse study published in Nature in 2019 indicates that MDMA may revert the adult brain to a previously soft state.
About 7% of the US population will experience PTSD at some point in their lives, and up to 13% of veterans in combat have experienced PTSD.In 2018, the US Department of Veterans Affairs spent $ 17 billion in pediatric pay. Disabled for more than 1 million veterans with PTSD.
For about half to a third of people who do not receive relief from PTSD treatment, it can become chronic for many years or even throughout life.
90 participants in the Phase III trial, including veterans, first responders, and victims of rape, mass shootings, domestic violence or childhood trauma, all had severe PTSD and were diagnosed on average. For more than 14 years, many people have a history of alcohol and substance use disorders, and 90% have been thought to commit suicide. The trial included data collected by 80 therapists in 15 locations in the United States, Canada and Israel.
Albert Garcia-Romeu, a psychiatry researcher at the Johns Hopkins University School of Medicine who was not involved in the study, said more research is needed to explore the effectiveness of the therapy for people of various races and ethnicities because of three quarters. Of the trial The participants were white. This restriction also emphasized that “the importance of access to this type of treatment is for people of color and people of lower socioeconomic status who suffer from health inequality. And the injury rate is already high “
But overall, Garcia-Romeu said the findings “are a clear case for medical approval,” something that “represents a sea change that could revolutionize healthcare.”
Nathan McGee, 43, is another example of how patients benefit from the drug. Since he was a teenager, he has been in and out of therapy and turned on and off medications for depression and anxiety.
“I tend to get angry for no reason,” he said. In 2019, McGee was diagnosed with PTSD due to an incident that occurred when he was 4.
As a participant in the first trial, he thought he had taken a placebo. But about an hour during his start at the study site in Boulder, calm awareness was over him and he felt himself stepping inside.
Under the influence of MDMA and advised by his therapist, McGee was able to revisit his traumatic memories through his 4-year-old’s own eyes, without stigmatizing, adult interpretations or the emotions that heavily
“This allowed me to accept myself and know who I am,” he said.
Since joining the trial in early 2020, he has felt less anger and more enjoyment of the moment.
“I’m constantly discovering new things and improving,” McGee said. “It really made me understand what a feeling of happiness was.”
This article originally appeared in The New York Times.
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