In an important step toward medical approval, MDMA, the illicit drug known as ecstasy or moth, has been shown to bring relief to those suffering from severe post-traumatic stress disorder when combined with speech therapy.
Of the 90 people who participated in the new study, which is expected to be published later this month in Nature Medicine, those who received MDMA during therapy had a significantly greater reduction in the severity of their symptoms in compared with those receiving therapy and inactive placebo. Two months after treatment, 67% of participants in the MDMA group no longer met the requirements for a PTSD diagnosis, compared with 32% in the placebo group.
MDMA does not cause serious side effects. Some participants temporarily experienced mild symptoms such as nausea and loss of appetite.
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“It’s as exciting as I can be for a clinical trial,” said Gul Dolen, a neurologist at Johns Hopkins University School of Medicine who is not involved in the study. “There is nothing similar in the results of clinical trials for neuropsychiatric illness.”
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 being conducted with 100 participants. Approval may come as early as 2023.
Mental health experts say the study – the first phase 3 study on assisted psychedelic therapy – could pave the way for further research into the potential of MDMA to help deal with other difficult-to-treat mental conditions, including abuse. with substances, obsessive compulsive disorder, phobias, eating disorders, depression, end-of-life anxiety and social anxiety in adult autistic people.
And, according to mental health researchers, these studies may encourage further research on other banned psychedelics, including psilocybin, LSD and mescaline.
“It’s a wonderful, fruitful time to discover, because people are suddenly inclined to see these substances as therapeutic agents, 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 research.
But some mental health experts have called for restraint. Alan James Francis, an honorary professor and former president of psychiatry at Duke University who is not involved in the new study, warned that new treatments “are never as wonderful as they first seem.”
“All new treatments in medicine have always had a temporary halo effect because they are new and promise more than they can achieve,” Francis said.
Unlike traditional pharmaceuticals, MDMA does not act as a patch that tries to dull the symptoms of PTSD. Instead, in people with PTSD, MDMA combined with therapy appears to allow the brain to process painful memories and heal, Mitchell said.
It is critical that MDMA, taken in isolation, without therapy, does not automatically lead to a beneficial effect.
“This is not a drug – this is a drug-enhanced therapy,” said Rick Doblin, senior author of the study and director of the Multidisciplinary Psychedelic Research Association, a nonprofit research group that sponsors and funds clinical trials.
For this process to work, one must be prepared to commit to one’s trauma. Participants first undertook preparatory sessions with two trained therapists. Then, in three eight-hour sessions, one month apart, they received either inactive placebo or MDMA. Neither the participants nor the therapists knew which ones. While most participants correctly guessed whether they had received placebo or MDMA, this did not undermine the results of the study or its methodology, for which the FDA approved in advance.
Scott Ostrom, who is involved in the study, has suffered from PTSD since returning home from his second deployment in Iraq in 2007. He has had debilitating nightmares for more than a decade. “The bullets would run out of the end of my gun, or I would break away from my team and get lost in a city where rebels were watching me,” he said.
Ostrom’s days were interrupted by panic attacks and he left college. He pushed away his friends and family and entered into an unhealthy romantic relationship. He is accused of assault and attempted suicide. Therapy and medication did not help.
But after participating in the process, 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 sofa with eye shadows and in a conscious sleepy state, Ostrom encountered a spinning greasy black ball. Like an onion, the ball had many layers, each a memory. At the center, Ostrom was experiencing the moment in Iraq, he said, “I became the person I needed to be to survive this deployment.” Over the next two sessions, Ostrom got engaged to the “bully” as he called his alternative ego to PTSD. and asked permission for Scott to return.
Ostrom, 36, now works hard as a HVAC specialist and owns a home near Boulder, Colorado, which he shares with his girlfriend Jamie Ehrenkrantz and his service dog, an English lab named Tim.
“The reason I like to call this medicine is because it stimulates the ability of my own mind to heal itself,” Ostrom said. “You understand why it’s good to feel unconditional love for yourself.”
Merck pharmacists invented MDMA, which was abbreviated to 3,4-methylenedioxy-N-methylamphetamine, in 1912. But the compound was largely forgotten until 1976, when Alexander Shulgin, a famous psychedelic chemist, synthesized MDMA and tried it himself. . Realizing that his discovery could have therapeutic value, Shulgin shared MDMA in 1977 with Leo Zeff, a psychotherapist who introduced him to other mental health professionals. Over the next eight years, hundreds of therapists and others administered approximately half a million doses of MDMA. Some report that in just a few sessions with the drug, patients have made some progress, which usually takes years.
In the early 1980s, however, MDMA escaped from the dance floor clinic, where it became known as ecstasy. In 1985, the Drug Enforcement Administration criminalized MDMA as a Schedule I substance, defined as “no medical use at present and high potential for abuse.”
Some mental health professionals continue to use MDMA-assisted therapy, but most stop. The number of scientists who have studied MDMA is also declining. But several people continued to push hard on behalf of MDMA research, including Doblin, who founded his association in 1986 to focus on developing MDMA and other psychedelics in FDA-approved drugs. It took nearly two decades to overcome the alarming claims about the dangers of ecstasy, including that it was eating holes in consumers’ brains to finally get approval to start research. Animal and human studies confirm that MDMA does not cause neurotoxic effects at the doses used in clinical trials.
Ecstasy or moths, on the other hand, can be spiced with other potentially dangerous substances and consumers can take much higher doses than are safe. In 2011, MDMA accounted for 1.8% of all emergency department visits related to drugs, according to a database maintained to date by the Substance Abuse and Mental Health Administration. In Europe, MDMA was responsible for 8% of emergency drug-related visits to 16 major hospitals in 10 countries from 2013 to 2014.
Scientists still do not fully understand the source of the therapeutic effects of MDMA. The substance binds to proteins that regulate serotonin, a neurotransmitter that can, among other things, lift the mood. Antidepressant drugs such as Prozac bind to these same proteins and block their reabsorption of serotonin, but MDMA continues this process by causing proteins to pump serotonin into synapses, amplifying their chemical signal.
MDMA also increases levels of oxytocin, dopamine and other chemical messengers, creating a sense of empathy, trust and compassion.
But its main therapeutic effect may come from its apparent ability to reopen what neurologists call the “critical period,” the window to childhood, when the brain has the superior ability to create new memories and store them. Evidence from a study of mice published in Nature in 2019 shows that MDMA can return the brain of an adult to this earlier state of susceptibility.
Approximately 7% of the US population will experience PTSD at some point in their lives, and about 13% of combat veterans are able to. In 2018, the U.S. Department of Veterans Affairs spent $ 17 billion on disability payments to more than 1 million PTSD veterans.
Approximately half to one-third of people who do not find relief from treatment, PTSD can become chronic, last for years or even a lifetime.
The 90 participants in Phase 3 included combat veterans, first responders and victims of sexual violence, mass shootings, domestic violence or child trauma. All had severe PTSD and were diagnosed on average for more than 14 years. Many of them had a history of alcohol and substance abuse and 90% considered suicide. The study included data collected from 80 therapists at 15 locations in the United States, Canada and Israel.
Albert Garcia-Romeu, a psychopharmacology researcher at Johns Hopkins University School of Medicine who did not participate in the study, said further research was needed to examine the effectiveness of therapy for people of different races and ethnicities, as three-quarters from the study, participants were white. This limitation also emphasizes, he said, “the importance of the availability of these types of treatments for people of color and people of lower socio-economic status who already suffer from health inequalities and high levels of trauma.”
But overall, Garcia-Romeu said, the findings “provide a clear argument for medical approval,” something that “represents a maritime change that can revolutionize healthcare.”
Nathan McGee, 43, is another example of a patient taking advantage of the drug. From an early age, he went in and out of therapy and turned on and off medications for depression and anxiety.
“I’ve always been angry, for no reason,” he said. In 2019, McGee was diagnosed with PTSD, resulting from an event that occurred when he was 4 years old.
As a study participant, he first thought he had received a placebo. But about an hour after his initial session at a training ground in Boulder, a calm consciousness settled on him, and he felt himself moving inward.
Under the influence of MDMA and guided by his therapists, McGee was able to reconsider his traumatic memory through the eyes of his 4-year-old self, untainted by stigmas, interpretations of adults or heavy emotions.
“It allowed me to accept myself and recognize who I am,” he said.
Since taking part in the trial in early 2020, he has been more easily angered and more able to enjoy the moment.
“I’m constantly discovering new things and improving,” McGee said. “It really made me feel happy.”
This article originally appeared in The New York Times.
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