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The New York Times

A psychedelic drug passes a major test for the treatment of PTSD

In an important step towards medical approval, MDMA, the illegal drug popularly known as ecstasy or molly, has been shown to bring relief to those suffering from severe post-traumatic stress disorder when combined with psychotherapy. Of the 90 people who participated in the new study, due 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 to those who received therapy and an inactive placebo. Two months after treatment, 67% of participants in the MDMA group no longer qualified for the diagnosis of PTSD, compared with 32% in the placebo group. MDMA has not produced serious adverse side effects. Some participants temporarily experienced mild symptoms, such as nausea and loss of appetite. Subscribe to the New York Times newsletter The Morning “It’s as excited as I can get a clinical trial,” said Gul Dolen, a neuroscientist at the Johns Hopkins University School of Medicine, who was not involved in the research. “There is nothing like this in the results of clinical tests for neuropsychiatric illness.” Before MDMA-assisted therapy can be approved for therapeutic use, the Food and Drug Administration needs a second Phase 3 positive study, which is underway with 100 participants. Approval may come as early as 2023. Mental health experts say this research – the first Phase 3 trial conducted in assisted psychedelic therapy – could pave the way for further studies on the potential of MDMA to help address other difficult mental health conditions. to treat, including substance abuse, obsessive-compulsive disorder, phobias, eating disorders, depression, end-of-life anxiety and social anxiety in autistic adults. And, say mental health researchers, these studies may also encourage additional research on other banned psychedelics, including psilocybin, LSD and mescaline. “This is a wonderful and fruitful time for discoveries, because people are suddenly willing to consider these substances as therapeutic again, which was not the case 50 years ago,” said Jennifer Mitchell, a neuroscientist at the University of California, San Francisco, and author main point of the new study. But some mental health experts called for moderation. Allen James Frances, an emeritus professor and former professor of psychiatry at Duke University, who was not involved in the new study, warned that the new treatments “are never as wonderful as they look.” “All new treatments in medicine have always had a temporary halo effect because they are new and promise more than they can offer,” said Frances. Unlike traditional pharmaceutical products, MDMA does not act as a Band-Aid that tries to alleviate the symptoms of PTSD. Instead, in people with PTSD, MDMA combined with therapy appears to allow the brain to process painful memories and heal itself, said Mitchell. Critically, MDMA taken alone, without therapy, does not automatically produce a beneficial effect. “It’s not the drug – it’s drug-enhanced therapy,” said Rick Doblin, senior author of the study and director of the Multidisciplinary Association for Psychedelic Studies, a nonprofit research group that sponsored and funded clinical trials. For this process to work, the person must be prepared to be involved with his trauma. Participants first held preparatory sessions with two trained therapists. Then, in three eight-hour sessions each, one month apart, they received an inactive placebo or MDMA. Neither the participants nor the therapists knew which one. Although most participants correctly guessed whether they received a placebo or MDMA, it did not detract from the results of the study or its methodology, which was previously agreed by the FDA. Scott Ostrom, who participated in the study, has suffered from PTSD since returning home from his second deployment in Iraq in 2007. For more than a decade, he has had debilitating nightmares. “The bullets would come out of the tip of my gun, or I would separate from my team and get lost in a city where insurgents were watching over me,” he said. Ostrom’s days were punctuated by panic attacks and he dropped out of college. He alienated friends and family and had an unhealthy romantic relationship. He was accused of assault and attempted suicide. Therapy and medication did not help. But after participating in the test, he has no more nightmares. “Literally, I am a different person,” he said. During his first of three sessions in early 2019, lying on a sofa with dark glasses and in a state of lucid dreaming, Ostrom found an oily, spinning black ball. Like an onion, the ball had many layers, each with a memory. At the center, Ostrom relived the moment in Iraq, he said, that “I became the person I needed to be to survive that combat stance.” In the next two sessions, Ostrom became involved with “the bully”, as he calls his alter ego PTSD, and asked permission for Scott to return. Ostrom, 36, now works continuously as an HVAC specialist and owns a home near Boulder, Colorado, which he shares with his girlfriend, Jamie Ehrenkranz, and his service dog, an English lab called Tim. “The reason I like to call it is this medicine that stimulates the self-healing ability of my own conscience, ”said Ostrom. “You understand why it’s okay to experience unconditional love for yourself.” Merck pharmacists invented MDMA, short for 3,4-methylenedioxy-N-methylamphetamine, in 1912. But the compound was largely overlooked until 1976, when Alexander Shulgin, a well-known psychedelic chemist, synthesized MDMA and experimented with it. 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 about half a million doses of MDMA. Some reported that, in just a few sessions with the medication, patients achieved progress that normally took years. In the early 1980s, however, MDMA escaped from the clinic to the dance floor, where it became known as ecstasy. In 1985, the Drug Enforcement Administration criminalized MDMA as a substance in Table I, defined as “no medical use currently accepted and a high potential for abuse”. Some mental health professionals continued to administer MDMA-assisted therapy in the basement, but most stopped. The number of scientists who have conducted studies with MDMA has also declined. But some individuals continued to press hard on behalf of MDMA research, including Doblin, who founded his association in 1986 to focus on the development of MDMA and other psychedelics in FDA-approved drugs. It took nearly two decades to overcome alarmist claims about the dangers of ecstasy, including that it ate holes in users’ brains, to finally get approval to start studies. Animal and human research confirms that MDMA does not produce neurotoxic effects at doses administered in clinical trials. Ecstasy or molly, on the other hand, can be adulterated with other potentially dangerous substances, and users can take much higher doses than are safe. In 2011, MDMA was responsible for 1.8% of all U.S. drug-related emergency department visits, according to a database maintained until that year by the Substance Abuse and Mental Health Services Administration. In Europe, MDMA was responsible for 8% of emergency visits related to medicines in 16 large hospitals in 10 countries from 2013 to 2014. Scientists still do not fully understand the origin of the therapeutic effects of MDMA. The substance binds to proteins that regulate serotonin, a neurotransmitter that can, among other things, improve mood. Antidepressant medications like Prozac bind to these same proteins and block their serotonin reabsorption, but MDMA takes this process further, causing proteins to pump serotonin to synapses, strengthening its chemical signal. MDMA also raises levels of oxytocin, dopamine and other chemical messengers, producing feelings of empathy, trust and compassion. But its main therapeutic effect may come from its apparent ability to reopen what neuroscientists call the “critical period”, the window during childhood when the brain has the superior capacity to make new memories and store them. Evidence from a mouse study published in Nature in 2019 indicates that MDMA may return the adult brain to that previous state of suppleness. It is estimated that 7% of the US population will experience PTSD at some point in their life, and up to 13% of combat veterans have the disease. In 2018, the U.S. Department of Veterans Affairs spent $ 17 billion on disability payments to more than 1 million veterans with PTSD. For about half to a third of people who do not find relief through treatment, PTSD can become chronic, lasting for years or even a lifetime. The 90 participants who participated in the Phase 3 trial included combat veterans, first responders and victims of sexual assault, mass shootings, domestic violence or child traumas. All had severe PTSD and had been diagnosed, on average, for more than 14 years. Many had a history of alcohol and other substance use disorder and 90% had thought about suicide. The study included data collected by 80 therapists at 15 locations in the United States, Canada and Israel. Albert Garcia-Romeu, a psychopharmacology researcher at the Johns Hopkins University School of Medicine, who was not involved in the study, said additional research is needed to explore the effectiveness of the therapy for people of different races and ethnicities, due to three quarters of the study the participants were white. This limitation also underscores, he said, “the importance of accessibility to these types of treatments for people of color and people with a lower socioeconomic level, who already suffer from health disparities and high rates of trauma.” But in general, said Garcia-Romeu, the findings “give a clear case for medical approval”, something that “represents a radical change that could revolutionize healthcare.” Nathan McGee, 43, is another example of a patient who has benefited from the drug. Since he was a teenager, he was in and out of therapy and in and out of medication for depression and anxiety. “I was always angry, for no reason,” he said. In 2019, McGee was diagnosed with PTSD due to an event that happened when he was 4 years old. As a study participant, he first thought he had received the placebo. But about an hour into his initial session at a Boulder study site, a calm conscience came over him and he felt himself moving inward. Under the influence of MDMA and guided by his therapists, McGee was able to revisit his traumatic memory through the eyes of his 4-year-old self, free from stigmas, adult interpretations 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 less irritated and better able to seize the moment. “I am continually discovering new things and improving,” said McGee. “It really made me understand what the feeling of joy is.” This article was originally published in The New York Times. © 2021 The New York Times Company

Paula Fonseca