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The drug company Lykos Therapeutics had spent much of this year expecting to vault to meteoric heights. It had sent an application to the Food and Drug Administration seeking approval to use MDMA to treat post-traumatic stress disorder. It was the capstone to months of increasingly loud concerns being voiced over the quality of Lykos’s clinical trials. Lykos has spent years conducting clinical trials testing whether MDMA-assisted psychotherapy could alleviate the symptoms of PTSD. Its most recent drug trial showed that more than 86 percent of people treated had a measurable reduction in symptom severity.
Persons: , Lykos Organizations: Lykos Therapeutics, Food and Drug Administration, Lykos, Merck
The initial application from Lykos presented positive data from two late-stage clinical trials that used MDMA in combination with talk therapy to treat PTSD. The advisers said it was also difficult to parse how much the accompanying talk therapy — an area that the FDA does not regulate — contributed to outcomes. Advocates for the treatment, including some veterans groups, said they were “incredibly disappointed” by the FDA decision. Dozens of clinical trials involving psychedelics are in various stages, and additional scrutiny can help strengthen the findings and build confidence. Psychopharmacology did not allow the study authors to publish a correction with data that excluded findings from one study site, said Allison Feduccia, an author in all three retracted studies.
Persons: Lykos, , ” Martin Steele, Brett Waters, , Rachel Yehuda, , , Michael Bogenschutz, Yehuda, It’s, Lori Bruce, Psychopharmacology, caressed, “ it’s, Amy Emerson, ” Lykos, Allison Feduccia, Dr, Sanjay Gupta, Brian Barnett, ” Bruce, Nadia Kounang Organizations: CNN, Food and Drug Administration, Lykos Therapeutics, FDA, Veteran Mental Health Leadership Coalition, Hope, Center, Psychedelic Psychotherapy, Mount, Icahn, of Medicine, NYU Langone Center, Psychedelic Medicine, Oxford, NUS, Neuroethics, Interdisciplinary Center, Bioethics, Yale University, , Multidisciplinary Association for Psychedelic Studies, Health Canada, Institutional, Board, CNN Health, Cleveland Clinic Locations: Canada,
The journal Psychopharmacology has retracted three papers about MDMA-assisted therapy based on what the publication said was unethical conduct at one of the study sites where the research took place. Several of the papers’ authors are affiliated with Lykos Therapeutics, the drug company whose application for MDMA-assisted therapy to treat post-traumatic stress disorder was rejected last week by the Food and Drug Administration. The company said the research in the retracted papers was not part of its application to the F.D.A. has asked Lykos to conduct an additional clinical trial of its MDMA-assisted therapy, which would have been the first psychedelic medicine to win approval by federal regulators. Lykos has said it would appeal the decision.
Persons: Lykos Organizations: Lykos Therapeutics, Food and Drug Administration
Tracey Tee founded Moms on Mushrooms, a platform where moms can discuss, both online and in person, their interest and experiences with microdosing psilocybin mushrooms. "Some girlfriends invited me to a camping trip that summer [in 2020] to just camp out with some moms," Tee says. She lives in Colorado where psilocybin mushrooms are legal to grow, use and share. So, Tee sought out an alternative solution for managing her mental health as she began to wean herself off the SSRI: microdosing psilocybin mushrooms. Moms on Mushrooms is the platform Tee created for moms to discuss their interest and experiences with psilocybin mushrooms.
Persons: Tracey Tee, Tee, that's, wean, Tee wasn't, Microdosing, microdosing, Louis, Joshua Siegel, Siegel Organizations: Lancet, Facebook, CNBC, Washington University School of Medicine, Washington University, NYU Langone Health, Center, Psychedelic Medicine, Psychedelic Locations: Colorado, St
The Food and Drug Administration on Friday declined to approve MDMA-assisted therapy for the treatment of post-traumatic stress disorder, dealing a serious blow to the nascent field of psychedelic medicine and dashing the hopes of many Americans who are desperate for new treatments. An additional clinical trial could add years, and millions of dollars, to the approval process. If approved, MDMA would have become the first psychedelic compound to be regulated by federal health authorities. “This is an earthquake for those in the field who thought F.D.A. approval would be a cinch,” said Michael Pollan, the best-selling author and co-founder of the UC Berkeley Center for the Science of Psychedelics.
Persons: F.D.A, , Michael Pollan Organizations: Drug Administration, Lykos Therapeutics, UC Berkeley Center, Psychedelics
Read previewAdministered ketamine is being used in concert with therapy to treat Ukrainian veterans who experience post-traumatic stress disorder from fighting on the battlefield. AdvertisementA study published earlier this year focused on the treatment of depression among veterans using ketamine taken through an IV. The doses provided at least partial relief to many of the test subjects and after six weeks of ketamine infusions, depression scores dropped significantly. "Soldiers, for them, it's natural to consider themselves like a strong man," Matrenitsky said, explaining that the effects of the ketamine therapy allow individuals to overcome defensive barriers over their emotions. In partnership with Heal Ukraine Trauma, Matrenitsky along with other healthcare professionals have teamed up to form the Ketamine-Assisted Psychotherapy initiative in hopes of educating Ukrainian therapists on Ketamine-Assisted Therapy.
Persons: , Elaine Klein, Julia Rendleman, Dr, Vladislav Matrenitsky, Yulia Brockdorf, Wolfgang Schwan, Matrenitsky, Bandura, Paula Reynal, Klein Organizations: Service, Business, Heal, Washington, Center, Psychotherapy, 24th Brigade, Getty, Strategic, International Studies Locations: American, Ukraine, US, Kyiv, Anadolu, That's, Washington
This is a healthy brain on psilocybin
  + stars: | 2024-07-17 | by ( Sandee Lamotte | ) edition.cnn.com   time to read: +8 min
It wasn’t until his brain morphed into a computer, however, that he knew for sure he was on a psychedelic trip. “We found that psilocybin desynchronizes the brain,” said co-senior author Ginger Nichols of the study published Wednesday in the journal Nature. “When psilocybin is on board, the brain is disconnecting from its typical pathways and reconnecting to different parts of the brain,” said Nichols, an associate professor of psychiatry at Washington University School of Medicine in St. Louis. “Science doesn’t fully understand the brain yet, but I felt as if I suddenly knew exactly how the brain works. Sara Moser/Washington University School of MedicineA window for changeScans showed that in the days after the psilocybin trip, most brain networks returned to normal.
Persons: Dr, Nico Dosenbach wasn’t, he’d, it’s, , Dosenbach, St . Louis, , ” Dosenbach, Ginger Nichols, Nichols, ” Nichols, psychotherapists, Petros Petridis, ” Petridis, Sara Moser Organizations: CNN, Washington University School of Medicine, US Food and Drug Administration, NYU Langone Center, Psychedelic Medicine, Washington University School of Locations: , St ., Oregon, New York City, reconnection
"It layers on, these losses, these injuries, the ungrieved pain," Brockdorf told Business Insider. Ukrainian soldiers walk past a volunteer bus burning after a Russian drone hit it near Bakhmut. Ukrainian soldiers firing mortars from trench positions. Pierre Crom/Getty ImagesSome of Ukraine's soldiers have been serving on the front lines for long stretches as Ukraine grapples with manpower shortages. AdvertisementAnd, indeed, that damage can be lasting, which is why Brockdorf says it's important to be there for Ukrainian soldiers.
Persons: , Yulia Brockdorf, Brockdorf, she's, DAWN, Shandyba Mykyta, Vladislav Matrenitsky, Matrenitsky, Pierre Crom, Mark Hertling, Ryan Pickrell Organizations: Service, Business, Mountain Assault, AP, Center, Psychotherapy, Ukrainian, Washington Post, US Army, CNN Locations: Ukraine, Russian, Bakhmut, Ukrainian, Europe, Kyiv
You could get a mushroom that has a little bit more or a little bit less psilocybin ... which, depending on the activity of the day, might be more than you bargained for. Some corporate elites are seeking out psychedelic retreats to improve their leadership skills, shift their perceptions, and, in some cases, even bond with their teams. My main concern is that people understand the risk, any risk — bad-trip risk, psychiatric risk, or legal risk. "My main concern is that people understand the risk, any risk — bad-trip risk, psychiatric risk, or legal risk," Johnson said. A lot of executives and workers have a little bit of Elon Musk in them.
Persons: Elon, he's, Musk, à, Steve Jobs, they're, Greg Fonzo, Matthew Johnson, Sheppard Pratt, hasn't, Johnson, It's, Katrina Michelle, Rob Grover, Gary Logan, Grover, that's, Michelle, Justin Townsend, it's, performancewise, Townsend, Emily Stewart Organizations: SpaceX, Twitter, Center for Psychedelic Research, University of Texas, Austin's Dell Medical School, Center, Multidisciplinary Association for Psychedelic Studies, Marijuana, Elon Musk, Business Locations: New York, Vancouver , British Columbia, Jamaica
Last year, Australia became the first country in the world to legalize clinical prescribing of MDMA, more commonly known as ecstasy, and psilocybin for certain mental health disorders. Elite athletes experience mental health disorder symptoms and psychological distress at similar, if not higher, rates to the general population, researchers pointed out in a study published in the Journal of Applied Sport Psychology. Researchers in the field say that psychedelics are shown to work when treating some mental health conditions. Later, he founded Wesana Health, a biotechnology company which focuses on developing psychedelic medicine for mental health, the most recent being a CBD and psilocybin-based drug. Since her retirement as a professional athlete, Symonds explains that she uses psychedelic drugs for clarity, though not under the direction of a doctor.
Persons: CNN — Daniel Carcillo, Carcillo, , Jeff Gross, , , Aaron Rodgers, ayahuasca, Dustin Satloff, ” Rodgers, Mike Tyson, Dana White, Courtney Walton, ” Walton, Jeff Novitzky, White, Novitzky, Johns Hopkins, we’ve, , ’ ”, Chris Unger, ” Robin Carhart, Harris, Ralph Metzner, University of California San Francisco, psychedelics, ” Carhart, Carhart, psychedelics aren’t, ” James Rucker, ” Rucker, I’ve, Jonathan Daniel, Lucy, Anna Symonds, Symonds, James MacDonald, Rucker, “ They’re Organizations: CNN, Canadian, NHL, Philadelphia Flyers, New York Rangers, Los Angeles Kings, Chicago Blackhawks, CNN Sport, ” Sporting, Harvard Health, Oregon, UFC, Elite, Applied Sport Psychology, Melbourne School of Psychological Sciences, Athlete Health, University of Miami, Neurology, Psychiatry, University of California San, Centre for Psychedelic Research, Imperial College London, King’s College London, Imperial College of London, Getty, Wesana Health, US Food and Drug Administration, NASDAQ, Lucy Scientific, Former US, Addiction Center, US National Institutes of Health, Numinus Bioscience, Bloomberg, Prevention, Befrienders Locations: Denver, Colorado, psychedelics, Australia, , Nanaimo
Australia ushers in a new era of psychedelic medicine
  + stars: | 2023-06-30 | by ( Katie Hunt | ) edition.cnn.com   time to read: +8 min
Australia may be the first country to regulate the therapeutic use of MDMA and psilocybin, but it isn’t alone in ushering in a new era of psychedelic medicine. In October 2022, Alberta became the first jurisdiction in Canada to regulate the use of psychedelic drugs. Combining psychotherapy with psychedelic drugs is thought to be necessary for a beneficial outcome. He said that psychedelic drugs resulted in “powerful altered states of consciousness that can be intensely therapeutic, but also intensely destabilizing. “If you have a regulated, insured, safe context, and a good psychotherapeutic relationship, and yes, there’s the potential for great benefit there.”However, Rucker stressed that psychedelic drugs were not “a chemical switch to make everything seem fine.
Persons: , haven’t, Colleen Loo, Loo, , Cole Burston, Celia Morgan, Morgan, James Rucker, “ You’re, ” Morgan, ” Rucker, prescriber, Rucker Organizations: CNN, Goods Administration, US Food and Drug Administration, University of New, Black Dog Institute, The Royal, New Zealand College of Psychiatrists, Oregon Health Authority, Getty, University of Exeter, The New England, of Medicine, of Psychiatry, Neuroscience, King’s College London, Therapeutic Goods Locations: Australia, University of New South Wales, Sydney, RANZCP, Alberta, Canada, AFP, United Kingdom, The, psychopharmacology
CNN —For decades after returning home from World War II, my grandfather did not talk about his wartime experiences. Frank Murphy, the grandfather of CNN's Chloe Melas, after he was captured and taken a prisoner of war by the Nazis in 1943. Everyone could see the physical toll of war on his body, but we didn’t know about his invisible wounds. After World War I, it was “shell shock”; post-World War II it was known as “combat fatigue,” and after Vietnam it was called “post-Vietnam syndrome.” In 1980, the American Psychiatric Association officially recognized it as post-traumatic stress disorder, or PTSD. “When your grandfather and my grandfather served in World War II, they didn’t talk about it,” Paul Rieckhoff, founder and CEO of Iraq and Afghanistan Veterans of America, told me.
Some moms are microdosing, or taking small doses of psychedelics, for their mental health. A therapist who specializes in working with moms shared some advice in The Washington Post. She added that she helped support one patient in particular who wanted to try microdosing to amplify the psychotherapy she was already undergoing. Consider the source of the psychedelic you plan to takeMany psychedelics have a long history of use in Indigenous cultures. Whippo writes that as a result, it's important to figure out who is making the psychedelic you're taking and who is benefiting from its sale.
Psychedelic therapy is nowhere near as simple as filling a prescription and taking a pill at home. A clinical psychologist, she founded and now leads the first accredited psychedelic therapy training program in the U.S. at the California Institute of Integral Studies. The psychedelic therapy program entails 150 hours of instruction and several in-person training sessions. So why the growing interest in using psychedelic drugs for mental health? Treatment with psychedelic drugs is not as simple as giving the patient a pill to take at home, and it’s not for everybody.
The company is creating psychedelic drugs that work faster and may not have hallucinogenic effects. The company just raised $39 million from investors and plans to start clinical trials next year. One of the treatments in development is called GM-1020 and is similar to ketamine, a dissociative anesthetic with hallucinogenic effects that has shown promise in treating depression. GM-2505 will have psychedelic effects, though they're expected to last just an hour. By comparison, some other psychedelic drugs in development — like psilocybin and MDMA — have hallucinatory effects that are expected to last up to 8 hours in the clinic.
RA Capital is one of the few mainstream biotech VCs wading into the psychedelics space. The number of companies touting the benefits of psychedelics for healthcare is rapidly growing, but not all biotech investors are on board yet. Last year RA Capital made two investments into the psychedelics spaceIn 2021, RA made its first investments into the psychedelics space by funding two startups: GH Research and Delix Therapeutics. Dublin, Ireland-based GH Research is one of the only psychedelics companies to have garnered a flurry of interest from mainstream healthcare investors including RA Capital, RTW Investments, and BVF Partners. Lusaris' treatment is designed to be taken sublingually — placed under the tongue — for treatment-resistant depression.
Bogenschutz and his team specifically set out to test whether or not psilocybin, in addition to sessions of therapy, could cut cravings and help people with alcohol use disorder stay sober. Earlier research from institutions around the world has indicated that psilocybin has the potential to treat a variety of addiction disorders, including alcohol use disorder, opioid use disorder and addiction to smoking. Jon KostasWhen he began the psilocybin trial at age 25, he was consuming almost 23 drinks in a single bender. At the beginning of the first dose sessions, participants were given eye masks and headphones that played classical music. Bogenschutz said the rule of thumb with alcohol addiction treatment is that about one-third of patients who seek treatment will get better.
Johns Hopkins University, Yale University, and New York University announced on Thursday they were collaborating to create a psychedelics curriculum for psychiatrists. Benjamin Kelmendi is an assistant professor of psychiatry at Yale University and a codirector of the Yale Program for Psychedelic Science. YaleNYU's Ross told Insider it was "daunting" to think about the sheer number of therapists that needed to be trained to expand access for patients. Researchers are working to fill the gap that exists between psychedelics and the medical systemChristopher Pittenger is a codirector at the Yale Program for Psychedelic Science. YaleDr. Benjamin Kelmendi, a codirector of the Yale Program for Psychedelic Science, told Insider that he saw psychedelics as having broad applications that will attract other branches of medicine.
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