By Megan TwoheyDanielle Ivory and Carson Kessler As marijuana legalization spreads across the country, people are consuming more of the drug, more often and at ever-higher potencies. Most of the tens of millions of people using marijuana, for health benefits or for fun, don’t experience problems. But a growing number, mainly heavy users, have experienced addiction, psychosis and other harmful effects, The New York Times found. “Cannabis is a lot of things at once,” said Dr. Kevin Gray, a psychiatrist and specialist in bio-behavioral medicine at Medical University of South Carolina Health. “It can be medically therapeutic. It also can be highly problematic.” In interviews and surveys, hundreds of people told The Times about serious — sometimes frightening — symptoms that they were stunned to learn could be caused by cannabis. Here are some of their stories. David Krumholtz, an actor known for films like “10 Things I Hate About You” and TV shows like “Numb3rs,” resumed smoking marijuana in 2016, after a decade-long break. Within months, he started to experience cycles of intense nausea and vomiting — a sometimes debilitating condition called cannabinoid hyperemesis syndrome. It can lead to dehydration, seizures, kidney failure, cardiac arrest and even death in rare instances. He lost 100 pounds and was in and out of emergency departments. At home in New Jersey, he would spend 10 hours at a time in hot baths, which for unknown reasons can temporarily relieve symptoms. “I had numbness in my extremities, pain in my chest and my blood pressure skyrocketed,” he said. Mr. Krumholtz, 46, believes he would have eventually died had he not suffered an episode that almost derailed his dream job, a role in the blockbuster 2023 film “Oppenheimer,” and inspired him to quit marijuana for good. © 2024 The New York Times Company

Keyword: Drug Abuse
Link ID: 29511 - Posted: 10.09.2024

Pien Huang More than half of all U.S. states have legalized cannabis, be it for medical purposes, recreational use, or both. The shelves of cannabis dispensaries offer an ever-widening array of gummies, drinks and joints. Meanwhile, the federal government still considers most types of cannabis illegal. A new report from the National Academies of Sciences, Engineering and Medicine, released this week, finds this disconnect between the states and the federal government is leading to fragmented policies, and risks to the public. As states built new commercial markets for cannabis, they initially focused on regulating sales and revenue. “The consequence of that is the public health aspects were often given a backseat and we're now playing catch up for that,” says Dr. Steven Teutsch, chair of the National Academies committee that wrote the report on how cannabis impacts public health. The report calls for federal leadership and national standards on cannabis quality and potency, to safeguard public health. Here are five takeaways: 1. People consume cannabis more regularly than alcohol in the U.S. In 2022, more U.S. adults reported using cannabis than alcohol on a near-daily basis, according to the National Survey on Drug Use and Health. It was the first time that regular marijuana use surpassed regular alcohol use. © 2024 npr

Keyword: Drug Abuse
Link ID: 29499 - Posted: 10.02.2024

By Elie Dolgin The first schizophrenia medication in decades with a new mechanism of action won US regulatory approval today. The approval offers the hope of an antipsychotic that would be more effective and better tolerated than current therapies. The drug, known as KarXT, targets proteins in the brain known as muscarinic receptors, which relay neurotransmitter signals between neurons and other cells. Activating these receptors dampens the release of the chemical dopamine, a nervous-system messenger that is central to the hallmark symptoms of schizophrenia, such as hallucinations and delusions. But muscarinic signalling also modulates other brain circuits involved in cognition and emotional processing. This mode of action provides KarXT with a more comprehensive therapeutic effect than other schizophrenia treatments, which mainly blunt dopamine activity alone. In clinical trials, KarXT not only alleviated core symptoms of schizophrenia, but also showed signs of improving cognitive function, all while avoiding many of the burdensome side effects commonly associated with older antipsychotics. “This will be a revolution of the treatment of psychosis, and I’m not saying this lightly,” says Christoph Correll, a psychiatrist at the Zucker School of Medicine at Hofstra/Northwell in Hempstead, New York, who helped to analyse data from the trials. “Now we will now be able to treat people who haven’t been helped with traditional antipsychotics. That’s highly exciting.” KarXT is just the first of many next-generation drug candidates designed to engage muscarinic receptors in the brain. Several follow-on schizophrenia therapies are already in or nearing clinical trials, showing promise for improved tolerability and more convenient dosing schedules. This progress is leading clinicians and drug developers to imagine a future in which schizophrenia treatment becomes more tailored to individual needs — providing an alternative for the many people who don’t benefit from current therapies or abandon them owing to intolerable side effects. © 2024 Springer Nature Limited

Keyword: Schizophrenia
Link ID: 29498 - Posted: 09.28.2024

By Maia Szalavitz Last year over 70,000 Americans died from taking drug mixtures that contained fentanyl or other synthetic opioids. The good news is that recent data suggests a decline in overdose deaths, the first significant drop in decades. But this is not a uniform trend across the nation. To understand this disparity, it’s important to examine how we got here. Today’s crisis is often described as a series of waves. But if you look at the data, it was more like a couple of breakers followed by a tsunami. First, prescription opioid fatalities rose. Then heroin deaths surged. And finally, illicitly manufactured fentanyl overtook all that preceded it. Once fentanyl and other synthetic opioids dominate a market, whether a state is red or blue doesn't matter. Skyrocketing overdose deaths are nearly unavoidable, regardless of whether a state enforces tough penalties for drug possession or decriminalizes it. Understanding how fentanyl saturated the drug supply, moving from the East Coast of the United States to the West, is critical to ending the worst drug crisis in American history. In 2000, America was in its first wave of the opioid crisis. This was dominated by deaths from prescription painkillers like OxyContin. As you can see in the first map, though not entirely new to the country, illicitly manufactured fentanyl made up a tiny percentage of total drug seizures nationwide. Because escalations in opioid prescribing to treat pain were seen as the cause of the overdose problem, doctors began cutting off patients and law enforcement shuttered so-called pill mills. The number of opioid prescriptions began plummeting. © 2024 The New York Times Company

Keyword: Drug Abuse
Link ID: 29496 - Posted: 09.28.2024

Brian Mann For the first time in decades, public health data shows a sudden and hopeful drop in drug overdose deaths across the U.S. "This is exciting," said Dr. Nora Volkow, head of the National Institute On Drug Abuse [NIDA], the federal laboratory charged with studying addiction. "This looks real. This looks very, very real." National surveys compiled by the Centers for Disease Control and Prevention already show an unprecedented decline in drug deaths of roughly 10.6 percent. That's a huge reversal from recent years when fatal overdoses regularly increased by double-digit percentages. Some researchers believe the data will show an even larger decline in drug deaths when federal surveys are updated to reflect improvements being seen at the state level, especially in the eastern U.S. "In the states that have the most rapid data collection systems, we’re seeing declines of twenty percent, thirty percent," said Dr. Nabarun Dasgupta, an expert on street drugs at the University of North Carolina. According to Dasgupta's analysis, which has sparked discussion among addiction and drug policy experts, the drop in state-level mortality numbers corresponds with similar steep declines in emergency room visits linked to overdoses. Dr. Nabarun Dasgupta, a researcher at the University of North Carolina, is an expert on the U.S. street drug supply. He believes data shows a sudden drop in drug overdose deaths nationwide that could already by saving Dr. Nabarun Dasgupta, a researcher at the University of North Carolina, is an expert on the U.S. street drug supply. He believes data shows a sudden drop in drug overdose deaths nationwide that could already by saving "roughly 20,000 lives" per year. © 2024 npr

Keyword: Drug Abuse
Link ID: 29486 - Posted: 09.21.2024

By Roni Caryn Rabin Adults under age 50 have been developing breast cancer and colorectal cancer at increasingly higher rates over the last six decades, and alcohol use may be one factor driving the trend, according to a scientific report published on Wednesday. The report, by the American Association for Cancer Research, highlights scientific breakthroughs that have led to new anticancer drugs and improved overall survival. But the authors also described a troubling pattern: Even as cancer death rates have declined, the overall incidence of several cancers has been rising inexplicably, with an especially alarming increase among younger adults in cancers of the gastrointestinal system, like colorectal cancer. The report estimates that 40 percent of all cancer cases are associated with modifiable risk factors. It recommends reducing alcohol consumption, along with making lifestyle changes such as avoiding tobacco, maintaining a healthy diet and weight, exercising, avoiding ultraviolet radiation and minimizing exposure to pollutants. The authors called for raising awareness through public messaging campaigns and adding cancer-specific warning labels to alcoholic beverages. The recommendations come amid a radical rethinking of the putative health benefits of moderate alcohol consumption, which for years was considered to be protective against heart disease. Just last month, a large study that followed more than 135,000 older British adults for over a decade found that moderate and light drinkers did not benefit from a reduction in heart disease when compared with occasional drinkers. And both moderate and light drinkers experienced more cancer deaths than occasional drinkers, a finding accentuated among low-income seniors and those with existing health problems. © 2024 The New York Times Company

Keyword: Drug Abuse
Link ID: 29483 - Posted: 09.18.2024

By Angie Voyles Askham Nathaniel Daw has never touched a mouse. As professor of computational and theoretical neuroscience at Princeton University, he mainly works with other people’s data to construct models of the brain’s decision-making process. So when a collaborator came to him a few years ago with confusing data from mice that had performed a complex decision-making task in the lab, Daw says his best advice was just to fit the findings to the tried-and-true model of reward prediction error (RPE). That model relies on the idea that dopaminergic activity in the midbrain reflects discrepancies between expected and received rewards. Daw’s collaborator, Ben Engelhard, had measured the activity of dopamine neurons in the ventral tegmental area (VTA) of mice as they were deciding how to navigate a virtual environment. And although the virtual environment was more complex than what a mouse usually experiences in the real world, an RPE-based model should have held, Daw assumed. “It was obvious to me that there was this very simple story that was going to explain his data,” Daw says. But it didn’t. The neurons exhibited a wide range of responses, with some activated by visual cues and others by movement or cognitive tasks. The classic RPE model, it turned out, could not explain such heterogeneity. Daw, Engelhard and their colleagues published the findings in 2019. That was a wake-up call, Daw says, particularly after he watched videos of what the mice actually experienced in the maze. “It’s just so much more complicated, and high dimensional, and richer” than expected, he says. The idea that this richness could be reduced to such a simple model seems ludicrous now, he adds. “I was just so blinded.” © 2024 Simons Foundation

Keyword: Attention; Drug Abuse
Link ID: 29479 - Posted: 09.14.2024

By Christina Caron Patients and caregivers have struggled for two years to find stimulant medications like Adderall, Vyvanse and Concerta to treat attention deficit hyperactivity disorder. Some spend hours each month going from pharmacy to pharmacy to find a drug, while others are forced to switch to a different brand or formulation, or go without medication for weeks. This week the Drug Enforcement Administration announced a potential solution: It is raising the amount of lisdexamfetamine (Vyvanse) that can be produced by U.S. manufacturers this year by nearly 24 percent to meet demand in the United States and abroad. Vyvanse is an amphetamine that has been approved for use in children and adults with A.D.H.D. and has become commonly prescribed after the generic version was introduced last year. According to the D.E.A., the latest data shows that demand for the drug has been rising globally. But right now every manufacturer of generic Vyvanse listed on the Food and Drug Administration website is experiencing a shortage. Many health care providers who specialize in treating patients with A.D.H.D. said that the D.E.A.’s decision was a positive development but that it was unclear just how much of an effect it might have on the shortage. “Obviously it’s not going to solve the problem completely,” said Ami Norris-Brilliant, clinical director of the Division of A.D.H.D., Learning Disorders, and Related Disorders at the Icahn School of Medicine at Mount Sinai in New York City. “But I think anything that helps increase drug availability is a good thing.” It is not the first time that the D.E.A. has increased production quotas for A.D.H.D. drugs. Last year it announced a new 2023 limit for methylphenidate, which is used to make drugs like Ritalin and Concerta, raising the allotted amount by 27 percent for 2023. The drug remains in shortage, however, in the extended release formulation. © 2024 The New York Times Company

Keyword: ADHD
Link ID: 29473 - Posted: 09.11.2024

By Olivia Gieger Unlike traditional antidepressants, ketamine acts quickly to relieve depression symptoms, and its effects last long after the drug has cleared the system. Researchers have puzzled over what ketamine is doing in the brain to achieve these results. For one thing, the drug acts on N-methyl-D-aspartate (NMDA) glutamate receptors, which appear on neurons all over the brain. “Then the question is: Does the drug hit on all these brain regions simultaneously?” says Hailan Hu, professor of brain science at Zhejiang University. Or does it affect one region first, which sets off a series of downstream antidepressant effects? The answer is the latter, Hu and her colleagues report in a new study. Ketamine acts first on neurons in the lateral habenula, they found, in mice with depression-like symptoms. The structure—known as the “anti-reward” center—is hyperactive in people with depression and in mice modeling the condition, previous work has shown. That activity makes it highly susceptible to the drug’s effects, Hu and her colleagues discovered. Ketamine binds the NMDA receptors of cells in the lateral habenula and renders them inactive, which in turn interrupts downstream mechanisms of depression. The findings, published in Science in August, help explain how the known targets of ketamine are involved in such a rapid antidepressant response, explains Christophe Proulx, associate professor of psychiatry and neuroscience at Laval University. Proulx was not involved in the work but co-authored a Perspective article on it. Spotlighting the lateral habenula’s role also represents a new way of thinking about ketamine’s effects on depression—involving a shift away from a focus on weakened circuits and impaired plasticity, says Todd Gould, professor of psychiatry and neurobiology at the University of Maryland School of Medicine, who was not affiliated with the study. “[The work provides] additional strong evidence supporting a different view about how ketamine may be working.” Although ketamine inactivated NMDA receptors in the lateral habenula of the depressive-like mice, it had less impact in the CA1 region of the hippocampus, Hu and her colleagues observed using in-vitro slice electrophysiology and electrode recordings in awake animals. © 2024 Simons Foundation

Keyword: Depression
Link ID: 29472 - Posted: 09.11.2024

By Cassandra Willyard Megan Hodge’s first bout of intense pain arrived when she was in her mid-20s. Hodge and her husband were getting ready to visit family for Thanksgiving. Though Hodge had been dealing with a variety of chronic health issues, her workout had gone well that morning and she finally felt like she was getting a handle on her health. Hodge began packing. As she reached into her closet to grab a sweater, her back gave out. The pain was excruciating, so intense that she felt light-headed and thought she might vomit. As the years passed, Hodge had more frequent and more severe bouts of back pain. Any small movement could be a trigger — grabbing a towel from the linen closet, picking up a toy off the floor, sneezing. In 2021, Hodge experienced a particularly bad flare-up. None of the strategies she had previously used to help her manage seemed to be working. She was afraid to make any movement. She felt hopeless. “I just could not regain footing, metaphorically and physically,” she says. “I truly felt frozen in my chronic pain and chronic health journey.” Hodge is far from alone. In the United States, chronic pain affects tens of millions of people — about 1 in 5 adults and nearly 1 in 3 people ages 65 and older. “The amount of suffering from arthritis and aging that I’ve seen in my pain clinic, it’s overwhelming to me as a pain doctor,” says Antje Barreveld, an anesthesiologist at Mass General Brigham’s Newton-Wellesley Hospital in Massachusetts. What’s more, the mainstay therapy for severe acute and chronic pain — prescription opioids — has helped fuel an epidemic that kills tens of thousands of people each year. “We have to have some better alternatives,” she says. So researchers have doubled down in their quest to find new pain treatments that aren’t as addictive as opioids. “The pain field has really made very rapid and tremendous progress in the last decade,” says D.P. Mohapatra, a former pain scientist who now oversees research at the National Institute of Neurological Disorders and Stroke in Bethesda, Md. © Society for Science & the Public 2000–2024.

Keyword: Pain & Touch; Drug Abuse
Link ID: 29470 - Posted: 09.07.2024

By Christina Jewett The number of teenagers who reported using e-cigarettes in 2024 has tumbled from a worrisome peak reached five years ago, raising hopes among public health officials for a sustained reversal in vaping trends among adolescents. In an annual survey conducted from January through May in schools across the nation, fewer than 8 percent of high school students reported using e-cigarettes in the past month, the lowest level in a decade. That’s far lower than the apex, in 2019, when more than 27 percent of high school students who took the survey reported that they vaped — and an estimated 500,000 fewer adolescents than last year. The data is from the National Youth Tobacco Survey, a questionnaire filled out by thousands of middle and high school students that is administered each year by the Food and Drug Administration and the Centers for Disease Control and Prevention. Overall, it found that just under 6 percent of middle and high school students reported vaping in the last month, down from nearly 8 percent among those surveyed last year. Use among high school students largely accounted for this year’s decline; middle school use stayed fairly steady with 3.5 percent reporting they had vaped compared to 4.6 percent the year before. “I want to be unequivocally clear that this continued decline in e-cigarette use among our nation’s youth is a monumental public health win,” Brian King, the director of the F.D.A.’s tobacco division, said during a news briefing on Wednesday. Public health experts said several factors may have contributed to the decline in teenage vaping, including city and state flavored tobacco bans, a blitz of enforcement against sellers of flavored vapes and three public messaging campaigns aimed at young people about the dangers of vaping. © 2024 The New York Times Company

Keyword: Drug Abuse
Link ID: 29467 - Posted: 09.07.2024

By Jan Hoffman The message emblazoned on a walkway window at the airport in Burlington, Vt., is a startling departure from the usual tourism posters and welcome banners: “Addiction is not a choice. It’s a disease that can happen to anyone.” The statement is part of a public service campaign in yet another community assailed by drug use, intended to reduce stigma and encourage treatment. For decades, medical science has classified addiction as a chronic brain disease, but the concept has always been something of a hard sell to a skeptical public. That is because, unlike diseases such as Alzheimer’s or bone cancer or Covid, personal choice does play a role, both in starting and ending drug use. The idea that those who use drugs are themselves at fault has recently been gaining fresh traction, driving efforts to toughen criminal penalties for drug possession and to cut funding for syringe-exchange programs. But now, even some in the treatment and scientific communities have been rethinking the label of chronic brain disease. In July, behavior researchers published a critique of the classification, which they said could be counterproductive for patients and families. “I don’t think it helps to tell people they are chronically diseased and therefore incapable of change. Then what hope do we have?” said Kirsten E. Smith, an assistant professor of psychiatry and behavioral sciences at Johns Hopkins School of Medicine and a co-author of the paper, published in the journal Psychopharmacology. “The brain is highly dynamic, as is our environment.” The recent scientific criticisms are driven by an ominous urgency: Despite addiction’s longstanding classification as a disease, the deadly public health disaster has only worsened. © 2024 The New York Times Company

Keyword: Drug Abuse
Link ID: 29461 - Posted: 09.04.2024

By Steve Paulson Oliver Sacks wasn’t always the beloved neurologist we remember today, sleuthing around the backwaters of the mind in search of mysterious mental disorders. For a few years in the 1960s, he was a committed psychonaut, often spending entire weekends blitzed out of his mind on weed, LSD, morning glory seeds, or mescaline. Once, after injecting himself with a large dose of morphine, he found himself hovering over an enormous battlefield, watching the armies of England and France drawn up for battle, and then realized he was witnessing the 1415 Battle of Agincourt. “I completely lost the sense that I was lying on my bed stoned,” he told me in 2012, a few years before he died. “I felt like a historian, seeing Agincourt from a celestial viewpoint. This was not ordinary imagination. It was absolutely real.” The vision seemed to last only a few minutes, but later, he discovered he’d been tripping for 13 hours. These early experiences with hallucinogens gave Sacks an appreciation for the strange turns the mind can take. He had a craving for direct experience of the numinous, but he believed his visions were nothing more than hallucinations. “At the physiological level, everything is electricity and chemistry, but it was a wonderful feeling,” he said. When I asked if he ever thought he’d crossed over into some transpersonal dimension of reality, he said, “I’m an old Jewish atheist. I have no belief in heaven or anything supernatural or paranormal, but there’s a mystical feeling of oneness and of beauty, which is not explicitly religious, but goes far beyond the aesthetic.” I’ve often thought about this conversation as I’ve watched today’s psychedelic renaissance. Clinical trials with psychedelic-assisted therapy show great promise for treating depression, addiction, and PTSD, and a handful of leading universities have recently created their own heavily endowed psychedelic centers. © 2024 NautilusNext Inc.,

Keyword: Drug Abuse; Consciousness
Link ID: 29453 - Posted: 08.28.2024

By Rachel Nuwer One person felt a sensation of “slowly floating into the air” as images flashed around. Another recalled “the most profound sense of love and peace,” unlike anything experienced before. Consciousness became a “foreign entity” to another whose “whole sense of reality disappeared.” These were some of the firsthand accounts shared in a small survey of people who belonged to an unusual cohort: They had all undergone a near-death experience and tried psychedelic drugs. The survey participants described their near-death and psychedelic experiences as being distinct, yet they also reported significant overlap. In a paper published on Thursday, researchers used these accounts to provide a comparison of the two phenomena. “For the first time, we have a quantitative study with personal testimony from people who have had both of these experiences,” said Charlotte Martial, a neuroscientist at the University of Liège in Belgium and an author of the findings, which were published in the journal Neuroscience of Consciousness. “Now we can say for sure that psychedelics can be a kind of window through which people can enter a rich, subjective state resembling a near-death experience.” Near-death experiences are surprisingly common — an estimated 5 to 10 percent of the general population has reported having one. For decades, scientists largely dismissed the fantastical stories of people who returned from the brink of death. But some researchers have started to take these accounts seriously. “In recent times, the science of consciousness has become interested in nonordinary states,” said Christopher Timmermann, a research fellow at the Center for Psychedelic Research at Imperial College London and an author of the article. “To get a comprehensive account of what it means to be a human being requires incorporating these experiences.” © 2024 The New York Times Company

Keyword: Consciousness; Drug Abuse
Link ID: 29450 - Posted: 08.22.2024

By Marla Broadfoot When doctors ask Sara Gehrig to describe her pain, she often says it is indescribable. Stabbing, burning, aching—those words frequently fail to depict sensations that have persisted for so long they are now a part of her, like her bones and skin. “My pain is like an extra limb that comes along with me every day.” Gehrig, a former yoga instructor and personal trainer who lives in Wisconsin, is 44 years old. At the age of 17 she discovered she had spinal stenosis, a narrowing of the spinal cord that puts pressure on the nerves there. She experienced bursts of excruciating pain in her back and buttocks and running down her legs. That pain has spread over the years, despite attempts to fend it off with physical therapy, anti-inflammatory injections and multiple surgeries. Over-the-counter medications such as ibuprofen (Advil) provide little relief. And she is allergic to the most potent painkillers—prescription opioids—which can induce violent vomiting. Today her agony typically hovers at a 7 out of 10 on the standard numerical scale used to rate pain, where 0 is no pain and 10 is the most severe imaginable. Occasionally her pain flares to a 9 or 10. At one point, before her doctor convinced her to take antidepressants, Gehrig struggled with thoughts of suicide. “For many with chronic pain, it’s always in their back pocket,” she says. “It’s not that we want to die. We want the pain to go away.” Gehrig says she would be willing to try another type of painkiller, but only if she knew it was safe. She keeps up with the latest research, so she was interested to hear earlier this year that Vertex Pharmaceuticals was testing a new drug that works differently than opioids and other pain medications. That drug, a pill called VX-548, blocks pain signals before they can reach the brain. It gums up sodium channels in peripheral nerve cells, and obstructed channels make it hard for those cells to transmit pain sensations. Because the drug acts only on the peripheral nerves, it does not carry the potential for addiction associated with opioids—oxycodone (OxyContin) and similar drugs exert their effects on the brain and spinal cord and thus can trigger the brain’s reward centers and an addiction cycle.

Keyword: Pain & Touch; Drug Abuse
Link ID: 29445 - Posted: 08.21.2024

By Paula Span Mary Peart, 67, a retired nurse in Manchester-by-the-Sea, Mass., began taking gabapentin a year and a half ago to reduce the pain and fatigue of fibromyalgia. The drug helps her climb stairs, walk her dog and take art lessons, she said. With it, “I have a life,” she said. “If I forget to take a dose, my pain comes right back.” Jane Dausch has a neurological condition called transverse myelitis and uses gabapentin as needed when her legs and feet ache. “It seems to be effective at calming down nerve pain,” said Ms. Dausch, 67, a retired physical therapist in North Kingstown, R.I. Amy Thomas, who owns three bookstores in the San Francisco Bay Area, takes gabapentin for rheumatoid arthritis. Along with yoga and physical therapy, “it’s probably contributing to it being easier for me to move around,” Ms. Thomas, 67, said. All three are taking the non-opioid pain drug for off-label uses. The only conditions for which gabapentin has been approved for adult use by the Food and Drug Administration are epileptic seizures, in 1993, and postherpetic neuralgia, the nerve pain that can linger after a bout of shingles, in 2002. But that has not stopped patients and health care providers from turning to gabapentin (whose brand names include Neurontin) for a startling array of other conditions, including sciatica, neuropathy from diabetes, lower back pain and post-surgery pain. Also: Agitation from dementia. Insomnia. Migraines. Itching. Bipolar disorder. Alcohol dependence. Evidence of effectiveness for these conditions is all over the map. The drug appears to provide relief for some patients with diabetic neuropathy but not with some other kinds of neuropathic pain. Several small studies indicate that gabapentin can reduce the itching associated with kidney failure. But the data for its effectiveness against low back pain or a number of psychiatric disorders are limited and show no meaningful impact. “It’s crazy how many indications it’s used for,” said Dr. Michael Steinman, a geriatrician at the University of California, San Francisco, and a co-director of the U.S. Deprescribing Research Network. “It’s become a we-don’t-know-what-else-to-do drug.” © 2024 The New York Times Company

Keyword: Pain & Touch; Drug Abuse
Link ID: 29438 - Posted: 08.19.2024

By Sara Reardon Last week’s decision by the US Food and Drug Administration (FDA) to reject MDMA, also known as ecstasy, as a psychiatric treatment surprised many researchers. Lykos Therapeutics, the company that has been testing MDMA, plans to ask the FDA to reconsider the decision, but scientists are now wondering what the agency’s ruling will mean for other potential psychedelic therapies. In a press release posted on 9 August, Lykos, which is based in San Jose, California, said that the FDA had sent a letter requesting that the company undertake another large-scale trial of the drug in people with post-traumatic stress disorder (PTSD) and resubmit its application. “The FDA request for another study is deeply disappointing,” Lykos chief executive Amy Emerson said in the press release, adding that the company plans to work with the agency to “resolve scientific disagreements”. Conducting another study “would take several years”, she said, adding that Lykos has already addressed many of the FDA’s concerns. In an e-mail to Nature, Lykos declined to provide the complete letter detailing the agency’s specific concerns and directed the news team instead to its press release. Experts say that without access to the letter, it’s hard to determine why the FDA reached the decision it did. “We really are going off incomplete information,” says Mason Marks, who studies drug policy at Florida State University in Tallahassee, adding that he was “a little surprised” by the agency’s decision. Trial concerns But Marks points out that the FDA typically follows the advice of its independent advisory committees — and the one that evaluated MDMA in June overwhelmingly voted against approving the drug, citing problems with clinical trial design that the advisers felt made it difficult to determine the drug’s safety and efficacy. One concern was about the difficulty of conducting a true placebo-controlled study with a hallucinogen: around 90% of the participants in Lykos’s trials guessed correctly whether they had received the drug or a placebo, and the expectation that MDMA should have an effect might have coloured their perception of whether it treated their symptoms. © 2024 Springer Nature Limited

Keyword: Drug Abuse; Depression
Link ID: 29433 - Posted: 08.15.2024

By Andrew Jacobs 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. In declining to approve Lykos’s application, the agency cited concerns about missing data and problems with the way the company’s study was designed, according to a statement released by Lykos on Friday. 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. The journal retraction was first reported by Stat, the health and medical news website. On Sunday, Lykos said that it disagreed with Psychopharmacology’s decision and that it would file an official complaint with the Committee on Publication Ethics, a nonprofit that sets guidelines for academic publications. “The articles remain scientifically sound and present important contributions to the study of potential treatments for PTSD,” the company said in the statement. The incident cited by Psychopharmacology has been well documented. © 2024 The New York Times Company

Keyword: Stress; Drug Abuse
Link ID: 29431 - Posted: 08.13.2024

By Roni Caryn Rabin Even light drinking was associated with an increase in cancer deaths among older adults in Britain, researchers reported on Monday in a large study. But the risk was accentuated primarily in those who had existing health problems or who lived in low-income areas. The study, which tracked 135,103 adults aged 60 and older for 12 years, also punctures the long-held belief that light or moderate alcohol consumption is good for the heart. The researchers found no reduction in heart disease deaths among light or moderate drinkers, regardless of this health or socioeconomic status, when compared with occasional drinkers. The study defined light drinking as a mean alcohol intake of up to 20 grams a day for men and up to 10 grams daily for women. (In the United States, a standard drink is 14 grams of alcohol.) “We did not find evidence of a beneficial association between low drinking and mortality,” said Dr. Rosario Ortolá, an assistant professor of preventive medicine and public health at Universidad Autónoma de Madrid and the lead author of the paper, which was published in JAMA Network Open. On the other hand, she added, alcohol probably raises the risk of cancer “from the first drop.” The findings add to a mounting body of evidence that is shifting the paradigm in alcohol research. Scientists are turning to new methodologies to analyze the risks and benefits of alcohol consumption in an attempt to correct what some believe were serious flaws in earlier research, which appeared to show that there were benefits to drinking. © 2024 The New York Times Company

Keyword: Drug Abuse
Link ID: 29428 - Posted: 08.13.2024

Ross Ellenhorn and Dimitri Mugiani Earlier this month, an advisory panel rejected MDMA-assisted therapy for PTSD, possibly dooming US Food and Drug Administration (FDA) approval of the drug commonly called ecstasy. In a public meeting alongside FDA staff, panel members said that the research neither adequately accounted for abuse risks nor proved the drug’s efficacy in combination with psychotherapy. This decision dealt a major blow to Lykos Therapeutics, the for-profit public benefit corporation of the non-profit Multidisciplinary Association for Psychedelic Studies (Maps), which sponsored the trials. More broadly, the rejection has been described as a drastic setback for the psychedelic movement as a whole. For several years now, it seemed that greater acceptance and new legal spaces for psychedelics were a certainty. Then, scientists appeared at the FDA hearing and everything went dark. As practitioners and leaders in the realm of human transformation, and in creating and running organizations that serve individuals experiencing complex psychiatric symptoms, we believe in psychedelics as a force for good. Yet, to us, this FDA decision is the natural and expected outcome of a basic and fatal conceptual error that our brothers and sisters in the movement have adopted. By joining larger trends within the behavioral health milieu that focus on the elimination of distinct symptoms by drugs and by expert-driven techniques, today’s psychedelic movement is teetering on the edge of becoming unpsychedelic. What do we mean by this? Psychedelics free our minds to novelty, liberating us from habitual patterns. The common term for this property is “brain plasticity”, and it may be the core reason these substances can also affect areas of psychological suffering related to habits of the mind – those that experienced psychiatrists label as depression, anxiety, addiction and, yes, PTSD. Psychedelics are pro-imagination, pro-creativity, pro-innovation – qualities that research shows are at the very root of personal growth. © 2024 Guardian News & Media Limited

Keyword: Stress; Drug Abuse
Link ID: 29424 - Posted: 08.11.2024