Category Archives: Psychedelics

This story originally appeared on Benzinga

A letter on behalf of the federal Health and Human Services (HHS) department acknowledges that the ongoing mental health and substance use crises require for the potential of psychedelic-assisted therapies to be further explored. The department would establish a task-force to do so, first reported by Mattha Busby in The Intercept.

The document, written in May 2022 and signed by the Substance Abuse and Mental Health Services Administration (SAMHSA) on behalf of the HHS secretary Xavier Becerra, constitutes the federal response to a February letter signed by five Congress members proposing a task force towards addressing the issues associated with the expected FDA approval of MDMA for PTSD treatment and psilocybin for depression treatment within the next two years.

RELATED: Are Psychedelics a Good Investment? What You Need to Know

According to the reply letter, Biden's administration is "exploring the prospect" of establishing the suggested federal task force to monitor the emerging psychedelic treatment ecosystem, which could involve collaboration with the private sector as well as across federal agencies.

Joining the bipartisan Congressional lawmakers, other state legislators and military veterans had sent a companion letter to the HHS urging the agency to decide on a course of action, considering that "people are going to use them (the psychedelics) regardless of whether regulators act."

The battle towards federal legalization of psychedelic medicine is up and running. Besides the potential federal taskforce, two bipartisan bills co-sponsored by Senators Cory Booker and Rand Paul along with Representatives Earl Blumenauer and Nancy Mace have recently been introduced against the DEA's denial to allow terminally-ill patients from accessing controlled substances.

Accordingly, the federal agency is currently facing another lawsuit regarding access to psilocybin for oncology patients backed by Right To Try laws.

So far, the DEA has responded positively to a separate claim: following a significant pushback from research and advocacy groups, it revoked its proposal to ban five potentially very therapeutic tryptamines.

More legislation to widen access to psychedelics is soon to be discussed, including one regarding research and pilot programs within the U.S. Department of Veterans Affairs.

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Biden Administration Says Task Force Is Needed to Advance Psychedelics Research - Green Entrepreneur

And a lot of people here are availing themselves of D.C.s unique decriminalization rules. Microdosing mushrooms as a kind of performance-enhancing brain boost already wildly popular among the California tech set is now fairly common in Washington, especially in media circles. Recreational use macrodosing? isnt all that uncommon either. If you want a fully legal psychedelic experience, you can stop by Field Trip, on 15th St. NW, where licensed therapists treat PTSD, depression and other mental health issues with psychedelic-assisted therapy using ketamine.

A lot of the new curiosity about psychedelics was sparked by Michael Pollans 2018 book, How to Change Your Mind: What the New Science of Psychedelics Teaches Us About Consciousness, Dying, Addiction, Depression, and Transcendence. (The book has now been turned into a show on Netflix.) In other circles, Joe Rogans podcasts about mushrooms created a flurry of interest.

The Department of Veterans Affairs is now conducting clinical trials with psilocybin, the drug in psychedelic mushrooms, to treat mental health issues. And The Intercept reported this week that in a recent letter to Rep. Madeleine Dean (D-Pa.), the Biden administration revealed that the FDA is likely to approve the use of psilocybin to treat depression sometime in the next two years.

But cities and states are way ahead of the federal government. There are movements in more than two dozen states to either study, decriminalize or outright legalize mushrooms and other psychedelics. With many veterans as the face of the movement, its happening in blue states like California, New York and Vermont, as well as in red states like Utah, Kansas and Florida.

The epicenter of this movement, as was the case with cannabis legalization, is Colorado, where voters in November will decide whether to approve the Natural Medicine Health Act of 2022, which would create state-regulated healing centers where anyone over 21 could receive psilocybin-assisted therapy.

Its safe to say we are on the cusp of a new frontier in drug legalization, and in the next few years psychedelics are going to be as easily obtainable in cities and states across the country, as they are right now in D.C. And most politicians havent even started to think through what their position on this issue should be.

On this weeks episode of Playbook Deep Dive, Ryan traveled to Littleton, Colo.,and sat down with Veronica Lightning Horse Perez, the co-leader of the Colorado mushroom campaign. They talked about how psychedelics helped treat her mental health issues, what its like to undergo psychedelic therapy with mushrooms and ayahuasca, and her own journey to becoming the unlikely political activist at the forefront of mushroom legalization.

CORRECTION: The story has been updated to correct the spelling of Littleton, Colorado.

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Legalizing the trip: One 'shroom advocate's playbook - POLITICO

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'The result was a rebirth. I finally got where I wanted to go': Celebs who have tried psychedelics - The Daily Post-Athenian

"WITHIN is creating an environment that aims to address the root causes of [addiction] by enabling people to come together in community to heal." - Dr. Molly Maloof

AUSTIN, Texas (PRWEB) August 01, 2022

WITHIN, a first-of-its-kind psychedelic medical clinic, retreat center and integration program offering cutting-edge treatment services through the use of ceremonial psychedelics hosted a Grand Opening event Friday, July 22, 2022 at its inaugural facility located in Austin, TX. WITHIN opened its doors on May 1, 2022, in the heart of the city and has been successfully guiding individuals through ceremonial psychedelic treatments over the past two months. The sold-out event included live music, educational talks from leaders in the psychedelic space and interactive wellness experiences including live painting, massage, sound, light and wave therapy.

A series of talks from psychedelic industry leaders kicked off the evening, with a keynote presentation by Greg Fonzo, Ph. D., Co-Director, Center for Psychedelic Research & Therapy and Assistant Professor, Department of Psychiatry & Behavioral Sciences at UT Health. Other speakers included Dr. Molly Maloof, Founder and CEO of Adamo Bioscience, Deanne Adamson, CEO of Being True to You, Mary Olivar from the Center for Shamanic Education and Exchange, and Dr. Mike North, CEO/Founder of Slow Wave.

Founder and CEO of WITHIN, David Naylor, a veteran of the mental health industry, shared his vision in opening this type of facility. Working in the mental health and addiction field for close to a decade, owning 4 treatment centers and 10 aftercare sober living properties, I saw the revolving door and 85% relapse rate, said Naylor. I watched too many of my friends and clients bounce from center to center, and I watched too many parents grieve losing their children. Psychedelic therapy changed my life four years ago after I, myself, was suffering from a lifelong battle with anxiety and fear. It was like doing 10 years of therapy in one session. I confronted and healed my fear of death and an anxiety thats been with me most of my life. I finally experienced what Johns Hopkins, MAPS, UT and others have been showing us for years with their data and research on psychedelic medicine and it gave me a whole new perspective and understanding for my life and why I am here. Today, we get to see these kinds of transformations and miracles every day in our clinic through individuals overcoming their biggest fears, sabotaging behaviors and addictions and finding a deep belonging, safety and connection within themselves.

According to Maloof, One of the biggest problems in society today is a lack of social connection due to social isolation and loneliness. Psychedelics administered in a healing context with proper preparation, set, setting, safety and integration, can be enormously helpful for helping people suffering from mental illness and diseases of despair. We need to consider that disconnection from oneself, ones life, and ones social environment contributes to the development of maladaptive coping habits such as addiction. WITHIN is creating an environment that aims to address the root causes of this condition by enabling people to come together in community to heal.

Clients from WITHINs first two months boast its success:Psychedelic therapy released attachments, blocks, and got me out of behaviors I had tried to break my entire life, says Luke Carver.

I got more out of one blindfold Therapy session Within using transformative psychedelic medicine than 20 years in therapy, boasts Misty Squires.

As the country experiences a growing interest in the use of psychedelics as therapyas evidenced by the popularity of Netflixs new smash hit, How to Change Your Mind, which explores the history of the use of psychedelics in a clinical settingWITHIN is leading the way by offering those seeking a reprieve from psychological strife or deep-rooted traumas with an alternative treatment option. WITHIN not only treats those in recovery from drug and alcohol addiction, but also those battling depression, anxiety, traumas, PTSD, chronic pain and those navigating life transitions. Unlike clinics that tend to be sterile and cold, WITHIN offers a warm ceremonial approach, merging ancient traditions with modern medicine. There is a retreat center with a focus on integration and community along with four conscious living homes. To date, WITHIN has raised $600,000 to launch the flagship Ausin location and is currently raising a $1.5 million seed round with plans to expand to three more states by the end of 2023.

For information about available treatments or investment opportunities, contact: info@within.center.

ABOUT WITHIN:WITHIN is a psychedelic medical clinic, retreat center and integration program based in Austin, Texas, that provides safe, transformational healing modalities for those looking to release trauma, to combat stress, anxiety, addiction, and depression and to regain their mental health and well-being. WITHIN is pioneering the future of health and is revolutionizing the current healthcare model, offering breakthrough psychedelic therapy merging the ancient traditions with western medicine. A medical clinic with a medical license and staff, WITHIN has a unique model of therapy, shifting the paradigm around how we collectively view ourselves and our lives; our wholeness, our wellness, and our quality of life.

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Texas' first Ceremonial Psychedelic Treatment Center WITHIN opens in Austin - PR Web

About the opportunity

The Drug Discovery Initiative and the School of Chemistry is seeking a motivated Postdoctoral Research Fellow with prior experience in behavioural and molecular neuroscience. This exciting opportunity involves investigating how psychedelic molecules impact the neurodevelopment in preclinical models of disease. The successful applicant will work under the supervision of Professor Michael Kassiou, and Dr Eryn Werry from the Drug Discovery Initiative in the School of Chemistry at the University of Sydney.

Your key responsibilities will be to:

The Drug Discovery Initiative aspires to enable improved health outcomes through innovative drug discovery. Its mission is to design and develop innovative tools and techniques for identifying novel therapeutic targets, delivery mechanisms and bioactive molecules with high potential for industry uptake and clinical translation. By providing an overarching framework that links aligned areas of research strength from across the University, the Initiative will accelerate impactful research and enhance multi-disciplinary collaboration both within the University community and with broader health industry partners.

The School of Chemistry at the University of Sydney is a leading Chemistry department in the country, with outstanding staff and students undertaking world-leading teaching and research. With more than 30 academic staff, 100 research staff, and 100 research students we conduct research across the full spectrum of pure and applied chemistry. Our research excellence is recognised by numerous prizes and awards to individual staff members and the award of almost $10 million in research funding each year. With the support of over 30 professional, technical and administrative staff, the School of Chemistry administers and delivers undergraduate teaching for more than 3 000 students. We are committed to creating a diverse workplace by improving equity, access and opportunity, and we are continuously working to identify and remove biases and barriers in an effort to make our workplace open, supportive and safe for everyone.

To learn more about the Drug Discovery Initiative, click here

About you

The University values courage and creativity; openness and engagement; inclusion and diversity; and respect and integrity. As such, we see the importance of recruiting talent aligned to these values and are looking for a

Postdoctoral Research Fellow who has:

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Please note: Visa sponsorship is not available for this position.

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Your employment is conditional upon the completion of all role required pre-employment or background checks in terms satisfactory to the University. Similarly, your ongoing employment is conditional upon the satisfactory maintenance of all relevant clearances and background check requirements. If you do not meet these conditions, the University may take any necessary step, including the termination of your employment.

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At the University of Sydney, our shared values include diversity and inclusion and we strive to be a place where everyone can thrive. We are committed to creating a University community which reflects the wider community that we serve. We deliver on this commitment through our people and culture programs, as well as key strategies to increase participation and support the careers of Aboriginal and Torres Strait Islander People, women, people living with a disability, people from culturally and linguistically diverse backgrounds, and those who identify as LGBTIQ. We welcome applications from candidates from all backgrounds.

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For a confidential discussion about the role, or if you require reasonable adjustment or support filling out this application, please contact Helen Efstathiou, Recruitment Consultant. Recruitment Operations, Human Resources on +61 2 8627 7137 or by emailrecruitment.sea@sydney.edu.au

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Wednesday 17 August 2022 11:59 PM

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Postdoctoral Research Fellow in Psychedelics, Neurodevelopment and Electrophysiology job with UNIVERSITY OF SYDNEY | 303322 - Times Higher Education

DENVER--(BUSINESS WIRE)--Unlimited Sciences, a psychedelic research nonprofit, today announces a seminal new observation research study that will measure the potential healing effects of ayahuasca on individuals with past experiences of trauma. The study, beginning this summer, will engage mostly female immigrants and refugees seeking remedial therapy through the powerful psychoactive brew, which has been identified as a candidate for the treatment of trauma. To fund the groundbreaking endeavor, Unlimited Sciences kicked off a GoFundMe campaign to raise the necessary $50,000 to conduct the study.

Despite robust reports and significant historical roots recognizing the vast therapeutic potential of ayahuasca, the psychoactive alkaloid present in ayahuasca, N-dimethyltryptamine (DMT), is a Schedule I controlled substance classified as having no currently accepted medical use and a high potential for abuse, said Matthew X. Lowe, Ph.D., Research Director at Unlimited Sciences and principal investigator for the study. As a result, there has been little research conducted on ayahuasca. Current therapeutic options may be insufficient to meet the increasing needs of a growing number of individuals presenting with symptoms of trauma. Alternative treatment options are desperately needed, and ayahuasca has been identified as a candidate therapy for the treatment of trauma.

Ayahuasca produces powerful experiences that have been likened to intense psychotherapy, indicating its therapeutic potential for treating trauma and its resulting mental health disorders, such as post-traumatic stress disorder (PTSD). High numbers of refugees and immigrants endure complex and multilayered forms of distress, including physical and sexual violence, persecution, experiences of war and torture, life-threatening situations and tense journeys before and during the process of migration. The mind-altering psychedelic effects produced by ayahuasca can have lasting and severe long-term mental health consequences, yet few studies have examined the impact of trauma experienced after migration.

DMT is a particularly intriguing psychedelic. The visual vividness and depth of immersion produced by high doses of the substance seems to be on a scale above what is reported with more widely studied psychedelics such as psilocybin or magic mushrooms, said Dr. Robin Carhart-Harris, co-principal investigator on the study and Founding Director of The Neuroscape Psychedelics Division and newly endowed Ralph Metzner Distinguished Professor of Neurology and Psychiatry at the University of California San Francisco. Its hard to capture and communicate what it is like for people experiencing DMT but likening it to dreaming while awake or a near-death experience is useful.

Donations raised through the GoFundMe campaign will help pay for expenses related to key research personnel, equipment, institutional review board and other direct costs such as materials and publication expenses. Unlimited Sciences was invited to observe the ceremony and study health outcomes related to the event, and is solely focused on observational research which does not include organization, facilitating the ceremony, or administering ayahuasca to participants. Unlimited Sciences is aware of the risk psychedelic substances can pose to vulnerable individuals or individuals predisposed to mental health conditions, and does not endorse the use of ayahuasca outside of clinical settings. Unlimited Sciences will eventually publish the studys results and share them with the general public in the interest of advancing scientific understanding of both the risks and benefits of using ayahuasca for therapeutic purposes. To learn more about Unlimited Sciences and real-world psychedelic research, please visit http://www.unlimitedsciences.org.

About Unlimited Sciences

Unlimited Sciences is a psychedelic research nonprofit that uses the power of data to serve the community, educate the public, and inform common-sense practices and policies regarding psychedelic use. At Unlimited Sciences, we are focused on driving psychedelic research forward, and our goal is to capture observational data in real-world settings and share these results with the public. Its estimated that over 30 million people have used some form of psychedelics in the U.S. alone. Our goal is to access this knowledge, mitigate harm and reduce stigma through education.

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Unlimited Sciences Announces Groundbreaking New Study to Observe Ayahuasca's Effects on Trauma - Business Wire

Last summer, Gaetano, a 35-year-old financial adviser from New Jersey, traveled with his wife to the rainforest outside Sayulita, Mexico, near Puerto Vallarta, where they stayed in a well-appointed villa overlooking the Pacific Ocean. For five days they did what any couple might do on a wellness retreat. They practiced yoga with the handful of other guests and tried a sound bath, lying on the floor and feeling vibrations produced by a local healer. They watched the sunset from their balcony every evening and dined on five-star cuisine.

But twice on their trip they also consumed something else: psilocybin, the hallucinogen more commonly known as magic mushrooms. No longer just a recreational drug favored by club kids and Grateful Dead fans, psilocybin and similar psychedelics are increasingly gaining acceptance by psychiatrists and other mental-health professionals as genuine treatments for all manner of ills. Any skeptics need only consider the spate of respected academic institutions that have recently founded research centers to study their efficacy, including Johns Hopkins University, New York University and Harvard Universitys Massachusetts General Hospital.

Human beings, for thousands of years, have intentionally changed their brain chemistry to think about things a little differently, reasons Gaetano, who asked Robb Report not to publish his last name to protect his privacy.

He was on a mission for self-improvement. Specifically, he wasnt happy with his tendency to anger quickly. I could be combative, and I kind of recognized myself as an angry person. I never really ran from confrontation, and in my mid-30s this started not serving me.

In 2019 he had picked up the No. 1 New York Times best seller How to Change Your Mind: What the New Science of Psychedelics Teaches Us About Consciousness, Dying, Addiction, Depression, and Transcendence by Michael Pollan. He couldnt put it down and after finishing it read another half dozen books on psychedelics. Some of them were mainstream books like Terence McKenna, Gaetano says, referring to the late ethnobotanist who advocated the use of plant-based hallucinogens. Others were more under the radar. I was fascinated by it.

In May 2021 he and his wife were celebrating their fifth wedding anniversary. She had been suffering from anxiety and depression, brought on partly by unsuccessful efforts to have a baby. It was a very emotional time, so we were thinking about doing something different that wasnt going to be the normal go away and just drink, he says. It was actually my wifes idea to go on a retreat, but it was sort of a long time coming, because we had both been fascinated by this.

On the second day of the retreat, at 8 pm, just as the sun was setting, Gaetano and his wife lay on mattresses on the ground next to the infinity pool with eye masks on to block out any distractions. Retreat leaderspeople trained in yoga, hypnotherapy, nutrition and spiritualitystationed themselves close by in case anyone needed help. As Gaetano listened to native Spanish songs and the shruti box, an Indian instrument that makes a droning sound, the mushrooms kicked in, setting off a series of visions.

He observed himself revisiting events from his childhood. Some were bright moments spent with his family, times he felt really loved. Others, however, were dark. I saw kids bullying me in school, being embarrassed by rejection as a child, he says.

During a trip, some hallucinate and see themselves flying through the universe, swimming the oceans depths or riding a shooting star. Others revisit actual memories that theyve buried.

To get something particular out of a journeyin Gaetanos case, pinpointing the sources of his angerits possible to guide the mind by setting intentions or asking clear questions ahead of time. Gaetano had journaled before leaving for Mexico and discussed his goals with some of the retreat leaders once he arrived. His work led him to uncover memories, such as the ones of being bullied, that shed light on the root of his feelings.

When the drugs wore off, he found himself crying hysterically before finally being able to articulate what had happened to him. That changed everything for me, he says. He felt closer to his wife after sharing the humiliating experiences hed had as a kid. Immediately after he returned home, he started seeing a traditional therapist, at first weekly and now monthly. His blood pressure dropped so much his doctor reduced his medicines dosage. I had this feeling of tightness in my chest that used to be so worrying, he says. I havent felt it since the retreat.

The thing about these mushrooms is, they get rid of your ego, he explains. Sometimes you have to push that aside and let your guard down so you can really evaluate what is going on.

And the experience he had on the retreat is not the same as doing drugs at a party, he adds. If your eyes are open, and you are living outside your body, you might have a fun time and experience cool things, he says. But that is not the same as doing work within yourself.

One reason Gaetano traveled to Mexico to try psilocybin is that most psychedelics remain illegal in the United States. Ketamine has been legalized nationally if prescribed medically, but only Oregon has approved psilocybin for medical and wellness use, beginning by years end. MDMA has also shown promising results, though it, too, remains illicit except in approved studies. Advocates say all three have the power to help people overcome trauma.

Jennifer Mitchell is a professor of neurology and psychiatry at the University of California, San Francisco, where she has spent the past four years studying potential psychedelic therapeutics for a wide range of psychiatric disorders. These [psychedelics] reopen critical times in a patients memory, says Mitchell, who is also affiliated with the UC Berkeley Center for the Science of Psychedelics. They help you to see all the stuff inside of you that you might not know is there or you might not feel comfortable sharing.

Psychedelics work by changing a users perspective. People report emerging from their trips feeling at one with nature or having newfound empathy. Sometimes, as they did for Gaetano, hallucinogens resurface buried memories, allowing users to see the roots of their problems and address them head on.

Its a new approach to processing trauma, says Rachel Yehuda, director of Mount Sinais Center for Psychedelic Psychotherapy and Trauma Research. Sometimes trauma is very distressing, and our bodies and our minds dont cooperate with processing very negative events. This provides a way to do that work that might be very efficient.

A more scientific explanation is that psychedelics promote neurogenesis, which makes your brain reorganize and growmeaning the drugs literally wipe away old patterns and launch new ones.

Mitchell, Yehuda and other researchers hold that the science is there to warrant their legalization. What is truly exciting is that a number of psychedelics can really impact a series of mental-health conditions, and many of them dont have particularly valuable treatments at present, Mitchell notes. We know they can help PTSD, depression, alcohol- and drug-use disorder, end-of-life distress and other conditions. One dose of ketamine can work for about 10 days to fight depression, she adds, while a session of MDMA or psilocybin might do the trick for years.

There is clinical data that backs up all this stuff, says Jonathann Kuo, M.D., medical director at Hudson Medical, a practice in New York Citys West Village that administers IV ketamine for chronic pain and depression. At this point we know that talk therapy and putting you on Prozac for years at a time doesnt really work in the vast majority of people, so this is the next frontier.

Advocates for psychedelics agree that SSRIs, pharmaceuticals (including Prozac) that were hailed as game changers when they were introduced decades ago, have run their course. There is a mental-health crisis, and we dont have too many good traditional solutions, says Yahuda. This is something that looks like it might work. So the question is not why are we doing this? The bigger question is how could you ignore this?

Mount Sinai gave the go-ahead for the research center after the FDA declared MDMA a breakthrough therapy for PTSD in 2017, allowing scientists easier access to the drug for study. There is a lot of hype in the field, a lot of investment and drug development, and its very important for academic institutions to get involved and produce scientific data so we can see what is really going on, she says. When academic medical centers get involved, they will probably be very rigorous, [and] the research will be done by people who are skeptical, which is very important. It should be done by skeptics and not just people who have become very enamored of psychedelics.

Advocates believe and anecdotal evidence suggests that the substances can also help some users without full-blown mental illness. Fewer studies have examined psychedelics for what scientists call the betterment of healthy populations, but Mitchell predicts such testing is right around the corner. In Oregon, a diagnosis will not be required to access psilocybin. As for the danger of addiction, the experts Robb Report interviewed say that neither psilocybin nor MDMA is chemically addictive. Ketamine may beresearch is ongoingthough taking the drug under medical supervision probably lowers the risk.

Ketamine, which requires a patient to have some form of anxiety or depression to obtain a prescription, is currently being administered in clinics, in homes and on retreats across the country. Experts predict the FDA will approve MDMA by next year and psilocybin by 2025, and Senators Cory Booker and Rand Paul, normally on opposite sides of the aisle, cosponsored a bill in July that would give patients with terminal illnesses the right to use MDMA and psilocybin as therapeutics. Startups are already busy setting up centers to treat patients once these drugs get the green light.

In January, Business Insider identified 11 venture-capital firms that have invested around $140 million into the treatment industry. A month later, Mindstate Design Labs, a biotech company that develops psychedelic therapeutics, raised $11.5 million. The funders know a new drug application is in the works, says Mitchell. Everyone now wants to get behind it.

To be sure, psychedelics have already seeped into mainstream culture. During the pandemic, Netflix released Have a Good Trip: Adventures in Psychedelics, a documentary featuring celebrities from Sting to Sarah Silverman recounting their experiences with hallucinogens. Pollan has developed his seminal book into a four-part docuseries that premiered on Netflix this month. Silicon Valley CEOs are openly discussing their own experiences with microdosing, ingesting just a bit of a drug to get the mental-health benefit without the same level of high. Joe Rogan claimed to be on mushrooms during his podcast with rapper Post Malone.

I just think a lot more people are more focused on mental health, especially after Covid, says Kuo.

Before the pandemic, Jay Godfrey owned a namesake fashion line that was sold at Saks and seen on celebrities including Jennifer Lopez and Viola Davis. Then, in May 2019, he journeyed to Mexico, where he did plant-based hallucinogens with a shaman. My first experience was like five years in [therapy]. It was mind-blowing, he says. I felt like this needed to be brought in a legal, medically sound, hospitality-driven way to the United States.

Godfrey cofounded Nushama, a psychedelic wellness center with three locations in New York City. The flagship is on the 21st floor of a gilded building in midtown Manhattan; the goal is to open 35 in five years. Treatment rooms are decorated with wallpaper hand-painted with cherry blossoms, a symbol of renewal, and decked out with white zero-gravity chairs.

Before opening Nushama, Godfrey studied the history of psychedelics. The first wave goes back thousands of years, when Indigenous cultures across the worldin the Amazon, in West Africa, in Mexicowere using sacred plants to heal what they called ailments of the spirit, he recounts. Medicine likes to use words like mood disorders or depression or anxiety or PTSD, or there is a new one, protracted grief syndrome, but ultimately they are all the same thing, which is that something has happeneda trauma, a woundto create a sense of being dispirited.

The second wave was a 20th-century phenomenon. Harvards psychology department became the unlikely epicenter of research into then still-legal hallucinogens in the early 1960s, when a pair of academics, Timothy Leary and Richard Alpert, started studying their effects on human consciousness. After their scholarly colleagues objected to their methodologyLeary and Alpert often went on trips of their own alongside their subjectsthe duo were booted from the faculty. Though disgraced in academic circles, the men became counterculture icons. It was Leary who, promoting recreational use of LSD, coined one of the eras most iconic taglines: Turn on, tune in, drop out.

Still, Mitchell says, their theories werent entirely discounted. Even in the 60s we knew they had a medical use, but the drugs were terrifying to the public, so they were scheduled very severely by the FDA, she says. Even to this day, if you want to study them and research them, you have to jump through hoops.

Following the governments failed War on Drugs, we are now in the third wave, characterized by serious studies elevating psychedelics to the level of medicines developed by Big Pharma, mostly thanks to two important non-profit players in the field: the Multidisciplinary Association for Psychedelic Studies (MAPS) and the Usona Institute, which helps fund clinical research on psilocybin and other consciousness-expanding medicines, as the website puts it. (Big Pharma has been mostly quiet, but its clear they are watching, says Mitchell.) MAPS, in particular, has been around for 35 years and persevered with studies even after the government criminalized LSD and psilocybin.

When studies showed promising results, other scientists were forced to pay attention. A lot of people have paved the way for us to not be scared of psychedelics and understand that in the right environment and in the right container, they can be very useful, says Yehuda.

Patients like Gaetano, who are not willing to wait for MDMA and psilocybin to be cleared for use, are traveling to foreign countries such as Mexico, Jamaica and Costa Rica to try the therapies now. They should do their homework. Its a mixed bag, Mitchell says. Some places are fantastic, she notes, but some individuals have also told her team that they felt vulnerable while tripping because they did not feel safe with their guidesor even that they were physically or sexually abused while under the influence.

And, of course, theres always the potential for a bad trip, with creepy or frightening hallucinations. Afterward, users might still feel lost and confused, especially if they relive a painful experience while on the drug. They might even feel worse than they did before. We dont have enough data to know what the long-term effects of a bad trip are and how long these could last, Mitchell acknowledges. My guess is that as much harm as healing can occur in the throes of a vulnerable psychedelic experience. That is why facilitators are so very important. They guide the experience and help make the journey.

Even good trips can have a downside, according to Mike Arnold, director of Silo Wellness, a mushroom company that also stages psychedelic retreats in Jamaica (for psilocybin) and Oregon (for ketamine, but mushrooms will follow as soon as they are legal). One of the risk factors is that there are people who think they are not only communing with God but have some sort of special relationship with the divine, like the ancient Gnostics, he says, adding that their grandiose notions can lead them to believe they now possess the secrets of the universe. That is so dangerous. They are so vulnerable and impressionable, and its so important that the participants in this industry do the least amount of harm and the most amount of good possible.

At Silo, in addition to tripping, participants meditate in waterfalls, white-water raft and dance under the stars. People need to travel inwards and outwards, says Arnold.

The benefit of these retreats, which last about a week, is that they allow participants to gain trust with the facilitators before their mind explorations. Research shows trust takes 40 to 80 hours of person-to-person contact, he says. That is what we are trying to cultivate.

Experiencing hallucinogens in nature the way first-wavers did may hold a certain primal allure, but metropolitan outposts are proliferating, offering ketamine treatments for $500 to $1,000 per session; a series generally consists of six sessions over three weeks, each lasting an hour. (MDMA, by contrast, will probably take three eight-hour sessions to show any therapeutic impact. Godfrey is getting price estimates of $15,000 to $30,000 per treatment series, although the effects could last for life.)

Hudson Medical, for example, stands on the same block as a sex-toy shop and a coffee store. Inside, patients seeking to alleviate their depression or anxiety are taking ketamine trips, armed with noise-canceling headphones and eye masks and surrounded by living green walls and Native Americaninspired dream catchers.

Scientists in psychedelics talk a lot about set and setting, the former being a users mindset (Are they relaxed? Stressed? Do they trust the professional?) and the latter being the physical space. We expect that set and setting matters a lot, says Mitchell. In other words, whether you are tripping in the Ritz, the rainforest or a hospital, in the presence of your friends, a doctor or a total stranger, might make a big difference. Which seems plausible.

Anecdotally, people do seem to have more positive trips in places where they feel comfortable, according to Ronan Levy, executive chairman of Field Trip, which operates 12 psychedelic wellness centers, most of them in the US. If you are in an environment where you feel safe and at ease and relaxed, he says, you will have a better experience.

So, many centers are trying to evoke spas, with weighted blankets to help guests feel cozy and protected, plus plenty of snacks as well as coachesoften therapists, nurse practitioners or medical assistantstrained to guide them. Mindbloom, by contrast, sends ketamine lozenges to a clients home to be taken in front of a telehealth provider, which is a boon for patients who live in more remote areasor those who want to undergo the treatment at a ski or beach house or on a business trip.

Whatever the venue, the results, for some, can be remarkable.

In January 2020, Kris Giorgetti, who lives in Atlanta, started a new job working as a management consultant at the director level for a 10,000-person firm. He was thriving until the following December, after a public run-in with a team member. I was waking up in the middle of the night with anxiety attacks, he says. I was having trouble remembering things. I couldnt even watch television shows because I couldnt concentrate long enough. After 10 years without a sick day, he asked for a leave of absence.

A psychiatrist diagnosed him with PTSD. Researching treatment options, Giorgetti came across ketamine infusions. I read that it reorganizes your brain and creates new neurons and connections, he says. I chose to do ketamine-assisted psychotherapy over other medicine because I wanted something that would cure me. You dont want to take cold medicine when you could take something that cures the cold.

He did six sessions and had powerful visions from the get-go. I could see everything from how I came together as cells to myself being buried, he says. I saw my entire cycle of life. But it wasnt scary.

During the experience, you realize you are part of nature, and now when my feet touch the ground, I no longer feel separate from the earth.

Giorgetti also saw memories of himself coming out as gay in high school and feeling ostracized by friendsjust as hed felt shunned by his colleagues. Witnessing the bullying, he strengthened his empathy for himself back then as well as in the present.

I had what I called the worry wheel in my head, where I couldnt stop thinking about what had been done to me at work, he says. After the first treatment, there was nothing in my mind. It was clear of all the lists, the worries, the things to do, the pain, everything. It was all gone. It was the most peaceful, calming experience to sit there and not hear any of the background noise. By the third treatment he was sleeping through the night. After six he was back at work.

Start-ups report their audiences have diversified, especially over the past year. Last night I talked to a conservative Mid-western Catholic who wants to come to a retreat, says Arnold from Silo Wellness. We saw the same thing with cannabis years ago: different kinds of people slowly hearing about success stories and wanting to try it.

Once more psychedelics are approved for use, doctors in the field say they will be able to create mix-and-match regimens for patients depending on their needs. You will come in, fill out a survey; we will map your brain and do functional MRIs, says Kuo of Hudson Medical, and then we will have this treatment algorithm where we say, OK, were going to start with ketamine and then move on to MDMA and this and that until youre healed.

There is an opportunity for this to be part of everyones wellness regime, he enthuses. The same way you might seek out a doctor when you are sick, you might do ketamine once in a while when you need a new perspective.

Even though Giorgetti says his PTSD is 90 percent gone, he continues to take ketamine every six months for maintenance. Every time I do a session, I feel something remarkable, he says. Its almost like you could pick up the phone and call the universe and say, What is wrong with me? Its like communing with the universe.

Read more from the original source:

Good Trip? How Psychiatrists Got Serious About Using Psychedelics to Treat Mental Health - Robb Report

Inside the underground world of psychedelic therapy and the controversial charity pushing hard to bring the treatmentinto the mainstream.

Nine relative strangers are about to embark on a psychedelic voyage in bushland on Sydney's outskirts.

Their organiser is a self-styled guru offering healing and hope in the form of bags of green-grey powdered cactus dust the psychedelic drug mescaline.

The drug is illegal in Australia, but those here appear unfazed. They say the benefits are worth the risks.

Some are simply here for an adventure, but for many there's something deeper.

They're traumatised, struggling with life, and hoping to break through the pain.

"It's like a big reset on your brain," one participant, Jennyexplains.

"It's like you're a computer that's been going, going, going, going, going, and then you just push the reset button and then you kind of start again."

It's not her first time seeking healing through psychedelics but it's her first with mescaline. It's clear she's anxious.

She lines up with the others and quickly swallows a mix of gluggy cactus powder and organic apple juice. The group plans to hike through the national park until nightfall.

Within an hour, Jenny's feeling the effects.

"It's kind of a big reset on life," she offers.

"I think this medicine, what it does, it takes the logic away. You just get into your body and you forget what it's like being in your body because we fall into these " she trails off, staring into the distance.

"Ah, I can't do this." She's crying.

Around the country people like Jenny are being drawn to the hope and hype of psychedelic drugs like psilocybin (found in magic mushrooms), LSD and MDMA (commonly known as ecstasy).

The hope that psychedelics might hold the key to treating a range of mental health issues from anxiety to depression and PTSD isn't without merit. There are clinical trials happening around the world, including in Australia, which are showing promising results.

But some scientists say there's far more work to be done before these powerful drugs can be made safely available to the masses.

At a health and wellness retreat on the Sunshine Coast, investment banker Peter Hunt and his wife, opera singer Tania de Jong, have been fasting for several daysand are hoping to re-energise their mission.

Their psychedelic journey began on a trip to the Netherlands a few years earlier, where they ingested a large legal dose of psychedelic drugs known as "Psilohuascha" through a private therapist.

"It was wild," Peter says.

"It was like nothing I'd experienced before."

Tania describes it as "one of the most profound experiences in our lives".

It inspired them to found Australia's only registered charity advocating for the use of psychedelic therapy to treat mental illness, Mind Medicine Australia (MMA).

In just three years, they've established a for-profit training institute, a telephone hotline, and are lobbying to get psychedelics legalised for therapeutic use in clinical settings.

"We see a lot of people out there who are suffering, and we're determined to bring these therapies into the medical systemso psychiatrists can use them with their patients," Peter says.

But MMA is mired in controversy, with former staff alleging internal chaos, allegations of links to the underground, and claims it's used threats and intimidation to silence critics.

MMA's mission to get psychedelic therapy to the masses faces a major hurdle getting the drugs rescheduled by Australia's Therapeutic Goods Administration (TGA).

So far it's failed to clear that hurdle.

Tania says, with both state and federal regulations involved, the process has been complicated.

"And often, you're dealing with bureaucrats who are quite challenged by change," she says.

"Because you know, this is a paradigm shift."

The charity's TGA application would have allowed both MDMA and psilocybin to be used in therapeutic settings.

The application was drafted with the help of key scientific adviser Victor Chiruta, who until recently was listed on the charity's website under the heading "management team".

"Victor's got great scientific knowledge," Peter says.

Victor Chiruta is also a convicted drug cook.

Court documents obtained by Four Corners reveal earlier this year he pleaded guilty to manufacturing 57 grams of the drug MDA a similar drug to MDMA. He was arrested in 2014 after police allegedly discovered a commercial-scale illegal drug lab in the Blue Mountains.

"We are aware he's got difficulties, and we've given character references," Peter explains, noting Chiruta is also disabled after suffering burns to his body.

Tania tells Four Corners she's unconcerned about Victor's role at the charity.

"I'm not sure why you're making such a big thing of it, actually," she says.

"We're trying to focus on getting suffering people well, so this seems to be a bit of a red herring."

Despite the use of psychedelic drugs intherapy being illegal in Australia outside of strictly controlled trialsMMA has started running a training certificate for psychedelic therapists.

Tania says finding participants isn't a problem.

"Being a psychedelic-assisted therapist is probably one of the most popular and, I guess, sexy professions around at the moment," she says.

For $9,000, these hopeful psychedelic therapists can take a four-month, mostly online training course run by MMA's for-profit Mind Medicine Institute (MMI).

They receive MMI's Certificate of Psychedelic Assisted Therapy.

Melbourne psychotherapist Yury Shamis enrolled in the first intake, expecting an accredited course.

"[The] reality was, it was a good course, but it wasn't accredited at all. So the certificate really didn't mean anything," he said.

PhD student Kayla Greenstein enrolled last year, when the course was plagued with delays due to COVID.

"It was certainly presented as that if this became legal in Australia that Mind Medicine were the ones who would be certifying people.

"I recognise now that if I had spent more time on YouTube, I could have found a lot of the same information that I learned in that course, and I certainly didn't gain anything practical out of it.

"[I] ultimately decided to leave and I got a partial refund."

One of the issues raising eyebrows in the psychedelic community was a "major healthy persons trial" MMA announced it would be funding earlier this year, in which 200 participants would be able to "experience the medicines".

An email sent by the charity stated it had secured the MDMA for the trial and that "this trial will give graduates and participants in our Certificate of Psychedelic- Assisted Therapies (CPAT) Program the chance to actually undergo Psychedelic Assisted therapy in a clinically controlled environment".

Dr Emma Tumilty, a bioethicist from Deakin University, says that advertisement raised suspicions "that the research was in part being used as a vehicle to provide access to the drug so that MMA could offer training that included that experience".

"That would, of course, be ethically and scientifically inappropriate." she says.

The charity was eventually instructed to pull an advertisement for the study by the ethics committee that conditionally approved the trial. MMA says a "breach was innocently made".

After inquiries from Four Corners, the ethics committee advised the trial wasbeing withdrawn late last week.

Former MMA employees Diego Pinzon and his partner ScarletBarnett worked in fundraising and public relations at the charity.

Within weeks of starting in the job, they were called into a meeting with Tania de Jong after Scarletbecame upset at work.

The couple says she started asking whether Scarlethad any trauma or other issues.

"And then she suggested, 'Because if you do have abuse, you might consider MDMA therapy. I think that could be really beneficial for you. And here's someone you can call or put you in touch. You can set up a session with them'," Scarlet says.

Scarletclaims she wasgiven the number for Yury Shamis.

"He offered MDMA and psilocybin together as a session. And I think it would cost around $2,000," Scarlet recalls.

"He told me that if I did decide to go ahead, that I would need to let him know very soonbecause he books out about four months in advance."

Peter and Tania strongly deny they've ever referred anyone to underground psychedelic therapy and say they don't encourage people to break the law.

"We know there are good psychedelic therapists out there working in the underground. And yet, we can't refer these people to those people," Peter explains.

"Were we to do that, and were we to be caught in doing that, that would be the end of the charity."

Yury Shamis's therapy rooms sit above a share house in the Melbourne suburb of Balaclava. In the front yard, his sign has been defaced and reads "Dr Psycho Sham".

Yury is a psychotherapist which is not a legally protected title in Australia with a PhD in microbiology and a masters in counselling.

He says he got into psychedelics through "self-experimentation" for his own mental health struggles in the party scene.

"I noticed a lot of benefits. And I think when I became a therapist going into the psychedelic therapy kind of world was a no-brainer for me," he says.

Yury says he can be with patients who are on psychedelics, "technically if they've taken the drug before they've walked in", but chooses not to, and maintains he's not doing anything illegal.

On the windowsill in his office is an empty box of ketamine next to a hypodermic syringe packet.

His Facebook page was, until recently, public. There is a photo of a bag of white powder referred to in one of his posts as "K", and a pile of mushrooms with the caption "good day at the office".

In April 2021, Yury Shamis was listed online as one of the people MMA referred to callers who contacted their psychological support hotline.

A month later, he posted a status update: "that moment when you realise you've been taking peeps psychedelic virginity since your teens; and now you get paid for it".

At the time, MMA was fielding constant calls from desperate members of the public seeking psychedelic drugs for mental health treatment or information about where to get them.

The two head trainers and directors of the Mind Medicine Institute, Tra-ill Dowie and Nigel Denning, say they're concerned by "whispers" within the organisation of people being referred to underground psychedelic therapists, through the charity's hotline.

"If we're talking about a body and an organisation which is purporting clinical application, then there can be no room, in fact at all, for underground referrals or any of these kinds of things," Tra-ill says.

Nigelsays the idea of setting up the hotline was a disaster due to "the absence of any governance".

"There was an absence of any clarity about process and procedure, the absence of any security about referrals, and the absence of any vetting of how therapists within that process were treating, what they were treating," he explains.

The hotline was eventually shut down.

MMA's unconventional efforts to promote its cause have courted controversy.

Tania composed and performed a song promoting the effects of psilocybin titled Shroom Boom for a live cabaret performance called Songs for Psychedelics.

An accompanying music video was posted on the charity's YouTube channel this year.

Its lyrics include:

"Why can't I get out of bed. It's not because I am dead.

And yet the pain never stops antidepressants and side effects.

So I tried magic mushrooms and now I'm feeling so great.

Shroom boom magic, magic mushroom.

Taking us into a magical world of mushrooms.

Shroom boom. Mushrooms karma pharma."

Many in the scientific community felt the video was ill-advised and dangerous, promoting the use of psychedelics over antidepressants.

Dr Rosalind Watts, the former clinical lead of the Imperial College's Centre for Psychedelic Research, shared her concerns in the video's comments.

"Taking magic mushrooms to treat depression is a high-risk therapy that requires ongoing support from trained professionals. They do not magically reset the depressed brain, or heal the world, or the soul"

That commentmysteriously disappeared.

Former MMA employee Dr Alana Roy says on the charity's YouTube the video "received significant negative feedback, which were censored and edited".

Alana left the charity as the head of psychological services earlier this year after she raised concerns about the treatment of staff within the organisation.

"I was told by a senior member of Mind Medicine that if I continued to speak out, to expect litigation, and that if I did not tell them who else was speaking out, that I would face litigation as well," she says.

"They also told me in that meeting, that they had started to monitor my phone and emails and that they had hired the best technical investigator that they could find to monitor me."

See the original post:

The hope and hype of psychedelic therapy - ABC News

Repeated use of small quantities of the psychedelic substance psilocybin can improve mood and mental health, a new study suggests.

Researchers found that people who microdosed psilocybin saw small- to medium-sized improvements in symptoms of depression, anxiety, and stress over a 30-day follow-up, compared to those who did not.

This observational study, published June 30 in Nature-Scientific Reports, included over 900 people who reported microdosing psilocybin during the past month, and a control group of 180 people who did not engage in microdosing psychedelics.

This is the largest longitudinal study of this kind to date of microdosing psilocybin and one of the few studies to engage a control group, study author Zach Walsh, PhD, a professor of psychology at the University of British Columbia Okanagan Campus in Kelowna, said in a press release.

[The results] add to the growing conversation about the therapeutic potential of microdosing, he added.

When it comes to psychedelics, microdosing involves consuming psychedelic substances in amounts too small to impair daily functioning. The dosage may vary but could be taken 3 to 5 times per week.

The 2021 Global Drug Survey (GDS) found that 1 in 4 people who used psychedelics reported microdosing psilocybin mushrooms or LSD in the past 12 months. These two substances are the most widely used for microdosing, but the survey also found that about one-third of people who used psychedelics microdosed another psychedelic substance.

Although most people have a sense of a microdose as being very small, Dustin Hines, PhD, an assistant professor of neuroscience in the department of psychology at the University of Nevada, Las Vegas, said one challenge for this kind of research is accurately defining the size of that dose.

In establishing a microdose, people are looking to have normal cognitive functioning they can still carry out their work duties or other responsibilities without noticing a negative impact, he said, adding that the appropriate microdose may vary from person to person and situation to situation.

In the new study, participants reported on their recent use of microdosing psychedelic mushrooms and completed a number of assessments on their mood and mental health, noting a number of improvements.

In addition to studying mental health outcomes, researchers took a smartphone finger-tapping test that has been used to assess psychomotor symptoms of neurodegenerative conditions such as Parkinsons disease and Multiple Sclerosis.

People 55 years or older who microdosed psilocybin experienced improvements in psychomotor performance, as measured by this tapping test.

Researchers also assessed whether combining psilocybin with a non-psychedelic substance, a process known as stacking, changed the outcomes.

Combining psilocybin with lions mane (a non-psychedelic mushroom) and niacin (a B vitamin) did not affect the changes in mood or mental health, the researchers found. However, older individuals who microdosed and combined psilocybin with both of these substances were more likely to have improved psychomotor performance.

The new study used a subset of participants from a larger, prior study from the same researchers that was published in November 2021 in Nature-Scientific Reports.

The earlier study found that people who microdosed either psilocybin or LSD reported lower levels of anxiety, depression, and stress than those who did not mircrodose psychedelics.

Whats more, a smaller 2019 study found that people who microdosed psychedelics had reductions in symptoms of depression and stress, and lower levels of distractibility. However, this study did not include non-microdosers as a comparison group.

And though the new study is the largest of its kind to date, its important to note that its still observational rather than a randomized controlled trial (RCT). As such, researchers were unable to fully account for other factors that might affect the outcomes, such as age, gender, mental health prior to the study, and other types of treatment.

Factors such as these may also affect how people respond individually to psilocybin.

One thing that varies hugely in these studies is who people are going in. Some people are resilient to depression but have lots of problems with anxiety, and vice versa, said Hines. So a microdose may affect somebody with high levels of anxiety very differently than somebody with high levels of depression.

Due to the way the new study was designed, the researchers were unable to control for expectancy, an effect in which people know they are taking psilocybin, so they expect to experience positive benefits.

This is a common problem in psychedelic research, as well as with other research in which a treatment is difficult to mask from the participants (i.e., studies of acupuncture, ice therapy, and electrostimulation).

The power of expectancy is huge, and its very difficult to control for in these kinds of studies, said Rochelle Hines, PhD, an assistant professor of neuroscience in the department of psychology at the University of Nevada, Las Vegas. This study wasnt even really designed to try to take expectancy out of it, but that doesnt necessarily mean the results are not accurate.

Psychedelic research has historically been challenging because psilocybin, LSD, and other psychedelics are currently illegal in the United States under federal law.

Although prior clinical trials on psychedelics have been challenged in the past, the Food and Drug Administration (FDA) has since granted breakthrough therapy status for psychedelics and is now encouraging scientific research.

And despite the potential therapeutic potential for psychedelic drugs like psilocybin, the adverse risks are not fully understood, hence the need for more rigorous research.

One concern with psilocybin mushrooms is that long-term use might lead to valve damage or cardiac valvulopathy. When ingested, psilocybin is metabolized by the liver and converted to the pharmacological compound psilocin, which binds to serotonin receptors in the heart.

Rochelle Hines said in order to accurately assess the risks and benefits of microdosing psilocybin, these kinds of potential risks need to be investigated long-term.

For the occasional use, it seems like psilocybin might not pose too much threat in that regard, she said. But I dont know that we have a lot of longitudinal data looking at regular chronic users to understand what is the potential role that this compound has on the heart.

While Dustin Hines is pleased with the design and results of the new study, he said one thing that strikes him when studies like this come out is that researchers have to continue proving to the general public that some of these psychedelic compounds are beneficial.

Part of the problem, he said, is the negative stigma attached to psychedelics, even though psilocybin and LSD carry a low risk of addiction, especially compared to legal substances such as tobacco and alcohol.

These are not highly risky medications to microdose, said Sherry Walling, PhD, a licensed clinical psychologist and host of Mind Curious, a podcast exploring the benefits of psychedelics for mental health. The risk profile for addiction and overdose is really low.

In fact, psilocybin-related deaths are rare since the substance is considered to have extremely low toxicity. As such, researchers are investigating psychedelics as possible treatments for various substance use disorders.

Theres a really nuanced story here around how substances can be dangerous to us, but can also be incredibly healing, Walling said.

As the field of psychedelic research continues to advance, more evidence is showing the therapeutic potential for microdosing substances like psilocybin.

Yet despite the potential benefits seen, experts like Walling caution that more research is still needed, particularly when it comes to using psychedelics as a treatment for anxiety, depression, or other mental health conditions.

As a psychologist, my job is to help take care of vulnerable people, she said. So thats where the level of research does matter significantly, in terms of what I am comfortable saying to patients about these compounds.

Dustin Hines agreed, but only if the studies are well-designed, as these can help advance psychedelic therapies to clinics without the risk of re-stigmatizing these compounds. We really want this to roll out well because I think it will have profound effects on humanity, he said. But it has to be done right, and we have to have all the facts.

See the rest here:

Microdosing Psilocybin Mushrooms May Improve Mental Health and Mood - Healthline

Welcome to TDRs review of the Top 5 Psychedelic Developments for the week of July 18. Aside from presenting a synopsis of events, we provide market commentary to summarize the week that was for publicly-listed companies.

5. Cory Booker And Rand Paul Bill Would Force DEA To Let Patients Use Psychedelics And Marijuana

Bipartisan and bicameral congressional lawmakers filed companion bills on Wednesday to clarify that federal Right to Try (RTT) laws give seriously ill patients access to Schedule I drugs, including marijuana and psychedelics like psilocybin and MDMA.

Sens. Cory Booker (D-NJ) and Rand Paul (R-KY), along with Reps. Earl Blumenauer (D-OR) and Nancy Mace (R-SC), are the lead sponsors of the legislation.

4. COMPASS Pathways appoints Kabir Nath as Chief Executive Officer

COMPASS Pathways plc (Nasdaq: CMPS) announced that it has appointed Kabir Nath as Chief Executive Officer, effective August 1, 2022. George Goldsmith, COMPASS current CEO and Chairman, will serve as the companys Executive Chairman from August 1, 2022 to December 31, 2022 to facilitate the transition, and remain as Chairman after that.

Kabir Nath brings decades of experience in the health care industry to his new role, most recently serving as Senior Managing Director of global pharmaceuticals at Otsuka Pharmaceutical Co., Ltd. and previously as President and CEO of Otsukas North America Pharmaceutical Business, where he led the development of pharmaceutical products and digital solutions addressing complex mental health needs.

Prior to Otsuka, Kabir held various leadership positions at Bristol Myers Squibb, a global biopharmaceutical company focused on innovative medicines for patients with serious diseases. Kabir holds an MA in Mathematics from the University of Cambridge and an MBA from INSEAD.

__________

Numinus Wellness Outpatient Therapy Growth Metrics Are Trending In The Right Direction

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3. Psychedelic Stocks Outperform Biopharma Peers

The biggest psychedelic stocks were higher on balance, as the sector shows continued resilience lately in the face of volatile markets. TheHorizon Psychedelic Stock Index ETF(PSYK) sank2.74%and outperformed direct peerNasdaq Junior Biotechnology Index(1.54%) and theNasdaq Biotechnology Ishares ETF(0.51%). TheNASDAQ 1003.51%andS&P 5002.54%also rose, as the market found a bid in the face of decent corporate earnings and renewed stock buybacks.

Heres how the Health Care (Biotechnology) sector performed:

Weekly Top Gainers:

In the news

Awakn Life Sciences announced that the National Institute for Health and Care Research, a UK government agency, has approved grant funding for 66% of the costs of Awakns Phase III clinical trial exploring the use of ketamine-assisted therapy for the treatment of AUD. The trial is currently forecast to cost approximately CA$3.75 million in total.

COMPASS Pathways announced that it has appointed Kabir Nath as Chief Executive Officer, effective August 1, 2022. George Goldsmith, COMPASS current CEO and Chairman, will serve as the companys Executive Chairman from August 1, 2022 to December 31, 2022 to facilitate the transition, and remain as Chairman after that.

Delic Holdings shared a corporate update.

Drug Enforcement Administration is being suedagainover its refusal to allow a doctor to treat terminally ill patients with psilocybin therapy pursuant to federal and state Right to Try (RTT) laws, which are aimed at expanding access to Schedule I investigational drugs that arent currently approved for general use (July 22).

Enveric Biosciences announced the formation of its Scientific Advisory Board comprised of science and technology leaders, including globally renowned CNS and mental disorders experts, and chaired by Maurizio Fava, M.D.

Field Trip Health announced the first successful dosings in the Phase 1 Clinical Study entitled A Double-Blind, Randomized, Placebo-Controlled Study to Investigate the Safety, Tolerability, and Pharmacokinetics of Single, Ascending, Subcutaneous Doses of FT-104 HCl In Healthy Volunteers. The study is being conducted at PARC Clinical Research at the Royal Adelaide Hospital in Australia.

KGK Sciences And Halucenex sign contract for Phase II clinical trial on psilocybin for PTSD.

Lobe Sciences has filed a provisional patent for the preparation and use of its proprietary and stable psilocin related compounds.

Mydecine Innovations Group has successfully synthesized multiple short-acting MDMA analogs. This family of analogs have been specifically designed by experts at Mydecine to have a shorter half life than traditional MDMA.

Oregon will soon be the first state in the US where you can take magic mushrooms legally. Heres everything you need to know.

Red Light Holland provided a clarification and update with additional information regarding its partnership with Mistercap LLC.

Stephen Colbert recalls horrible trip on magic mushrooms.

TDR Feature article: 5-Year Anniversary Of Chester Benningtons DeathHow The Linkin Park Vocalist Brought Mental Health Into The Mainstream

2. DEA Sued Over Unlawful Delays On Psychedelic And Marijuana Public Records Requests Through FOIA

The Drug Enforcement Administration (DEA) is being sued over repeated delays to requests for records related to psychedelics and marijuana.

DEA Sued Over 'Unlawful' Delays On Psychedelic And Marijuana Public Records Requests Through FOIA: "This policy and pattern or practice rests on a perversion of FOIAs plain language." https://t.co/Hq98xamsUN

This comes amid a multitude of drug policy-focused legal challenges the agency has faced in recent years, including one that concerns DEAs refusal to provide a doctor with access to psilocybin to treat terminally ill patients under right to try laws.

But while connected, and involving some of the same plaintiffs and attorneys, this new suit centers on DEAs alleged unlawful policy of delaying responses to Freedom of Information Act (FOIA) requests, specifically pertaining to psychedelics and marijuana documents that advocates say theyve sought for legal and journalistic purposes.

1. Psychedelic Mushroom Decriminalization Makes Colorado Ballot

Colorado voters will decide in November whether to decriminalize psychedelic mushrooms, and the initiative could open the door for decriminalizing other hallucinogens. On Thursday, the Colorado Secretary of States Officesaid 225,140 signatureswere submitted forInitiative 58. The office projects that about 138,760 are valid, putting the campaign more than 111% over its required signature goal.

Colorado voters will decide in November whether to decriminalize psychedelic mushrooms, and the initiative could open the door for decriminalizing other hallucinogens. https://t.co/4Fs1Nhkh9Q

The Natural Medicine Health Act of 2022 would decriminalize psilocybin, better known as psychedelic or magic mushrooms, for people aged 21 and up. Coloradans of age could have it, ingest it and cultivate it at home without criminal penalty under state law. The law would also allow for licensed healing centers where people could buy and consume the mushrooms. It would remain a crime for anyone else to sell them, but not to give them away to other adults.

The measure will be on the Nov. 8 ballot.

See the rest here:

TDR's Top 5 Psychedelic Developments For The Week Of July 18 - The Dales Report