Category Archives: Psychedelics

Republican lawmakers in the House and Senate have introduced new legislation that would make it easier for scientists to research Schedule I drugs like marijuana and psilocybin.

Companion bills filed by Sen. Bill Cassidy (R-LA) and Rep. Morgan Griffith (R-VA) largely reflect a plan that was recently released by the White Houses Office of National Drug Control Policy (ONDCP), with the backing of the Drug Enforcement Administration (DEA).

Titled the Halt All Lethal Trafficking of (HALT) Fentanyl Act, the main intent of the identical companion measures is to curb trafficking of the powerful opioid. While reform advocates have expressed concern about provisions that would permanently place fentanyl analogues in the strictest federal drug category, the legislationalso contains provisions to streamline the research process for all Schedule I drugs under the Controlled Substances Act. That strict category currently includes cannabis as well as psychedelics like LSD, mescaline and MDMA.

The bills would facilitate studies in part by aligning the research requirements for Schedule I drugs with those of the less-restricted Schedule II. Scientists and lawmakers have consistently pointed out that the existing rules for studying Schedule I controlled substances are excessively burdensome, limiting vital research.

Rather than having each scientist involved in a Schedule I drug study obtain DEA registration, the GOP lawmakers and White House want to make it so multiple researchers at a given institution would be allowed to participate under a single registration.

They also proposed a policy change where a research institute with studies taking place over multiple locations would only require one overall registration instead of needing to have a specific one for each site.

Another change would allow certain researchers to move ahead with conducting their studies after submitting a notification to the Department of Justice instead of waiting for officials to affirmatively sign off on their proposals.

The plan would also waive the requirement for additional inspections at research sites in some circumstances and allow researchers to manufacture small amounts of drugs without obtaining separate registrations. The latter component would not allow cultivation of marijuana, however.

Marijuana Moment is already tracking more than 1,300 cannabis, psychedelics and drug policy bills in state legislatures and Congress this year. Patreon supporters pledging at least $25/month get access to our interactive maps, charts and hearing calendar so they dont miss any developments.Learn more about our marijuana bill tracker and become a supporter on Patreon to get access.

Griffith said in a press release that the legislation would recognize the danger of fentanyl related substances by permanently scheduling them while also allowing researchers to study their effects.

Its important to include that research component because one of the things weve done in the past is weve put things on Schedule I and then weve not researched it, the congressman said at a briefing, seemingly alluding to cannabis.

There may be potential out there for the therapeutic use of fentanyl analogues, he said. Its got to be done carefully. Its got to be done in the way that weve set it up so that we have the protections there. But we may find something good as part of the research.

When ONDCP first announced itsproposed Schedule I policy changesin September, some experts tempered expectations about the practical effects of aligning Schedule I and Schedule II applications. The difference is largely a matter of extra paperwork for the more restrictive category, they contend.

At a House hearing earlier this month, DEA and National Institute on Drug Abuse (NIDA) officials endorsed the idea of making it easier to research Schedule I drugs.

The White Houses intent to streamline research into Schedule I drugs has been notable and seems to be part of a theme that developed within the administration.

For example,DEA has repeatedly proposed significant increasesin the production of marijuana, psilocybin and other psychedelics for research purposes, with the intent of aiding in the development of new federally approved therapeutic medications.

NIDA Director Nora Volkow told Marijuana Moment in a recent interview that she was encouraged by DEAs prior proposed increase in drug production quota. She also said that studies demonstrating the therapeutic benefits of psychedelics could be leading more people to experiment with substances like psilocybin.

Volkow, who heads the nations top drug research agency, even said that she personally hesitates to study cannabis because of Schedule I research barriers.

Still, advocates remain frustrated that these plants and fungi remain in the strictest drug category in the first place, especially considering the existing research that shows their medical value for certain conditions.

There has been at least one recent development in the fight to modernize marijuana research. President Joe Biden signed a massive infrastructure bill last month that includes provisions aimed at allowing researchers tostudy the actual cannabis that consumers are purchasing from state-legal dispensariesinstead of having to use only government-grown cannabis.

But thats just one of numerous research barriers that scientists have identified. A report that NIDA recently submitted to Congress stressed that the Schedule I status of controlled substances like marijuanais preventing or discouraging researchinto their potential risks and benefits.

Last Congress, the House and Senate approved separate bills with the shared objective of promoting marijuana research.

The Senates measure would have streamlined the application process for researchers who want to study cannabis and to encouraged the Food and Drug Administration (FDA) to develop cannabis-derived medicines.

Sens. Dianne Feinstein (D-CA) and Brian Schatz (D-HI), chief sponsors of that legislation, which was not ultimately enacted, also tried to get the reform passed as an amendment to a defense spending bill this month. The amendment didnt make the cut, however.

The House bill that passed last year would have established a simplified registration process for researchers interested in studying cannabis, in part by reducing approval wait times, minimizing costly security requirements and eliminating additional layers of protocol review.

The U.S. Department of Health and Human Services (HHS) and the attorney general would have been required under the bill to create a process for marijuana manufacturers and distributors to supply researchers with cannabis from dispensaries.

Ohio Marijuana Activists Submit Signatures To Force Legislature To Consider Legalization

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GOP Lawmakers File Bills To Streamline Research Into Marijuana, Psychedelics And Other Schedule I Drugs - Marijuana Moment

Mike "Zappy" Zapolin is a filmmaker, entrepreneur, and investor in the psychedelic space. He ... [+] predicts that soon, many more will hold the title of psychedelic concierge.

As a psychedelic concierge to the stars, Mike Zappy Zapolin doesnt just rub shoulders with celebritieshe isa shoulderforthem.

When I first heard that moniker, I thought, oh, thats interesting, saysZapolin, who has helped celebrities like Lamar Odom and Michelle Rodriguez navigate psychedelic experiences with drugs like ketamine and ayahuasca.

I realized that its pretty accurate. When you go to a hotel and you say to the concierge, where should I go to dinner tonight? theyre going to ask you certain questions, says Zapolin.

Its the same sort of thing, only the questions are a little different.

Where a hotel concierge might ask about dining preferences or ambiance, a psychedelic concierge will go deeper, says Zapolin: Whats your intent for doing this? What are some of the traumas that youre trying to heal from? (And like any good hotel concierge, he recommends that a psychedelic concierge only makes recommendations about experiences theyve had themselves.)

While he has no medical training, Zapolin is a filmmaker, entrepreneur, and investor in the psychedelic space and predicts that soon, many more will hold the title of psychedelic concierge; not just because psychedelics are becoming more popular, but because society is in desperate need of alternative solutions for mental health conditions such asdepression, anxiety, and PTSD.

In his latest film,Lamar Odom: Reborn,Zapolin introduces the NBA star to a protocol of psychedelics and daily practices to help him overcome his battle with depression and addiction.

Zapolin says he learned quickly that Odom wasnt the spoiled celebrity he had been made out to be in the media. He lost his mother at age 12, just seven years before being awarded his first NBA contract. Not long into his career, his grandmother and six-month old son both died on the same day, just a few years apart. Then in 2015, Odom experienced a near-fatal overdose and fell into a coma, suffering several heart attacks and strokes.

There was so much trauma that hed never dealt with and so he did whatever he had to do to forget about it, says Zapolin. Though hed never had an experience with hallucinogens before, Odom was willing to give psychedelics a try with Zapolins guidance. He began with ketamine, a dissociative anesthetic shown to have fast-acting anti-depressant effects.

During a ketamine session shown in the film, Odom sits up gently, eyeshades intact, and repeats to himself, Im reborn; Im reborn.

The next step for Odom, according to Zapolin, was to take a trip to Mexico to doibogaine, a powerful alkaloid derived from the root of a shrub native to Gabon that has been shown to help interrupt opioid dependence. (The schedule I substance is unregulated in Mexico.)

The last part in the formula is a daily practice, so meditation, therapy, breathing; things like that, that are going to reconnect you to present moment awareness, says Zapolin. That formula is going to lead to a conscious transformation. We went through it all with Lamar, and it was beautiful to see.

Some viewers might be drawn to Zapolins films for their celebrity appeal, but the director hopes the impact they leave goes further. His goal is to reduce stigma and make psychedelics less scary.

Lamar Odom is featured in Zappy Zapolin's latest film, Lamar Odom: Reborn.

My motivation is to have someone finish my movies and say, you know what, I could handle that, he says.

Im always asking myself; how do I bring the fear down? What do I have to show people without candy-coating it? What can I do to frame this in a way that if somebody is suicidal, or struggling with addiction or depression or anxiety, that theyre going to be comfortable enough to show their family and say, Can you watch this with me?

So far, the film has been streamed more than 15 million times.

Zapolin believes strongly that psychedelics have the power to interrupt the ongoing global mental health crisis, which has only been exacerbated by Covid-19. A futurist who found himself on the leading edge of the dot-com boom after a stint as a VP at Bear Stearns in the early 90s, Zapolins interest in converting the rest of the world into psychedelic believers doesnt stop with his films.

In 2020, he co-founded KetaMD, a telemedicine platform offering at-home ketamine treatments. He is also the chief visionary officer atPsycheceutical, a company with two delivery patents that allow psychedelic drugs to bypass the stomach, liver, and blood-brain barrier, increasing bioavailability and potentially eliminating unwanted side effects.

One patent uses layered nanoparticles and enables the delivery of multiple medicinal compounds at different rates. We can time-release different layers, so we could start with an anti-nausea drug, and then five minutes later, have ketamine, and then maybe an hour later, end with CBG, says Zapolin of the patented technology.

The second is a patent for delivering compounds at the back of the neck, directly to nerves at the base of the brain. Were doing this right now in a trial, says Zapolin. It eliminates the psychedelic effect, but they get the neurogenesis of the ketamine metabolizing, and it comes on immediately.

Rather than competing with other companies in the space, Zapolin uses the word coopetition to refer to Psycheceuticals place in the industry and says if its patents can help make another companys psychedelic drugs more effective, thats a good thingespecially if it puts psychedelics on more peoples radar.

How do we get the doctors, the medical establishment, and the government to be okay with this? It has to look like a pharmaceutical, and thats what Psycheceutical is doing, he says. Its like the movies. How am I going to get someone to think about ketamine and ibogaine? Ill give them to a celebrity.

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Meet Zappy Zapolin, The Psychedelic Concierge Who Turned Lamar Odom On To Ketamine - Forbes

Numinus is a life sciences company with a focus on mental health and wellness. The company is engaged in research, development and delivery of safe, evidence-based psychedelic-assisted psychotherapy. During 2021 the company has made steady progress in revenue generation and in the development of new capabilities. In this report, we examine some of these developments.

Numinus has recently released its results for Q4 2021 (period ending August 31). The company reported revenue growth of 81% versus Q4 2020, and 72% growth in full-year revenue. Growth was driven by increased activity at the therapy clinics, with 2,671 therapy appointments in Q4. We expect continued growth in revenue during FY 2022, and we maintain our revenue forecasts for the company. Our full forecasts can be found on p8-10.

In September 2021 Numinus completed the acquisition of the Neurology Centre of Toronto (NCT), a leading Canadian provider of clinical neurological care with specialist expertise in the use of medical cannabis. Going forward NCT will expand into a clinical neurology centre with specialization in psychedelic neurology. The acquisition takes Numinus to five wellness clinics in total and will contribute to further revenue growth in the coming quarters.

Also in recent months, the company announced that it had finalized the study design and protocol for a phase I clinical trial for a proprietary formulation called PSYBINA, which is based on psilocybin derived from mushrooms. The trial will ascertain the safety and bioavailability of the formulation in comparison with pure psilocybin. There is growing evidence that psilocybin based therapies can provide benefit to patients being treated for a variety of indications, and we believe that Numinus work with PSYBINA positions the company to become an early implementer of these therapies as and when regulations allow wider patient access.

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Numinus Wellness inc: Leading in the psychedelics race - Proactive Investors UK

This is how one ought to see, how things really are.

To be shaken out of the ruts of ordinary perception, to be shown for a few timeless hours, the outer and inner world, not as they appear to an animal obsessed with survival or to a human being obsessed with words and notions, but as they are apprehended directly and unconditionally by Mind at Largethis is an experience of inestimable value to everyone and especially to the intellectual.

These words, from Aldous Huxleys seminal book The Doors of Perception, signaled a crucial turn in the popular perception of hallucinogenic drugs and the direction of hallucinogenic drug research.

It is hard to imagine a sharper departure from the psychotomimetic paradigm than that espoused by Huxley in his book. Whereas previous research referred to the hallucinogenic phenomena as distortions and disorders, Huxley extolled the perceptual alterations of mescaline, declaring, This is how one ought to see, how things really are. While researchers noted the incoherent ramblings of patients undergoing LSD treatment, Huxley used hallucinogenic drug experiences as the basis for an articulate philosophical exploration, drawing inspiration from Meister Eckhart, the Buddha, Plato, Aquinas, Whitman, and Henri Bergson. In his view, psychedelics were not simply experimental tools that could be used to artificially induce a demented mind; Huxley recognized hallucinogens potential as tools for achieving a spiritual and philosophical experience of insurmountable value, not only for psychiatrists but also for artists, intellectuals, mystics, and anyone interested in exploring the secrets of existence.

A distinguished author and intellectual who gained international fame following the publication of his novel Brave New World, Huxleys immense enthusiasm for the intellectual and spiritual implications of hallucinogenic drugs would prove formative for the generation of psychedelic drug enthusiasts that subsequently changed the face of American society.

While researchers noted the incoherent ramblings of patients undergoing LSD treatment, Huxley used hallucinogenic drug experiences as the basis for an articulate philosophical exploration.

Relevantly, one might surmise that it was a difference in set and setting that was responsible for Huxleys new and highly divergent interpretation of hallucinogenic effects. Huxley, after all, had been an aspiring mystic for much of his life. He had cultivated a steady interest in Vedanta Hinduism since the end of the 1930s; his 1945 book The Perennial Philosophy, a comparative study of mystical traditions, argued for the universal compatibility of all spiritual systems. Huxleys unique perspective certainly contributed to the development of his perennial interpretation of the effects of psychedelics, which not only enlisted the teachings of mystics from various traditions but also interpreted the drugs as revealing a perennial type of knowledge, which he termed a Mind-at-Large. In addition, Huxleys profound interest in Eastern religions led him to his invocation of Eastern concepts and ideas as avenues through which one might explore and understand the effects of psychedelics, a thesis that had a profound impact on the subsequent exegesis of psychedelia. In sum, Huxleys religious interests placed him in the unique position of shifting the discourse by being one of the first Western thinkers to point to the potential religious importance of hallucinogens.

An additional factor that contributed to Huxleys unique set was his long-standing interest in mind-transforming substances, which ran all the way back to his early writing. By 1931, the English author had already published an essay, Wanted, a New Pleasure, in which he lamented humankinds scant advancements in fashioning new forms of pleasure over the course of the past millennia. So far as I can see, the only possible new pleasure would be one derived from the invention of a new drug, he asserted at the time. For Huxley, mind-altering drugs harbored a promise to quench a deep running thirst of human existence:

If we could sniff or swallow something that would, for five or six hours each day, abolish our solitude as individuals, atone us with our fellows in a glowing exaltation of affection and make life in all its aspects seem not only worth living, but divinely beautiful and significant, and if this heavenly world transfiguring drug were of such a kind that we could wake up the next morning with a clear head and an undamaged constitutionthen, it seems to me, all our problems (and not merely the one small problem of discovering a novel pleasure) would be wholly solved and earth would become paradise.

Read with the benefit of hindsight, these daring utopian propositions present us with an exceptionally prescient description of the 1960s psychedelic ideology epitomized in DuPonts company slogan, Better living through chemistry adopted and appropriated by the flower children some 30 years after it was first coined. It was a seed that gave birth to a whole branch of utopian psychedelic thought.

Huxleys fascination with the threat and promise of consciousness-altering chemicals constitutes a thread that runs through his writing. Brave New World features the fictional drug Soma, described in the novel as the perfect escapist drug. Huxleys Soma functions as a foremost agent for social engineering, a tool for the repression of the deeper longings and higher aspirations found in mans soul. This theme of psychochemical social engineering was further developed in Huxleys 1936 essay Propaganda and Pharmacology, which envisioned a future society subjected to a state of complacent hypnosis by the mass employment of powerful mind-control drugs. By contrast, Huxleys final work, the 1962 utopian novel Island, features another fictional drug, evidently inspired by Huxleys involvement with psychedelics. This drug, Moksha, could be seen as the mirror image of Soma: a fantastic agent for spiritual liberation that provides a full-blown mystical experience and stands at the foundation of the utopian society described in the novel.

In May 1953, psychiatrist Humphry Osmond spent a few days at the Huxley residence in Los Angeles with the author and his wife. Huxley, who was fascinated by the accounts of hallucinogenic drugs and their peculiar effects, had implored Osmond to allow him to experience these effects firsthand. Osmond was reluctant at first, worried that he might become infamous as the person who rendered the famous novelist insane. However, he eventually consented, and on May 4, 1953, Huxley had his first experience with mescaline.

The experience exceeded his wildest expectations. Huxley called it without question the most extraordinary and significant experience this side of the beatific vision. Gazing on the flower arrangement in the room, he felt that he was seeing what Adam had seen on the morning of his creation the miracle, moment by moment, of naked existence. The visual effects of the mescaline, previously labeled as distortions, turned Huxleys mind to classical art. Looking at a chair and then examining Van Goghs painting of a chair, he could not help but think that the chair Van Gogh had seen was obviously the same in essence as the chair I had seen; the folds and creases in his trousers, suddenly spectacularly detailed, seemed straight from a painting by Botticelli. He described his experiences with unbridled elation, using mystical concepts such as the Godhead and the beatific vision, and depicted a world in which mescaline and similar drugs would be used for intellectual and spiritual education. For Huxley, mescaline and drugs like it represented potential educational tools that could make it possible for young people to taste and see what they have learned about at second hand, or directly but at a lower level of intensity, in the writings of the religious or the works of poets, painters and musicians. Going back to his 1931 concept of a new drug that could salvage humanity, he wrote:

What is needed is a new drug which will relieve and console our suffering species without doing more harm in the long run than it does good in the short. Such a drug must be potent in minute doses and synthesizable. If it does not possess these qualities, its production, like that of wine, beer, spirits or tobacco will interfere with the raising of indispensable food and fibers. It must be less toxic than opium or cocaine, less likely to produce undesirable social consequences than alcohol or barbiturates, less inimical to heart and lungs than the tars and nicotine of cigarettes. And on the positive side, it should produce changes in consciousness more interesting, more intrinsically valuable than mere sedation or dreaminess, delusions of omnipotence or release from inhibitions. To most people, mescaline is almost completely innocuous. Unlike alcohol, it does not drive the taker into a kind of uninhibited action which results in brawls, crimes of violence and traffic accidents.

Mescaline was not yet the ideal drug. Huxley noted that along with the happily transfigured majority of mescaline takers there is a minority that finds in the drug only hell or purgatory. However, he was confident that modern chemistry and physiology were capable of achieving practically anything if the psychologists and sociologists will define the idea.

Huxleys Doors of Perception evoked a gamut of responses: some hostile, some sympathetic, some clearly bewildered. Several magazine writers noted that Huxleys radical ideas could easily be rejected as the fantasies of a misguided crackpot had they been presented by anyone other than the respected English author. Some magazines celebrated Huxleys proposition for a superior drug that could replace alcohol; others worried that the authors ruminations might inadvertently encourage undisciplined hordes of youths to experiment with drugs. Authors were notably disturbed by Huxleys association of the mescaline experience with Christian theology and mysticism. Stephen Siff, who has conducted an exhaustive review of media reactions to Huxleys essay, notes that Time magazine went as far as to skip the parts of Huxleys text that it considered potentially offensive to readers because of their Christian content. Particularly instructive was the response from some Central European intellectuals, who were quick to point out some of the ethical and cultural concerns that would resurface repeatedly in future discussions on psychedelics. German intellectual Thomas Mann described the book as a new and particularly scandalous stage of Huxleys escapism, arguing that Huxleys sympathetic treatment of experimentation with hallucinogens amounted to an encouragement to the youth of America to engage in doping, which they do not at all need. Another scathing critique came from Swiss psychoanalyst Carl Gustav Jung.

Huxleys Doors of Perception evoked a gamut of responses: some hostile, some sympathetic, some clearly bewildered.

In an April 1954 letter to Dominican priest Victor Francis White, Jung opined that there is no point in wishing to know more of the collective unconscious than one gets through dreams and intuitions. The renowned psychiatrist acknowledged the interest of mescaline, yet he was suspicious of experiencing it himself for fear of doing so out of idle curiosity. I should hate the thought that I had touched on the sphere where the paint is made that colours the world, where the light is created that makes shine the splendour of the dawn, the lines and shapes of all form, the sound that fills the orbit, the thought that illuminates the darkness of the void, he stated. In Jungs response, one can identify an often subterranean but nevertheless recurring notion in the LSD debate, one that frames the drugs ability to elicit spiritual experiences as an artificial and therefore immoral shortcut, defying celestial mandates. I am profoundly mistrustful of the pure gifts of the Gods. You pay very dearly for them, Jung warned, enlisting Virgils Aeneid to his side: (Men of Troy, beware the horse!) Whatever it is, I fear the Greeks, even bearing gifts. As for Huxley, he was described by Jung as a Zauberlehrling, a sorcerers apprentice who has learned how to call on ghosts but does not possess the knowledge needed to control them. It would be rash to proceed any further, the psychiatrist argued, before fully understanding the unconscious.

Though seldom fully articulated, Jungs negative estimation of Huxleys new pursuit was characteristic of many others opinions voiced on both sides of the Atlantic. The English author had become a suspicious eccentric in the eyes of many, a situation that he lamented with great bafflement and bitterness. However, as the years progressed, Huxleys views proved to be highly influential with a new generation of hallucinogenic drug researchers, as well as with the nascent psychedelics movement.

Ido Hartogsohn is Assistant Professor in the Graduate Program in Science, Technology, and Society at Bar Ilan University. He is the author of American Trip, from which this article is excerpted.

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When Aldous Huxley Opened the Doors of Perception - The MIT Press Reader

Welcome to The Dose, Bloombergs newsletter about the cannabis and psychedelics industries.

Atectonic shift is taking place as previouslyunderground drugs are thrust into the mainstream.With The Dose, youll get a weekly chronicleof the biggest news about the companies and personalities that are shaping this change.

This week, guest writer Brody Ford offers a look at a substance used for pain relief that is attracting investors attention.

Investors in cannabis and psychedelic drugs often talk excitedly about their promise to take a slice of the $20 billion-plus market for opioids and fix a societal addiction crisis along the way.

Now, an under-the-radar drughas joined them as a potential disruptor. Itsalready drawing interest from Atai Life Sciences, a biopharma companyknown for putting psychedelic compounds into clinical trials. And a recent decision from the World Health Organization could help it gain further traction.

The drug is called kratom, and itsmade from the ground leaves of a psychoactive plant native to Southeast Asia. Kratom isalready a $1.3 billion industry in the U.S. with sales occurring online and in smoke shops, according to the American Kratom Association. Its also among the most commonly seized substances in the world among drugs classified as new by the United Nations.Millions of peopleuse it for pain relief, to alleviate the symptoms of opiate withdrawalor simply forrecreation.

U.S. agencies have sought to bankratom for years, but they have faced opposition from some members of Congress, including Democratic Senators Ron Wyden and Cory Booker. Users of the drug are also so well organized that theyve been known to send a flood of letters to their representatives in Washington any time there is movement on the issue.

Although kratom isnt bannedin the U.S., some states have their own restrictions and the Food and Drug Administration has seized dietary supplements containing the drug.

Kratom is illegal in six U.S. states while unregulated federally

Source: American Kratom Association

A closely watched World Health Organization panel decided Dec.7 that kratom didnt warrant a critical review,which could have led to UNrestrictions and a federal ban. The panel found that while the substance can be toxic in very high doses, it is difficult to link kratom to overdose deaths with much certainty.

Advocates say the decisionshould reduce stigmas and boost business opportunities. Jenn Lauder, the marketing and advocacy director for Kraken Kratom, one of the largest online kratomcompanies, said investment interest has surged andarecent industry convention in New York was crawling with venture capitalists.

I definitely think it opens doors for more companies, Lauder said. When people see this is potentially lucrative, thats always the final push they need.

Now, some pharmaceutical companies are looking to get into the game. Atai is developing a drug derived from kratom to treat pain and opioid-withdrawal symptoms. The company aims to begin clinical trials early next year, according to its chief scientific officer, Srinivas Rao.

Justover 2 million Americans a year consume kratom, with the highest rates occurring among users of opiates, according to a recent New York University study. Dafna Revah, co-owner of a nearly 50-store retail chain calledCBD Kratom, said the WHO panels decision should open doors for customers who were previously hesitant due to the pending assessment.

The American Kratom Association says growth has been limited by legal ambiguity. In most of the country, its sold as a dietary or herbal supplement. Six states have banned it outright, although no new statewide restrictions have occurred since 2016. Five states have passed industry-backed rules dubbed the Kratom Consumer Protection Actthat include age restrictions and quality standards.

Regulatory concerns keep away most mainstream companies. The FDAs jurisdiction to seize shipments creates major supply-chain riskssince almost all U.S. kratom is imported from Southeast Asian countries like Indonesia and Thailand. Earlier this year, 75,000 pounds of the substance wereintercepted and destroyed,and an FDA official said the agency would continue to take action against shipments.

Therisks havent stopped small companies from exploring the market.LFTD Partners, which largely focuses on cannabis and vaping, is in talks to acquire kratom companies, according to a spokesperson. Kratom-infused gum is being developed by Tauriga Sciences Inc.

Aspublic acceptance grows, Lauder sees kratom following the legalization path set by cannabis regulationsat the state level first and then a push forfederal recognition. In the past fiveyears, weve been able to move from being on the defensive to really going on the offense, she said.

8,583 Number of comments submitted in response to a notice that the World Health Organization would meet to discuss the benefits and harms of kratom

We continue to note that most publicly traded banks will likely avoid the marijuana industry until pot is federally legalized. State-chartered banks may fill the void,said Bloomberg Intelligence analyst Nathan R. Dean in a Dec. 14 note titled Marijuana Bank Bill Mostly Smoke, Mirrors Without Legalization.

Know someone else who would like this newsletter? Have them sign up here. And get in touch with any questions, concerns, or news tips.

With assistance by Tiffany Kary

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Kratom Attracts Investor Attention After Regulatory Win - Bloomberg

SAN DIEGO, Dec. 20, 2021 (GLOBE NEWSWIRE) -- CB Therapeutics today announces the appointments of Dr. Stephen Wright and Dr. Brian Barnett to its newly formed Medical Advisory Board.

Dr. Wright has more than 30 years of experience in medicines development, having worked on both sides of the Atlantic in large and small pharmaceutical companies. He was Chief Medical Officer and a Main Board Director of GW Pharmaceuticals from 2004 up to the company's successful listing on NASDAQ and the development of Epidiolex, which is now heading for blockbuster status. He is currently Senior Medical Adviser to Compass Pathways. Dr. Wright has a Master's degree in Social and Political Science from the University of Cambridge and is qualified in Medicine (MB BS) at The Royal London Hospital. His other higher degrees include an MD from The University of Cambridge and a Diploma in Pharmaceutical Medicine. He is a Fellow of the Royal College of Physicians of Edinburgh, is a Fellow of the Royal Society of Medicine and was elected to Fellow of the Faculty of Pharmaceutical Medicine in 2000. In addition, he holds a diploma in Pharmaceutical Business Management from The Wharton School at The University of Pennsylvania.

"I believe that the therapeutic potential of cannabinoids has not yet been fully explored and am excited by the innovative approach that CB Therapeutics is taking to the production of novel cannabinoids in particular," said Wright. "This should allow for the investigation of the value of novel cannabinoids in so far unexplored areas of high unmet medical need and avoid some of the pitfalls associated with other production methods. It is a privilege to be working with CB Therapeutics."

Dr. Barnett is co-Director of the Cleveland Clinic Center for Interventional Psychiatry. He and his team treat patients who have not responded to standard psychiatric treatments with both established and innovative modalities such as intravenous ketamine and electroconvulsive therapy, and transcranial magnetic stimulation. Dr. Barnett's research covers a wide range of topics, including catatonia, the efficacy of ketamine in treatment-resistant depression, and psychiatry's relationship with emerging psychedelic-assisted therapies. Dr. Barnett also writes about psychiatry for the public, and his works have been published in national publications such as STAT, The Wall Street Journal, The Washington Post, and HuffPost.

Story continues

"I look forward to collaborating with CB Therapeutics in the development of innovative psychedelic treatments for patients with mental health conditions and addictions who have been failed by existing interventions," said Barnett.

About CB Therapeutics

CB Therapeutics produces high-value molecules, compounds, and rare ingredients from simple sugars utilizing yeast and the process of fermentation. CB Therapeutics' expertise in synthetic genomics and bio-engineering has significantly advanced its proprietary production platform of microorganisms, enzymes, and production processes. After more than four years of research and development, the CB Therapeutics team can produce a broad range of phytochemicals faster, utilizing fewer resources, at greater yields, and with more purity, consistency, and efficiency than competing platforms. Its 16,000 sq. ft. fully-licensed commercial batch facility in southern California includes research labs, advanced bioreactor systems production facility with off-gas analysis, and coupling to analytical equipment (HPLC, LC-MS) for streamlined process development and cost-effective fermentations. In addition to this, the new facility also includes an extensive suite of micro-scale, bench-top, and large-scale bioreactor systems to optimize the production of a broad range of fermentation-based production applications.

Contact Information

Media Contact:Alana ArmstrongAlan Aldous Communications Inc.Email: alana@alanaldous.com

Partnership Inquiries:Sher Ali ButtCEO, CB TherapeuticsEmail: sher@cbthera.com

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Two esteemed doctors join CB Therapeutics in its exploration of innovative approaches to the production of novel psychedelics and cannabinoids so...

Thanks to Covid-19, this years travel landscape has been rocked with more ups and downs than a rollercoaster ride. But with travel finally taking off again (fingers crossed!), its time we looked ahead to a brand new year.

With so much lost time to make up for, the travel scene looks set to soar in interesting ways from alternative wellness retreats to revenge travel to nomadic work arrangements . Heres our peek into what lies ahead for travel trends in 2022.

Youve heard of revenge procrastination and revenge spending now get ready for revenge travel. The pandemic has taken its toll in years of zero vacation time and countless missed celebrations anniversaries, birthdays, honeymoons and now its payback time.

Experts are predicting travellers urge to splurge post-pandemic, whether its plumping for room upgrades, luxe packages, or dining experiences. Expedia has dubbed this the Greatest of All Trips (aka GOAT) mindset, with their Travel Trends 2022 survey reporting that nearly three-quarters of Singaporeans planned to splash out big on their next trip.

Forget mini getaways close to home the future belongs to long-haul, extended trips. What with all the fuss of PCR testing and form-filling, weekend jaunts will become more of a hassle than a relaxing escape. Many workers are also facing a backlog of leave to clear, and taking a long holiday is just the ticket.

After staying grounded for so long, theres no denying the thrill of jet setting to a far-flung destination Tripadvisors Seasonal Travel Index for end-2021 reveals that London, Paris, and Munich top the wishlist for Singapore travellers.

Wellness getaways have become pretty much synonymous with yoga and spa pampering, but for folks seeking spiritual healing, alternative trends are on the rise. Were talking ayahuasca and magic mushroom retreats retreats that center around journeys of self-discovery and therapy through plant-based psychedelics . Post-pandemic stress, a dose of spiritual wellness is likely to become more sought after than ever.

With mainstream views on psychedelics shifting to understand their therapeutic potential, demand for such retreats has mushroomed in recent years. Sometimes dubbed the shroom boom, the trend looks set only to grow according to Data Bridge Market Research, the psychedelic market is projected to soar from USD2 billion (S$2.7 billion)in 2019 to USD6.9 billion by 2027.

Hotspots for psychedelic retreats include Costa Rica, the Netherlands, and Peru, where participants can typically take part in meditation, yoga, and other programs amidst lush nature.

ALSO READ:Post-pandemic travel: What will travel look like in 2022?

Working from a beach might once have been only thinkable for freelancers, but the pandemic has fast-tracked the rise of the digital nomad.

Months of lockdowns and work-from-home arrangements have shown us that many types of work dont really need an office or facetime to get the job done and wed all be better off for it. For both employees and bosses, a mindset shift is happening the idea of roaming the world while working remotely is now within our reach.

Businesses havent been slow to jump on the trend either. Blueground, a startup that rents out fully furnished apartments in 15 cities across the world, recently launched the Blueground Pass.

This pass gives digital nomads the freedom to hop between their 4,000-strong collection of apartments, all under only one master lease. Meanwhile, Hiltonis capitalizing on the workcation trend by rolling out work-from-hotel packages, tailored toward those mixing business and pleasure.

Eco-awareness has sprouted up over the last decade, and green travel is set to remain strong in post-pandemic times. One encouraging sign of this is a recent surveyby travel technology giant Amadeus, which found that a whopping two-thirds of travellers across the globe view sustainable travel as a priority.

This plays out in a penchant for venturing off the beaten track. Travellers are eschewing big cities for wilderness destinations and rural villages, exploring safaris and nature resorts, and seeking out farm-to-table dining experiences.

The pristine Galpagos Islands, for one, has seen an exponential rise in backpackers for its rich wildlife snorkeling with sea lions, anyone? Meanwhile, hotels and resorts are taking the lead in cutting down on single-use plastics, turning to organic toiletries and bedding, and investing in composting systems.

Once upon a time, the worst mishap we had to worry about was lost luggage or plane delays. These days, pandemic-shaped worries lurk round every corner: medical costs, quarantine woes, and trip cancellations, all of which can rack up hefty bills when they strike.

With new strains of Covid-19 on the rise, lets just say our travel anxiety isnt going away anytime soon. That means travel insurance with Covid-19 coverage is no longer an extra frill its set to become an essential safety net.

This article was first published in City Nomads.

Excerpt from:

Revenge travel and psychedelic retreats: The travel trends taking flight in 2022 - AsiaOne

- Expands intellectual property portfolio and strengthens position as leading innovator in developing putative psychedelic compounds -

TORONTO--(BUSINESS WIRE)-- Cybin Inc. ( NEO:CYBN) ( NYSE American:CYBN) ( Cybin or the Company), a biopharmaceutical company focused on progressing Psychedelics to Therapeutics TM today announced that it has been awarded a Notice of Allowance from the U.S. Patent and Trademark Office (USPTO) for patent application No. 17/394,038 related to CYB004, the Companys investigational deuterated psychedelic tryptamine compound for the potential treatment of anxiety disorders. The allowed claims include other forms of deuterated psychedelic tryptamine, notably certain deuterated forms of DMT and 5-MeO-DMT. The patent, which is expected to expire in 2041 before consideration of any patent term extensions, covers composition of matter for the CYB004 drug substance as a putative new chemical entity.

The receipt of this Notice of Allowance from the USPTO represents an important milestone in expanding our intellectual property portfolio progressing psychedelics to therapeutics for the countless patients in need, and strongly demonstrates the Companys dedication to the discovery and development of differentiated psychedelic-based compounds for addressing mental health, said Doug Drysdale, Chief Executive Officer of Cybin. Once issued, this patent may have the opportunity to cover a broad range of claims supporting our IP in psychedelic medicine and further strengthen our emerging best-in-class position in this evolving industry.

According to the U.S. National Institute of Mental Health, anxiety disorders are one of the most common mental illnesses in the U.S., affecting 40 million adults, or approximately 18% of the population every year1. Despite the availability of many prescription medicines, these treatments are not equally efficacious in all patients with up to 50% of patients with general anxiety disorder failing to respond to first line treatments2. Current standardized treatments for anxiety disorders also require chronic administration of medicines that have a long time to onset and present several potential side effects including weight gain, gastrointestinal disturbances, sexual dysfunction and withdrawal symptoms.

CYB004 is a proprietary deuterated psychedelic tryptamine that has the potential to effectively treat anxiety disorders without the well-known side effects of the current treatment landscape, concluded Drysdale.

Cybin continues to pursue multiple opportunities to secure and support its patent position for research and development evaluating deuterated tryptamines for future psychedelic-based treatments for mental illnesses.

About Cybin Cybin is a leading ethical biopharmaceutical company, working with a network of world-class partners and internationally recognized scientists, on a mission to create safe and effective therapeutics for patients to address a multitude of mental health issues. Headquartered in Canada and founded in 2019, Cybin is operational in Canada, the United States, United Kingdom and Ireland. The Company is focused on progressing Psychedelics to Therapeutics by engineering proprietary drug discovery platforms, innovative drug delivery systems, novel formulation approaches and treatment regimens for mental health disorders. Patent filings described herein are held by Cybin IRL Limited, a wholly owned subsidiary of Cybin.

Cautionary Notes and Forward-Looking Statements Certain statements in this press release constitute forward-looking information. All statements other than statements of historical fact contained in this press release, including, without limitation, statements regarding Cybins future, strategy, plans, objectives, goals and targets, and any statements preceded by, followed by or that include the words believe, expect, aim, intend, plan, continue, will, may, would, anticipate, estimate, forecast, predict, project, seek, should or similar expressions or the negative thereof, are forward-looking statements. Forward-looking statements in this news release include statements regarding the Companys proprietary drug discovery platforms, innovative drug delivery systems, novel formulation approaches and treatment regimens to potentially treat psychiatric disorders.

These forward-looking statements are based on reasonable assumptions and estimates of management of the Company at the time such statements were made. Actual future results may differ materially as forward-looking statements involve known and unknown risks, uncertainties, and other factors which may cause the actual results, performance, or achievements of the Company to materially differ from any future results, performance, or achievements expressed or implied by such forward-looking statements. Such factors, among other things, include: implications of the COVID-19 pandemic on the Companys operations; fluctuations in general macroeconomic conditions; fluctuations in securities markets; expectations regarding the size of the psychedelics market; the ability of the Company to successfully achieve its business objectives; plans for growth; political, social and environmental uncertainties; employee relations; the presence of laws and regulations that may impose restrictions in the markets where the Company operates; and the risk factors set out in the Company's management's discussion and analysis for the period ended September 30, 2021 and the Company's listing statement dated November 9, 2020, which are available under the Company's profile on http://www.sedar.com and with the U.S. Securities and Exchange Commission on EDGAR at http://www.sec.gov. Although the forward-looking statements contained in this news release are based upon what management of the Company believes, or believed at the time, to be reasonable assumptions, the Company cannot assure shareholders that actual results will be consistent with such forward-looking statements, as there may be other factors that cause results not to be as anticipated, estimated or intended. Readers should not place undue reliance on the forward-looking statements and information contained in this news release. The Company assumes no obligation to update the forward-looking statements of beliefs, opinions, projections, or other factors, should they change, except as required by law.

Cybin makes no medical, treatment or health benefit claims about Cybins proposed products. The U.S. Food and Drug Administration, Health Canada or other similar regulatory authorities have not evaluated claims regarding psilocybin, psychedelic tryptamine, tryptamine derivatives or other psychedelic compounds. The efficacy of such products has not been confirmed by approved research. There is no assurance that the use of psilocybin, psychedelic tryptamine, tryptamine derivatives or other psychedelic compounds can diagnose, treat, cure or prevent any disease or condition. Rigorous scientific research and clinical trials are needed. Cybin has not conducted clinical trials for the use of its proposed products. Any references to quality, consistency, efficacy and safety of potential products do not imply that Cybin verified such in clinical trials or that Cybin will complete such trials. If Cybin cannot obtain the approvals or research necessary to commercialize its business, it may have a material adverse effect on Cybins performance and operations.

Neither the Neo Exchange Inc. nor the NYSE American LLC stock exchange have approved or disapproved the contents of this news release and are not responsible for the adequacy and accuracy of the contents herein.

1)

Bandelow B, Michaelis S. Epidemiology of anxiety disorders in the 21st century. Dialogues Clin Neurosci. 2015;17(3):327-335. doi:10.31887/DCNS.2015.17.3/bbandelow

2)

Ansara ED. Management of treatment-resistant generalized anxiety disorder. Ment Health Clin. 2020;10(6):326-334. Published 2020 Nov 5. doi:10.9740/mhc.2020.11.326

View source version on businesswire.com: https://www.businesswire.com/news/home/20211215005174/en/

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Cybin Awarded Notice of Allowance from US Patent and Trademark Office for CYB004 (Deuterated Psychedelic Tryptamine) for the Treatment of Anxiety...

Australia's medicines regulator has rejected a call to legalise psychedelic drugs for use in mental health settings.

The Theraputic Goods Administration (TGA) has rejected an application to amend current poisons regulations to allow for psilocybin also known as magic mushrooms and MDMA (methylenedioxymethamphetamine) to be used in medically controlled environments.

Following research findings here and abroad, the application soughtto have the drugs used as part of psychotherapy treatment for mental illnesses,depression and post-traumatic stress disorder.

TGA's decision means the drugs will not be downscaled from Schedule 9 drugs, which are prohibited substances, to Schedule 8 drugs which are controlled substances.

The TGA's stance is the same as its earlier interim decision.

"I am satisfied that psilocybin poses a high danger for both acute and long-term effects if abused or misused by way of access outside of strictly controlled medical and scientific research settings," the author of the final decision, who is not named, said.

"Given this increased risk to individuals of acute and long-term effects, a high level of control across the supply chain commensurate with Schedule 9 is warranted."

Earlier this year, an expert panel review commissioned by the TGA found that psychedelics could possibly be used to manage treatment-resistant mental illnesses in closely supervised medical settings.

"I agree with the committee that the preliminary findings from clinical trials although still in early phases evaluated by the panel are promising," the decision's author said.

"However, given the extent and issues with the quality of the completed studies detailed by the panel, I reiterate my statement in my interim decision that I consider that evidence is still emerging, and the therapeutic value of psilocybin has not been established.

A trial to help terminally ill patients confront their "terror" through the use of a psychedelic compound is the kind of treatment advocates had hoped would become more widely available, before yesterday's rejection from the drug regulator.

"I am of the view that ensuring administration of psilocybin according to the strict protocols used in clinical trials that have showed promise of efficacy to date would be hard to achieve outside a clinical trial framework."

On the use of MDMA in clinical settings, the TGA's decision outlined similar concerns to those it had about psilocybin.

"I consider that the benefits of MDMA have not been fully established, although there is emerging evidence in treating PTSD, with [a] demonstrated low risk of adverse events in controlled settings," the decision said.

"I am concerned with how, in accordance with the qualification included in the expert report's conclusion about the promise of MDMA in highly selected populations, namely the controlled clinical trial environment, can be replicated in real-world settings.

"I have considered the impacts on public health, were access to MDMA to be increased through an entry in Schedule 8 of the Poisons Standard I am of the view that there would be an increased risk of misuse by individuals outside of a highly controlled environment or diversion for illicit purposes."

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TGA blocks bid to have MDMA, magic mushrooms used to treat mental health conditions - ABC News

Delivering LSD via microneedle patch unlocks potential for desired dosage forms and pharmacokinetic profiles for improved safety and effectiveness

Pursuing Phase 2 clinical studies in 2022 with LSD and notable psychedelics

TORONTO, Dec. 14, 2021 (GLOBE NEWSWIRE) -- PharmaTher Holdings Ltd. (the Company or PharmaTher) (OTCQB: PHRRF) (CSE: PHRM), a clinical-stage psychedelics biotech company, is pleased to announce that it has successfully completed its first research study evaluating MicroDose-MN, a proprietary microneedle (MN) patch for the intradermal delivery of psychedelics, in delivering lysergic acid diethylamide (LSD). These results provide support to file for an IND application with the FDA to conduct Phase 2 clinical studies in 2022 with LSD for various indications.

The aim of PharmaThers research program was to develop a suitable prototype of MicroDose-MN patch for transdermal (intradermal) drug delivery to confirm compatibility and suitability to deliver LSD. The research program scope included, full characterization of LSD conjugated on the microneedle patch backbone, establishment and demonstration of the loading capacity for LSD, and release rate evaluations for the LSD conjugated materials using appropriate models that will be used to support the Companys IND application with the FDA in the future.

The Companys research program with LSD conjugated microneedles have been successfully fabricated, optimized, and characterized. Both structural aspects and ex-vivo skin insertion assessments of the LSD conjugated microneedles have demonstrated successful fabrication and acceptable performance. The incorporation of LSD into microneedles without issue and the ability to demonstrate complete ex vivo skin model release over several days demonstrates potential for larger doses and modified release profiles. With these results, the Company believes it has an acceptable prototype for completing IND-enabling studies with the aim to conduct clinical studies in 2022. Details of the research program will be published in a scientific journal.

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The Company believes that its MicroDose-MN patch for delivering LSD and other psychedelics may enable flexible drug load capacity and combinations, controlled released delivery, and be able to present desired pharmacokinetic and safety profiles. In addition, the MicroDose-MN patch for psychedelics aims to empower patients to dose their medication remotely, safely and conveniently rather than under supervision by a healthcare provider at a certified medical office or hospital. To achieve this, the Company will incorporate anti-tampering and anti-abuse features that would parallel the approach used for the tamper-resistant transdermal fentanyl patch.

The Company is completing its evaluation of MicroDose-MN with 3,4-methylenedioxy-methamphetamine (MDMA) and N, N-dimethyltryptamine (DMT) and expects to provide results before the end of this year and pursue clinical studies in 2022.

The Company is actively engaged in partnering discussions for the use of its microneedle patch system to deliver psychedelics including, but not limited to, MDMA, LSD, DMT, ibogaine and mescaline. As such, PharmaTher offers potential partners a differentiated and validated delivery system for psychedelics, desired pharmacokinetic profiles, intellectual property protection, cGMP microneedle patches for IND-enabling and clinical studies, and a clear clinical pathway towards clinical studies in 2022.

About PharmaTher Holdings Ltd.

PharmaTher Holdings Ltd. (OTCQB: PHRRF) (CSE: PHRM) is a clinical-stage psychedelics biotech company focused on the research, development and commercialization of novel uses, formulations and delivery methods of psychedelics, such as ketamine, to treat mental health, neurological and pain disorders. PharmaTher is currently advancing an FDA approved phase 2 clinical study with ketamine to treat Parkinsons disease and is developing a novel microneedle patch for the intradermal delivery of psychedelics and infectious disease treatments.Learn more at: PharmaTher.com and follow us on Twitter and LinkedIn.

For more business development opportunities or information about PharmaTher, please contact:

Fabio ChianelliChief Executive OfficerPharmaTher Holdings Ltd.Tel: 1-888-846-3171Email: info@pharmather.com Website: http://www.pharmather.com

Neither the Canadian Securities Exchange nor its Regulation Services Provider have reviewed or accept responsibility for the adequacy or accuracy of this release.

Cautionary Statement

This press release contains 'forward-looking information' within the meaning of applicable Canadian securities legislation. These statements relate to future events or future performance. The use of any of the words "could", "intend", "expect", "believe", "will", "projected", "estimated", "potential", "aim", may and similar expressions and statements relating to matters that are not historical facts are intended to identify forward-looking information and are based on PharmaTher Holdings Ltd. (the "Company") current belief or assumptions as to the outcome and timing of such future events. Forward-looking information is based on reasonable assumptions that have been made by the Company at the date of the information and is subject to known and unknown risks, uncertainties, and other factors that may cause actual results or events to differ materially from those anticipated in the forward-looking information. Given these risks, uncertainties and assumptions, you should not unduly rely on these forward-looking statements. The forward-looking information contained in this press release is made as of the date hereof, and Company is not obligated to update or revise any forward-looking information, whether as a result of new information, future events or otherwise, except as required by applicable securities laws. The foregoing statements expressly qualify any forward-looking information contained herein. Factors that could cause actual results to differ materially from those anticipated in these forward-looking statements are described under the caption "Risk Factors" in Company's management's discussion and analysis for the period of August 31, 2021 ("MD&A"), dated October 27, 2021, which is available on the Company's profile at http://www.sedar.com.

This news release does not constitute an offer to sell or the solicitation of an offer to buy, and shall not constitute an offer, solicitation or sale in any state, province, territory or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state, province, territory or jurisdiction.

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PharmaTher Announces Positive Research Results for LSD Microneedle Patch - Yahoo Finance