Category Archives: Psychedelics

Psychedelic drugs have made their way from the Woodstocks and Playas of the world to health clinics, where LSD, MDMA, psilocybin (aka magic mushrooms), and more are being used to treat everything from anxiety to opioid addiction. As these drugs become destigmatized, regulators are increasingly approving the research and use of them by companies like MindMed, a three-year-old psychedelic medicine company that went public last spring.

To learn more about the fledgling psychedelics industry, we spoke with MindMeds CEO Rob Barrow.

How would you explain what MindMed does to someone unfamiliar with it?

What MindMed is ultimately building is a biopharmaceutical company that's going to be a powerhouse in treating brain health disorders. Our starting point is some classic psychedelics: the LSDs and psilocybins of the world. The regulatory environment is favorable at this point, and the resurgence of research has created an environment where we can accelerate the development of these programs.

But beyond that, we have broader ambitions of improving mental health and addiction outcomes for patients. That ranges from the classic psychedelics to novel uses of those molecules and to other molecules that are structurally related but aren't psychedelic in and of themselves.

How is taking psychedelic drugs recreationally different from administering them in a medical setting?

If it were the case that just by simply taking a psychedelic drug one time, you never had depression, you would have a large part of the population whos taken LSD or psilocybin at some point in their lives who would never have depression or anxiety risk. We don't think that's the case.

We try to be a bit realistic in terms of the opportunity and potential here. There is enormous potential, but this isn't magic, right? These are drugs that get into your brain and engage an important system, and they have scientifically and medically interesting perceptual effects and compelling signs of clinical efficacy. But it's important to do that in a controlled environment, in a medical setting, and have them delivered in a therapeutic context in order to realize their therapeutic potential.

Whats the biggest misconception that you hear about MindMed?

One of the things we really try to emphasize is that we are a pharmaceutical company developing treatments for brain health disorders. So when conversations come up about parallels to the cannabis industry and parallels to recreational use of products, that has nothing to do with what we are pursuing as a mission. We always want to make it very clear about what we're trying to achieve and how we're going about that, which is to bring new drugs to the market through regulated processes.

Whats next for you in the short term?

In the very near term, we're launching several clinical trials that are going to be high impact for us. These include our 18-MC molecule in treating opioid withdrawal, LSD for the treatment of generalized anxiety disorder, and then as we progress through the year, launching a clinical research program for MDMA and autism spectrum disorder.

This interview has been edited and condensed for clarity.

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Icebreakers with...MindMed CEO Rob Barrow - Morning Brew

Whether its solving the worlds biggest problems or investigating the potential of novel discoveries, researchers at UCF are on the edge scientific breakthroughs that aim to make an impact. Through the Research in 60 Seconds series, student and faculty researchers condense their complex studies into bite-sized summaries so you can know how and why Knights plan to improve our world.

Name: Shana HarrisPositions: Assistant professor of anthropology in theCollege of Sciences with a secondary joint appointment as an assistant professor of internal medicine in the College of Medicine.

Why are you interested in this research?Over the last two decades, there has been a marked increase in research into the therapeutic possibilities of psychedelics. We are also seeing more and more people, especially in the global North, seeking out these substances for all kinds of reasons, including to treat drug problems.

As someone who has researched drug use practices, policies and interventions for over 20 years, I am fascinated by the growing uptake in using psychedelics for drug treatment. It raises so many questions for me as an anthropologist: How and where is such treatment being offered? Who is seeking it out? Who is providing it? What does it look like? Why are people interested in psychedelic-based drug treatment instead of more mainstream treatments? All of these questions (and more) are challenging my assumptions about drug treatment and what counts as therapeutic in this context, and that is exciting.

Who inspires you to conduct your research?Above all, I am inspired by my research participants. Their willingness to speak so openly with me and to allow me into their space is invaluable as a researcher. But it also incredibly meaningful and heartening that they feel comfortable enough to tell me about their lives and to share their experiences with me (good, bad and everything in between). They teach me so much just by being themselves and letting me tag along for the ride.

Are you a faculty member or student conducting research at UCF? We want to hear from you! Tell us about your research at bit.ly/ucf-research-60-form.

How does UCF empower you to do your research?I have benefited greatly from many opportunities offered at UCF to support my research. I have received significant mentoring from senior and other women faculty, as well as financial and technical support from my departments, college and the university. As an assistant professor,

I also had the rare pre-tenure opportunity to conduct fieldwork in Mexico for a year, which was essential for advancing my research.

What major grants and honors have you earned to support your research?I am very lucky to have received research grants from several institutions (public, private and nonprofit). Most recently, I have been funded by the National Institutes of Health, the Wenner-Gren Foundation for Anthropological Research and the Florida Education Fund. Without their generous support, my research would not be possible.

Why is this research important?My research is important because people are using and providing psychedelics for therapeutic reasons, whether we like it or not. They believe these substances can help, and perhaps they provide people with something that mainstream treatments do not. I want my work to be a platform for conversation about this complicated phenomenon and the people engaged in it. I believe [psychedelics for therapeutic reasons] deserve consideration, not condemnation.

Are you a faculty member or student conducting research at UCF? We want to hear from you! Tell us about your research at bit.ly/ucf-research-60-form.

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Research in 60 Seconds: How Taking Psychedelics Can Be Therapeutic - UCF

Welcome to TDRs review of the Top 5 Psychedelic developments for the week of January 17. Aside from presenting a synopsis of events, we provide market commentary to summarize the week that was for publicly-listed companies.

5. Numinus Announces Key Milestones in MAPS-Sponsored MDMA-Assisted Therapy for PTSD Clinical Trial

Numinus Wellness (TSE:NUMI)(OTCMKTS:NUMIF) has completed key steps to prepare to enroll participants at its clinics participating in A multi-site open-label extension study of MDMA-assisted psychotherapy for PTSD (MAPPUSX), sponsored by the Multidisciplinary Association for Psychedelic Studies (MAPS).

This is an exciting next step in the MAPPUSX study, happening at our clinics in bothBritish ColumbiaandQuebec, and we look forward to how this work supports expanded collaboration with MAPS in the future.

The Canadian study sites, which will continue to study the safety of MDMA-assisted therapy in treating severe PTSD, under the leadership of MAPS Public Benefit Corporation (MAPS PBC) as study sponsor, have recently received regulatory authorization from Health Canada, ethical approval from an Institutional Review Board (IRB) and a Section 56 exemption from the Controlled Drug and Substance Act, which will allow the use of MDMA throughout the duration of the clinical trial.

4. Awakn Life Sciences Signs Memorandum of Understanding with MAPS

Awakn Life Sciences (NEO: AWKN) (OTCMKTS:AWKNF) has signed a Memorandum of Understanding (MOU) with the Multidisciplinary Association for Psychedelic Studies (MAPS) to explore a partnership to utilize MDMA-assisted therapy to treat Alcohol Use Disorder (AUD) in Europe.

Under the terms of this MOU, Awakn will explore a data licensing agreement with MAPS to support Awakns Phase IIb and planned Phase III studies for MDMA-assisted therapy for AUD in Europe. Awakn and MAPS will also assess a partnership to secure marketing authorisation/regulatory approval for the ethical commercialization of MDMA-assisted therapy for the treatment of AUD in Europe.

AUD is a chronic disease affecting 40 million people in Europe and 390 million people globally. It is also a pervasive and persistent public health issue, with alcohol use being one of the top five causes of disease and disability in the majority of countries in Europe. And for each person suffering from AUD, there is a friend, a partner, or a family also deeply affected by it.

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Mental Health Crisis Among Working Class Driving Labor Shortages and Recruitment Difficulties for Employers

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3. Biopharma Stocks Hammered As Market Goes Risk-Off Across Multiple Asset Classes

The psychedelic sector plunged this past week, following broad weakness in almost everything listed on the exchanges. TheHorizon Psychedelic Stock Index ETF(PSYK) fell9.46%, minting its 8th weekly loss over the past 10. The decline in PSYK was inline with the biotechnology sector in general, with theNasdaq Junior Biotechnology Index(10.48%) andNasdaq Biotechnology Ishares ETF(7.39%) both falling hard on pervasive risk off sentiment.

Another dreadful week for psychedelic companies from a capital markets perspective. Unlike much of 2021, the latest weakness appears to be a byproduct of plunging broad markets in general, for which there is little cover. As always, early-stage speculative industries generally bare a disproportional brunt of decline in such environments, and this week was no exception. And its hardly limited to the juniors in the space.

For example, COMPASS Pathways continued its deep dive lower, falling another 11.89% on the week and right through its IPO final go-public price of $17/share, which offered just a brief period of support. With its $15.77 close, CMPS has fallen 63.37% since releasing generally positive Phase 2b endpoints for Treatment Resistant Depression along with assisted-therapy using proprietary psilocybin formulation, COMP360. When a sector leader falls this hard in the absence of bad news, hard times will befall the rest of its peer group.

ATAI Life Sciences is another curiosity to the downside. Despite US$430.3 million in cash and cash equivalents (as of September 30, 2021) and an investment in COMPASS Pathways worth approximately $120 million in current dollars, ATAIs undiluted market cap is only $843 million. Thus, the market is ascribing little value to the companys drug developing pipeline or assets. ATAI has lost 47.50% in value since December 15 after announcing a key shareholder post-IPO lockup that could extend up to two years. The selling has been that indiscriminate.

Where the market goes next is anyones guess. However, when not even one industry bellweather is valued at a billion dollars (undiluted), despite rapidly advancing research and enough cash to fund full-cycle clinical trials, we may be getting overdone.

In the news

BetterLife Pharma has obtained positive results from an in vivo oral bioavailability and food-effect pharmacokinetic (PK) study on BETR-001 in beagle dogs. BETR-001 (2-bromo-LSD, formerly TD-0148A) is a non-hallucinogenic derivative of lysergic acid diethylamide (LSD).

Betterlife has also received a written response from the FDA to its pre-investigational new drug application for the treatment of MDD with BETR-001. BETR-001 is currently undergoing IND-enabling non-clinical studies and GMP manufacturing for clinical trials.

Bipartisan members of Congress sent a letter on Tuesday requesting that the Drug Enforcement Administration (DEA) allow terminally ill patients to use psilocybin as an investigational treatment without the fear of federal prosecution.

A new survey conducted by The Harris Poll on behalf of Delic Holdings reports that nearly 2/3 of Americans who suffer from anxiety/depression/PTSD (65%) believe that psychedelic medicine should be made available to patients with treatment-resistant anxiety, depression or PTSD.

Eleusis, a clinical-stage life science company that aims to unlock the therapeutic potential of psychedelics, and Silver Spike Acquisition Corp. II, a publicly traded special purpose acquisition company (SPAC) sponsored by an affiliate of Silver Spike Capital announced a definitive business combination agreement expected to make Eleusis a public company. The implied combined enterprise value is $446 million.

Jupiter Wellness announces that its merger partner, Next Frontier Pharmaceuticals, Inc., through its wholly owned subsidiary, Benuvia Manufacturing, Inc., has entered into the global psychedelic drug development and active pharmaceutical ingredient market.

Levitee Labs announced that it is proposing to complete a non-brokered private placement of up to 15,000,000 units at a price of $0.20 per Unit for aggregate gross proceeds of up to CAD$3,000,000. The Private Placement is subject to approval from the Canadian Securities Exchange.

Mind Medicine has enrolled the first subjects into its Session Monitoring System study evaluating the passive collection of sensory data during a consciousness-altering therapeutic session.

Mindset Pharma insiders are buying stock following itstransformative collaborationwithThe McQuade Center for Strategic Research and Development.

Mydecine Innovations Group has signed a Letter of Intent withThe Newly Institute Inc., a Calgary, Alberta based company opening private inter-disciplinary mental health clinics across Canada, to collaborate on expanding psychedelic-assisted psychotherapy to patients.

Novamind has closed its acquisition of Arizona-based Foundations for Change, Inc., a mental health practice specialized in ketamine-assisted psychotherapy.

Numinus Wellness announced its fiscal first quarter results for the three months endedNovember 30, 2021.

Red Light Holland announced a collaboration with Psychedelic Medicine Alliance Washington to promote a psilocybin legalization bill in Washington State.

Revitalist Lifestye And Wellness Ltd. recapped the milestones is has reached in calendar year 2021. The company has significantly scaled its operations during 2021, ending the year with seven clinics and providing approximately 5,000 patient treatments which represented a 128% increase year over year.

Virginia lawmakers,Del. Dawn Adams (D),andSen. Ghazala Hashmi (D)along withSen. Jennifer Boysko (D), introduced new bills to decriminalize the possession of psychedelics.

2. Kansas Lawmaker Files Bill To Legalize Psilocybin Possession And Cultivation

A Kansas lawmaker has filed a bill to legalize the low-level possession and cultivation of psilocybin mushrooms. Rep. Aaron Coleman (D), a 21-year-old legislator who has been embroiled in controversy over a series of encounters with law enforcement, is sponsoring the legislation. It would remove criminal penalties for possessing up to 50 grams of psilocybin or psilocyn or cultivating the psychedelic compounds.

Kansas Lawmaker Files Bill To Legalize Psilocybin Possession And Cultivation: The legislation would remove criminal penalties for possessing up to 50 grams of psilocybin or psilocyn. https://t.co/NbiVePGOhf

Under the proposal, possession of more than 50 grams but less than 100 grams would be a civil offense punishable by a maximum $250 fine. Possessing more than 100 grams of the psychedelic would be considered a Class C misdemeanor, carrying a fine of up to $500 and a one month in jail.

Thelegislation, titled the Legalized Homegrown Psilocybin Mushroom Act of 2022, would amend state statute to make it so it shall not be a violation of state law to cultivate psilocyn or psilocybin.

1. Bill Could Open the Door to Legalize Medical-Use Psychedelics in Utah

Rep. Brammer, R-Pleasant Grove, has filedHouse Bill 167, which creates a task force to explore whether psychedelics ought to be considered as a viable treatment option for mental health, PTSD and other issues. The bill is already being backed by one of the groups that got medical cannabis legalized in Utah.

It doesnt legalize anything. It asks our Huntsman Mental Health Institute and other experts in the field to review the science thats out there, the research thats out there, and make any recommendations that they have if they feel psychedelics can be safely administered through a prescription basis and under what circumstances, he said.

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TDRs Top 5 Psychedelic Developments For The Week Of January 17 - The Dales Report

Ketamine was first synthesised in 1962 as researchers looked for an alternative to phencyclidine more commonly known as PCP or angel dust. Since then, it has been used by millions around the world for both medical and recreational purposes but what actually is it?

Following early research into ketamine, the drug became known as a dissociative anaesthetic due to its psychoactive effects and ability to induce unconsciousness. However, studies also identified some odd effects when the drug was taken in low doses.

In 1964, two years after the first synthesis of the drug, a doctor named Edward Domino conducted the first human trials of ketamine on inmates at Jackson State Prison, in Michigan. While the substance was observed to be a powerful sedative at higher doses, lower doses appeared to separate the mind from the body, having some strange effects on the participating inmates.

Despite these findings, the focus was placed on the sedative and anaesthetic potential of the drug as opposed to its psychotropic properties. It was soon to become a common anaesthetic in medical rooms.

The FDA approved ketamine as an anaesthetic in 1970, just as US legislation was to be introduced banning psychotropic substances such as LSD and psilocybin. Ketamine was widely used by the US military in the Vietnam War and is still a standard anaesthetic used in medical settings around the world.

Not much later, researchers and medical professionals began to notice other interesting properties of ketamine. Clinicians at Yale University in the US used ketamine to mimic the symptoms of schizophrenia however, they also noticed that the drug also seemed to improve the mood of participants. This led to the assessment of the substance as a possible treatment for depression.

As ketamine is licensed for use as an anaesthetic, it can also be used off-license for other applications most notably as a treatment for depression.

In 2006, the National Institute of Mental Health (US) concluded that ketamine had rapid antidepressant effects. Since then, hundreds of studies have been carried out in this area many of which suggest that a single dose of ketamine can relieve symptoms of depression for days and even weeks. Interestingly, researchers also observe that talking therapies (a common treatment option for patients with depression) tend to be more effective during this period.

A recent study (published in June 2020) found that a single low dose of ketamine was associated with an increased number of serotonin 1B receptors. Participating patients had been diagnosed with difficult-to-treat depression, following the inability of common antidepressant treatments such as selective serotonin reuptake inhibitors (SSRIs).

Serotonin is a chemical produced naturally in our bodies to send signals between nerve cells. It has been found to contribute to mood regulation and feelings of wellbeing. While SSRIs work by increasing serotonin levels, this may not be an effective treatment for depression if there are still not enough receptors to catch these compounds. Increasing the number of serotonin receptors can also lead to the more efficient release of another feel-good chemical dopamine.

Ketamine is also considered a rapid treatment option in emergency situations for acutely suicidal patients.

Thanks to this impressive potential, a number of clinics offering ketamine-assisted therapy are popping up around the world. Last year, Bristol welcomed the UKs first ketamine clinic the Awakn Clinic. Prior to this, however, a number of clinics had begun to offer ketamine-assisted therapy across the US and other countries.

In addition to these impressive medicinal properties, ketamine also has powerful psychotropic effects that have made it an increasingly popular drug for recreational users.

Often labelled a psychedelic drug despite the efforts of early investors and researchers to avoid the drug being linked with other substances that had quickly become associated with counter-culture movements and recreational drug use it wasnt long before the drug was adopted by party-goers and ravers.

Recreational users more commonly snort the drug in lower doses in order to experience distortions to reality while still being capable of social interaction. However, when taken at higher doses, ketamines sedative effects can cause users to become unresponsive and appear unaware of their surroundings. This is referred to as being in a K-hole.

So, while ketamines psychoactive properties have at times made this drug controversial, its striking potential in the treatment of mental illness, as well as its ongoing use as an anaesthetic, appear to have secured the drugs place as an important medical product.

As governments and private and public investors continue to fund research into alternative treatments for mental illnesses, including depression and addiction, ketamine is expected to be a key drug in the ongoing psychedelics renaissance that is in full swing around the world.

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The Psychedelics Series: The history and future of ketamine - The Cannabis Exchange

Its no secret that psychedelics are on the comeback trail, with a record number of trials and total investment in the hundreds of millions of dollars in 2021 alone. This interest from the public, investors, and researchers alike has made 2021 the biggest year for psychedelics research to date and 2022 is set to be even bigger

The ongoing expansion of the psychedelics sector has led to the development of more products and an explosion of clinical studies and trials. The evidence collected through these trials is continuously adding to the evidence base first collected in the mid-20th century.

Early psychedelics studies led to some key discoveries, such as the potential for the substances to be used as a tool for psychotherapy including for tackling addiction and depression. However, the introduction of the Controlled Substances Act in the US in 1970 stopped the vast majority of this important research in its tracks.

Soon after the US legislation, the introduction of the Convention on Psychotropic Substances, 1971 controversially halted psychedelics research, globally. Over the following years, the flood of psychedelics research was reduced to a trickle until recently.

This so-called Psychedelics Renaissance represents the largest flux of research in the area since the 1950s and 60s. In 2021 alone, dozens of trials and hundreds more studies were completed to expand our knowledge of these substances.

A record number of studies were carried out to assess the therapeutic potential of psychedelic substances including ketamine, DMT, and psilocybin in a number of clinical settings. Many of these studies and trials were carried out in the US, with over 1,000 clinical psychedelic trials currently sanctioned by the FDA there.However, the rest of the world is beginning to catch up, with more psychedelic studies being carried out globally, including in the UK.

Several studies and trials focused on DMTs potential as a treatment for depression. In 2021, a UK trial was approved to assess this potential by administering the psychedelic to patients with depression, alongside professional psychotherapy. Researchers believe that the substance may work by loosening and breaking up existing thought patterns and pathways which can then be rebuilt in a more logical pattern with therapy.

Other studies have assessed the potential of ketamine a psychedelic drug that has previously been used as an anaesthetic and sedative as a treatment for addiction, PTSD, and depression. Previous studies have shown that ketamine can be useful as an emergency treatment for depression and suicidal feelings.

One study, carried out in 2021 revealed that ketamine, when delivered alongside psychotherapy was able to help alcoholics abstain from drinking for longer. UK clinic Awakn also announced last year that it would be carrying out a trial into the use of ketamine as a treatment for gambling addiction.

However, the vast majority of studies over the last year have focused on MDMA and psilocybin the psychoactive compound that is found in a number of mushroom and fungus species widely referred to as magic mushrooms.

MDMA was prohibited in the US in 1985 through an emergency ruling, despite promising findings suggesting it could be useful for the treatment of PTSD. A number of studies have supported this theory, with one of the most recent a phase III double-blind, placebo-controlled trial, published in 2021 demonstrating that MDMA therapy results in a significant and robust attenuation of PTSD symptoms and functional impairment.

Psilocybin is perhaps one of the most popular and widely used psychedelic drugs. Like many psychedelics, magic mushrooms are commonly used recreationally, but the key to the effects of these mushrooms may also have some promising therapeutic properties. For example, a phase IIb clinical study found that a psilocybin-based treatment (COMP360 psilocybin) was able to produce a highly statistically significant and clinically relevant reduction in depressive symptom severity after three weeks, with a rapid and durable treatment response.

Researchers are also increasingly showing an interest in the physiological effects of psilocybin. Heroic Hearts Project UK and the USA have invited Imperial College to attend upcoming psychedelic therapy retreats to conduct an observational study about the effects of psilocybin on veterans with a history of traumatic brain injury (TBI).

While we have touched upon a few studies here, we really have only scratched the surface of the important research being carried out on the potential of psychedelics. There are hundreds more studies, trials, and reviews that are continuing to open our eyes to how useful these substances could be in the future.

In addition to an increase in trials, interest in psychedelics has expanded to other aspects related to these substances, including product development and legislation.

Funding for the psychedelics sector is also seeing a dramatic increase, surpassing $730 million across 61 deals in 2021 alone (compared with $359 million in 2020). 2021 also saw the first billion-dollar IPOs and/or valuations of psychedelics companies (ATAI Life Sciences; GH Research; MindMed).

Reports show that product R&D is the fastest growing sector of the psychedelics industry as demand continues to climb. In addition to Compass Pathways development of their psilocybin-derived product COMP360, Delix Therapeutics raised $70 million for the development of LSD-like compounds that could potentially help to re-wire the brain and serve as a useful treatment for mental health conditions.

California-based Bexson Biomedical also announced last year that it is developing a subcutaneous medical device that can be worn. The device will be designed to deliver a pre-determined dose of psychedelic substances.

The interest of funders is also reflected in the legislative sector, with more jurisdictions considering the decriminalisation and even the legalisation of psychedelics such as magic mushrooms. For example, at the end of 2020, voters in Oregon voted in favour of the decriminalisation of all drugs including psychedelics.

Throughout 2021, more jurisdictions both within the US and further afield announced moves to follow suit with Oregon. In the UK, prime minister Boris Johnson revealed that he had approved the legalisation of psilocybin for medical purposes. Psilocybin has also been decriminalised in a number of US cities, including Oakland, Arcata, and Santa Cruz, CA; Denver, CO; Port Townsend, WA; and Washinton D.C.

Already in 2022, the Canadian government has announced that it will be legalising psychedelics for medical uses across the country. In addition, the Australian government has also announced that it will be handing out a reported $15 million to fund psychedelic research for a number of mental health conditions.

Over the last few decades, a significant proportion of students have shown a growing interest in alternative treatments for a variety of conditions and illnesses including the potential of medical cannabis and now increasingly, psychedelics. This is set to come to a head over the next few years as funding increases and restrictions loosen.

While many traditional pharmaceutical treatments may help to alleviate symptoms of conditions such as anxiety, depression, PTSD, and addiction, current research shows that psychedelics can be useful at addressing their root causes. As such, these substances could play an essential role in the modern world, as an ever-rising proportion of the population report experiencing symptoms of anxiety and depression.

The continued pace of the psychedelics law reform movement and ever-growing investment in the sector is expected to make 2022 the biggest year for the industry to date.

For more on the growing psychedelics industry keep an eye out for our upcoming podcast series Not That High: The Psychedelics Series!

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How 2021 became the year of psychedelics - and why 2022 is set to be even bigger - The Cannabis Exchange

In Southampton, soccer moms drop their kids off at school after taking their thrice-weekly microdose of psilocybin mushrooms, then meet for oat milk lattes. In Sun Valley, private retreats dedicated to tripping on MDMA or the Amazonian elixir ayahuasca are becoming almost as common as backyard barbecues. (Just dont bring the kids.) In Silicon Valley, tech entrepreneurs and financiers turned psychonauts believe that taking small doses of LSD, in either liquid or tab form, helps with creativity and productivity in the workforce. Even rightwing internet investor Peter Thiel has put a formidable stake in Compass Pathways, a publicly traded psychedelic medicine company.

But now theres a weirder, wilder new drug appearing on the menu for moneyed types in search of mind expansion: the Toad, otherwise known as 5-MeO-DMT (or, if you really want to know its correct name, 5-methoxy-N, N-dimethyltryptamine), or DMT, or Bufo. In his landmark 2018 memoir, How to Change Your Mind, Michael Pollan referred to it as the Everest of psychedelics.

Bufo is one of the most potent psychotropic drugs ever discovered.

Tamer El-Shakhs, an owner of the chic Malibu dispensary 99 High Tide and a sommelier, if you will, of all things hallucinogenic, told me that just as Everest is a mountain you would climb only a few times in your life, Bufo is a drug you would not want to take more than a few times. It is so intense, and the experience so total and so life-changing, that I dont think you would want to do itor need to do itmore than a couple of times, he says. Yet none of that has stopped a number of celebrities from openly talking about their experiences, from Mike Tyson to Chelsea Handler to reality TV star Christina Haack, who wrote about her Bufo experience in an Instagram post last July. I had taken time off social, hired a spiritual coach, and smoked a Bufo toad (which basically reset my brain and kicked out years of anxiety in 15 mins), she wrote. Hunter Biden has described it as a salve in helping him kick drug addiction.

What exactly are these people smoking? Bufo is the venom of the Sonoran desert toad, Bufo alvarius, which contains the molecule 5-MeO-DMT, one of the most potent psychotropic drugs ever discovered. Until recently it was so obscure the U.S. government did not list it as a controlled substance until 2011. For nine months of the year the Sonoran desert toad lives under the sands of the Mexican desert to survive the scorching heat, but when the winter rains arrive, it emerges for a Caligula-like orgy of eating and fornicating. Glands on the sides of its neck and legs emit a venom so toxic it can cause death in a predator within seconds. Bufo hunters catch the toads at night using flashlightsthe toads freeze when confronted by a bright lightthen milk the venom from the toads parotid glands, typically holding a mirror up to catch the spray. Overnight, the milky venom dries on the glass, turning into flaky crystals, leaving behind only the 5-MeO-DMT and none of the lethal toxin. (The toads are allegedly unharmed.)

Brad Wilson, DVMGetty Images

The crystals (typically a dose is 50 mg) are smoked in a glass pipe; participants are asked to inhale slowly for eight seconds and hold in the vapor for at least several seconds more. And then they enter a consciousness rocket ship ride. The effects are immediate and intense.

Most people who try Bufo describe a feeling of oceanic boundlessness, of oneness with the universe. They describe a high level of ego dissolution. Some describe a fusion with God, a visceral connection with the divine source of all life, and a sense of connection with all beings. From my one experience taking ecstasy, or MDMA, that all sounds par for the course for hallucinogenic drugs. (The next day I remember thinking, I felt one with the universe with that person? Sheesh.)

Some describe a fusion with God, a visceral connection with the divine source of all life.

With Bufo, however, most users experience such a dissolution of the self and ego that they feel they are dead, or dying, that they exist in a blank space, and they slowly reemerge, to be born again, flushed of all their perceived flaws and addictions and no longer able to feel pain from past trauma. In Pollans book he says, I felt an inexplicable urge to lift my knees, and as soon as I raised them, I felt something squeeze out from between my legs, but easily and without struggle or pain.

On a Joe Rogan podcast in 2019, Mike Tyson spoke about how Bufo had completely changed his life. Its almost like dying and being reborn Its almost like youre dying, youre submissive, youre humble, youre vulnerablebut youre invincible still in all. And in late 2021 Tyson told the New York Post that in my trips, Ive seen that death is beautiful.

Hunter Biden has described it as a salve in helping him kick drug addiction.

This might, in part, explain Bufos surprising ascent to trip du jour among a certain social set. For those who trade in power, it might be the one thing that can help them see past their own egos, if only temporarily. Maybe it feels especially good for those who are expected to meet high standards of success and image, allowing them to let go of some of the demand for effortless, excessive perfection. Also, its expensive, rare, hot fodder for dinner party conversationsand its also less of a commitment than some other trendy trips. Unlike an ayahuasca ceremony, during which you might spend hours hallucinating and vomiting and days recovering, the Bufo trip is intense but fast. Typically, participants in a Bufo ceremony are clearheaded within an hour. Many of the companies that lead tours outside the United States for the Bufo ceremony, such as Behold Retreats, limit groups to five people, with three facilitators.

For those who trade in power, it might be the one thing that can help them see past their own egos.

Bufo is of course just part of a larger psychedelic wave washing over the United States. Microdosing psilocybin is being promoted as a method for healing trauma and treating depression and addiction, and theres a recognition that Silicon Valley is placing big financial bets on psychedelic drugs, which lends the movement credibility. Whereas psychedelics were once the symbol of a radical generational counterculture led by Timothy Leary and Jim Morrison, these drugs (LSD, psilocybin, ibogaine, MDMA) are now practically a mainstay among the class of people who 40 years ago would have clutched their pearls and invoked Nancy Reagan, Richard Nixon, and Carrie Nation. Today Americas intelligentsia is in the grip of a hallucinogenic fever dream, where its normal to walk into a house in the Hamptons or Malibu and have the hostess, pearls swinging around her neck (perhaps the same ones her mother was wearing 40 years ago) offer you something that half a decade ago you never would have thought of ingesting. After all, recreational marijuana is legal in 18 states plus the District of Columbia.

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The shift came in 2018, when Pollan published How to Change Your Mind: What the New Science of Psychedelics Teaches Us About Consciousness, Dying, Addiction, Depression, and Transcendence. Here was a guy I had met a few times in the New York Times newsroom (I was a reporter there); he would occasionally come in to see the food editors, a shambling, middle-aged intellectual white guy from Long Island who had taught at Harvard and Berkeley, who wrote mostly about food and the value of vegetarianism. And now, instead of admonishing us to eat food, not too much, mostly plants, he had written a book and he was preaching a new gospel: Try psychedelic drugs. I did. And now I think maybe we all should.

In Los Angeles on a sunny December weekend, El-Shakhs, the marijuana entrepreneur, told me that dozens, if not hundreds, of ceremonies featuring ayahuasca, psilocybin, ibogaine, MDMA, and Bufo take place in Southern California every weekend. He introduced me to a friend of his, a hallucinogenic facilitator (who asked not to be named, since use of Bufo is illegal in the U.S.); she told me that she will conduct Bufo ceremonies for people coming out of trauma. Another facilitator told me she prefers a synthetic, lab-made version of Bufo, mostly because its vegan. (Remember, this was in L.A., where kosher LSD is also a thing. Id really like to find the rabbi who blesses the LSD.)

Today Americas intelligentsia is in the grip of a hallucinogenic fever dream.

Dr. Lea Lis, a New York psychiatrist, told me psilocybin, MDMA, and ketamine are now available in more medicinal, controllable formats, and that is the appeal. Were not seeing the 1960s paradigm, with people overdosing on acid. The old trope was a hippie freaked out on too much acid who jumped off a roof. Now were seeing clinical studies and careful doses, and that gives people a sense of greater safety. (Coincidentally, we spoke on the phone while she was at a convention for MAPS, the Multidisciplinary Association for Psychedelic Studies, a nonprofit organization that promotes awareness and acceptance of the use of psychedelics and marijuana in place of or along with more traditional psychotherapeutic treatments.)

A healer in California who has worked with what he describes as American royalty, and some of whose clients I know personally, told me Bufo is perhaps the most ideal form of hallucinogen. Ayahuasca, thats like McDonalds or Burger King by now, he says, adding that the original shamans from Peru have been overtaken by North American Instagram healers and former reality TV stars. You know, some guy with a white feather and 15,000 followers.

How to Change Your Mind: What the New Science of Psychedelics Teaches Us About Consciousness, Dying, Addiction, Depression, and Transcendence

Penguin Pressamazon.com

In 2019, Johns Hopkins scientists published a paper titled Fast-Acting Psychedelic Associated with Improvements in Depression/Anxiety, in which they described a lessening of anxiety and depression when Bufo was given in a ceremonial group setting. Approximately 80 percent of the participants reported improvements in anxiety and depression after a Bufo session. These improvements were related to more intense acute mystical effects during the 5-MeO-DMT experience, as well as increases in rating of the personal meaning and spiritual significance of the experience. Improvements were also related to stronger beliefs that the experience contributed to enduring well-being and life satisfaction.

I spoke to a close friend about her experience with Bufo. Because she comes from a well-known and wealthy family, she spoke on condition of anonymity. She had severe childhood trauma beyond what most of us experience and has spent several years dealing with personal health issues. I finally decided talk therapy wasnt enough, she told me. She invited a facilitator to New York, and for a week he prepared her for the ceremony by having her take a mild hallucinogen twice before her DMT trip and learn breathing techniques to keep herself calm during the experience. And by setting her intentions.

He spent a lot of time with me before I did it, she said. He connected with me and grounded me, and I felt like he prepared me well for the experience. This is not something you would want to do with someone who is unfamiliar with the drug.

" It was like doing 30 years of therapy in two weeks."

Within seconds of inhaling the Bufo, all of a sudden I was seeing prisms and geometric shapes, and I felt like I was passing out, but not in a bad way. I started to drift into something; a different world was opening up.

Often, if users have experienced past trauma, they may start crying and screaming. I suddenly felt this massive amount of rage come out of me, she said, and I came out punching and I wanted to attack him and punch him, and he said go ahead, let it out. She did punch him. For a couple of weeks afterward, the ocean shimmered a little more brightly and the plants and flowers in her garden seemed to bloom more beautifully. What it did was essentially open up a huge emotional vortex in me that allowed all of this rage and sorrow to pass through my body and out of my life forever. It was like doing 30 years of therapy in two weeks.

She kept going to see the psychiatrist who had been treating her for depression for a year and a half after the experience. He said, Wow, youre doing amazingly. You do not have depression. It was a huge energetic shift.

To be clear, this is not a party drug, as the hallucinogenic facilitator in Los Angeles told me. This is an experience that requires preparation and trust and intention. But you dont always know what the Bufo will bring out in you. You dont want to write a script before you get to the play. Without proper preparation, things can go terribly wrong, as they did in 2020, when a Spanish porno actor was charged with the murder of a fashion photographer during an ill-conceived Bufo ceremony. Even Pollan writes in his book that his own experience was just horrible.

When I spoke with an intake specialist for Behold Retreats, a company that organizes various hallucinogenic retreats around the world, he asked me a number of questions about my health, especially my mental and cardiac health. (Because, frankly, I am now curious about trying Bufo. Ive had my share of trauma over the past few years, and to have them sandblasted out of my system, Eternal Sunshine of the Spotless Mindstyle, seems irresistible.)

This is not a drug youd use at a house party, like, Hey, let me lose my ego here! one facilitator said. This is more about assuming you can ride a roller coaster and not die of fear but give in to the freedom. Then get off safely.

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Numinus Wellness has released its latest quarterly results for the three-month period ending on November 30 of 21. The financials within the report are in Canadian dollars as the company is based in Canada and trades on the TSX under the symbol of NUMI. Numinus Wellness is also available to psychedelics investors in the United States through the over-the-counter (OTC) market under the symbol of NUMIF.

Numinus Wellness ended the latest financial quarter with just under $54 million in cash. The companys revenues spiked 245% on a year over year basis, hitting $0.8 million for the period. Numinus earned a gross profit of just under $50,100 during the financial quarter, equating to a 6.5% gross margin. These financial figures indicate Numinus has strategically positioned itself to provide psychedelic-assisted psychotherapy to those in need throughout Canada via the countrys recently expanded Special Access Program.

Numinus revenue soared an incredible 244.5% on a year over year basis, hitting $0.8 million in the initial quarter of 21, largely as a result of the acquisition of fellow psychedelics specialist Mindspace. The companys sequential revenue jumped nearly 61% in this period of time compared to the fourth quarter of 21. It is also interesting to note Numinus growth profit was $38,135 in the first quarter of 21 and $50,965 in the initial quarter of 22.

The companys growth margin was 6.5% for the initial quarter as compared to -16.6% in the initial quarter of 21. The company lost $1.9 million in the first quarter of 21 and $5.4 million in the initial quarter of 22.

Numinus Q1 22 revenue of $141,702 represents a 27.7% decrease from Q1 of 21 and a 56.4% increase from Q4 of 21. These mixed results are primarily the result of the company putting a halt to its cannabis-related business operations in 21, choosing to redirect efforts toward bolstering its psychedelic treatment modalities. Indeed, Numinus succeeded in creating proprietary psychedelic drug tests with new potency scans and toxicity scans in the winter of 21. Such analytical tests will hasten the companys research and development, setting the stage for the generation of that many more revenue streams via product testing.

Numinus submitted a clinical trial application to Health Canada to start the initial study of its proprietary psilocybe extract. The MDMA therapy trial sponsored by MAPS is likely to help patients struggling with post-traumatic stress disorder, also known as PTSD. The company recently received approval from the Institutional Review Board and Health Canada for the study.

Payton Nyquvest, the Chief Executive Officer and founder of Numinus has stated the company has made significant progress in every aspect of its business in the prior financial quarter. He pointed to exciting opportunities for expansion that loom on the horizon. Nyquvest also highlighted the companys partnership with its clinical and lab teams serving as a catalyst that propelled Numinus past its milestones pertaining to two important clinical trials. One of those trials pertains to the MDMA therapy study sponsored by MAPS. The other trial is centered on the use of a proprietary psilocybe treatment modality.

The announcement of the quarterly results also provided Nyquvest with the opportunity to expound on discoveries made within Numinus Bioscience lab. The company recently commenced genetic testing on multiple recently acquired psychedelic mushrooms. These mushrooms are distinct from the others used by the Numinus as they are new species.

Nyquvest also took the opportunity to state Health Canadas amendments to the Special Access Programme reinforce the growth prospects and importance of the companys wellness clinic network. The hope is the network will continue to expand to provide individuals in need with psychedelic treatment modalities. The companys acquisition of the Health Canada distribution license empowers it to produce, possess, import and distribute a litany of psychedelic compounds.

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Breaking Down Numinus Wellness Quarterly Results - The Dales Report

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A new study has found that the leaders of Wari may havelaced their beerwith hallucinogens to keep their political control for centuries. The drugs are said to have been extracted from plant seeds. The Wari are a South American civilization that ruled the highlands of what is now known as Peru, before the Incas. The culture occupied the highlands between 600 AD and 1000 AD.

Archaeological excavations that were conducted between 2013 and 2017 at the Quilcapampa site in the south of Peru have discovered that the tribe used seeds derived from the vilca tree then

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NOTE TO INVESTORS:The latest news and updates relating to Mydecine Innovations Group Inc. (NEO: MYCO) (OTC: MYCOF) are available in the companys newsroom athttps://ibn.fm/MYCOF

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Ancient Latin American Empire Could Have Thrived Thanks to Psychedelic-Infused Beer - StreetInsider.com

I study psychedelics. The organization I work for the Multidisciplinary Association for Psychedelic Studies (MAPS) has been researching MDMA since 1992, seven years after the substance was prohibited. Our organization was founded in 1985.

One of a few treatments designated a breakthrough therapy by the FDA, MDMA-assisted therapy for post-traumatic stress disorder is an incredibly promising treatment for this devastating mental injury. Survivors of PTSD may struggle to stay connected in their work, families, and communities. They often live with symptoms like insomnia, hyper-vigilance and isolation; these commonly lead to substance use disorder, depression, chronic pain or heart problems. Yet most of the available treatments provide symptom relief for only about half of the people with the diagnosis, with even fewer people experiencing remission.

In May 2021, Nature Medicine published the results of the most advanced trial of psychedelic therapy to date. In our Phase 3 trial of MDMA-assisted therapy for PTSD, 88% of participants who received MDMA in conjunction with trauma-focused therapy experienced a clinically significant reduction in symptoms; 67% of participants no longer met criteria for a PTSD diagnosis. Many participants reported MDMA-assisted therapy helped them address the root cause of their trauma for the first time.

An exploratory study suggests a role for MDMA in couples therapy. MAPS has combined its MDMA-assisted therapy protocol with Cognitive Behavioral Conjoint Therapy (CBCT) for PTSD, in which both the person with PTSD and their partner are administered MDMA. Results demonstrated dramatic reductions in PTSD symptoms and partner accommodation, improving the quality of relationships for six couples.

Ketamine studies have shown promise for chronic suicidal tendencies, PTSD symptoms and depression. Legal ketamine clinics which pair therapy with the drug can play a key role in maximizing the benefits and reducing the risks of the psychedelic experience. Psilocybin-assisted therapy is a breakthrough therapy for depression. Ibogaine may be an effective treatment for opioid use disorder.

In fact, four separate systematic reviews have been published this year highlighting the potential of psychedelic-assisted therapies for those conditions and more: end of life care, brain injury, neurodegenerative disorders, mood disorders, smoking cessation and addiction or dependence. Dozens of studies make a compelling case for rapid expansion of research into psychedelic-assisted therapies for serious mental health conditions.

Evidence indicates that psychedelic use is associated with pro-social, personal growth benefits including increased nature relatedness, potentiating conflict resolution and sustaining compassion among first responders. Indigenous communities around the globe have used psychedelics in spiritual ceremony and healing for millennia.

Conversely, the well-documented devastation of the war on drugs has been responsible for untold trauma. But is the legalization and regulation of all substances reversing the course on the war on drugs too dangerous? Simply: No. Its more dangerous not to.

Decades of research and far more extensive use outside clinical settings demonstrate that the risks of drugs, for most people, are generally short-term and manageable through compassionate risk-reduction measures. For those who become dependent on drugs, treatment-on-demand is a more effective intervention than criminalization. In lieu of a legal, safe supply of substances, drug checking can identify adulterants like fentanyl. Peer support is so successful in transforming emotionally challenging experiences that Denvers first responders and police officers will soon be trained in the method as an alternative to criminalization or sedation.

Last year, Oregon became the first US state to decriminalize the possession of most drugs and to create a legal system for supervised psilocybin experiences. California, Vermont and Hawaii are actively considering new legal frameworks for psychedelics; Texas is directing state funding to research. In the face of an epidemic of veteran suicide, the US veterans administration is hosting small psychedelic-assisted therapy trials. Members of Congress from both sides of the aisle support federal funding. Lawmakers, regulators, funders, insurance providers and therapists who take a clear-eyed look at the research may be surprised to find their fears dissolving.

MAPS recognizes that the people who are most marginalized by society are often those who are most traumatized, have least access to a diagnosis and even less access to adequate treatment. MAPS is working with researchers around the world to facilitate studies of psychedelic-assisted therapy with refugees, transgender communities, first responders exhausted by Covid, people of color subjected to racial trauma and more. We envision a day when psychedelics will be more than a last-ditch treatment: they will be a catalyst for mass mental health.

Continued here:

Psychedelics can change humanity for the better. Its time ...

We compared people who microdose that is, who take a psychedelic substance such as LSD (lysergic acid diethylamide) or magic mushrooms (psilocybin) in very small quantities with those who dont, and found that microdosers had healthier scores on key mental health and well-being measures.

Specifically, we found that microdosers scored higher on measures of wisdom, open-mindedness and creativity.

Microdosers also scored lower on measures of dysfunctional attitudes and negative emotionality, which is very promising.

Subtle changes, not hallucinations

Psychedelics microdosing can mean taking five to 20 micrograms of LSD, 0.1 0.3 grams of dried psilocybin-containing mushrooms or very low doses of more exotic substances, like 1P-LSD, ALD-52 or 4-AcO-DMT.

No matter the substance, microdosing implies a dose so low that the individual experiences only subtle changes, not hallucinations. People are not tripping on a microdose; they just go about their regular day, whether that means studying at school, going to work or taking care of the kids at home.

At the time of publishing this story, in 2018, there had been no published science on whether microdosing works, but despite this, microdosing for self-enhancement and mental health has hit the media.

For example, a 2016 article in Wired magazine described young professionals in San Francisco and Silicon Valley microdosing to enhance their creativity and focus, and to gain a competitive advantage.

Ayelet Waldman attributed her increased well-being to microdosing in A Really Good Day: How Microdosing Made a Mega Difference in My Mood, My Marriage and My Life. Michael Pollans How to Change Your Mind has further attracted mainstream attention to psychedelics.

Higher wisdom and creativity

As of November 2018, no experimental study had evaluated psychedelic microdosing, and neither did we.

Randomized placebo-controlled trials are needed to talk definitively about the effects of microdosing. In the meantime, we investigated the experiences of people who already microdose.

Our survey investigated the relationship between microdosing psychedelics and mental health. We recruited participants online, especially from Reddits microdosing community.

We asked our study participants about their microdosing patterns by having them fill in some questionnaires. As firm believers in Open Science, we have openly shared all our materials and you can find them here. Our findings are soon to be published in Psychopharmacology and you can access the preprint here.

We found that microdosers scored higher on wisdom, but wisdom is a tricky thing to define. In this context, wisdom implies considering multiple perspectives, learning from mistakes, being in tune with emotions and people and feeling a sense of connection. Using this definition, microdosers were more wise.

They were also more creative and open. If wisdom is tricky, creativity is even more so. In this case, creativity meant finding unusual uses for regular household objects: A brick and a knife. Microdosers came up with more useful, unusual and unique uses for these objects. This is a well-validated measure of divergent thinking, though certainly not the be-all and end-all of creativity.

Microdosers also scored lower on measures of dysfunctional attitudes and negative emotionality. What does that mean?

Well, dysfunctional attitudes and negative emotionality (aka neuroticism) are bad. Dysfunctional attitudes are beliefs such as, my value as a person depends greatly on what others think of me or if I ask a question, it makes me look inferior. Neither of these are true, and they are unhealthy to believe as they imply vulnerability to stress and depression.

Microdosers endorsed less of these unhealthy beliefs. Likewise, high negative emotionality means a higher likelihood of having a mental health disorder, and microdosers had lower negative emotionality.

An exciting future for clinical science

Our results are promising. As promising as they seem, we dont know whether microdosing actually caused any of these differences.

Maybe people with better mental health were more likely to experiment with microdosing, or perhaps there is some unknown cause that made people both more likely to microdose and to be creative.

At this point, we simply dont know what caused the differences between the groups just that these differences existed. We need to run controlled lab studies to actually find out.

Our preliminary work also shows that people report downsides to microdosing. For example, some people found microdosing increased anxiety and mood-instability; increased aches, pains and gastrointestinal distress were also relatively common.

The most common drawback was that microdosing is illegal. Did we forget to mention that? Yes, psychedelics are totally illegal!

LSD and psilocybin were made illegal in the 1971 UN Convention on Psychotropic Substances and remain so today. The exact laws differ depending on where you live, and using analogue substances can sometimes be a legal grey area but, for the most part, microdosing makes you a criminal.

What we need now are controlled lab experiments randomized placebo-controlled trials of psychedelic microdosing to test safety and efficacy. Microdosing research, alongside full-dose psychedelics, promises an exciting future for clinical science and the study of human flourishing. DM/ML

This story was first published in The Conversation in November 2018.

Thomas Anderson is a PhD student at the University of Toronto. Rotem Petranker is a PhD student in Clinical Psychology at York University, Canada.

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'Microdosers' of LSD and magic mushrooms are wiser... - Daily Maverick