Category Archives: Psychedelics

Aaron Orsini took the psychedelic drug LSD for the first time when he was 27, about four years after he had been diagnosed with autism. The experience, in 2014, transformed his life: During his acid trip, he walked through the woods and encountered another person, and in a simple exchange of greetings, he says he experienced a deep joy in and understanding of human connection that he hadnt previously known.

Since then, Orsini has continued to take LSD periodically, as well as another psychedelic substance, psilocybin. Low to moderate doses of LSD, he says, make him capable of more directly feeling and labeling my own emotional states and perceiving the cues relating to the emotional states of others.

Orsini has had similarly profound experiences taking another substance, MDMA, commonly called ecstasy or molly a psychoactive drug that is not generally considered psychedelic yet shares some similar effects and biochemical targets. MDMA has helped him not only to experience the enhanced social connections many users describe, he says, but to re-examine and deal with the trauma, confusion and self-doubt he carries as an autistic person in a largely non-autistic world.

Orsini detailed his experiences in a 2019 self-published book, Autism on Acid, and a year later co-founded a peer support group called the Autistic Psychedelic Community. Some people describe bad experiences, Orsini says, but growing numbers of autistic people in his forum, and in others focused on autism more generally, are sharing their strongly positive impressions of these substances.

Despite that enthusiasm, researchers are hesitant about the promise of psychedelics for people with autism. The therapeutic potential is far from implausible: Studies in animals models show positive results for MDMA in particular. And psychedelics act primarily on the serotonin system, which is already implicated in autism.

Yet researchers dont know how the biological differences underlying the condition whether in serotonin signaling, brain wiring or other factors might intersect with the drugs effects. And the researchers and pharmaceutical companies exploring these questions need to balance any potential benefits against the risks: MDMA, which is derived from amphetamines, has potential for misuse, for example, and LSD and psilocybin can prompt episodes of psychosis.

Theres a lot of caution, but theres certainly discussion, says Clinton Canal, assistant professor of pharmaceutical sciences at Mercer University in Atlanta, Georgia. I think the big thing is, we need a lot more research.

Its hard to ignore the current boom of studies on psychedelic therapies for a range of neuropsychiatric conditions, including post-traumatic stress disorder (PTSD), chronic pain and intractable depression. Several dozens of companies are testing psychedelic or related compounds to treat such conditions.

To date, little work has directly investigated the role these substances could play in easing autism traits. Yet research on psychedelics as therapies for autism has a documented history: About a dozen small studies conducted from the late 1950s to the 1970s tested psychedelic compounds mainly LSD, psilocybin and a synthetic analog of LSD in autistic children and adolescents.

None of it would stand up today, says Alicia Danforth, a clinical psychologist in private practice and researcher at the Lundquist Institute for Biomedical Innovation at the Harbor-UCLA Medical Center in Torrance, California in part because the diagnostic criteria for autism have changed since then. Also, those studies consisted of only about 100 children in total, and most were observational with poorly defined outcome measures. Just two approach modern standards, she says, and most which included children as young as 5 or those with intellectual disability would be deemed unethical under todays guidelines.

In several cases, children experienced the intense panic and fear characteristic of a so-called bad trip, but on the whole, the studies hinted that many children benefited from the drugs, at least in the short term, showing gains in emotional responsiveness, for example.

Danforth and her colleagues have conducted the only study since then in which autistic people took a psychedelic-like substance in this case, MDMA. That work was funded by the Multidisciplinary Association for Psychedelic Studies, a nonprofit organization that also supported research on psychedelics that demonstrated positive results last year in a late-stage trial using MDMA to treat PTSD.

Danforths trial, published in 2018, was small but yielded some promising results, she says. Eight autistic adults with low support needs took MDMA, and four took a placebo, during two eight-hour psychotherapy sessions, spaced about a month apart. All the participants then attended another three drug-free psychotherapy sessions. Those who had taken MDMA experienced a marked reduction in social anxiety, as measured by a clinician-administered social anxiety scale an effect that lasted at least several months. Afterward, the four people who had received the placebo were offered and accepted the option to take MDMA.

There was definitely a notable and durable drop in social anxiety scores, Danforth says. One participant didnt respond to the drug, she noted, adding that early estimates suggest that about 10 percent of people dont. Seven participants contacted her after the study one as recently as last year just to tell her how positive their experience on the drug had been.

This doesnt work for everybody. But when it does work, it can be quite profound, she says.

Lab studies support the idea that MDMA in particular could benefit autistic people, says Robert Malenka, professor of psychiatry and behavioral sciences at Stanford University in California. My personal feeling is that there really may be a place in the drug armamentarium for MDMA in treating autism. The drug boosts sociability in four mouse models of autism, he and his colleagues reported in 2021.

There is less preclinical evidence for classic psychedelics such as LSD and psilocybin, although their mechanism of action, too, suggests they hold potential. Unlike MDMA, which acts primarily on molecules that transport serotonin and other neurotransmitters, these drugs work largely by stimulating a specific serotonin receptor called 5-HT2A. Decades of research suggest that people with autism have lowered levels of serotonin in the brain, though the nature of the connection is poorly understood, says Gabriella Gobbi, professor of psychiatry at McGill University in Montreal, Canada.

To understand whether and how psychedelic compounds might be used to treat autism, researchers will have to delineate the underlying biology more carefully, Gobbi speculates, and pin down which of the many serotonin receptors are especially important to the condition. We propose a revisitation of the serotonergic hypothesis of autism, she says.

Much of the research on serotonins role in neuropsychiatric disorders focuses on the serotonin 2A receptor, Canal says. But his lab, which is exploring serotonin-based therapies for fragile X syndrome, a leading genetic cause of autism, is investigating other serotonin receptor subtypes as well. Their studies suggest that targeting other receptors, such as 5-HT1A and 5-HT1B, improves social behaviors, prevents sound-elicited seizures and lessens anxiety in mouse models.

Regardless of the target, some drug trials for autism-related conditions have likely faltered because of autisms heterogeneity, and that issue may muddle studies of psychedelic for autism, too, Gobbi says. Its possible some autism syndromes are linked more specifically to the serotonin receptor, so maybe in some subtypes of autism, psychedelics could be good but not in all.

LSD signaling also activates the mTOR pathway, Gobbi and her colleagues reported last year. But because some genetic forms of autism, such as tuberous sclerosis, have disruptions in the mTOR pathway, LSD and other drugs that act on that pathway may not work in the same way in those people, she says.

Individual differences in peoples biological response to psychedelics may also be revealing, says Grainne McAlonan, professor of translational neuroscience at Kings College London in the United Kingdom. She and her colleagues are working to enroll 40 autistic people whose autism has no known genetic cause, plus 30 non-autistic people, for a study of how small doses of psilocybin likely too small to induce psychoactive effects but not as small as the microdoses touted by popular culture affect brain circuitry and responses to sensory stimuli.

They also plan to track how these effects align with blood levels of serotonin, which previous work suggests is elevated in at least a quarter of autistic people. Its likely, she says, that different people have different underlying mechanisms that contribute to their particular suite of autism traits. Looking closely at the underlying biology can begin to identify patterns in these drugs effects on those traits, she says. Our hypothesis is that there is going to be a difference in response to psilocybin in people with and without autism.

Many conceptual questions remain about how psychedelic compounds should be used in autistic people and how they should be tested. For example, researchers are debating whether the psychedelic experience these compounds engender is central to their therapeutic value.

Also, most work on autism therapeutics focuses on children, but giving psychedelic drugs to children may not be ethically justified at least, not if they are administered in doses high enough to cause a trip, as they have been in clinical trials for other conditions, such as PTSD and depression, Malenka says.

Similarly, current clinical trials involving psychedelic therapies for other conditions involve intensive psychotherapy before and along with the treatment so that a trained therapist can help participants find meaning in their experience. But that component could be challenging with an autistic person who is nonverbal or who struggles with communication, Malenka says.

Despite these complexities, several companies are beginning to explore the territory. For example, COMPASS Pathways, a London-based firm testing psychedelic therapies for several mental health conditions, funds McAlonans study. Nova Mentis, based in Canada, is seeking approval in that country to launch a clinical trial to test the therapeutic effects of repeated microdoses of psilocybin in people with fragile X syndrome. The U.S. Food and Drug administration granted the company orphan drug status to pursue a psilocybin compound for fragile X in 2021.

Another company, MindMed, is beginning to investigate a molecule closely related to MDMA one with psychoactive properties but less potential for misuse for treating social anxiety in people with autism or other conditions. (Malenka chairs MindMeds scientific advisory board.) And many more companies are actively exploring psychedelics for conditions that frequently co-occur in people with autism, such as anxiety and depression.

For autistic people to really benefit from psychedelics, researchers will need to look past the usual medical model of drug development, in which a pharmaceutical intervention targets specific features of autism, such as repetitive or social behaviors, McAlonan says. Orsini, for example, is collaborating with researchers at University College London to probe autistic peoples experiences with psychedelic drugs, using a questionnaire. He notes that psychedelics have benefited him in ways researchers might not traditionally think to measure, in terms of quality-of-life improvements rather than shifts in symptoms.

McAlonan puts it this way: Who are we to say what is the target for an individual?

Cite this article: https://doi.org/10.53053/AKMF5393

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Tripping over the potential of psychedelics for autism | Spectrum - Spectrum

As psychedelic medicine edges toward the mainstream, some are trying to make drugs that offer therapeutic benefits without the mind-altering experience. But the experience might be key to how psychedelics transform people's lives

By Thomas Lewton

Janelle Baron; pexels/cottonbro

SWITCHED OFF, short-circuited and shut down. This is how three participants described their depression before they took part in a clinical trial for psychedelic-assisted psychotherapy at Imperial College London in 2016.

Their outlook changed dramatically after taking a high dose of psilocybin, the active ingredient in magic mushrooms. I was a ball of energy bouncing around the planet, one recounted in an interview with Rosalind Watts, a clinical psychologist who led the trial. Another described the experience as akin to defragging a computer hard drive: I visualised as it was all put into order, a beautiful experience with these gold blocks going into black drawers that would illuminate.

Such transformations are no longer surprising. Similar trials have established psychedelics as a game changer when it comes to tackling the global mental health crisis. Theres a huge unmet need, and psychedelics do have radical potential, says Watts.

Now, some scientists are creating new drugs that remove the psychedelic experience, or trip, while still offering therapeutic benefits. But Watts and others are warning that this approach misunderstands how psychedelic therapy works and that if we try to squeeze it into a pill-popping industrial healthcare model, its vast promise may never be realised.

They arent just dishing out warnings, though. Some of the pioneers of the field are moving beyond the simple story that psychedelics reset the brain by carefully investigating the role of the psychedelic experience, and the therapy that accompanies it. The aim is to establish exactly what we cant lose if we are to make good on the hopes raised by psychedelic medicines recent successes.

In psychedelic therapy, people

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Can you take the trip out of psychedelics and still treat depression? - New Scientist

The World Economic Forum (WEF) in Davos, Switzerland where the financial and political elite gather to more or less decide the fate of the world looked a little different this year.

For the first time since the cold war, Russia was blacklisted from the event, its typically lavish party house replaced with a gruesome multimedia exhibit on the promenade titled Russian War Crimes. Due to Covid concerns which has kept the event out of commission for the last two years the forum was held in the spring instead of the typical January, so world leaders were cheated out of their ski breaks in the Swiss Alps.

And to the surprise of many, psychedelic drugs were one of the hottest topics of discussion on the streets of Davos.

Like the Russian War Crimes exhibit, the Psychedelic House of Davos was one of several satellite events happening in conjunction with the World Economic Forum (though not directly associated with it). As with every year, each building along the promenade of downtown Davos hosted different countries including India, Poland and Ukraine businesses such as the Wall Street Journal, and industries like blockchain and cryptocurrency, which put on weeklong parties with speakers, panelists and networking mixers, all designed to seduce world leaders into supporting their agenda.

We spark curiosity with the neon sign out front, said Maria Velcova, one of the organizers of Psychedelic House of Davos. Once people get curious and brave enough to come down here, they realize that this isnt some underground electronic dance party. They find themselves meeting world-renowned scientists, clinicians, policymakers, people from for-profit and non-profit sectors, and experts from leading academic institutions.

While psychedelic treatments for mental health problems have garnered wild enthusiasm from the media and parts of the scientific community, news of this booming new industrys presence at Davos this year was a bit too surreal for some to handle.

After a headline on Bloomberg news declared Forget Burning Man, Psychedelic Shamans Are Heading To Davos, late-night comedian Stephen Colbert quipped in his opening monologue, Oh good, just what billionaires need: a looser grip on reality.

Colbert was specifically referring to event speaker and shamanic investing expert Silvia Benito, whom Bloomberg described as having deep expertise in ayahuasca and experience managing family investments.

Hopefully at the same time, said Colbert. We split your investments between high yield stocks, medium yield bonds and the sense-memory of your wronged ancestors, who will appear to you as a wolf with your fathers voice. Now walk with me into the fire, where we will itemize your deductions.

While the weeklong event did feature plenty of woo-woo fodder for late-night comedians, such as sound healing ceremonies, psychedelic breathwork and immersive art installations designed to stimulate immersive hepatic reprogramming, the Psychedelic House of Davos was dominated by a sober catalog of lectures and panels.

Science, investment and ethics made up the bulk of topics discussed, while the audience included an eclectic range of burner psychonauts, big pharma investors and humanitarians from around the globe concerned about the escalating mental health crisis.

I am a firm believer that psychedelics have the ability to unlock novel approaches to disorders notoriously difficult to treat, like PTSD, alcoholism, opioid addiction and pain, said Kevin McKenzie, co-founder of Carvin Medicines, a Swiss drug company entering the psychedelic drug market. Hosting this in Davos at the same location as WEF is a genius strategy it brings fresh eyes and bright minds to psychedelic drug development, which builds credibility for these medicines.

Its difficult to identify any one moment that inspired the sudden recent popularity of psychedelic drug therapy after all, the treatment seemed poised for breakthrough in the 1950s. But many point to author Michael Pollans massively popular 2019 book How To Change Your Mind: What the New Science of Psychedelics Teaches Us About Consciousness, Dying, Addiction, Depression and Transcendence.

That same year, Denvers decriminalization of psilocybin created a domino effect of legislative reforms across the US, leading Oregon to decriminalize all drugs in 2020. Just last week Senators Cory Booker and Brian Schatz sent a letter to the NIH and FDA requesting they identify regulatory roadblocks keeping psychedelic research from moving forward.

And earlier this year, the health minister of Australia approved $15m in funding to research whether MDMA can be an effective tool in treating PTSD and alcoholism.

Often the world of psychedelic science finds itself in a catch-22 triangle of needing more research before politicians will change drug laws, yet needing more funding to do the necessary research, while investors need the laws to change before they will risk funding the research. Still, a handful of recent developments have kept this momentum alive.

Last year the UK psychedelic company Compass Pathways completed the first randomized, double-blind trial of psilocybin for the treatment of depression, given to 233 patients across Europe and North America. Those treatments were administered by trained therapists, while MindBio Therapeutics just completed phase one of their research around LSD microdose therapy, which, for the first time, allowed participants to self-administer the drug at home.

Its all changed very quickly and dramatically when it comes to the business interest in psychedelics, said chemist and documentarian Hamilton Morris, after his presentation at the Psychedelic House of Davos. And thats led to increased interest from the public and academia, and increased pressure for government funding of psychedelic research. Until recently theres been virtually no funding for this kind of research, either government or commercial.

Funding is still relatively scarce it costs about $2.6bn to bring a single drug to market but the marriage of high finance and the science of highs is beginning to seem inevitable.

Billionaires like Peter Thiel (PayPal), Bob Parsons (GoDaddy) and dozens of others have already invested heavily in psychedelic companies. In 2021 alone, 45 different investments led to a $595m windfall into the psychedelic medicine industry, leading Elon Musk to flirt with the trend when tweeting last month: Ive talked to many more people who were helped by psychedelics & ketamine than SSRIs & amphetamines.

A Vice News journalist, Shayla Love, was somewhat of a wet blanket at the Psychedelic House of Davos which at times felt like a pep rally for the industry by bringing attention to concerns around unethical business practices, overpromising the efficacy of psychedelic treatments and instances of sexual abuse against patients while under the influence of drugs in clinical trials.

Psychedelics in the last two or three years, particularly since Michael Pollans book came out, have had extremely positive coverage, she said during a panel discussion. And unfortunately a lot of the people who write about psychedelic studies may not have a background in science, and present too simplistic a conclusion on this research. Im not working in opposition to anyone, but I do report on these issues as they arise and as I see them. I think the coverage has been overwhelmingly positive and theres room for more nuanced approaches.

By the end of the week, Hamilton Morris said the Psychedelic House of Davos felt more or less like any of the other dozens of psychedelic business and science conferences popping up all over the world these days.

While hes a little burnt out on them and wants to get back to his chemistry lab, he admits coming here due to some degree of morbid curiosity, because I never thought Id see something like this at Davos. It has a reputation for being the international epicenter of avarice and business, things that seem superficially antithetical to the world of psychedelics.

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We spark curiosity: how the psychedelics industry is taking on Davos - The Guardian

TORONTO--(BUSINESS WIRE)--Cybin Inc. (NEO:CYBN) (NYSE American:CYBN) (Cybin or the Company), a biopharmaceutical company focused on progressing Psychedelics to Therapeutics, is pleased to announce the publication of a peer-reviewed article introducing EMBARK, a model of psychedelic-assisted psychotherapy that integrates leading clinical approaches to promote effective facilitation and supportive healing with psychedelic medicines.

Its a pleasure to see our work published in this respected journal. In developing EMBARK, we looked at 17 models of psychedelic-assisted psychotherapy, and we noticed that many are missing critical elements: a focus on ethics, on human relationships, on the body as a site of somatic healing, and on evidence-based practices. We designed EMBARK to overcome some of these limitations as an integrative model of psychedelic therapy. Wed like to honor the contributions of many teachers and leaders in the field who have helped chart this course, said Alex Belser, PhD, EMBARKs co-creator and Cybins Chief Clinical Officer.

The article was published on June 2, 2022 in the peer-reviewed journal Frontiers in Psychology and is titled, Models of Psychedelic-Assisted Psychotherapy: A Contemporary Assessment and an Introduction to EMBARK, a Transdiagnostic, Trans-Drug Model. Written by EMBARKs co-creators, Bill Brennan, PhD and Alex Belser, PhD, Cybins Chief Clinical Officer, the article provides a detailed overview of EMBARK to the academic and clinical communities. Frontiers in Psychology is the largest journal in the field of psychology.

We are excited to present our model to the field in a way that highlights its thoughtfulness and responsiveness to current concerns in psychedelic research. We have listened carefully to what has worked, and what has been found lacking, and offer EMBARK as an innovative step forward, said Bill Brennan, PhD, EMBARKs co-creator.

The article also provides an overview of EMBARKs six clinical domains (Existential-Spiritual, Mindfulness, Body Aware, Affective-Cognitive, Relational, and Keeping Momentum) and highlights the strengths and limitations of existing psychedelic-assisted psychotherapy approaches and evidence-based therapies. The article is the first of a series of publications aimed at presenting EMBARK as an open-source model of practice and training for therapists and facilitators supporting psychedelic-based treatments.

If psychedelics are ever to be integrated into modern clinical medicine, the usage protocols are as important as the medicines themselves. In this respect Cybin is a leader. Cybin has assembled a faculty of top-notch therapists to lead its EMBARK program, which incorporates a multi-dimensional approach to therapies that enable them to be tailored to a variety of patient needs. With the implementation of EMBARK, Cybin is setting high standards for the future of psychedelic therapy, said Dennis J. McKenna, Ph.D., Founding Board Member of Heffter Research Institute and President and Principal Founder of McKenna Academy of Natural Philosophy.

The article can be accessed online here.

Cybins upcoming clinical trials evaluating the Companys proprietary psychedelic-based molecules CYB003 and CYB004 for treating major depressive disorder, alcohol use disorder, and anxiety disorders will use EMBARK to support study participants.

About CybinCybin 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, the 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.

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 December 31, 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.

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Cybin Announces Publication in Frontiers in Psychology Journal Introducing EMBARK, an Integrative Model of Psychedelic Therapy - Business Wire

When he gets up to go to the bathroom, you should help him.

I shook my head at my friend, Jimi. The advice, given to him by a guide over Zoom, suggested Jimi would have to do some things to help me that he hadnt signed up for when he agreed to watch me take ketamine for therapy.

It struck me as unlikely that Jimi would have to help me go to the bathroom. But really, I had no way of knowing. I consider myself highly experienced in the Jimi Hendrix sense of the word (this cowboy isnt new to the psychedelic rodeo), but I was entirely unfamiliar with ketamine.

In March 2022, I signed up to go on an interior journey with Mindbloom, a psychedelic therapy company that provides what is for all practical purposes ketamine-by-mail accompanied by therapeutic treatments given over Zoom. It is essentially an emerging form of teletherapy, taken to a new participatory extreme.

Editors note: This is a personal opinion essay.

Mindbloom is part of a vanguard of emerging healthcare providers using the technology we have all come to rely on during the Covid-19 pandemic to deliver a similarly innovative medical intervention for psychiatric conditions: psychedelics.

Along with ketamine, psilocybin and LSD are being reconsidered as treatments for brain conditions like depression, post-traumatic stress disorder, anxiety, and other behavior and mood issues after years of being maligned as illegal party drugs.

Scientific studies demonstrate ketamine has rapid antidepressant effects for individuals with major depression and bipolar depression, says Lawrence Park, Director of the Clinical Research Unit at the National Institute of Mental Healths Experimental Therapeutics and Pathophysiology Branch.

Ketamine hasnt been approved by U.S. regulators for treating depression, but the Food and Drug Administration approved an intranasal form called esketamine for treating resistant depression in adults. The FDA has Fast Tracked ketamine and designated it a Breakthrough Therapy distinctions that speed up research and clinical trials to help combat what some experts call an epidemic of depression.

Teletherapy, in turn, offers an innovative opportunity to expand these emerging treatments reach until the drugs become more widely accepted as an option for treating conditions that often get missed in the clinic.

HORIZONS is a newsletter on the innovations and ideas of today that will shape the world of tomorrow. This is an adapted version of the June 2 edition. Forecast the future by signing up for free.

The Mindbloom kit.Courtesy of Mindbloom

Mindbloom insists that for a clients first session they be surveilled by a peer treatment monitor. In other words, Jimi joined me for my first session as my trip-sitter to borrow a classic psychedelic phrase whose job it was to keep an eye on me as I took powerful drugs that can occasionally cause a bad trip. (Its worth noting that studies have shown 84 percent of people who experience a bad trip in fact find them to be positive experiences overall.)

This monitor functions as an on-hand check to make sure your session doesnt go off the rails one of the pros and cons of telehealth, after all, is that the therapist isnt in the room with you.

Once my Mindbloom guide had delivered instructions to myself and Jimi, I put on a set of headphones and turned on the audio track Mindbloom sent me to accompany the therapy session. Then I slipped on the eye mask that had come with my ketamine kit, placed two big pink pills in my mouth, and waited for them to dissolve as directed.

Did I hallucinate and freak out? Did I find bliss and enlightenment? Did Jimi have to help me go to the bathroom?

Before we dive into my experience, lets consider the science behind ketamine therapy.

In teletherapy, doctors deliver therapy to clients via online software.Su Arslanoglu/E+/Getty Images

Ketamine was first used as a surgical anesthetic for horses, dogs, and eventually soldiers during the Vietnam War. It gained recreational popularity in the 1990s when ravers took advantage of its dissociative, hallucinogenic qualities. The War on Drugs set Special K in its sights, and for about 20 years, all most of us heard about the substance is that it induces a K-Hole a dissociative state as feared as it was sought after.

However, innovative approaches to treating psychiatric conditions suggest the very same K-Hole might have offered therapeutic potential all along. Yesterdays drug-fueled dissociative drop-out is todays scientifically supported psychedelic therapy candidate.

Ketamine was initially studied as an intravenous infusion 0.5 mg/kg given over 40 minutes and it demonstrated antidepressant effects as soon as several hours after the infusion, peaking at one day after the infusion, NIMH scientist Park explains to Inverse.

Ketamine has also been studied for a number of other conditions social anxiety, PTSD, obsessive-compulsive disorder, substance abuse, suicidality but there is not enough data yet to support its use for these conditions, he adds.

Park explains that the people who may benefit most from ketamine therapy are people who have major depressive episodes and do not benefit from standard antidepressants. But ketamine is not suitable for everyone, he cautions, and individuals should be assessed by a clinician. (This is a good moment to mention that you should consult your doctor before embarking on any medical treatment.)

Paul Glue, professor of psychiatry at the University of Otago in New Zealand, points out that the research so far suggests that in addition to depression, ketamine may also be used to treat different types of anxiety conditions, OCD, and anorexia nervosa.

One explanation for this broad therapeutic effect could be that ketamine is affecting a personality trait common to all of these conditions in this case, neuroticism, he says.

Neuroplasticity may also be critical to how ketamine works, Glue adds. People with depression and other psychiatric conditions show brain connectivity issues that ketamine and other drugs could alleviate, he says. In turn, it appears the neuroplasticity ketamine induces also requires very low doses of the drug.

Neuroplasticity is a broad term that relates to the brain's capacity to change both in function and structure in response to life experience or over time, he says. Ketamine and serotonergic psychedelics (e.g. psilocybin, MDMA) have common effects on cellular processes that promote new connections between nerve cells.

These neuroplastic effects occur at drug concentrations that are lower than those associated with psychedelic effects, adds Glue. [This report supports] the idea that microdosing of psychedelics might have useful effects on mood/creativity.

Ketamines dissociative qualities may be its advantage.Marco_Piunti/E+/Getty Images

When I initially poked into the ketamine therapy scene, the majority of providers offered in-clinic intravenous treatment. Mindbloom is one of the first companies to deliver ketamine into patients homes and try counseling using new video chat tools that have become a staple of life during the lockdown.

This mode of treatment suited my schedule and geography but also felt like a natural choice in a world coming out of lockdown. With pandemic-fueled depression soaring and social distancing still a thing, at-home teletherapy makes a lot of sense.

In the U.S., a doctor can prescribe drugs for off-label purposes that are not approved by the FDA. Ketamine is approved for use as an anesthetic, so it can also be prescribed for depression. Doctors at Mindbloom can mail clients prescribed ketamine tablets.

Mindbloom has a rather straightforward intake process to ensure you are eligible for therapy. Then, you embark on a series of six therapy sessions in which you take ketamine in a controlled environment and talk to guides and doctors over Zoom.

The first session involves taking an initial dose of ketamine, speaking with a trained Mindbloom guide before and after your trip, and having someone (Jimi) with you to make sure you dont freak out on the drug.

As you go through the six sessions, Mindbloom sets up video appointments with a guide and medical check-ins. Doctors ask you over the computer about any side effects you might be having, inquire about your state of mind, and catalog any experiences you have on the drug, like hallucinations or epiphanies.

When I did my first session, I wasnt sure what to expect. My tolerance for psychedelics is high, and so is my skepticism toward mail-order ketamine. I felt as if Id left my body, but only a little. I didnt have any breakthroughs or see any elaborate hallucinations, but I did have some intriguing thoughts on my life circumstances and felt a gentle sensation that my mind was tumbling in a series of foamy waves. It was as if my brain was being smoothed in a rock polisher.

After about an hour I sat up and it was over. I felt unusually calm. Jimi did not have to help me go to the bathroom.

My first therapy session was followed by what Mindbloom calls an integration session. Over Zoom, I talked with a guide about my experience and they advised me to dwell a little on those intriguing thoughts. I had a check-in with my Mindbloom-provided doctor, and based on what I told them, they upped my dosage a little from 400 mg to 600 mg. I got the pills for my next five sessions in the mail soon after.

My next session was substantially more visual and thought-provoking. This time it felt as if Id left my body and was traveling someplace dark and expansive (space?). Suddenly, I found myself at the site of past trauma. It was as if I was there but in an abstract way. A sort of ghost of Christmas past situation. For me, it afforded an opportunity to view the traumatic experience through fresh, distant eyes.

For such a personal therapy experience, teletherapy is impersonal by design. But the Mindbloom guide and doctor with whom I worked were both highly empathetic and seemed to want to help. As we increasingly become accustomed to living and working over video calls, conducting therapy sessions via video makes sense. But taking medication and working with a professional over Zoom or another video chat provider is still an emerging area of medicine. I would not have had such easy and quick access to this therapy if it were not for teletherapy companies like Mindbloom I am sure I am not alone.

Personally, I dont see any dramatic upside to being in the clinic. The key benefits are garnered from the ketamine itself.

Was I cured of my issues? No, but thats not really the point. I can say this: I came away from my teletherapy sessions with novel questions about some issues about which Id long held static beliefs. To put it another way, it broke me out of a pattern of thought. And for several days after each session, I felt noticeably calmer. Perhaps many of us might benefit from having our brains polished now and again.

HORIZONS is a newsletter on the innovations and ideas of today that will shape the world of tomorrow. This is an adapted version of the June 2 edition. Forecast the future by signing up for free.

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Ketamine can treat depression but teletherapy could make it accessible - Inverse

MIAMI, June 01, 2022 (GLOBE NEWSWIRE) -- Ehave, Inc. (OTC Pink: EHVVF) (the Company”), a leading healthcare services and technology company, announced today its KetaDASH subsidiary will begin using precision medicine to improve patient outcomes through its partnership with Entheon Biomedical Corp.’s (CSE: ENBI) (OTCQB: ENTBF) (FSE: 1XU1) ("Entheon") wholly-owned subsidiary, HaluGen Life Sciences Inc. (HaluGen”) to use its psychedelics genetic test kit. KetaDASH will become one of the first psychedelic companies to use precision medicine to test patients by using HaluGen’s expanded psychedelics genetic testing panel, which analyzes a series of relevant DNA biomarkers and utilizes pre-screening mental health surveys in order to provide insights into an individual's risk and potential of adverse reactions with the use of ketamine.

By utilizing precision medicine, medical professionals will be able to test patients for genetic, personal and familial insights to better inform each patient’s psychedelic assisted therapy experience. KetaDASH believes that DNA test results, and data from mental-health surveys, will allow individuals to make more informed decisions around psychedelic assisted therapy, potential side effects and risk profile.

Genetics can play a key role in determining how an individual may respond to psychedelic-assisted psychotherapy. The gene mutation CYP2B6 can influence the metabolism of ketamine for the 10-20% of people that carry a specific CYP2B6 gene variant. Similarly, the HTR2A gene mutation, which is carried by approximately 20% of the population, can impact how a person responds to serotonin, which is the primary mechanism of action for serotonergic psychedelics such as psilocybin, LSD and DMT. Precision medicine will provide KetaDASH with the ability to tailor the treatment based on an individual or sub-groups variability in genes and lifestyle choice.

Ben Kaplan, CEO of Ehave, said, The benefit of the psychedelic profile is that it will enable the individuals and healthcare professionals at KetaDASH to personalize psychedelic therapy by providing an individual’s metabolic status for ketamine with their CYP2B6 genotype. We are pleased with the results from the initial launch of KetaDASH in the San Francisco and Sacramento area. Having the ability to personalize psychedelic therapy will prove beneficial and set us apart from our competitors as we expand KetaDASH into other markets.”

Timothy Ko, CEO of Entheon, commented, We are thrilled to support Ehave and KetaDASH with the use of our genetic test kits. We believe that personalization will become an increasingly important feature of the psychedelic therapeutics landscape and applaud the pioneering steps that they are taking to deliver a standard of care that takes into account the individual nuance of every patient.”

About Ehave, Inc.

Ehave is a leading healthcare services and technology company, focused on progressing psychedelics-to-Therapeutics by engineering novel compounds and new treatment protocols for treating brain health. Together with our network of scientists and mental health professionals, we are on a mission to create safe and effective therapeutics for patients to address a multitude of mental health issues, leveraging clinical data to help us achieve optimal patient outcomes. Ehave’s operations span across the entire USA, Canada, Jamaica, and Australia. Additional information on Ehave can be found on the Company’s website at: http://www.ehave.com.

About Entheon Biomedical Corp.

Entheon is a biotechnology research and development company committed to developing and commercializing a portfolio of safe and effective Dimethyltryptamine based psychedelic therapeutic products ("DMT Products") for the purposes of treating addiction and substance use disorders. Subject to obtaining all requisite regulatory approvals and permits, Entheon intends to generate revenue through the sale of its DMT Products to physicians, clinics and licensed psychiatrists in the United States, certain countries in the European Union and throughout Canada. https://www.entheonbiomedical.com

About HaluGen Life Sciences Inc.

HaluGen has developed a DNA testing and personalized psychedelic pre-screening platform that provides genetic, personal and familial insights to better inform the psychedelic experience, with the goal of improving patient care and reducing side effects and risk. HaluGen's genetic-based psychedelic pre-screening platform helps evaluate an individual's overall sensitivity and risk profile when using hallucinogenic drugs. This platform is the first of its kind with test results within days. https://www.halugen.com

Forward-Looking Statement Disclaimer

This press release contains forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements may be preceded by the words intends,” may,” will,” plans,” expects,” anticipates,” projects,” predicts,” estimates,” aims,” believes,” hopes,” potential” or similar words. Forward-looking statements are based on certain assumptions and are subject to various known and unknown risks and uncertainties, many of which are beyond the Company's control, and cannot be predicted or quantified and consequently, actual results may differ materially from those expressed or implied by such forward-looking statements: (i) the initiation, timing, progress and results of the Company’s research, manufacturing and other development efforts; (ii) the Company’s ability to advance its products to successfully complete development and commercialization; (iii) the manufacturing, development, commercialization, and market acceptance of the Company’s products; (iv) the lack of sufficient funding to finance the product development and business operations; (v) competitive companies and technologies within the Company’s industry and introduction of competing products; (vi) the Company’s ability to establish and maintain corporate collaborations; (vii) loss of key management personnel; (viii) the scope of protection the Company is able to establish and maintain for intellectual property rights covering its products and its ability to operate its business without infringing the intellectual property rights of others; (ix) potential failure to comply with applicable health information privacy and security laws and other state and federal privacy and security laws; and (x) the difficulty of predicting actions of the USA FDA and its regulations. All forward-looking statements included in this press release are made only as of the date of this press release. The Company assumes no obligation to update any written or oral forward-looking statement unless required by law. More detailed information about the Company and the risk factors that may affect the realization of forward-looking statements is contained under the heading "Risk Factors" in Ehave, Inc.’s Registration Statement on Form F-1 filed with the Securities and Exchange Commission (SEC) on September 24, 2015, as amended, which is available on the SEC's website, http://www.sec.gov.

For Media and Investor Relations, please contact:

David L. Kugelman

(866) 692-6847 Toll Free - U.S. & Canada

(404) 281-8556 Mobile and WhatsApp

Email: Ir@Ehave.com

Skype: kugsusa

LinkedIn: https://www.linkedin.com/in/davidkugelman

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2022-06-01 | PINL:EHVVF | Press Release | ehave Inc - Stockhouse

Welcome to my latest video presentation. The article below is a condensed transcript; the video provides additional details as well as several charts.

For decades, the establishment waged a relentless propaganda war against marijuana. Consider this 1905 Washington Post article, in which an anthropology professor describes his experimental smoking of marijuana and the symptoms that he claims to have experienced:

Everything seems to move around the smoker, this whirl becoming faster and faster, until all sense of his surroundings is lost

The next step of his intoxication is full of terrors. Troops of ferocious wild animals march before the vision of the smoker. Lions, tigers, panthers, and other wild beasts occupy his vision. The wild animals are then attacked by hosts of devils and monsters of unheard of shapes. The smoker becomes brave and possessed of superhuman strength. It is at this stage of the debauch that murders are committed by the smoker.

Mmmkay! Fast forward to 2022, and marijuana is increasingly legal, as well as lucrative and socially accepted. Based on New Frontier Datas latest analysis of state legalization campaigns, U.S. legal sales of recreational and medical pot (combined) are on track to exceed $72 billion on an annual basis in 2030. Lets look at the latest news in the mainstreaming of what used to be called the devils weed.

Marijuana and Federal Law. Several major cannabis companies, lobbyists, and investors are joining forces to sue the federal government over what they decry as unconstitutional policies harming their operations. Theyve retained a prominent law firm led by attorneys who have been involved in several highly publicized federal cases.

The marijuana companies, many of them large multi-state operators (MSOs), have retained the high-powered law firm of Boies Schiller Flexner LLP. David Boies, the firms chairman, boasts a long list of famous and powerful clients, including Al Gore and Jeff Bezos.

One of the goals of the coalition is repeal of a tax provision called 280E that prevents the marijuana industry from taking tax deductions that are available to any other non-marijuana company.

Among members of the coalition is The American Trade Association for Cannabis and Hemp (ATACH). The plan is to file lawsuits in federal district court sometime this summer.

Massachusetts. Adult-use marijuana sales in the Bay State have officially surpassed $3 billion (as of May 14), since the market launched in 2018, the states Cannabis Control Commission reported last week.

Massachusetts marijuana tax revenue is now exceeding that being generated from alcohol sales. Thats a welcome development for marijuana advocates who have long argued that marijuana is less harmful than alcohol and should be viewed as a favorable substitute.

Michigan. In a minor setback for the movement to legalize psychedelics, the East Lansing, Michigan City Council last week rejected a resolution to decriminalize psychedelics in the jurisdiction. The mayors office, city attorney, and local lawmakers expressed concerns about legal blowback of the reform proposal.

But the vote in Michigan represents a mere speed bump for the fast-growing psychedelics industry. A slew of jurisdictions across the nation have decriminalized psychedelics, laying the groundwork for a new industry. In coming years, the psychedelics industry could capture a major slice of the $28.6 billion global antidepressant market.

New Jersey. One month into the implementation of legal marijuana in the Garden State, consumers have bought $24 million in recreational marijuana, state regulators reported last week. Jeff Brown, executive director of the states Cannabis Regulatory Commission, stated: Its really only a beginning, and I think it shows that theres a lot of growth left in this market.

Rhode Island. The governor of Rhode Island signed a bill last week to legalize marijuana, making it the 19th state to end prohibition. Gov. Dan McKee (D) signed the measure just one day after the legislature sent it to his desk. Adults 21 and older can now legally possess up to one ounce of cannabis in the Ocean State and grow up to six plants for personal use, only three of which can be mature.

Consumer Behavior. A recent study shows that younger generations are purposely choosing cannabis over alcohol. The study, conducted by New Frontier Data, underscores the argument of pro-marijuana advocates that pot is better for public safety and health than alcohol. Indeed, physicians increasingly make the claim that weed is far healthier than booze.

Read This Story: Marijuana and Money: An Insider Interview

Worried about inflation, recession, and rising interest rates? The trends Ive just described are resistant to short-term ups-and-downs. The mainstreaming of marijuana is making investors rich, in good times or bad.

Your portfolio needs exposure to marijuana stocks, but selectivity is key. Thats why I urge you to read my new book: The Wide World of Weed and Psychedelics. Its your definitive guide for making money in the thriving cannabis and psychedelics industries. Click here to get your free copy.

John Persinos is the editorial director of Investing Daily.

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VIDEO: The Weekly Weed Report (05-31-22) - Investing Daily - Investing Daily

Welcome to TDRs review of the Top 5 Psychedelic developments for the week of May 9. Aside from presenting a synopsis of events, we provide market commentary to summarize the week that was for publicly-listed companies.

5. Biden Administration Announces $1.5 Billion Funding Opportunity for State Opioid Response Grant Program

The U.S. Department of Health and Human Services (HHS), through the Substance Abuse and Mental Health Services Administration (SAMHSA), is announcing a State Opioid Response (SOR) grant funding opportunity that will provide nearly $1.5 billion to states and territories to help address the Nations opioid addiction and overdose epidemic. In President Bidens State of the Union, he named beating the opioids epidemic as a pillar of his Unity Agenda. Todays announcement is a critical step forward in that work, and the SOR program, along with theTribal Opioid Responsegrant funding opportunity announced recently, are critical tools in President Bidens inaugural National Drug Control Strategy released last month and the Health and Human Services (HHS)Overdose Prevention Strategy.

The State Opioid Response grant program delivers crucial aid to states and territories to help address in the crisis of overdose and death in our nations communities, said HHS Secretary Xavier Becerra. And, in line with HHS Overdose Prevention Strategy, this funding helps facilitate state- and territory-level efforts to ensure the full continuum of prevention, harm reduction, treatment and long-term recovery supports are in place and accessible to all who need them.

TheSOR grant programprovides formula funding to states and territories for increasing access to FDA-approved medications for the treatment of Opioid Use Disorder (OUD), and for supporting prevention, harm reduction, treatment, and recovery support services for OUD and other concurrent substance use disorders (SUD). The SOR program also supports care for stimulant misuse and use disorders, including for cocaine and methamphetamine. The SOR program helps reduce overdose deaths and close the gap in treatment needs across America by giving states and territories flexibility in funding evidence-based practices and supports across different settings to meet local community needs.

4. Awakn Life Sciences Completes Worlds First Ketamine Treatment Study for a Range of Behavioral Addictions

Awakn Life Sciences Corp.(NEO: AWKN)(OTCMKTS:AWKNF) announced today the completion of the worlds first ketamine treatment study for behavioral addictions. The behavioral addictions included in the study were Gambling Disorder, Internet Gaming Disorder, Binge Eating Disorder and Compulsive Sexual Behavior.

Results from Awakn's #ketamine treatment study for behavioral #addictions indicate the desired effects via potentially novel mechanisms and these results merit a larger study and further exploration, which Awakn is now initiating. Learn more: https://t.co/7DW4Tu3RCF $AWKN $AWKNF

The study was led by Prof. Celia Morgan, Awakns Head of Ketamine-Assisted Therapy, Professor of Psychopharmacology at the University of Exeter, U.K., and an internationally respected expert in the therapeutic use of ketamine. The study investigated ketamine as a new treatment approach for these behavioral addictions by opening a window in which the brain can make new connections to change behavior.

The results from the study indicate the desired effects via potentially novel mechanisms and these results merit a larger study and further exploration, which Awakn is now initiating. The study also supports Awakns Intellectual Property (IP) strategy and existing filed patent applications, positioning Awakn as a leading company in the behavioral-addiction therapeutic research and development industry. The company expects to update investors further on its IP strategy in the coming weeks.

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Antidepressants And Psychedelics Drug Interaction Chart

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3. Big Rebound As Psychedelic Stocks Outperform BioPharma Indexes

The biggest psychedelic stocks mostly rose this past week, noticeable outperforming peer biopharma indexes. TheHorizon Psychedelic Stock Index ETF(PSYK) climbed12.80%, which was materially stronger than both theNasdaq Junior Biotechnology Index(2.42%) andNasdaq Biotechnology Ishares ETF(2.18%). This occurred despite broad markets which slumped for a seventh consecutive weekNASDAQ1004.40%andS&P 5002.93%. This was the seventh consecutive week of decline in both of these indexes, which hasnt occurred since the Great Financial Crisis of 2008. Heres how the Health Care (Biotechnology) sector performed:

Weekly technical snapshot, PSYK ETF:

In the news

atai Life Sciences reported financial results for the quarter ended March 31, 2022 and provided a business update. Ended the first quarter with $335 million cash, maintaining atais position as a well-funded, leading mental health company.

TDRs Take: Atai Life Sciences: Optimizing Drug Development By Avoiding Big Pharmas Past Missteps

Australias national science agency CSIRO is aiming to develop new psychedelics for a variety of mental health conditions including depression, addiction, end-of-life anxiety and PTSD.

Awakn Life Sciences announced that Dr. ArunDhandayudham is joining Awakn as its Chief Medical Officer. Dr. Ben Sessa is stepping back from his role as CMO to become Awakns Head of Psychedelic Medicine, allowing him to continue his work in research, academic and training activities, as well as a greater focus on the day-to-day treatment of his clients as the Lead Physiatrist for Awakn Clinics Bristol.

Braxia Scientific receives Special Access Program (SAP) approval for use of psilocybin inOntario. Health Canada approval is for patients with Major Depressive Disorder in the absence of terminal medical illness or end of life distress.

CB Therapeutics has been granted a new patent covering the use of microorganisms to produce tryptamines and their analogs, such as psilocybin and various other molecules found in magic mushrooms.

Clearmind Medicine announced positive safety results of its proprietary molecule, MEAI, to treat alcohol abuse.

Clerkenwell Health opening Europes first commercial psychedelic research facility.

Davos 2022: The first ever medical psychedelics series will be hosted by Energia Holdings Incorporated. The worlds most prominent psychedelic industry leaders, drug development experts, clinicians, nonprofit organizations, advocates, and influencers will gather separately inDavosat the inauguralMedical Psychedelic Seriesto help shape the future of mental health.

Havn Life Sciences announced a partnership withTheraPsil a non-profit coalition dedicated to helping Canadians in medical need access legal psilocybin-assisted psychotherapy and GMP-quality psilocybin. Under the Partnership, TheraPsil will support prescribing healthcare professionals in requesting psilocybin from HAVN Life, and other licensed dealers enrolled in TheraPsils Project Solace, through the Special Access Program. TDR interviews CEO Tim Moore:

Mind Medicine announced that the registration statement on Form S-3, filed onMay 4, 2022, was declared effective by the U.S. Securities and Exchange Commission, which includes a prospectus for an at-the-market equity offering under which the company may offer and sell its Subordinate Voting Shares or common shares re-designated from the Companys Subordinate Voting Shares for up to$100,000,000in aggregate sales proceeds.

Nirvana Life Sciences announced the appointment of Mr. Jakson Inwentash to the companys Board of Directors.

Optimi Health has completed the acquisition of a diverse catalog of psilocybin and functional mushroom strains intended for cultivation in its 20,000 square foot, EU-GMP compliant facility in Princeton, British Columbia.

Red Light Holland has completed the third export of psilocybe truffles, from the Netherlands to Canada, under a Health Canada psilocybin import permit awarded to CCrest Laboratories Inc. in partnership with Shaman Pharma Corp.

Silo Pharma announced that it in conjunction with the University of California San Francisco (UCSF), researchers have successfully dosed patients suffering from Parkinsons disease. As part of this study, the researchers are collecting blood samples to determine the effects of psilocybin on inflammatory markers of patients who have exhibited signs of Parkinsons.

2. MindMed Reports Topline Data From Phase 1 Trial of MM-110 in Development for the Treatment of Opioid Withdrawal

Mind Medicine (NASDAQ: MNMD), (NEO: MMED) announced topline results from the Phase 1 placebo-controlled trial designed to assess the safety, tolerability, pharmacokinetics and neurocognitive effects of MM-110 in 108 healthy volunteers. The results showed favorable safety and tolerability, support the advancement of MM-110, and have guided the Phase 2a dose, schedule, and design in individuals undergoing supervised opioid withdrawal. MM-110 (also known as zolunicant HCl or 18-MC) is an 34 nicotinic cholinergic receptor antagonist and non-hallucinogenic proprietary congener of ibogaine.

MindMed today announced topline results from the Phase 1 trial of MM-110. The results showed favorable safety and tolerability, and have guided the Phase 2a trial design in individuals undergoing supervised opioid withdrawal. https://t.co/ax7DSiDT1Q

A total of 72 participants received up to 325 mg of MM-110 (n=51) twice on a single day or placebo (n=21), and 36 participants were administered up to 90mg of MM-110 (n=26) twice daily for seven days or placebo (n=10). The topline results and observations include the following:

1. First Patient In Quebec Gets Approval From Health Canada For Magic Mushroom Therapy

In Montreal, meanwhile, a pioneering clinic in the emerging field of psychedelic-assisted psychotherapy is about to become the first health-care facility in Quebec to legally treat depression with psilocybin. Bui-Nguyen said his Mindspace by Numinus clinic received Health Canadas approval on May 5 to care for a patient who had undergone several unsuccessful treatments for depression.

Mindspace by Numinus CEO Payton Nyquvest said psychedelics have the potential to become a widespread treatment. As Health Canada continues to approve more requests, he hopes the recognition will make the treatment much more accessible.

Health Canada on Jan. 5 restored its Special Access Program abolished under former prime minister Stephen Harper in 2013 allowing health-care experts to request access to restricted drugs that have not yet been authorized for sale in the country.

Related: Numinus Wellness Receives Health Canada Special Access Program Applicant Approval to Provide Psychedelic-assisted Therapy Treatment

See more here:

TDR's Top 5 Psychedelic Developments For The Week Of May 16 - The Dales Report

For years, US cannabis executives have protested a law that they say is obscure and outdated, and that makes it hard for them to turn a profit.

The law, a section of the federal tax code known as 280E, could now hamper psychedelics companies that want to enter the first state market for magic mushrooms in the US, similarly to how it affects cannabis firms.

Congress passed 280E to aid President Ronald Reagan's war on drugs. The law prohibits companies that illegally sell Schedule I and Schedule II drugs from deducting regular business expenses like office supplies or health-insurance premiums. Effectively, those companies have to pay more in taxes. Because cannabis and psilocybin are federally illegal, 280E affects businesses even in areas where the substances are locally legal.

Psychedelics companies haven't had to contend with the tax-related hassles associated with 280E because they've focused on pharmaceutical research and development or conducted their business in countries where the drugs aren't federally prohibited.

But now, as Oregon prepares to create the first legal-psychedelics market in the US, many psychedelics companies will have to grapple with the complicated tax implications for the first time.

According to Harris Bricken, an international law firm, psilocybin businesses in Oregon could face challenges like those that cannabis companies faced. Because psilocybin is illegal under federal law, it will likely be difficult for the companies to find banks or credit unions to work with them. It also makes securing funding more difficult.

Sam Chapman, the executive director for the Healing Advocacy Fund, a nonprofit focused on the implementation of Oregon's psilocybin program, told Insider that he expects the 280E tax issue to catch a lot of operators by surprise.

"There's still a pretty big cloud around how to successfully manage a 280E tax liability," he said.

Dina Burkitbayeva, a cofounder of Psymed Ventures, a psychedelics-focused venture-capital firm, said 280E would make doing business extremely challenging for a lot of the companies in Oregon, therefore making it difficult for investors like herself to deploy capital in the state.

"You're really not running a very sexy business," she said. "We're excited that these efforts are happening in Oregon, but from a venture-investment standpoint, we're not really seeing a lot of opportunity."

Mason Marks, an attorney who was the chair of the licensing subcommittee for Oregon's Psilocybin Advisory Board, said he expects 280E to affect most, if not all, of the psychedelics companies looking to operate in Oregon. He added that bigger businesses able to scale would have an advantage.

"Those are the ones that are going to be the most profitable, because the tax situation is really eating into your profits," Marks said. "You need to operate at a certain scale that keeps your overhead down."

Marks said operators from the cannabis industry would also have an edge because they've dealt with the same law.

It's still unclear which companies in Oregon 280E would directly affect. While cultivators who grow the mushrooms would undeniably be subject to the law, it likely would not affect data companies and other ancillary businesses.

Startups focused on training practitioners may also be exempt, though that may depend on whether the state's training criteria require training firms to supply psilocybin to trainees.

Elana Tamas, a tax advisor at the New York accounting advisory firm Anchin who has helped cannabis companies navigate 280E for years, said companies working with cannabis or psilocybin could restructure to limit the harm of 280E.

If a psychedelics-retreat firm, for example, can prove that its psilocybin-administering operation is separate from the retreat operation, it would be able to file separate taxes for those two entities. In this case, only the company that administers psilocybin would face elevated taxes.

"It's an analysis that you have to make based on what the economic realities are, so it's not something that you can just say and create. It's something that really needs to be economically true," Tamas said. "There really needs to be a really strong paper trail to support the differentiation between the expenses relating to one business and the income relating to one business."

Excerpt from:

Psychedelics Companies in Oregon Will Have to Grapple With 280E - Business Insider

Throughout history, groups, cultures, religions, and spiritual traditions, worldwide, have looked to breathwork and the use of psychedelic plant medicines to heal, grow, and transform the human experience. In this article, we look at the sacredness of the breath, and recent scientific studies that help us further understand the impact of breathing with Mindfulness Based Interventions (MBIs), combined with psychedelics.

Breathwork is a powerful tool to alter the neurology and psychology of human beings. It helps to regulate and balance the nervous system. When combined with plant medicine the breath can deeply alter, direct, and focus the mind to reset and change perceptions.

The root word for breath in Latin is Spir as in aspire, conspire, expire, inspire, perspire, respiration, respire, spiracle, spirit, transpire, etc. So, its easy to see why the breath has taken center stage historically, in religious and spiritual ceremonies that use chants, prayers, music, ecstatic dance, and symbolism to transcend dogma.

Modern day research has confirmed what sages have known for centuries. Sacred plant medicines and breathwork can help individuals reset, reboot, and reframe traumatic events and connect them with divine intention. We know that trauma challenges, inhibits, and triggers hyperarousal or hypoarousal modes and can dysregulate the autonomic nervous system. A recent study published in the Journal of Psychopharmacology shows that psychedelics and mindfulness-based interventions and breathwork, practiced together could be the future of mental health treatment. [1]

Researchers at Johns Hopkins University conducted[2] both psilocybin and MBI practices. These studies had a combined positive effect on participants who had chronic post-traumatic stress disorder (PTSD). The results of the study are promising and suggest that the combined use can further help people suffering from PTSD. Furthermore, the use of psychedelics in combination with MBIs could be an especially powerful tool to address both the cognitive and emotional aspects of mental illness. The synergistic effect offers both deep personal insights and improved self-regulation to help people recover from mental illness and live happier healthier lives.

MBIs and psychedelics have been shown to affect key aspects of mental health, such as depression, anxiety, and addiction. For example, a recent meta-analysis of 47 clinical trials found that mindfulness meditation is an effective treatment for reducing symptoms of anxiety[3](Creswell et al., 2017). Similarly, multiple studies have shown that psychedelic drugs are effective in treating a variety of mental health disorders such as depression[4](Carhart-Harris et al., 2016), anxiety[5](Grob et al., 2011), and addiction[6](Mithoefer et al., 2011).

Given the promising evidence for both MBIs and psychedelic drugs in the treatment of mental health disorders, it is not surprising that there is growing interest in combining these two approaches. One early study found that a single session of psilocybin-assisted coaching and MBIs were associated with reductions in depression and anxiety, as well as increases in self-compassion and mindfulness[7](Davis et al., 2016). These findings suggest that the combination of psychedelics and MBIs has the potential to powerfully treat mental health disorders.

MBIs and psychedelics help to reset the brains Default Mode Network (DMN), the self-referential side of the brain, which is active during passive rest and mind-wandering, by helping to throttle its activity. A beneficial outcome for people with mental disorders characterized by impaired DMN function. For example, PTSD is associated with reduced activity in the DMN, and psilocybin can increase activity in the DMN in people with PTSD. This suggests that psychedelics could be used to treat a wide range of mental disorders characterized by impaired DMN function. In addition to PTSD, these disorders include depression, anxiety, and addiction. When combined with focused MBIs, individuals can throttle arousal and better regulate.

These studies confirm and lift earlier research done by psychiatrist Stanislav Grof, with his LSD experimentation which focused on healing patients through altered states of consciousness using breathwork. Grofs research into consciousness and healing is still at the heart of modern-day breathwork.

Using an altered state technique called holotropic breathing, patients could self-regulate and achieve altered states of perception without psychedelics, drugs, or medicine. Indigenous, ancient wisdom cultures have seen the power of deep breathing, which scientifically regulates the autonomic nervous system. We humans naturally breathe. Its a part of our autonomic, sympathetic, nervous system, which helps to regulate our bodies. We dont need to think about it. But, when practiced with intention and focus, breathing takes on another role, as the mind is directed to regulate and manage stress levels, as well as recognize, accept, investigate, inquire, and nurture altered states of consciousness for longer periods of time.

MBIs and somatic practices used with psilocybin have effectively treated many individuals with depression. The complementary effects of these treatments are certainly an exciting prospect for future research on this topic.

Authors note:Breathing is a powerful way to change your brain chemistry when used in conjunction with psychedelics. But, you must consider intention, set, setting, and integration when practicing. Seek out help and support. If you are looking for ways to improve your mental health, start by being more mindful of your breath.

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Psychedelics and Mindfulness: The Future of Mental Health? | Microdose - Microdose Psychedelic Insights