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Category Archives: Psychedelics

The effects of psychedelics on the brain’s "consciousness conductor" – New Atlas

Posted: June 17, 2020 at 12:51 am

In 2004, Francis Crick, one of the 20th centurys greatest scientific minds, died of colon cancer. Crick was best known for describing the structure of DNA in the 1950s with collaborator James Watson, but over the last couple of decades of his life his research focused on perhaps the biggest scientific question of them all: how does our brain generate what we consider to be consciousness?

The last paper Crick ever penned homed in on a small and still relatively mysterious brain region called the claustrum. Co-authored with Christof Koch, Crick was reportedly still editing the manuscript in hospital the day he died. Subsequently published in 2005, the paper presented a novel hypothesis - the claustrum may be key to our experience of consciousness, unifying and co-ordinating disparate brain areas to help generate our singular experience.

The claustrum is a thin, irregular, sheet-like neuronal structure hidden beneath the inner surface of the neocortex in the general region of the insula, wrote Crick and Koch in the landmark paper. Its function is enigmatic. Its anatomy is quite remarkable in that it receives input from almost all regions of cortex and projects back to almost all regions of cortex.

The extraordinarily unique way the claustrum connects different brain regions fascinated Crick. While some researchers had previously suggested the claustrum could potentially be the brains epicenter of consciousness, Crick and Koch presented a different analogy to describe the role of this mysterious brain region.

We think that a more appropriate analogy for the claustrum is that of a conductor coordinating a group of players in the orchestra, the various cortical regions, the pair wrote. Without the conductor, the players can still play but they fall increasingly out of synchrony with each other. The result is a cacophony of sounds.

A new study, published in the journal Current Biology, is describing in unprecedented detail how the claustrum communicates with other brain regions. The project, an international collaboration between researchers in Sweden and Singapore, somewhat backs up Cricks "consciousness conductor" hypothesis, revealing the claustrum is less like a singular hub for cortical inputs and more like a collection of specialized synaptic pathways connecting specific cortical regions.

We found that the synaptic connectivity between the cortex and claustrum is in fact organized into functional connectivity modules, much like the European route E4 highway or the underground system, says Gilad Silberberg, lead author on the study, from the Karolinska Institutet.

Another recent and even more focused study zoomed in on the claustrums role in coordinating slow-wave brain activity. A team from Japans RIKEN Center for Brain Science generated a transgenic mouse model in which they could artificially activate neurons in the claustrum through optogenetic light stimulation.

Yoshihiro Yoshihara

The research discovered slow-wave activity across a number of brain regions increased in tandem with neural firing in the claustrum. Slow-wave brain activity is most often linked to a key period of sleep associated with memory consolidation and synaptic homeostasis.

We think the claustrum plays a pivotal role in triggering the down states during slow-wave activity, through its widespread inputs to many cortical areas, says Yoshihiro Yoshihara, team leader on the new RIKEN research. The claustrum is a coordinator of global slow-wave activity, and it is so exciting that we are getting closer to linking specific brain connections and actions with the ultimate puzzle of consciousness.

So, if increased claustrum activity seems to orchestrate a kind of synchronized slowing down of brain activity across a number of different cortical regions, what happens when claustrum activity is suppressed?

One hypothesis has suggested dysfunctional claustrum activity could play a role in the subjective effects of psychedelic drugs. One of the fundamental neurophysiological characteristics of a psychedelic experience is widespread dysregulation of cortical activity. Brain networks that dont normally communicate will suddenly spark up connections under the influence of psilocybin or LSD. So a team from Johns Hopkins University set out to investigate exactly how psilocybin influences claustrum activity.

Due to the claustrums location in the brain its activity has traditionally been quite difficult to study in humans. However, a recently developed functional magnetic resonance imaging (fMRI) technique has afforded researchers a new and detailed way to measure claustrum activity. The Johns Hopkins study recruited 15 subjects to measure claustrum activity after either a placebo or a dose of psilocybin.

The study found psilocybin reduced claustrum neural activity between 15 and 30 percent. The overall reductions in claustrum activity also directly correlated with the subjective psychedelic effects of the drug.

More specifically, psilocybin seemed to significantly alter how the claustrum communicated with a number of brain regions fundamentally involved in attentional tasks and sensory processing. For example, under the influence of psilocybin, functional connectivity between the right claustrum and the auditory and default mode networks significantly decreased, while right claustrum connectivity with the fronto-parietal task control network increased.

Our findings move us one step closer to understanding mechanisms underlying how psilocybin works in the brain, says Frederick Barrett, one of the authors on the new study. This will hopefully enable us to better understand why its an effective therapy for certain psychiatric disorders, which might help us tailor therapies to help people more.

As Barrett suggests, this new insight into the effect psilocybin has on claustrum activity may shine a light on how this psychedelic drug generates its beneficial therapeutic effects. Psilocybin in particular has been found to be significantly useful in treating major depression and substance abuse disorders. The Johns Hopkins scientists hypothesize psilocybins action on the claustrum may play a key role in both the subjective effects of this psychedelic drug, and its beneficial therapeutic outcomes.

Further research is certainly necessary to verify this hypothesis, and the next step for the Johns Hopkins team will be to use this new claustrum imaging technique to investigate the brain region in subjects with a variety of psychiatric disorders. Fifteen years on from Francis Cricks passing his final work is still inspiring new research. The new wave of psychedelic science, in tandem with novel neuroimaging techniques, brings us closer and closer to understanding how our brains create consciousness.

The new study was published in the journal Neuroimage.

Source: Johns Hopkins Medicine

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The effects of psychedelics on the brain's "consciousness conductor" - New Atlas

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Psilocybin Dulls Activity in Brain Region Linked With Consciousness – Psych Congress Network

Posted: at 12:51 am

Brain scans show psilocybin reduces activity in the claustrum, a thin sheet of neurons deep within the cortex considered by some to be the seat of consciousness, awareness, and sense of self, according to a study published online in the journal NeuroImage.

Researchers at the University of Maryland, Baltimore, reached the finding after developing a way to access the claustrum and detect activity in the deep-rooted location. For the study, they used functional magnetic resonance imaging (fMRI) to observe the claustrum in 15 participants after taking psilocybin, the hallucinogenic chemical found in certain mushrooms, and compared them with fMRI scans obtained after the participants took a placebo.

After psilocybin use, neural activity in the claustrum slowed by 15% to 30%, according to the study. Simply put, the area of the brain believed to be responsible for setting attention and switching tasks was turned down. The reduced neural activity, researchers added, appeared to be linked with stronger subjective effects in participants, such as emotional and mystical experiences.

Psychedelics and Wellness: Whats the Connection?

In addition, psilocybin changed how the claustrum communicated with brain regions involved in hearing, attention, decision-making, and remembering, according to the study.

The findings, researchers observed, mesh with first-hand reports on the typical effects of psychedelic drugs, such as feeling connected with everything and experiencing a reduced sense of the self or ego.

Our findings move us one step closer to understanding mechanisms underlying how psilocybin works in the brain, said researcher Frederick Barrett, PhD, assistant professor of psychiatry and behavioral sciences at the Johns Hopkins University School of Medicine, Baltimore, and a member of the school's Center for Psychedelic and Consciousness Research.

This will hopefully enable us to better understand why its an effective therapy for certain psychiatric disorders, which might help us tailor therapies to help people more.

Jolynn Tumolo

References

Barrett FS, Krimmel SR, Griffiths RR, Seminowicz DA, Mathur BN. Psilocybin acutely alters the functional connectivity of the claustrum with brain networks that support perception, memory, and attention. NeuroImage. 2020 May 23;[Epub ahead of print].

Research story tip: psychedelic drug psilocybin tamps down brains ego center [press release]. Baltimore, Maryland: Johns Hopkins Medicine; June 4, 2020.

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Champignon Brands revamps its brand identity to better reflect its scientific focus on psychedelic medicine – Proactive Investors UK

Posted: at 12:51 am

The firm is changing its name to Apotheosis Scientific Ltd and spinning out its consumer packaged goods division

Champignon Brands Inc (CSE:SHRM) (OTCQB:SHRMF) is headed into the future with a new identity that reflects the companys focus on scientific research.

The psychedelic healthcare company has proposed changing its name to Apotheosis Scientific Ltd or another name that better conveys its business activities going forward, Champignon told shareholders on Friday.

In addition, the Vancouver-based firm said it was planning to spin out its consumer packaged goods division by the third quarter of 2020.

The news comes after Champignon executed a series of game-changing acquisitions earlier this year, including AltMed, which owned ketamine clinic operatorthe Canadian Rapid Treatment Centre of Excellence (CRTCE) and California-based Wellness Clinic of Orange County.

AltMed has three trials in the Phase I stage and three trials in the preclinical stage during 2020, as well as seven patents for its ketamine/psilocybin delivery platforms and formulations. The company also has a preferred commercial relationship with InterVivo Solutions, Canadas largest neuroscience-focused preclinical contract research organization, to collaborate on Phase I testing and novel drug development of psychedelic molecules and delivery systems.

The CRTCE was founded by leading ketamine expert Dr Roger McIntyre, who took the reins as Champignons CEO last month.

While the topic of medical psychedelics has recently gained worldwide momentum, I am exceptionally pleased with the strategic approach our team has taken in establishing a differentiated platform with operating treatment clinics in the US and Canada that also facilitate research and development of a wide range of therapeutic and medical applications, McIntyre said in a statement.

We have made tremendous progress to date and have proven our ability to quickly seize opportunities in this rapidly emerging industry. Looking forward to the second half of 2020, we will continue to work towards entering new markets and delivering new and innovative solutions throughout North America.

The company recently closed a C$15 million financing to fund its ambition to open five ketamine clinics in North America by the end of 2020.

Contact Angela at [emailprotected]

Follow her on Twitter @AHarmantas

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Mota Ventures Appoints Roger C. Clinton as Member of Advisory Board to Verrian GmbH – Its Psilocybin Research Subsidiary – Stockhouse

Posted: at 12:51 am

VANCOUVER, BC, CANADA / ACCESSWIRE / June 15, 2020 / Mota Ventures Corp. (CSE:MOTA)(FSE:1WZ1)(OTC PINK:PEMTF) (the "Company") is pleased to announce the appointment of Roger C. Clinton, to the Advisory Board for its wholly owned subsidiary, Verrian GmbH. Clinton is active within the addiction treatment and specifically opiate addiction research sector, seeking to bring attention to the issue and enhance promising treatment options using psychedelics in conjunction with behavioral therapy through his global network.

"I'm honored to be working with the team at Mota in a patient first approach. We believe the work that we're doing can be transformative in people's lives as they work daily to overcome addiction," said Roger Clinton.

On June 2nd, Mota announced the $20,000,000 acquisition of Verrian, a European pharmaceutical manufacturer of natural psilocybin extracts. Verrian is focused on psychedelic and cannabis treatments of opiate addiction. Clinton will play a vital role in advising and enhancing the patient perspective as well as helping to shape R&D efforts of our world-renowned addiction medicine experts, resulting in best of breed psychedelic derived treatments for the global marketplace.

Ryan Hoggan, Chief Executive Officer, stated "We're honored to be working with Roger, an advocate for patient first treatment options. Roger's work in advocacy for opiate addiction research will enhance MOTA's research efforts and help to draw attention to our ground-breaking psychedelic research we as we jointly seek new treatments to help patients overcome addiction."

ABOUT ROGER

Roger Cassidy Clinton is a true multi-hyphenate: singer-songwriter, voice-over artist, actor, author, up-close political observer (quite the understatement) and, arguably, one of the world's biggest sports enthusiasts. He is also a living, inspiring story of recovery.

Roger, President Bill Clinton's younger brother, is blessed with a spectacular group of friends from all walks of life, including the "who's who" in the world of music, entertainment, sports (collegiate and professional) and, of course, politics. Working, associating and performing with people who have attained the highest levels of success in their professions has enabled Roger to forge priceless relationships that will last a lifetime. These relationships have brought him many unique, exciting experiences with more than a few once-in-a-lifetime opportunities.

Throughout it all, however, Roger has struggled with decades of alcohol and substance abuse that at one point left him clinically dead. Miraculously, medical personnel were able to revive Roger, and he improbably averted tragedy and survived. Through his personal, ongoing journey of recovery from a life complicated by addiction and trauma, Roger is grateful to have gained profound insight that he is privileged to share in order to help spread light and optimism with the world.

This press release is available for investor discussion on the Company's AGORACOM Discussion Forum, a moderated social media platform that enables civilized discussion and Q&A between Management and Shareholders.

About Mota Ventures Corp.

Mota Ventures is an established eCommerce, direct to consumer provider of a wide range of natural health products including CBD and psychedelic medicine products in the United States and Europe. In the United States, the company sells a CBD hemp-oil formulation derived from hemp grown and formulated in the US through its Nature's Exclusive brand. Within Europe, its Sativida brand of award winning 100% organic CBD oils and cosmetics are sold throughout Spain, Portugal, Austria, Germany, France, and the United Kingdom. In Germany, Verrian currently produces natural psilocybin extract capsules under the PSI GEN and PSI GEN+ brand. Mota Ventures is also seeking to acquire additional revenue producing CBD brands and operations in both Europe and North America, with the goal of establishing an international distribution network for CBD products. Low cost production, coupled with international, direct to customer, sales channels will provide the foundation for the success of Mota Ventures.

ON BEHALF OF THE BOARD OF DIRECTORS MOTA VENTURES CORP.

Ryan Hoggan Chief Executive Officer

For further information, readers are encouraged to contact Joel Shacker, President, at +604.423.4733 or by email at IR@motaventuresco.com or http://www.motaventuresco.com.

Neither the Canadian Securities Exchange nor its Regulation Services Provider (as that term is defined in the policies of the Canadian Securities Exchange) accepts responsibility for the adequacy or accuracy of this press release, which has been prepared by management.

Cautionary Note Regarding Forward-Looking Statement

All statements in this press release, other than statements of historical fact, are "forward-looking information" with respect to the Company within the meaning of applicable securities laws, including with respect to research and development projects with the University, its plans to become a vertically integrated global CBD brand, its plans to cultivate and extract cannabis to produce CBD and high-quality value added CBD products in Latin America for distribution domestically and internationally and its plans to acquire revenue-producing CBD brands and operations in Europe and North America. The Company provides forward-looking statements for the purpose of conveying information about current expectations and plans relating to the future and readers are cautioned that such statements may not be appropriate for other purposes. By its nature, this information is subject to inherent risks and uncertainties that may be general or specific and which give rise to the possibility that expectations, forecasts, predictions, projections or conclusions will not prove to be accurate, that assumptions may not be correct and that objectives, strategic goals and priorities will not be achieved. These risks and uncertainties include but are not limited those identified and reported in the Company's public filings under the Company's SEDAR profile at http://www.sedar.com. Although the Company has attempted to identify important factors that could cause actual actions, events or results to differ materially from those described in forward-looking information, there may be other factors that cause actions, events or results not to be as anticipated, estimated or intended. There can be no assurance that such information will prove to be accurate as actual results and future events could differ materially from those anticipated in such statements. The Company disclaims any intention or obligation to update or revise any forward-looking information, whether as a result of new information, future events or otherwise unless required by law.

SOURCE: Mota Ventures Corp.

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Mota Ventures Appoints Roger C. Clinton as Member of Advisory Board to Verrian GmbH - Its Psilocybin Research Subsidiary - Stockhouse

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New Psychedelics Stocks and Acquisitions | 2020-06-08 | Investing News – Stockhouse

Posted: June 13, 2020 at 3:12 pm

2020 is the year of many things: global conflict, devastating fires, the COVID-19 pandemic, and now civil unrest in response to racism and police brutality in the United States.

It’s been a tough year for everyone, but it has also brought about renewed conversations on societal progress. How can we improve, where do we go from here, and what changes can we start to make?

Strangely to some, one of those changes is coming in the normalization of psychedelics to treat medical conditions. What was once a stigmatized and prohibited class of substances is quickly having a second wind as a treatment for depression, PTSD, and substance-abuse disorders amongst a handful of many other potential therapeutic needs.

We’re also now starting to deal with a wave of new (and previously undiagnosed) cases of depression and anxiety on the back of the COVID-19 pandemic. One week into June, we’re quickly approaching a point where many people have been at home with limited social interaction (or physical activity) for months on end.

As if on queue, the market for psychedelics companies has started to open up in a big way. More and more companies directly and indirectly invested in psychedelics are coming to public markets, and others are starting to make their moves into psychedelics widely known. 2020 is the year of many things, and it’s looking like psychedelics is one of them.

Back in May, we highlighted the impressive rise of a few of the companies involved in the psychedelics market. Those included the recently-public psychedelics companies Champignon Brands Inc. (CSE:SHRM) and Mind Medicine Inc. (NEO:MMED), as well as indirect investments like those of Yield Growth Corp. (CSE:BOSS) and Revive Therapeutics Ltd. (CSE:RVV).

Fast-forward a few weeks and we’ve seen even more companies enter the fray. On May 20, fully-integrated psychedelics company Numinus Wellness Inc. (TSX-V:NUMI) went public, with business arms in clinic and therapy operation, research and development, and direct selling and distribution of psychedelics. On May 28, Ontario-based Red Light Holland Corp. (CSE:TRIP) also began listing with a plan to produce and sale psilocybin in the legal Netherlands market for the time being.

We’re also seeing an increasing wave of acquisitions and pivots into psychedelics from companies previously invested in healthcare, cannabis, and even technology. German medical cannabis distributor Pharmadrug Inc. (CSE:BUZZ) acquired Dutch psychedelics retailer Super Smart, California cannabis company Hollister Biosciences Inc. (CSE:HOLL) closed their acquisition of mushroom-based health product developer AlphaMind Brands Inc., and eCommerce CBD provider Mota Ventures Corp. (CSE:MOTA) acquired pharmaceutical psilocybin manufacturer Verrian Ontario Ltd.

And that’s not including the previous moves of companies like New Wave Holdings Corp. (CSE:SPOR) in psychedelics and esports, Empower Clinics Inc. (CSE:CBDT) in creating its own psilocybin and psychedelics division, and NewLeaf Brands Inc. recently adding a focus on psychedelics and rebranding as Mydecine Innovations Group Inc. (CSE:MYCO).

No matter where you look, people and companies are getting invested in psychedelics. Though this has been a somewhat comprehensive list, there are too many to include and more are continuing to pile in. With more excitement about psychedelics and their importance on one hand, and more viable investing options entering the markets on the other, the future for these alternative medicines seems bright.

New to investing in Healthcare? Check out Stockhouse tips on How to Invest in Healthcare Stocks and some of our Top Healthcare Stocks.

For more of the latest info on Cannabis, check out the Healthcare Trending News hub on Stockhouse.

FULL DISCLOSURE: Yield Growth Corp. is a client of Stockhouse Publishing

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Pure Extracts: The Second Wave of Psychedelic Operators – The Deep Dive

Posted: at 3:12 pm

Some years ago when the first wave of cannabis firms went public, operators were focused on building a narrative behind one common theme: capacity. Specifically, investment bankers and business executives were focused on touting the square footage of their facility, which in layman terms, could be converted into revenue. If an operator has X square feet, it translates into Y plants, and conversely, Z revenue.

Despite touting their own company as the best potential operator in the space, collectively, these investment bankers and executives would collaborate on one topic: the size of the market as a whole, which every year was grown by a few hundred million to entice further investment dollars.

The trouble however, was that these operators were focused on top line revenue potential, and not whether they could actually turn a profit.

Fast forward to the end of the boom and bust cycle, and numerous of these operators are now being sold off for pennies on the dollar, and seemingly have learnt nothing. Few cultivators show promise of generating profits at any point in the future, despite having years to develop proper processes and achieve profitability.

The second wave of operators, referred to commonly as extractors, are in a different category altogether however. Having seen the vast failures exhibited by the first round of contestants, these operators typically focused on a different financial metric: profitability. Having realized the need for certain services within the sector, namely the extraction of cannabinoids for the purpose of oils and cannabis 2.0 products, these operators set out to provide a service that was in high demand within the space and while being able to turn a profit at the same time.

Looking to the burgeoning psychedelics space, and things altogether have not changed much. While the first wave of operators have focused largely on a biotech angle, full of high clinical study costs and potential target markets for proposed cures to ailments, the already oncoming second wave is looking to tackle the space from a different angle.

Presently, that second wave only consists of Pure Extracts (Private), a gray market operator that has entered the legal side of operations. Well known for its years of producing premium quality, full spectrum oil (FSO) Pure Pulls vape pens within the gray market, the operator is now in the process of finalizing its licensing to process cannabis and hemp biomass. Given the strong experience behind it, the Company has already signed two tolling agreements for a total of 120,000 kgs/annum of hemp and cannabis despite not quite having its license yet, although it is believed to be imminent. Despite being significantly impressive, this isnt even the most interesting part of Pure Extracts story.

That is reserved for the Companys step into the psychedelics space. Rather than focus on biotech themselves, the Company has come to the realization that all these studies will require one key ingredient psilocybin extract. As a result, Pure Extracts is submitting its Dealers License application to Health Canada to enable the Company to extract this ingredient for operators in the space that need it to conduct clinical studies. Psilocybin extract, given its relative scarcity, is currently a high value item, and currently fetches upwards of $10,000 per gram.

Outside of research purposes, there is also currently a large demand for functional mushroom extracts think already legal markets for non-psychoactive variants. Here, the functional mushroom market is one of the fastest growing CPG segments. With research showing mushrooms containing properties such as immune boosting, detoxification, anti-tumor, and anti-viral and more the race is currently on for extractors to step into the growing segment. Many extraction competitors are unready for the new psychedelic and functional mushroom markets, whereas Pure Extracts is already moving with precision to tackle the segment head-on. The segment offers massive opportunity for those who elect to grab a first mover advantage.

In this regard, Pure Extracts has laid out a simple business development strategy. Theyve positioned themselves in a manner that enables them to become the premier commercialization and manufacturing partner for both functional and psychedelic firms within the space. While initial products under this operating segment will be focused on functional products, the Company is submitting an application for its Dealers License as previously mentioned, which will enable them to buy, sell, test and product psychedelics within an EU GMP environment.

Here, Canadas ability to export such products around the world, combined with Pure Extracts Good Production Practice (GPP) facility will enable the Company to be a prime partner for both functional and psychedelic mushroom firms. Furthermore, the Company has already set the strategy in motion, having signed several NDAs with functional product firms to explore joint development strategies. These product lines are currently targeting a third quarter 2020 launch.

While new operators seemingly appear each week within the biotech-based psychedelic space, Pure Extracts offers a compelling type of exposure to the niche market that has yet to be addressed. The need for such extracts is apparent given the growth in the sector, however the lack of competition gives Pure Extracts an early edge in what is set to be a high demand segment.

Pure Extracts is set to IPO in the coming months.

FULL DISCLOSURE: Pure Extracts is a client of Canacom Group, the parent company of The Deep Dive. The author has been compensated to cover Pure Extracts on The Deep Dive, with The Deep Dive having full editorial control. Not a recommendation to buy or sell. Always do additional research and consult a professional before purchasing a security.

As the founder of The Deep Dive, Jay is focused on all aspects of the firm. This includes operations, as well as acting as the primary writer for The Deep Dives stock analysis. In addition to The Deep Dive, Jay performs freelance writing for a number of firms and has been published on Stockhouse.com and CannaInvestor Magazine among others.

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New analysis claims the FDA rushed ketamine’s approval for depression treatment – Big Think

Posted: at 3:12 pm

There was a lot of excitement when the FDA fast-tracked ketamine trials for depression treatment in 2016. The announcement marked a major turning point in our understanding of psychedelics, which were deemed a Schedule 1 substance as part of Richard Nixon's racist 1970 "War on Drugs." Ketamine was approved for use as an anesthetic that same year; due to increasing recreational usage in the 1990s, however, it was deemed Schedule III in America in 1999.

Though ketamine is not a traditional psychedelicthey have an agonist (or partial agonist) effect at brain serotonin 5-HT2A receptorsit falls into this class due to its hallucinogenic and dissociative effects. Recently it has been referred to as a "party psychedelic." Psychedelic therapy advocates were pleased when the FDA approved a nasal spray medication for treatment-resistant depression known as esketamine in 2019. Janssen Pharmaceuticals launched Spravato shortly after.

This move is exciting. Trials of two types of ketamineracemic ketamine and esketamineshowed early positive results, even though researchers are not exactly sure how it functions in depression treatment. We do know antidepressants and antipsychotics are showing less efficacy and more chronic side effects than previously believed, however.

There is precedent in the psychedelic realm. Psilocybin, ayahuasca, ibogaine, MDMA, and LSD are showing early positive results in treating anxiety, depression, addiction, and PTSD. This does not mean we should rush blindly ahead, however.

That's the consensus reached by Mark Horowitz (writer) and Joanna Moncrieff (editor), whose recent analysis, published in The British Journal of Psychiatry, concludes that we're moving too fast in clinically adopting ketamine. As their data shows, caution is necessary.

Since its discovery in 1962, ketamine has been used broadly as a sedative and anesthetic; to aid in emergency surgeries in war zones; as a bronchodilator for severe asthmatics; to treat certain type of seizures; in postoperative pain management; and now, as a nasal spray to treat depression. Unlike SSRIs and SNRIs, esketamine works immediatelyin as little as two hoursmaking it more attractive to patients and clinicians.

While treatment-resistant depression sounds extreme, Horowitz notes the definition: patients unsuccessful with two different antidepressants, a low bar for the term "resistant." The problem with trying esketamine, he writes, falls back on the FDA fast-tracking of the drug.

"Out of the three short-term trials conducted by Janssen only one showed a statistically significant difference between esketamine and placebo. These were even shorter than the 68 week trials the FDA usually requires for drug licensing."

Each trial lasted only four weeks. The FDA normally requires that two such trials show better results than the placebo; in this case, only one achieved this goal. The successful trial showed a four-point margin on a scale that goes to 60.

Failing to provide two effective trials, the FDA allowed Janssen to submit a discontinuation trial as evidence. This 16-week trial let patients either continue or stop treatment. The problem: side effects were treated as evidence of relapse, not withdrawal symptoms.

Ketamine users have a long history of withdrawal issues, including anxiety, poor appetite, delusions, hallucinations, paranoia, addiction, rage, and craving. The discontinuation trial considers such effects as proof of ketamine's efficacy, not as symptoms of withdrawal.

Science writer Peter Simons explains why this is worrisome:

"Perhaps even more concerning is the fact that, within the discontinuation trial, a single site in Poland drove the apparent finding of efficacy. Data from this site suggested that 100% of the placebo group supposedly relapsed (compared with about 33% of the placebo group in all the other sites)an unlikely result. When data from this suspicious outlier was removed, the study analysis showed no evidence that esketamine was better than the placebo."

Add to this that six people in the esketamine group died during the trials, including three by suicidetwo of whom had previously shown no signs of suicidal ideationsand a troubling picture emerges. The FDA accepted Janssen's explanation: the problem wasn't esketamine, but their underlying condition. This is possible, but the company did not provide conclusive evidence.

Jennifer Taubert, executive vice president and worldwide chairman of Janssen Pharmaceuticals, Johnson & Johnson, testifies before the Senate Finance Committee on "Drug Pricing in America: A Prescription for Change, Part II" February 26, 2019 in Washington, DC. The committee heard testimony from a panel of pharmaceutical company CEOs on the reasons for rising costs of prescription drugs.

Photo by Win McNamee/Getty Images

According to Horowitz, this is a chronic problem with clinical trials and governing agencies.

"It would seem that themes from history are repeating: a known drug of misuse, associated with significant harm, is increasingly promoted despite scant evidence of efficacy and without adequate longterm safety studies."

He also notes that half of the patients experienced disassociation and one-third experienced dizziness. On this point, allow me to break the fourth wall. I've been experimenting with psychedelics since 1994 and am writing a book on psychedelics in ritual and therapy. I ingested a range of substances during my college years. By far, the most troublesome was ketamine. While I'm now aware of Parecelsus's dictumwhat is beneficial in small doses is toxic in large dosesI wasn't measuring it out in the 1990s.

Administered doses in Janssen's trials were considered similar to recreational usage. I recall that a bump provided an energetic lift, yet when I'd occasionally snort a line, all bets were off. After a hearty dose one evening, I laid down, sat up, and stood in succession. I couldn't tell the difference between those three physical positions. Ketamine is the most dissociative substance I've ever taken, and I stopped shortly after that last instance.

Psychedelics are the next wave of mental health treatmentscall it a continuation, given their role in traditional rituals. We came to rely on pharmacology too much in the twentieth century; hopefully we're learning from those mistakes. As Horowitz points out, however, it appears we're not.

The important word in psychedelic therapy is ritual. There are environmental and social factors entwined with our health. In the right context, psychedelics have tremendous healing power. And to be fair, some ketamine clinics are taking proper right safety precautions as well as designing treatment rooms to be more conducive to healing than sterile white rooms. Patients are anecdotally reporting success in depression treatment with ketamine. This isn't an either-or situation.

But we cannot make the same mistake we've made with CBD and believe these substances are cure-alls. We also can't afford to designate ketamine under the umbrella term "psychedelics." As Alan Watts wrote, hallucinogen is not a proper definition of the psychedelic experience, though it's fitting when describing ketamine. Conflating substances will only further confusion during a time when we need clarity. If the addictive properties and dangerous side effects of ketamine play out widely, it endangers the entire psychedelic therapy model.

We can hope for a clinically-effective dosage and delivery mechanism of ketamine. We can't, as Horowitz's analysis shows, make the same mistakes over. Pharmacological intervention has a place in psychiatry, but it's come to dominate the industry, often no better than placebo and psychotherapy. We need healing, not more side effects.

--

Stay in touch with Derek on Twitter, Facebook and Substack. His next book is "Hero's Dose: The Case For Psychedelics in Ritual and Therapy."

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New analysis claims the FDA rushed ketamine's approval for depression treatment - Big Think

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How Liv Vasquez Uses Plants & Food for Wellness and Healing – Thrillist

Posted: at 3:12 pm

As people face their issues, Vasquez is there to call out trauma responses so they know to soothe those reactions and keep working through it. While the cannabis, journaling, and talk therapy work helps soothe and process triggers, the psychedelic element can allow you to go deeper into the cause of that trigger.

"In small amounts, on a controlled schedule, you can process a lot of trauma very quickly with psychedelics," says Vasquez. Even those small amounts can shine a light on dark corners of your memory. You dont always know what you will find in those corners. I just let my clients know that they are safe and that I am here for them on the other side of it. When they come back for our next session, we unpack it together.

One thing Vasquez is clear about is that there is no one perfect dose. And there is often trial and error when first laying down dosing guidelines and a schedule. But thats why the communication and journaling are as important an element as the treatments themselves.

Oftentimes, her clients are on the right track when she meets them. They are on their way to getting to the root of their issues, and what she does can help expedite that process by lifting some of the barriers halting their progress. She explains how unresolved trauma can be a distracting burden in this internal work. How living with trauma is like trying unsuccessfully to sleep soundly every night and going through days half exhausted and half awake.

When you acknowledge what triggers your reactions and the feelings that are rooted in trauma, it can free up space in your life, says Vasquez.

"One of my clients is a medium and a mom, she continues. Mediums already kind of live on two planes, and you have to make a LOT of boundaries with ghosts. It can take a lot of energy. She came to me because she was having problems being fully present in both her day-to-day life and her spirit work.

After six weeks of work with Vasquez, on a regimen that included microdosing mushrooms and CBD with low doses of THC on a controlled schedule, the client reported an enormous difference in her day-to-day clarity. In that case, her client just needed help utilizing her time on both planes more efficiently. And Vasquez helped her do so.

Right now, were all doing more internal work during quarantine. If youre experimenting with different modes of wellness, Vasquez recommending everyone start by journaling every step of the way.

When you're starting any new journey in plant-based medicine, or even a new diet, you must be gentle with yourself, explains Vasquez. Start by microdosing once a month, and listen to your mind and your body as you go. Cannabis and psychedelics can affect your psyche so it is important to note your observations and effects in order to make those judgment calls about dose and schedule.

Vasquez also highly recommends having someone to talk to. As a sort of safety net that helps you process the experience, the talk therapy is as important as the substances themselves. Her favorite part of her work is being that perspective; that ally at her clients side as they work through those triggers.

"Helping others with trauma helps me understand my own trauma, she says. When you live with PTSD, and help people with PTSD, there is just no feeling like it. Its validating. I feel like I have truly stepped into my power.

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Companies are starting to bet big on psychedelic drugs to treat US mental health epidemic – Proactive Investors USA & Canada

Posted: June 6, 2020 at 5:09 pm

Once dismissed as a "party drug" for its hallucinogenic effects, ketamine is emerging as a novel alternative treatment for depression

Psychedelic medicine is having a moment.

Last year, the US Food and Drug Administration (FDA) approved esketamine to treat depression, making it the first-ever psychedelic drug to receive the regulatory green light in the US, withUK authorities also givingtheir approval for the ketamine-like druga few months later.

MDMA, commonly known as ecstasymeanwhile,has been given breakthrough therapy designation by the US regulatorfor post-traumatic stress disorder (PTSD). Against this backdrop, a flourishing new sub-sector of the life sciences industry is emerging.

READ:MindMed launches drug development program Project Lucy to treat anxiety disorders with LSD

For most, psychedelic drugs conjure up images of the 1960's, hippies tripping out on LSD or magic mushrooms. However, early studies are finding that psilocybin the active agent in magic mushrooms could treat addiction, depression, anxiety and mental health conditions like post-traumatic stress disorder (PTSD).

Similarly, cancer patients with painful anxiety over their illness have found more peaceful acceptance after participating in a study that involved intensive therapy and being given a drug that was once a symbol of the 60's counterculture.

While there are many parallels with the development of the cannabis industry, the trailblazers in the field of psychedelics are keen to stress the differences, particularly with reference to the recreational element of the former.

Psychedelics werent born of the counterculture. They were killed by it, says a report by investment bank , authored by Tania Gonsalves and Scott McFarland, which provides some of the first in-depth analysis of the sector.

Once dismissed as a "party drug" for its hallucinogenic effects, ketamine is emerging as a novel alternative treatment for depression. The approval ofs () nasal spray antidepressant that is chemically similar to often-abused ketamine, shines a light on New York-based ()which is advancing its own medication for depression.

Wall Street is bullish that Seelos SLS-002 intranasal ketamine depression drug under development is safe and will reach millions of patients with post-traumatic stress disorder (PTSD) and major depressive disorder (MDD) at risk of committing suicide.

The market for our SLS-002 depression drug is very large as more than 900,000 people were admitted to the ER for suicidality even though no effective drug treatment exists, Seelos Therapeutics CEO Raj Mehra told Proactive.

In November last year, the FDA granted SLS-002fast track designation for development of the drug as a treatment of Acute Suicidal Ideation and Behavior (ASIB) in patients withmajor depressive disorder (MDD).

Seelos has also saidit is on track to release additional safety data on the Phase I studies of SLS-002 in the second quarter of 2020.

The psychedelics industry itself is big enough to pique the interest of Big Pharma, with Canaccord Genuity estimating the total market size for all indications under investigation to be as much as $100 billion. However, it is still start-ups and innovators which are setting the pace.

Mind Medicine (MindMed) Inc (NEO:MMED) () recentlylaunched Project Lucy, a commercial drug development program for the treatment of anxiety disorders. The Reno-based company said it intends to initiate a Phase 2b human efficacy trial that will focus on experiential doses of lysergic acid diethylamide (LSD) administered by a therapist.

MindMed noted that this is the first experiential, psychedelic-assisted therapy to be added to its drug development pipeline.

With the launch of Project Lucy, the company said it is now preparing a total of three Phase 2 commercial drug trials based on psychedelic-inspired medicines, making it one of the most advanced and largest drug development pipelines in the psychedelics industry.

MindMed cofounder and co-CEO JR Rahn, a former Uber employee and Y-Combinator alumnus, believes America was on track to face a mental health crisis before the coronavirus (COVID-19) outbreak, and self-isolation, social distancing, and job losses are exacerbating the problem.

I went through the Y-Combinator program from where companies like and Dropbox developed and I was looking at my friends companies that were going to put a lot of people out of work, Rahn told Proactive.

Ultimately, what I saw was that addiction and mental health problems were going to skyrocket in America. These problems were already large, but they were going to get bigger in time. Thats all been fast-forwarded now. COVID-19 and the lockdown in terms of isolation just made these problems bigger.

MindMed is making a run at curbing opioid abuse, based on 18-MC, a proprietary non-hallucinogenic molecule derivative of psychedelic ibogaine. Ibogaine comes from iboga, a West African plant whose yellowish root bark induces powerful psychedelic experiences. It has its genesis in healing ceremonies among various African communities.

Among other players, Vancouver-based Champignon Brands Inc () (OTCMKTS:SHRMFF) is planning to open at least five ketamine clinics in North America by the end of 2020. It recentlyclosed the acquisition of AltMed Capital Corp, a Canadian ketamine clinic operator with strong research and development projects.

Empower Clinics Inc () (OTCQB:EPWCF), the CBD product producer and wellness clinic operator, is also leveraging its existing clinic network, which boasts some 165,000 patients and a robust team of physicians, to focus on psilocybin research and psychedelics therapy in the treatment of mental health issues.

Taking the active ingredients of psychedelics and clinically proving their efficacy offers hope for those with post-traumatic stress disorder, alcoholism, anxiety, deep-seated depression and addiction.

Psychedelics have shown promising efficacy across a broad range of both mental and substance abuse disorders, the analysts at Canaccord said in their research note. Together, the targeted indications affect over one-billion people globally.

Your need-to-know guide to psychedelics:

Psilocybin

Found in over 200 species of mushrooms.

Potential uses: Depression, anxiety, addiction, OCD (obsessive-compulsive disorder), anorexia, obesity, cluster headaches, Alzheimers disease.

Lysergic acid diethylamide (LSD)

Chemically combined lysergic acid and diethylamide.

Potential uses: Cluster headaches, depression, anxiety, pain syndromes, alcoholism, ADHD (attention deficit hyperactivity disorder)

Ibogaine

Found in the root bark of a West African shrub.

Potential uses: Alcoholism, addiction and smoking cessation.

Methylenedioxymethamphetamine

A popular club drug thats sold in pills (ecstasy) or as a powder (MDMA)

Potential uses: PTSD, anxiety and alcoholism.

Ketamine

Used for starting and maintaining anaesthesia

Potential uses: Treatment-resistant depression PTSD, anxiety, alcoholism, pain syndromes and chronic fatigue syndrome.

US companies to watch:

Codebase Ventures Inc() () (FSE:C5B): Focused on investing in the psychedelic healthcare sector through subsidiaryTitan Shrooms and Psychedelics Inc

Back of the Yards Algae Sciences (Private): Mycelial and plant entheogen therapeutics for major mental health challenges including PTSD.

(Private): Developing cannabinoids and tryptamine-based compounds (psilocybin and psilocin) for neuroscience.

Champignon Brands (OTCMKTS:SHRMF): Focused on using psilocybin to treat mental health disorders.

Empower Clinics (OTCQB:EPWCF): US-focused wellness clinic operator getting into psychedelic treatment.

Mind Medicine (MindMed) (OTCQB:MEDF): Neuro-pharmaceutical company that discovers, develops and deploys psychedelics.

(): An ecommerce retailer of CBD products in Europe and the US that recently entered the psychedelics market.

NewLeaf Brands (CSE:NLB): Recently agreed to acquire Colorado-based Mydecine Group for $1.2mln, a mycology company.

Orthogonal Thinker (Private): A holding company focused on health and well-being through clean label, whole plant products, including psychoactive compounds.

Psybio Therapeutics (Private): Developing biosynthetic psychoactive compounds.

PsyGen (Private): A GMP-grade manufacturer of pharmaceutical psychedelic drug products for clinical research and therapeutic applications.

(OTCPINK:RVVTF): Life sciences company with a pharmaceutical IP portfolio that utilizes Bucillamine,psychedelicsand cannabis to focus on rare inflammatory areas such as gout, lung inflammation, liver disease, ischemia and depression

Seelos Therapeutics (): A clinical-stage biopharmaceutical company focused on CNS and rare disorders. It is advancing multiple programs through clinical trials.

Silo Wellness (Private): A vertically integrated recreational psilocybin mushrooms company.

Tabula Rasa Ventures (Private): A VC investing in legalized psychedelics.

WAKE (Private): Fungi and plant-based medicine

Contact Angela at [emailprotected]

Follow her on Twitter @AHarmantas

Uttara Choudhury also contributed to this article

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Companies are starting to bet big on psychedelic drugs to treat US mental health epidemic - Proactive Investors USA & Canada

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CHECK IT OUT: New from Lady Gaga; take a wild ride; beach reading; and a screen gem – Wicked Local

Posted: at 5:08 pm

Patriot Ledger Staff

ThursdayJun4,2020at12:01PM

LAUGH

Wild ride: The documentary "Have a Good Trip" is a star-studded exploration of psychedelics. It features beloved comedians and musicians Sting, Nick Offerman, Sarah Silverman, Paul Scheer, Weymouth native Rob Corddry, A$AP Rocky, Rosie Perez, Adam Scott, the Grateful Dead, Natasha Lyonne and Ben Stiller breaking down all things magic mushrooms in a variety of interviews and animated sequences illustrating their experiences on psychedelics. Available to stream on Netlfix

READ

Beach book: "Big Summer," Jennifer Weiner's big summer book, is a hugely entertaining mashup of a beach read/murder mystery/rich-people's-lives-porn/romance. It doesn't make a lot of sense, but it's sprawling and fun, so read and enjoy and just don't try to think about it too much. You get glimpses into high fashion and pricey beach homes and rich lifestyles, and you get to watch a fake-it-till-you-make-it insecure protagonist slowly learn how to stop faking it and actually make it.

RENT

Sweet gem: One worthy rental features the final screen performance of the recently departed legend, Brian Dennehy. He is as good as he ever was in Andrew Ahn's lovely and sensitive "Driveways." This Independent Spirit Award nominated film is the story of an unlikely friendship between an elderly man and a young boy, struggling to find his footing in the world after he's been uprooted to a new town with his mother (Hong Chau). Don't miss this sweet gem, and raise a beer to the wonderful Dennehy. Available on VOD and digital platforms.

LISTEN

Go gaga: Lady Gaga's highly anticipated, "Chromatica," was released Friday. The superstar's 16-track, sixth studio album executive produced by Gaga and BloodPop will feature collaborations with Ariana Grande, Elton John and Blackpink and will be released by Interscope Records. The first single from the album, "Stupid Love," came out in February and debuted at No. 1 on iTunes in 58 countries. It has since amassed 300 million streams worldwide and marks Gaga's 16th Billboard Top 10 hit.

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CHECK IT OUT: New from Lady Gaga; take a wild ride; beach reading; and a screen gem - Wicked Local

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