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VA Studying Psychedelics As Mental Health Treatment For Veterans – Forbes

Posted: June 29, 2022 at 1:06 am

The U.S. Department of Veterans Affairs has launched clinical trials to study the effectiveness of psychedelic drugs including MDMA and psilocybin as a treatment for military veterans with post-traumatic stress disorder, addiction and other serious mental health issues. Building on previous research that has shown the potential for psychedelics to treat serious mental health conditions, the VA is now conducting at least five studies to gain more insight into the promising drugs, according to a report in The New York Times.

This is a watershed moment, said Dr. Rachel Yehuda, the director of mental health at the James J. Peters Veterans Affairs Medical Center in the Bronx, who is leading one of the studies. This is a time for a lot of hope.

Research into psychedelics including psilocybin, MDMA and ketamine has shown that the drugs have potential therapeutic benefits, particularly for serious mental health conditions such as depression, addiction and anxiety. A study published in the peer-reviewed journal JAMA Psychiatry in 2020 found that psilocybin-assisted psychotherapy was an effective and quick-acting treatment for a group of 24 participants with major depressive disorder. Separate research published in 2016 determined that psilocybin treatment produced substantial and sustained decreases in depression and anxiety in patients with life-threatening cancer.

Psychedelic magic mushrooms are being researched to see the benefits of psilocybin used in ... [+] psychedelic therapy. There is currently movement to legalize or decriminalize plant medicine because of it's therapeutic potential.

In 2017, the U.S. Food and Drug Administration designated MDMA as a breakthrough therapy for PTSD, a move which streamlined clinical trials to test the effectiveness of the drug. A year later, the FDA granted the same status to psilocybin as a breakthrough therapy for treatment-resistant depression. The new willingness to allow research has led to a push to study psychedelics as medicines for the nations military veterans, whose challenges with mental illness have led to a suicide rate among vets that is higher than that of civilians.

In New York, researchers are testing MDMA-assisted psychotherapy for a group of veterans in a trial that began in January. Three additional trials of MDMA and synthetic psilocybin, the active compound in psychedelic mushrooms, are scheduled to begin later this year at clinics in Portland and San Diego. Dr. Leslie Morland, a clinical psychologist at the Veterans Affairs Healthcare System in San Diego, is researching the potential for MDMA to enhance couples therapy in relationships challenged by PTSD.

The VA is in some ways the best place for this type of research to happen, said Dr. Leslie Morland, a clinical psychologist at the Veterans Affairs Healthcare System in San Diego, who is studying the possibility that MDMA can enhance couples therapy in marriages strained by PTSD. The VA is going to make sure that we have good data that supports the safety and efficacy before they offer it to veterans, as I think is appropriate.

Last month, The New York Times reported that hundreds of veterans have traveled to psychedelic retreat centers, which can be found in Mexico, Jamaica and other foreign countries. With vets seeking these often-unregulated options, Dr. Shannon T. Remick, a psychiatrist at the Veterans Affairs Healthcare System in Loma Linda, California, said that those charged with caring for vets have a responsibility to research into the drugs.

Theres a risk of doing nothing as veterans are seeking care elsewhere, said Remick, who is leading a study of MDMA as a treatment for PTSD among a group of 10 combat vets. Its our priority to make sure veterans are safe and getting the best care.

While the research into psychedelics shows a strong potential to help people struggling with mental illness, they are not miracle drugs. Although the effects have been shown to be quick and long-lasting, therapy with the drugs often entails intense, frightening sessions as patients deal with the trauma from their past. Yehuda said that the treatments can be exceedingly painful, likening the experience to giving birth.

The most common misconception about MDMA with psychotherapy is that youre taking this magic pill that will take away your symptoms, she said. Whats happening is you are getting in a state that is conducive to doing difficult work in a manner in which you are in the right window of tolerance where you can emotionally engage, where you can process the memory but not get so distressed by the memory that you become emotionally numb.

But the experience seems to be tremendously helpful. Standard treatments for PTSD at VA clinics, which can include prolonged exposure therapy and cognitive processing therapy, can help relieve patients distress. Early results of her research, however, show a much more profound effect.

Many people are showing what seems to look like remission, said Yehuda.

Researchers are optimistic about the potential for psychedelics to foster a new age of care for mental illnesses. But they are tempering their enthusiasm with the reality of the impact the substances can have on patients.

The VA is involved in at least five clinical trials to study psychedelics including MDMA and ... [+] psilocybin as treatments for mental illness.

Were taking vulnerable people, particularly people with severe mental illness, PTSD, substance abuse disorders, and were putting them in a vulnerable state of mind, a very suggestible state of mind, said Dr. Christopher Stauffer, a psychiatrist at the Veterans Affairs Healthcare System in Portland, who is leading two psychedelic studies. We have to be super careful about bias in all directions, from the researchers to the participants.

Kevin Nicholson, COO of psychedelics therapies firm Delic and CEO of Ketamine Wellness Centers, says that his company is already providing ketamine psychedelic therapy for veterans seeking mental health treatment. Last month, the company announced a new partnership with the VA in Arizona.

Veterans suffering from treatment-resistant depression, PTSD and anxiety will now have access to ketamine therapy at the KWC Arizona clinics in Phoenix, Tucson and Mesa-Gilbert at no out-of-pocket cost with prior authorization from the VA, Nicholson writes in an email, adding that more treatments will be available for vets and other patients in the future. We will continue to expand access to ketamine treatments through KWC, and as future medicines move towards legality, such as MDMA and psilocybin, we are prepared to support emerging markets and cater to those suffering from a growing range of conditions.

Yehuda is certain that psychedelics will become a successful therapy for many patients with mental illness. But she warns that the drugs arent for everybody.

I think its going to be a breakthrough for a bunch of people, she said. But we just have to figure out who they are, and more importantly, who they arent.

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10 Psychedelics CEOs To Pay Attention To In 2022 – Yahoo Finance

Posted: at 1:06 am

By Javier Hasse and Aaron Bry.

2020 and 2021 were defining years for the burgeoning psychedelics industry. In 2021 alone, more than $730 million were invested into various psychedelic companies, both private and public.

Businesses around the globe are researching and developing new drugs based on psychedelic properties to support a whole host of conditions. Some of the most active companies to watch boast impressive CEOs to keep an eye on in 2022. Here are a few to watch closely:

Amy Emerson - MAPS Public Benefit Corporation (MAPS PBC)

Amy Emerson is the Chief Executive Officer at the MAPS Public Benefit Corporation (MAPS PBC), a wholly-owned subsidiary of the Multidisciplinary Association for Psychedelic Studies (MAPS), a 501(c)(3) non-profit.

As CEO, Amy has led the growth and development of this subsidiary and is responsible for the overall global regulatory strategy and implementation of research programs. Emerson is focused on the MDMA-assisted psychotherapy program within MAPS PBC.

Amy started as a pro bono consultant at MAPS in 2003, and since then has built MAPS clinical department while managing the MDMA Clinical Development Program with a focus on the PTSD indication. In 2014, MAPS Public Benefit Corporation was incorporated to focus on psychedelic drug development, therapist training programs, and future sales of prescription psychedelics prioritizing public benefit above profit.

Come and meet extraordinary cannabis visionaries and lets network and learn together. Join us inSeptember at the Benzinga Cannabis Capital Conference and stay at the historicPalmer House Hotel. Don't miss out on a chance to hear aboutfuture market forecasts and worldly advice on investing and finance from those embedded in the cannabis industry. Ready, set, go!

Book your tickets HERE, and your room HERE.

Joseph Tucker, Ph.D. - Enveric Biosciences Inc. (NASDAQ: ENVB)

Dr. Tucker is a seasoned executive who has built several publicly traded biotechnology companies. Dr. Tucker was a founder and Chief Executive Officer of Stem Cell Therapeutics, which he took public on the TSX (TSX: SSS). Trillium Therapeutics (NASDAQ: TRIL) (TSX: TRIL) acquired Stem Cell Therapeutics in 2013. Dr. Tucker has also held the position of Co-Founder and CEO of Epimeron Inc., a University of Calgary start-up acquired in the creation of Willow Biosciences Inc. (OTC:CANSF) (TSX: WLLW). At Willow, Dr. Tucker served as Executive Chairman and Chief Operating Officer.

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Prior to founding companies, Dr. Tucker was a healthcare analyst with two investment banks and has also worked in technology commercialization for a university technology transfer office. Dr. Tucker received his Ph.D. in Biochemistry and Molecular Biology from the University of Calgary.

Connor Haslam - Microdose Psychedelic Insight

With almost a decade of experience in entrepreneurship and creative media pursuits, Connor Haslam brings rich experience and diverse insight into his role as Chief Executive Officer at Microdose. His lifelong advocacy for the therapeutic use of psychedelic medicine is expressed through artful, creative and ethical brand development.

Despite never having had a single cup of coffee Connor has somehow found the energy to be a CMO and Lead Designer at 24, build dozens of brand identities, and help establish numerous businesses as leaders in the cannabis industry. His unrestrained passion for psychedelic medicine and the immense hope it has to offer the world continues to fuel his progress in this rapidly emerging space. In addition to being professionally artistic, Connor is also a pianist in his spare time and a wizard at Jeopardy.

Colin Keating - MindBio Therapeutics Pty Ltd

A highly skilled executive leader, Col has over 25 years of experience across various industries including Financial Services & Payments, Corporate Travel, Property Tech, Health Tech and Wealth Management.

He has led both ASX listed and privately held businesses, delivering products and services through both SaaS and traditional technology platforms in B2B and B2C environments. He has held roles as CEO of a publicly listed ASX organization, MD roles in UK listed entities, and COO and executive management positions in large blue-chip organizations.

With an innate ability to identify, strategize and execute on commercial opportunities, Col has established a proven track record in developing and executing strategic initiatives focused on people, growth, M&A activity, capital raising, change management, transformation, optimization, and customer experience and employee engagement. Cols extensive global experience has seen him fulfilling roles in London and Hong Kong along with significant diversity in industries and scale of organizations, ranging from blue chips such as American Express (NYSE: AXP) and Andersens to scale-up and post-start-up operations. Col prides himself on the track record of establishing, developing and nurturing high-performing teams and cultures that have consistently delivered on both customer and organizational objectives.

Najla Guthrie - Wellbeing Digital Sciences

Ms. Guthrie joins Ketamine One as part of the previously announced acquisition of KGK Science Inc. from Auxly Cannabis Group Inc. (OTC: CBWTF), where she has held the role of President & CEO since 1997. Over 23 years, Ms. Guthrie has grown the London-based business to become a leading North American contract research organization that primarily provides high-quality clinical research trials with a focus on the nutraceutical, cannabis and emerging psychedelic industries. Ms. Guthrie has published over 50 papers in peer-reviewed journals and has given numerous presentations at both the national and international levels.

Kathryn Walker - Revitalist

Kathryn Walker is the CEO of Revitalist Lifestyle and Wellness (CSE: CALM) (OTC: RVLWF) which serves as a publicly-traded company on the Canadian Securities Exchange. She is one few entrepreneurial females in the publicly traded space of psychedelics. Kathryn worked at a Level 1 Trauma Center in Tennessee for 9 years before attending anesthesia school at the University of North Carolina-Charlotte. She practiced anesthesia of all specialties for 8 years before opening the first Revitalist location in Knoxville, TN. Today Kathryn operates as a leading advocate for CRNA lead businesses as she continues to advance her comprehensive skill set by pursuing her advanced degree in Psychiatric Nursing.

Deborah Mash PhD - DemeRx

Deborah Mash is one of the world's foremost experts on the hallucinogenic drug ibogaine. She is the CEO and Founder of DemeRx Inc., a clinical-stage drug development company advancing ibogaine and its active metabolite noribogaine for the treatment of opioid use disorder. DemeRx has partnered with ATAI Life Sciences -- a global biotech platform with a special focus on psychedelic medicine -- to develop ibogaine for those suffering from opioid use disorder. Building on the extensive human data available around ibogaine, DemeRx and ATAI (NASDAQ: ATAI) will submit Clinical Trial Applications for a Phase II study in opioid-dependent patients. This joint venture will also develop screening procedures, dosing guidelines, and best practices for opioid withdrawal management to ensure patient safety.

Come and meet extraordinary cannabis visionaries and lets network and learn together. Join us inSeptember at the Benzinga Cannabis Capital Conference and stay at the historicPalmer House Hotel. Don't miss out on a chance to hear aboutfuture market forecasts and worldly advice on investing and finance from those embedded in the cannabis industry. Ready, set, go!

Book your tickets HERE, and your room HERE.

Jemie Sae Koo - Psychable

Jemie Sae Koo is the CEO and Co-Founder of Psychable, the worlds largest trusted online community connecting those who would like to explore the healing power of psychedelics with a network of practitioners and psychedelic-based treatments, including integration, therapy, events, and retreats. Psychables mission is to transform the lives of millions of people suffering with conditions such as depression, PTSD and addiction; and to empower those who want to live a more optimized life.

Abraham Dreazen - Nextage Therapeutics Ltd.

Abraham Dreazen, CEO & Founder of Nextage Therapeutics and IMIO Life, is an experienced leader, entrepreneur and creative thinker. Dreazen's exposure to breakthrough technologies coupled with a deep understanding of innovative pharmaceutical development processes makes Nextage into a powerhouse in CNS drug development. He is a serial entrepreneur as well as an enthusiastic educator with a deep understanding of what it takes to transform research into a product.

Doug Drysdale Cybin (NASDAQ: CYBN)

An experienced Corporate Director and CEO: Doug has chaired the board of directors of a NASDAQ-listed company and as a CEO for the past 12 years has built and turned around three pharmaceutical companies.

During Dougs 30 years of experience in the healthcare sector, he has formed cohesive management teams, recruited board members, completed 15 corporate acquisitions across three continents and has raised $4 billion of both public and private capital.

Led the turnaround of Norwich Pharmaceuticals alongside investors and became the Founding CEO of parent company, Alvogen Group. During his 5.5-year tenure as CEO, Alvogen grew from inception to $450 million in revenues across 35 countries.

From November 2017 to July 2020, Doug was a Director and CEO of Tedor Pharma, a family-owned contract manufacturing business. Dougs efforts to turn around the business resulted in 60% revenue growth in 2019, leading to Tedor being recognized as one of Americas fastest-growing companies, making it to the 2020 Inc 5000 list.

Doug holds a bachelors degree in Microbial and Molecular Biology from the University of East Anglia in the U.K. and was recognized as Entrepreneur of the Year by Ernst and Young, in 2012. Doug is an enthusiastic traveler, having traveled to over 45 countries, is an avid reader and enjoys cooking and boating.

Encuentra contenido sobre psicodlicos en espaol en El Planteo.

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Secret ancient Andean passageways may have been used in rituals involving psychedelics – Livescience.com

Posted: at 1:06 am

Archaeologists have revealed a complex of hidden passageways and galleries deep inside the ancient Chavn de Huntar temple complex in the Peruvian Andes. The researchers think the network of chambers and galleries was used in religious rituals, possibly involving psychedelic drugs.

It's the first time in about 3,000 years that these particular hidden structures have been explored; some of the dark and isolated chambers may have been used for sensory deprivation, while some of the larger galleries seem to have been used for the worship of idols, said John Rick, a Stanford University archaeologist who is leading the research.

"These are stone-lined passageways, corridors, rooms, cells, and niches, big enough to walk through, roofed with stone beams," he told Live Science in an email. "The galleries have a diversity of function from what we can tell, [but] all are related to ritual activity."

Related: Lasers reveal 'lost' pre-Hispanic civilization deep in the Amazon

Rick explained that the newly discovered passageways weren't strictly tunnels, because they hadn't been dug into the ground. Instead, they were deliberately constructed inside the mass of the enormous temple complex as it was built in stages between 1200 B.C. and 200 B.C.

Some of the chambers seem to have originally been rooms near the surface that were kept accessible for a time with heavy-duty roofs and extended entrance passages, he said. The passageways are up to 300 feet (100 meters) long, but many are twisting, with right-angled corners and multiple levels.

A total of 36 galleries and their associated passageways have now been found at Chavn de Huntar over 15 years of excavations, but this latest network was detected only a few years ago and was not explored until this year, Rick said.

Archaeologists think Chavn de Huntar was a religious center for the mysterious Chavn people, who lived in the northern and central parts of what's now Peru between 3,200 and 2,200 years ago, according to Encyclopedia Britannica (opens in new tab). The complex is about 270 miles (430 kilometers) north of Lima, in a mountain valley at a height of more than 10,000 feet (3,000 m), and it's the largest of several Chavn religious sites found so far.

Rick said the latest passageways deep inside the complex were first detected in 2019 and were initially explored with a remote-controlled camera.

COVID-19 restrictions prevented further exploration until May of this year, when archaeologists were able to enter the passageways for the first time since they were apparently sealed off about 3,000 years ago, he said.

The passageways led to a main gallery that contained two large ritual stone bowls, one of them decorated with the symbolic head and wings of a condor, a large Andean bird of prey. The gallery is now known as the Condor Gallery as a result.

"We have now documented the gallery, but have much left to explore," Rick said. "Major excavations will start next year."

He added that the gallery was deeper than most of those found before, and appeared to be older. The Condor Gallery shows many lines of evidence pointing at an age of at least 3,000 years since the gallery was built, and probably since it was formally sealed," Rick said.

Little is known about Chavn beliefs, but the newly discovered passages and gallery seem to have had a religious purpose, like other chambers found in the past at Chavn de Huntar. "The galleries have a diversity of function, from what we can tell," Rick said.

They include several small chambers that might have been used for sensory deprivation or ritual visual, auditory and tactile disorientation, he said. Others chambers were used for worship or to store ritual equipment, including the famous carved ornamental trumpets made from giant conch shells (opens in new tab) that were unearthed at Chavn de Huntar in large numbers and that seem to have been used in ceremonies there, he said.

While some passageways and galleries have been discovered at religious sites of similar age in the Andes, they are usually much smaller and simpler "nothing like the profusion found in Chavn," Rick said.

"The most similar passages in the New World might be the caves beneath the pyramids of Teotihuacan in central Mexico, but the differences are still glaring," Rick said. "Chavn is effectively unique in the number and nature of galleries."

Anthropologist and archaeologist Richard Burger, an expert in South American prehistory at Yale University who was not involved in the latest research at Chavn de Huntar, said the two bowls in the Condor Gallery were probably mortars used to grind up psychedelic drugs for religious ceremonies.

"There was a tradition in Chavn to inhale hallucinogenic snuff," he told Live Science. He's argued (opens in new tab) that it was made from seed pods of the vilca tree, which contain a powerful hallucinogenic substance that includes dimethyltryptamine, or DMT.

University of Florida anthropologist Dan Contreras, who wasn't involved in the discovery but has worked with Rick at Chavn de Huntar, said the latest tunnels present a rare opportunity for archaeologists to study the passageways with new techniques.

While the temple complex at Chavn included several sealed networks of passageways, "this is one that has remained entirely unknown," he said. "Until now, not only had it not been entered, but nobody even knew that it was there."

Many of the passageways seem to have originally been near the surface, but they were sealed off as the complex was built higher over the centuries, he said. One of the most famous is a gallery with a stone monolith near its center.

"There is a compelling argument that this was originally an open plaza," Contreras said. "Then, as the temple was built around it, they kept access to what had been a plaza, but it was now an entirely enclosed space."

Originally published on Live Science.

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How psychedelics act on the brain to relieve depression – Daily Maverick

Posted: at 1:06 am

Up to 30% of people with depressiondont respond to treatmentwith antidepressants. This may be down to differences in biology between patients and the fact that it often takes a long time to respond to the drugs with some people giving up after a while. So, there is an urgent need to expand the repertoire of drugs available to people living with depression.

In recent years, attention has turned to psychedelics such aspsilocybin, the active compound in magic mushrooms. Despite a number of clinical trials showing that psilocybin can rapidly treat depression, including forcancer-related anxiety and depression, little is known about how psilocybin actually works to relieve depression in the brain.

Now two recent studies, published in The New England Journal of Medicine and Nature Medicine, have shed some light on this mysterious process.

Psilocybin is a hallucinogen that changes the brains response to a chemical called serotonin. When broken down by the liver (into psilocin), it causes an altered state of consciousness and perception in users.

Previous studies, using functional MRI (fMRI) brain scanning, have shown that psilocybin seems to reduce activity in themedial prefrontal cortex, an area of the brain that helps regulate a number of cognitive functions, including attention, inhibitory control, habits and memory. The compound also decreases connections between this area and the posterior cingulate cortex, an area that may play a role in regulating memory and emotions.

An active connection between these two brain areas is normally a feature of the brains default mode network. This network is active when we rest and focus internally, perhaps reminiscing about the past, envisioning the future or thinking about ourselves or others. By reducing the activity of the network, psilocybin may well be removing the constraints of the internal self with users reporting an opened mind with increased perception of the world around them.

Interestingly, rumination, a state of being stuck in negative thoughts, particularly about oneself, is a hallmark of depression. And we know that patients with higher levels of negative rumination tend to showincreased activity of the default mode networkcompared with other networks at rest literally becoming less responsive to the world around them. It remains to be seen, however, if the symptoms of depression cause this altered activity, or if those with a more active default mode network are more prone to depression.

The most compelling evidence of how psilocybin works comes from adouble-blind randomised controlled trial(the gold standard of clinical studies) that compared a group of depressed people taking psilocybin with those taking the existing antidepressant drugescitalopram something thats never been done before. The trial was further analysed using fMRI brain scans, and the results were compared with other fMRI findingsfrom another recent clinical trial.

Just one day after the first dose of psilocybin, fMRI measures revealed an overall increase in connectivity between the brains various networks, which aretypically reduced in thosewith severe depression. The default mode network was simultaneously reduced, while connectivity between it and other networks was increased backing up previous, smaller studies.

The dose increased connectivity more in some people than others. But the studies showed that the people who had the biggest boost in connection between networks also had the greatest improvement in their symptoms six months later.

The brains of people taking escitalopram, on the other hand, showed no change in connectivity between the default mode and other brain networks six weeks after treatment started. It is possible that escitalopram may bring about changes at a later time point. But the rapid onset of psilocybins antidepressant effect means it may be ideal for people who dont respond to existing antidepressants.

The study proposes that the observed effect may be due to psilocybin having more concentrated action on receptors in the brain called serotonergic 5-HT2A receptors than escitalopram. These receptors are activated by serotonin and are active throughout network brain areas, including the default mode network. We already know that the level of binding by psilocybin to these receptorsleads to psychedelic effects. Exactly how their activation leads to changes in network connectivity is still to be explored though.

This does raise the question of whether altered activity of the brains networks is required for treating depression. Many people taking traditional antidepressants still report an improvement in their symptoms without it. In fact, the study showed that, six weeks after commencing treatment, both groups reported improvement in their symptoms.

According to some depression rating scales, however, psilocybin had the greatest effect on overall mental wellbeing. And a greater proportion of patients treated with psilocybin showed a clinical response compared with those treated with escitalopram (70% versus 48%). More patients in the psilocybin group were also still in remission at six weeks (57% versus 28%). The fact that some patients still do not respond to psilocybin, or relapse after treatment, shows just how difficult it can be to treat depression.

Whats more, mental health professionals supported both treatment groups during and after the trial. The success of psilocybin is heavilydependent on the environment in which it is taken. This means it is a bad idea to use it for self-medicating. Also, patients were carefully selected for psilocybin-assisted therapy based on their history to avoid the risk of psychosis and other adverse effects.

Regardless of the caveats, these studies are incredibly promising and move us closer to expanding the available treatment options for patients with depression. Whats more, internalised negative thought processes are not specific to depression. In due course, other disorders, such as addiction or anxiety, may also benefit from psilocybin-assisted therapy.DM/ML

This story was first published inThe Conversation.

Clare Tweedy is a Teaching Fellow in Neuroscience at the University of Leeds.

In case you missed it, also read Magic mushrooms: Journeying into ones psyche

Magic mushrooms: Journeying into ones psyche

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How psychedelics act on the brain to relieve depression - Daily Maverick

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Magic mushrooms are all the rage. But are they Jewish? – The Guardian

Posted: at 1:06 am

On 10 January, just as the sun was setting behind the Rocky Mountains, uniformed narcotics officers raided an industrial storage facility in Denvers north end, in a commercial strip between a coffee wholesaler and a plumbing supply store. There, they found scales, petri dishes, grow tents and multiple white miniature freezer units, jam-packed with several pounds of magic mushrooms.

The facility was linked to Benjamin Gorelick, a rabbi who leads the Sacred Tribe, a multi-faith membership-based non-profit, which Gorelick calls a synagogue. The Sacred Tribe counts about 270 members and Jewishness is not a precondition of membership. (According to its website, they even welcome rascally atheists.) The Sacred Tribe celebrates the Jewish high holidays, hosts breath-work seminars, and routinely congregates for a sacred sacrament, in which the mushrooms feature.

Gorelick, 43, was raised Jewish, in New Mexico. He left the south-west (and religion) behind in his late teens, decamping to Alaska to teach mountaineering. In the mountains, he reconnected with his spirituality. He sought a deeper connection to his community and to God. In 2018, he began rabbinical training. He was ordained in 2019. In photos, Gorelick sports a spiky blue mohawk hairdo, bisecting his skull like a punk rock dorsal fin. His fingernails are painted sparkly silver and black. Definitely and, one gets the sense, rather deliberately not your bubbies rabbi.

While training, Gorelick also had his first psychedelic experience. That was the first time when I felt, in my body, God and oneness, he tells the Guardian, speaking from his home in Broomfield, Colorado, about 15 miles north of Denver. The Sacred Tribe is his way of facilitating such experiences with others. The group is donations-based, and he maintains that 90% of its members have never given him so much as a thin penny for anything, including access to psychedelic drugs.

Gorelick (who asks to be called Rabbi Ben) has been charged with felony possession of a Schedule I controlled substance with intent to distribute. The Denver district attorney sees him as a narcotics manufacturer. Rabbi Ben insists that his sacraments are (or ought to be) protected by the first amendments religious protections. At an upcoming court hearing this Monday, he faces a minimum of eight and maximum of 32 years in state prison. We didnt commit a crime, Gorelick insists. This is part of 2,300 years of Judaism.

In the US, religious groups have secured the right to use psychedelic drugs, under the first amendments protection of religious freedom. A unanimous 2006 supreme court ruled that a New Mexican Christian church, the Unio do Vegetal (UDV), could legally host ceremonies featuring DMT-containing ayahuasca. In How To Change Your Mind, his bestselling 2018 chronicle of the current psychedelic renaissance, Michael Pollan called the ruling a watershed event. It made crystal clear that the government was in no position to impinge on sincere exercise of religion.

Hes practicing in the lane of what seems like sincere religious belief to me, says Danny Peterson, a DC-based attorney advising on Gorelicks case. The question is not whether Bens actions constitute violations of controlled substance laws. They do. The question is: is the government committing a new crime by enforcing these laws against him? And they are.

Gorelicks fellow travelers seem similarly sincere. Yehuda, 24, flew to Denver to partake in the Sacred Tribes psychedelic sacraments. (Yehuda is a pseudonym.) He was raised Jewish and had nurtured an interest in Jewish mysticism, including the Kabbalah. He had never taken a psychedelic before congregating with Gorelick and other members of the Sacred Tribe. The reason that I was motivated to do it, he says, was because it was being done as a Jewish religious ceremony.

Some of the Tribes members are more Kabbalah-curious. Sofia (also a pseudonym), 33, identifies as culturally Lutheran and theologically Unitarian, and works at a multi-faith community center. She, too, was attracted to Gorelicks exploration of the Kabbalah by psychedelic means. She sees Gorelicks psychedelic exploration as falling squarely within the first amendments religious protections. She drank wine when she was 10, at her first communion a Christian sacrament that contravenes drinking age laws. I see that as very analogous, she says.

Some outside of Gorelicks direct orbit wince at the idea that psychedelic drugs are part of some age-old Jewish practice. Its just not the case, says Rick Strassman, research pharmacologist and author of DMT and the Soul of Prophecy. The only intoxicants mentioned specifically in the Hebrew Bible are strong wine and liquor. Thats it.

Still, the entwined histories of psychedelia and Judaism run wild with speculation. Strassmans own research compares biblical mysticism to psychedelic states. He theorizes that certain prophetic visions like Ezekiels description of a many-faced cherub, its wings bedecked with whirligig wheels are attributable to endogenous DMT, produced naturally in the human body. Others theorize that the burning bush, which commanded Moses to liberate the Israelites from Egypt, was made of acacia, a DMT-containing shrub. Still others wonder how Moses could have inhaled enough vaporized acacia to trip out, without dying of asphyxiation.

On a Facebook page for the Jewish Entheogenic Society, a discussion group organized by the Bay Area rabbi Zac Kamenetz, some question Gorelicks interpretation of Jewish texts and their validity. Even in a religion as decentralized and diverse as Judaism, Gorelicks approach seems non-doctrinaire. There are many, many paths, Kamenetz says. But for the past 2,000 years, weve liked to show our sources.

The American community of Jewish psychedelic enthusiasts is pretty tight-knit. And Gorelick had, until recently, a minimal presence in that community. Natalie Ginsberg, a policy lead at the Multidisciplinary Association of Psychedelic Studies (Maps) and co-founder of the Jewish Psychedelics Summit, had never heard of Rabbi Benjamin Gorelick until his arrest. I was a bit surprised, she says, That I had never come into contact, or heard from him, or worked with him.

Gorelicks arrest has thrust him into the spotlight. He has retained Grasslands, a Denver-based cannabis marketing agency, to manage his communications. Hes set up online petitions and crowdfunding campaigns. Hes being positioned as the Mushroom Rabbi: a victim of religious persecution and a spokesperson for Jewish psychedelia. A GoFundMe to Help R Ben Defend Religious Use of Psychedelics says that the Sacred Tribes regular operations have been put on hold, a claim which is highly suspect. Yehuda, for one, took part in a psychedelic sacrament in March, after the grow-up raid. Gorelick clarifies that ceremonies have not stopped. But membership, and active participation, has declined.

Gorelicks legal team does not seem bothered by his image as a newcomer, or even a bit of a pariah, in the Jewish psychedelic community. His version of certain rituals isnt really relevant to the legal question, Peterson maintains. It doesnt matter if people dont like the way he talks about it. Or his haircut.

But nobody is grousing about Gorelicks hairdo. His credentials bear more serious scrutiny. Gorelick trained at the Jewish Spiritual Leaders Institute, a one-year, online cyber-synagogue, whose graduates are not recognized by many major organizations, such as Central Conference of American Rabbis (CCAR). In an email statement, a spokesperson for the CCAR says, The depth and breadth of a rigorous rabbinic education is not possible in just a year.

Sidestepping more traditional, Torah-based teachings, Gorelicks interests are almost purely mystical, and Kabbalistic. Called a mysterious and sacred science by the 19th-century French-Jewish philosopher Adolphe Franck, Kabbalah was long regarded as an advanced course of study, undertaken only by those with an exhaustive knowledge of the Torah. Kabbalah was revived in America in the 1960s, alongside the first wave of psychedelia, and the reignited western interest in Buddhism, Hinduism, occultism and emerging New Age practices.

In 1968, theologian Arthur Green pseudonymously published Notes From The Jewish Underground: Psychedelics and Kabbalah, which analyzed the awesome implications of drug use for religious thinking. More recently, clinicians at Johns Hopkins and NYU have put Greens heady thesis to the test. In 2017, they dosed two dozen clergy (including rabbis) with psilocybin. They were studying the relationship between psychedelics and mystical experiences, which, according to veteran Hopkins researcher Bill Richards, seem to be at the origin of most religions. Still, in such studies psychedelics are seen as a chemical precursor to experiences that were traditionally spurred by periods of intense meditation, fasting and prayer a spiritual catalyst, or performance-enhancing drug.

Given the alleged links between psychedelic use and Jewish mysticism, its a bit of a mystery why a challenge like this has not arisen before. Gorelick is candid on this point. He may not be the first rabbi to use psychedelics. But he was the first to get caught. We always knew someone would come knocking at our door.

Certainly, such first amendment defenses tend to emerge, well, defensively. The supreme court decision on ayahuasca came after 30 gallons of the psychoactive brew were seized by US customs agents. Historic as such rulings are, some activists regard them as a bit old hat, especially in light of broader decriminalization efforts. It can be harmful if people are not working in coordination with the bigger movement, says Maps Ginsberg. Implying that certain use should be protected over other use? Thats where I see problems.

But Gorelick can seem like a casualty of that existing decriminalization patchwork. In 2019, Denver became the first US city to effectively decriminalize psilocybin. The law itself is a bit peculiar: while the drug remains illegal under federal law, local police were prohibited from allocating resources to prosecute use or possession. Still, selling shrooms remains a felony. Such piecemeal approaches produce legislative inanities: how are people supposed to procure the psychedelic mushrooms, which are permissible to carry and consume?

In November, Coloradans will vote on a ballot measure legalizing psilocybin, while also providing a framework for licensed psychedelic healing centres. (A similar measure was successfully passed in Oregon in 2020.) We are including retroactivity in our measure, says Kevin Matthews, an activist leading the charge. Any individual who would not have been in violation of whats included in the measure, can actually actively petition to have the record sealed.

So, in a few months, Gorelicks case could be old news. Yet hes still pursuing his explicitly religious crusade. Theyre trying to create a secular, medicinal, therapeutic structure with the ballot initiative thats coming out this fall, Gorelick says, But its not the place where were looking to have protection.

Gorelicks team thinks his case and cut-and-dried enough to be reduced to a misdemeanor, or be thrown out of court altogether. He is, as Peterson, Gorelicks co-counsel, terms it, a church of one, even if his credentials or approaches may raise a few eyebrows. Of course, a religious exemption can be opportunistic, even if its totally sincere. Decriminalization, legalization all these other paths are important, says Peterson. But right now, none of those keep Rabbi Benjamin out of prison.

Those who are working to expand legal psychedelic use for everyone, regardless of faith or affiliation, do not want to see Gorelick imprisoned, even if they take issue with his tactics. As someone who cares deeply about Jewish psychedelia, I dont want to see anyone in jail, Ginsberg says. I do believe we actually have a history of use.

In early June, I meet up with Gorelick in New York, a few weeks before his court date. Seated on a luxe leather sofa in the lobby of a midtown hotel, his once-defiant mohawk has grown shaggier, tufting out from under a kippah, as if wilting under the pressure of his current legal woes.

Hes in Manhattan, he says, to attend a Shavout dinner with a group of Hasidic Jews. Shavout is a traditional holiday celebrating the harvest, which, in some orthodox circles, also marks the occasion of the Torahs revelation to Moses. These particular orthodox Hasids followers of Rabbi Nachman of Breslov, a 19th-century Kabbalah revivalist had been conducting their own experiments with psychedelics to explore the faiths more mystical, further-out dimensions. Gorelick was not there to grace them with audience with the Mushroom Rabbi. He came to learn from them, and their traditions. I kind of invited myself, he admits.

Even as others pressure Gorelick to show his work to point out where in Torah, or in Kabbalah, or anywhere in rabbinic teachings, mind-expanding drugs are justified, or even explicitly mentioned hes confident in his legal standing and in the future of Jewish psychedelia. By showing people what is possible in the psychedelic space, he explains, it makes it more conceivable to achieve these insights in daily life.

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Treating Stress with Wearable Technology – Psychedelic Spotlight

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Its no secret that millions of people have been dealing with huge amounts of stress recently. From global crises, to the more mundane strains of work and family life, millions are burning out, leading to deteriorating mental and physical health. Its with this in mind that people have begun seeking natural and effective ways to counteract their bodys stress responses, including turning to wearable technology.

Many wearable devices have been shown to help with stress. These are pieces of wearable technology that use sensors to monitor biometrics like heart rate, and even can make interventions to promote better health. One similar tool that has been proven to work in scientific studies is the Apollo wearable. However, rather than passively tracking your biometrics, it actively improves your health and wellbeing.

A finalist in the World Changing Ideas Awards of 2021, the Apollo wearable is a watch-sized stress relief device that delivers soothing vibrations to your nervous system, harnessing the power of touch therapy. Developed by neuroscientists and physicians, Apollo helps you recover from stress more quickly, so you can sleep better, relax, and focus.

Because of its ability to reduce stress and promote feelings of safety, the Apollo wearable has also been a helpful addition for patients undergoing psychedelic-assisted therapy. In fact, Apollo Neuro is the only wearable technology with an issued patent to reduce unpleasant and undesired experiences associated with medicine assisted psychotherapy including psychedelics and traditional medicine. One could easily imagine how such a technology could be used to help induce a good trip, and avoid bad ones.

This is no surprise, as the founder of Apollo, Dr. Dave Rabin, is a trained psychedelic therapist who organized studies for MAPS, the largest group studying psychedelic research for mass mental health. In fact, Apollo Neuro is running a clinical trial in conjunction with MAPS to understand the long-term effectiveness of the Apollo wearable in PTSD patients who have undergone MDMA psychotherapy.

But even without combining its use with psychedelics, some have compared the positive effects of the Apollo wearable to microdosing. For example, Paul Austin, founder of Third Wave, said that I find Apollo can be like a microdose on your wrist, a wearable psychedelic. You do not go on a journey or see visions, of course, but you drop into your body and the present moment. The vibrations remind me to be here, now.

The Apollo Wearable Advantage

To explain how the Apollo wearable works, we first must understand the science behind it.

Stress is an evolutionary necessity that our ancestors relied on. When a person feels stress, the brain releases chemicals such as cortisol, which makes our breathing shallow and fast, and sends our hearts racing. In short, it activates what is commonly known as the fight-or-flight response. Obviously, this was very useful when stress was caused by a pack of hungry hyenas. It is somewhat less useful when the cause is an unopened email from your boss, or a toddler who wont stop shrieking MOM! in the supermarket.

When you are chronically stressed, its physiologically harder to focus, relax, sleep, exercise, or even get through the day. Modern life keeps sending signals to your body that youre under threat, but the hungry carnivore is nowhere to be found.

The Apollo wearable was designed to counteract the bodys fight-or-flight stress response by simulating the feeling of a comforting touch. Evolutionarily speaking, touch is the most important way that mammals communicate safety to one another. Think about your own life. When youre stressed, what helps more: a loved one saying everything will be alright, or them silently holding you? Of course, it is the latter. Perhaps you can feel the rhythmic beating of their heart, telling you that youre safe.

Moving to frequencies and vibrations, the first thing to understand is that your bodys systems already operate in certain frequencies. Your heart rate, pulse, and breathing frequencies will vary depending on your mood. For example, when youre about to fall asleep, these frequencies are slow moving and gentle. When you are competing in a sport, theyre rapid and strong.

By understanding our bodys internal frequencies, the Apollo wearable can, through vibrations, help induce a particular state. When your body is exposed to a vibrational frequency, it will naturally sync with it. Therefore, the premise behind the Apollo wearable is that it vibrates at the frequency of a desired state, be that a relaxed one or a hyper-focused one. Then, your body will naturally sync to that frequency, causing you to feel the intended effects whenever you need it.

The Apollo Wearable

There are seven different frequencies, or Modes, that the Apollo wearable offers. Clear and Focused mode can deepen your focus on any task at hand whether thats clearing your inbox, tackling a workout, or deep work. Social and Open mode can elevate mood and relieve stress in social situations. Rebuild and Recover mode can help ground yourself during psychedelic experiences. There are also frequencies that will put your body in a meditative flow state, a relaxed state, and one to help you unwind into deep sleep. The more you use it, the more naturally your body will learn to sync with whichever frequency you are using.

Importantly, the effectiveness of the Apollo wearable is backed up by extensive scientific study. For example, the University of Pittsburgh found that the Apollo wearable increases the ability to focus and remain calm during periods of stress and that these specific vibration patterns improve the bodys ability to recover and be resilient to stress. Similar studies have shown it improves athletic recovery, and supports access to meditative states. Impressively, in the meditation study, naive meditators EEG signatures looked like those of experienced meditators within twelve minutes of using the Apollo wearable. Likewise, other studies have shown it increases time spent in deep sleep by 19% on average, and increases focus and concentration by up to 25%.

Stunningly, a study of nurses using the Apollo wearable over the course of only two weeks, found that their stress and anxiety levels fell by an average of 40%! On top of this, their sleep, energy, mood, and focus all also improved.

Already, therapists are using the Apollo wearable. For example, neurofeedback therapist Heather Hargraves of Divergence Neuro swears by the device, saying I love my Apollo, I use it all day every day, and my clients like it too.

To learn more about the Apollo wearable, visit their website.

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Numinus Applies for International Patent Filing of Psychedelics Production Process – PR Newswire

Posted: at 1:06 am

Filing would offer added protection to IP already submitted to USPTO

VANCOUVER, BC, June 22, 2022 /PRNewswire/ - Numinus Wellness Inc. ("Numinus" or the "Company") (TSX: NUMI) (OTCQX: NUMIF), a mental health care company advancing innovative treatments and safe, evidence-based psychedelic-assisted therapies, today announced that its subsidiary Numinus Bioscience Inc. ("Numinus Bioscience") has filed a patent application to the World Intellectual Property Organization (WIPO), an agency of the United Nations, for a rapid production process for Psilocybe and other fungi species containing psilocybin and other compounds.

A provisional patent application for the process was submitted to the United States Patent & Trademark Office (USPTO) on June 24, 2021. With this additional filing, international patent protection would extend to all WIPO member states that have signed the Patent Cooperation Treaty (PCT), including Australia, Germany, Netherlands and the United Kingdom, where psychedelic research is currently active.

"The WIPO is an important global forum that provides reassurance to the patent offices of member states. Numinus is confident that the robust evidence supporting the production process will further inform regulators as they consider policy changes to make psychedelic-assisted therapies and products more accessible," said Sharan Sidhu, VP, Scientific Research, Innovation & Laboratory Operations, Numinus. "We look forward to advancing current research and paving the way for eventual commercialization and mainstream access."

The purpose of the process is to significantly increase production of therapeutics for use in psychedelic-assisted therapy, while reducing product variability, increasing production efficiency and ultimately reducing commercialization costs. Since the initial filing, data-sets validating the process for additional fungi specifies have been completed, broadening its potential application and scope from psilocybin to other active compounds.

"This application is part of Numinus' long-term IP strategic focus on scalable and sustainable production that advances research, development and delivery of innovative psychedelic-derived formulations in North America and beyond," said Payton Nyquvest, Founder and CEO, Numinus.

About Numinus

Numinus Wellness helps people to heal and be well through the development and delivery of innovative mental health care and access to safe, evidence-based psychedelic-assisted therapies. The Numinus model including psychedelic production, research and clinic care is at the forefront of a transformation aimed at healing rather than managing symptoms for depression, anxiety, trauma, pain and substance use. At Numinus, we are leading the integration of psychedelic-assisted therapies into mainstream clinical practice and building the foundation for a healthier society.

Learn more at numinus.comand follow us onLinkedIn,Facebook,Twitter, andInstagram.

Disclaimer

Neither Numinus Wellness Inc., nor any of its subsidiaries is a professional corporation licensed to practice health services. In jurisdictions where health services may only be provided by a corporation if that corporation holds a valid permit to do so, Numinus and its subsidiaries operate in a management services function to affiliated professional corporations, who provide health services to patients. Numinus and its subsidiaries do provide health services directly to patients in those jurisdictions where authorized to do so.

Forward-Looking Statements

Statements and other information contained in this press release about anticipated future events constitute forward-looking statements. Forward-looking statements are often, but not always, identified by the use of words such as "seek", "anticipate", "believe", "plan", "estimate", "expect" and "intend" and statements that an event "may", "will", "should", "could" or "might" occur or other similar expressions. Forward-looking statements are subject to risks and uncertainties and other factors that could cause actual results to differ materially from those contained in the forward-looking statements. Forward-looking statements are based on estimates and opinions of management at the date the statements are made. The Company does not undertake any obligation to update forward-looking statements even if circumstances or management's estimates or opinions should change except as required by applicable laws. Investors should not place undue reliance on forward-looking statements.

SOURCE Numinus Wellness Inc.

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This Week in Psychedelic Stocks: Compass Pathways Wins Patent Battle, MindMed Patents Candy Flipping, and More! – Psychedelic Spotlight

Posted: at 1:06 am

Compass Pathways (Mostly) Wins their Comp 360 Patent Battle

The biggest story in psychedelic stock news this week, is that Compass Pathways (Nasdaq: CMPS) appears to have won the patent battles surrounding their Comp 360 molecule. Earlier, the company had been granted two patents covering the synthetic psilocybin, but they were being challenged in the Patent Trial and Appeal Board.

The crux of the issue was whether Comp 360 is a novel compound that hasnt been created before, or whether it had previously existed in the public domain. The Board ruled in Compass favor, saying that Comp 360 was in fact novel. This means the patents hold, and can not be challenged in court. The decision was final, and can not be appealed.

To learn more about this decision, and its implications on competition in the psychedelic medicines industry, read Compass Pathways Psilocybin Patent Upheld.

Next up in psychedelic stock news, MindMed (NEO: MMED, Nasdaq: MNMD) has been granted a patent for the practice commonly referred to as Candy Flipping by the United States Patent and Trademark Office. As reported by Graham Pechenik, Editor-at-Large for Psychedelic Alpha, MindMeds patent gives them claims to a composition comprising an empathogen/entactogen and a psychedelic in the same single oral dosage form.

Essentially, this means MindMed has the sole right to combine empathogens (such as MDMA) and psychedelics (such as LSD) into the same single oral dosage form. As Pechenik writes, the patent also covers how such a combination will be used, including in the treatment of psychiatric disorders such as depression, anxiety, anxiety related to life-threatening disease, OCD, personality disorder, and addiction.

This patent will likely be controversial, as the act of combining LSD and MDMA has been done recreationally for decades. MindMed says the difference lies in the fact that their invention is that both drugs reside within the same single oral dosage form, whereas Recreational users use MDMA & LSD in separate dosage forms.

The patent will also cover the combinations of other empathogens (ex: MDA; MDEA; MDAI; and 3-MMC) with other psychedelics (ex: mescaline; and DMT).

To learn more, read Graham Pecheniks Twitter thread.

Numinus Wellness (TSE:NUMI, OTCMKTS: NUMIF) has filed a patent application to the World Intellectual Property Organization (WIPO) for a rapid production process for Psilocybe and other fungi species containing psilocybin and other compounds.

The company had already filed a patent for the same process in the USA, but if this new application is granted, patent protection would extend to all WIPO member states that have signed the Patent Cooperation Treaty (PCT), including Australia, Germany, Netherlands and the United Kingdom.

According to Numinus, the production process they are attempting to patent will significantly increase production of therapeutics for use in psychedelic-assisted therapy, while reducing product variability, increasing production efficiency and ultimately reducing commercialization costs.

Numinus thesis is that naturally produced psilocybin will be more cost-effective than synthetic psilocybin, and thus are trying to perfect the production process for psilocybe fungi.

Continuing with psychedelic stock news, Cybin (NEO: CYBN, NYSE American: CYBN) released financial data for the quarter and fiscal year that ended on March 31st, 2022.

As of March 31st, Cybin had C$53.6 million in cash and cash equivalents.

The net loss for the quarter was C$18.1 million, though C$5.1 million of that was non-cash expenses. Extrapolating into the future, if Cybin were to hold its cash expenditures steady at C$13.0 million per quarter, the company will have enough money for 1 year of operations. Though the company states that C$3.8 million were one-time, non-recurring costs, there are always various one-time costs, so I did not remove these from the calculation.

For the year, Cybin had a net loss of C$67.6 million, of which C$21.8 million were non-cash expenses.

Given these numbers, it seems likely that within a year Cybin will have to raise capital.

Mindset Pharma (CSE: MSET, FSE: 9DF, OTCQB: MSSTF) this week announced that they have entered into an innovative research collaboration with the Centre for Addiction and Mental Health. The Toronto-based hospital and Mindset will run a preclinical study on Mindsets patented next-generation psilocybin molecule, MSP-1014.

The study will investigate how macro and micro doses of both MSP-1014 and classical psilocybin modulate expression levels of molecular biomarkers of brain plasticity in rats. The goal is to understand how changes in biomarkers can cause behavioral changes associated with a single psychedelic experience and develop molecular insights into the magnitude of effects of its lead compound, MSP-1014, compared to psilocybin.

Mindset Pharma says that MSP-1014 has the potential to be a stronger, safer, more cost-effective alternative to psilocybin. This will be tested in future human clinical trials.

This week, Red Light Holland (CSE: TRIP, FSE: 4YX, OTC Pink: TRUFF) announced that they have closed their previously announced acquisition of 100 acres of farmland located in the township of Cavan-Monaghan in Peterborough, Ontario. The company paid C$1.85 million for the land.

Red Light plans to develop the Farm into approximately 65,000 sq. feet of two Mushroom production facilities, with the help of Acadian Exotic Mushrooms, a company that is majority-owned by Red Light. Construction is slated to begin this summer.

Speaking on the acquisition, and Red Lights cash position, Todd Shapiro, CEO and Director of Red Light, said We are extremely confident at Red Light because of how prudent we have been at running our psychedelic business, preserving cash at a time when most of our peers are straining to attract new capital. Red Light Holland, on the other hand, has a significant cash position as we are clearly focused on increasing revenues while having a strategic and aligned plan to grow, in order to weather difficult markets and harder economic times.

Optimi Health Requests Approval To Manufacture MDMA, Other Synthetic Psychedelics

This week, Optimi Health Corp. (CSE: OPTI, OTCQX: OPTHF, FRA: 8BN) submitted a request with Health Canada for an amendment to its Controlled Substances Dealers Licence.

The company, which already can manufacture and sell naturally derived psilocybin, is requesting its license be expanded to include the synthetic production of compounds such as MDMA, DMT, LSD, mescaline, and ketamine.

The company says that this move aligns with Optimis planned year of commercialization, allowing the Company to maximize revenue-generating opportunities through standardized psychedelic drug testing, R&D, and product development through approved clinical trials and exemption-based applications.

This week, Tryp Therapeutics (CSE: TRYP, OTCQB: TRYPF) announced that Sid Taubenfeld, a seasoned executive with healthcare and biotech expertise, has become their new Chief Operating Officer.

Before joining Tryp, Taubenfeld served as the CEO of Tikun Olam Pharma, an Israeli medical cannabis company.

According to Tryp, Sids primary responsibilities will include developing the organizations long-term vision and strategy alongside the CEO and Board; ensuring that the company operates effectively and efficiently in all areas; and helping ensure a high-performing portfolio and psychedelic medicine advancements at Tryp.

BetterLife Pharma (CSE: BETR, OTCQB: BETRF, FRA: NPAU) will present preclinical data for the drug 2-bromo-LSD (BETR-001) at the upcoming Federation of European Neuroscience Societies Forum, held on July 9-13 in Paris, France.

BetterLifes lead compound, 2-bromo-LSD/BETR-001, is a non-hallucinogenic derivative of LSD. At the conference, BetterLife will present preclinical data demonstrating the anti-depressant and neural plasticity-promoting properties of BETR-001 from both in vitro and in vivo studies.

BetterLife believes BETR-001 has the potential to be as effective as LSD in various neuropsychiatric and neurological disorders without the burden of being hallucinogenic. If this can be proved in human clinical trials, it would revolutionize the psychedelics industry, as BETR-001 would not have to be administered in specialized clinics under special treatment protocols. This would drastically cut the costs of psychedelic medicines.

However, we would need to see human clinical data showing non-hallucinogenic versions of psychedelics being effective in treating health conditions before we get too excited about this prospect. This is a topic that Psychedelic Spotlight Editor, James Kent, explored this week in the article, Is the Mystical Experience Necessary for Psychedelic Therapy?

To wrap up this weeks psychedelic stock news, Mydecine Innovations Groups (NEO: MYCO, OTC: MYCOF, FSE: 0NFA) version of psilocybin MYCO-001 has been cleared by the FDA to begin an in-human Investigator Initiated trial.

The trial, being headed by Jons Hopkins psychedelic researcher, Dr. Matthew Johnson, will aim to determine if psilocybin increases smoking abstinence compared to a placebo, when paired with therapy.

Interestingly, the trial is being funded with close to $4 million from the National Institutes of Health, making this the first time in 50 years the U.S. government has funded a study evaluating a psychedelic compound for therapeutic use.

Mydecine is also preparing to launch a phase 2b trial, again testing the ability of MYCO-001 to treat nicotine addiction.

____________________________________________________________________________

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This Week in Psychedelic Stocks: Compass Pathways Wins Patent Battle, MindMed Patents Candy Flipping, and More! - Psychedelic Spotlight

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Is there a future for psychedelic treatment in Saudi Arabia? – Arab News

Posted: at 1:06 am

RIYADH: Psychedelic researcher Stanislov Grof once wrote that psychedelics, used responsibly and with proper caution, would be for psychiatry what the microscope is for biology and medicine or the telescope is for astronomy.

To many, this may sound like an outlandish claim, but now more than ever, it is proving to be true and may very well become a frontier in practicing medicine.

Saudi Arabia was enduring a mental health epidemic and the psychological strains of the pandemic exacerbated that. People are finding themselves desperate for ways to cope. One of the most recent psychotherapy methods in the region, albeit stigmatized, is psychedelic-assisted psychotherapy. A recent study published by Neuropsychopharmacology showed that the substances were proven to achieve positive long-term mental health effects and their efficiency, safety and tolerability in treating major depression, post-traumatic stress disorder, obsessive-compulsive disorder and certain addictions.

I get more people contacting me asking me how they can receive this treatment, and its really heartbreaking to tell them, Im sorry, but youre gonna have to wait. Its not available yet.

Haya Al-Hejailan, Saudi well-being practitioner and psychedelic integration specialist

It is also associated with enhancing creativity and problem-solving, according to an article published by the Journal of Psychoactive Drugs in 2019.

While the stigma around mind-altering substances, both in the region and globally, is unavoidable, researchers and scientists argue that if these drugs are regulated and used purely for medicinal reasons, what is the harm?

The term psychedelics, a class of hallucinogens, comes from the Greek words psyche, meaning the mind, and delia, meaning manifesting. The psychoactive substances are meant to alter the mind and create an alternative cognitive perception.

Psychedelics are classified into classical, which includes lysergic acid diethylamide (LSD), psilocybin (commonly known as magic mushrooms), mescaline and others, and non-classical, such as methylenedioxymethamphetamine (MDMA or ecstasy) and ketamine.

(Theyre) really great tools for us being able to understand the brain and the study of consciousness better, Saudi well-being practitioner and psychedelic integration specialist Haya Al-Hejailan told Arab News. Her work centers on psychedelic research and the treatment of borderline personality disorder.

This point may seem counterintuitive: How can addiction be treated with a substance that may cause another addiction? But psychedelics are, in fact, anti-addictive in nature.

They have anti-addictive properties, meaning they dont constitute physiological addiction, but one can become psychologically addicted to anything, said Al-Hejailan, refererring to non-substance addictions such as coffee or mobile devices.

However, the use of psychedelics can pose certain dangers, making it crucial to undergo treatment strictly under professional medical supervision, which can only be accessible through clinics. Psychedelic therapists are trained to create a controlled environment for patients undergoing psychedelic therapy, with sessions prior to administering the treatment dose to identify any red flags or possible risks that would otherwise create a larger margin of error. Patients who self-dose could potentially be subject to health risks, retraumatization, depersonalization and dissociation.

I get more people contacting me asking me how they can receive this treatment, and its really heartbreaking to tell them, I'm sorry, but youre gonna have to wait. Its not available yet, Al-Hejailan said. But Im optimistic with highlighting the word yet.

An article published by The Lancet showed that most antidepressants are ineffective and can be harmful to adolescents and children.

In an attempt to fulfill that medical need, several research efforts and trials have been unertaken to evaluate alternative routes, such as psychedelic-assisted therapy.

A study published by the National Library of Medicine found that small IV doses of ketamine can have positive, long-lasting antidepressant effects in patients. Although the scientific research regarding psychotherapeutic psychedelic use in the region is insufficient, Saudi Arabia has been easing its way into their use use for other purposes. Last year, the Saudi Journal of Emergency Medicine published a paper describing a successful case of refractory status epilepsy, a life-threatening condition, in a child treated with a single dose of ketamine.

Despite its growing popularity in mainstream media, psychedelic science is one of the cutting-edge neurosciences, yielding insufficient research compared to other sciences. The 1950s saw the first English-language report published on LSD, and research continued into Richard Nixons US presidential term, ending in the 70s. However, research efforts were quickly banned under the justification of the war on drugs as a public enemy declared by the US president. However, it was supported by other factors, such as the lack of funding for psychedelic research and failed medical trials, according to an article published by the Cambridge University Press.

That area of medicine was considered niche until recently. In 2017, MDMA was given breakthrough therapy designation by the Food and Drug Administration, meaning it was granted an expedited review process. In 2018, the FDA granted a group of psychiatrists researching psilocybin-assisted therapy for treatment-resistant depression the same status.

In the same year, Michael Pollans book How to Change Your Mind created a public space for people to think differently about psychedelics and the consciousness expansion of the mind. Ketamine was granted the same status a year later. Arguably, that is when psychedelics hit the mainstream, although its resurgence into clinical research and trials resumed in the 1990s.

(Before that) I was met with a lot of skepticism. People literally thought I was talking about something thats crazy, Al-Hejailan said in reference to discussing psychedelic-assisted psychotherapy before 2018.

Theres a lot of interest, enthusiasm and curiosity that Im met with now when I talk about my work.

With a masters in applied positive psychology and coaching psychology from the University of East London, Al-Hejailans work also includes positive psychology integration and psychedelic education, providing training in psychedelic therapy and ketamine-assisted psychotherapy. She also co-directed and co-produced a documentary titled Psychedelic Renaissance, centered on the reemergence of the psychedelic movement globally and its cultural significance.

Al-Hejailan said that raising awareness about psychedelic studies was the first step in creating a regional environment that allows for alternative psychotherapy methods.

I think we need to, in general, focus more of our energy and attention on psychoeducation, educating the public about mental health and well-being. The more we do that, the more people are likely to continue becoming accepting and interested, she said.

Future steps to normalize the use of psychoactive drugs include active training for clinicians and therapists on their uses and benefits and eventually establishing specialized clinics and research centers.

My goal is to have presentations specifically on psychotherapy and to meet with therapists, psychologists, psychiatrists and other physicians, and policymakers at some point. To show them whats happening abroad, what the science shows and to discuss how we can replicate this here in a safe way that respects our culture and that respects our specific or unique needs, Al-Hejailan said.

I really want to open a clinic and research center here. Me and my colleagues would very much love to see Saudi pioneer in psychedelic research in the region, and maybe globally.

Excerpt from:

Is there a future for psychedelic treatment in Saudi Arabia? - Arab News

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Optimi Health Initiates Agreement With SABI Mind For Therapeutic Supplies Of Psilocybin, MDMA – Marketscreener.com

Posted: at 1:06 am

VANCOUVER, British Columbia, June 28, 2022 (GLOBE NEWSWIRE) -- Optimi Health Corp. (CSE: OPTI) (OTCQX: OPTHF) (FRA: 8BN) (Optimi or the Company), a homegrown, Canadian company producing natural, scalable, and accessible psychedelic and functional mushrooms, as well as synthetic formulations for transformational human experiences, is pleased to announce that it has entered into a supply agreement with SABI Mind, a Calgary-based clinic group providing psychedelic-assisted therapies.

The Company has signed an agreement which will provide SABI Minds trained clinical staff with supplies of GMP psilocybin and 3,4-Methylenedioxymethamphetamine (MDMA), pending the anticipated approval of its previously announced licensing amendment, for use by practitioners in psychedelic-assisted therapeutic protocols with approved patients via Health Canadas Special Access Program, clinical trials, and academic studies.

This agreement is an important step forward for both parties, said Optimi Health CEO Bill Ciprick. SABI Minds initiation of this agreement demonstrates a commitment to safe supply for the development and implementation of therapeutic modalities using psilocybin and MDMA.

Clinical distribution is a major milestone in the growth of Canadas psychedelics sector from the standpoints both of business operations, and as a medical option for those in need.

Theres growing evidence that MDMA and psilocybin assisted therapies can help treat PTSD, depression and other chronic mental health conditions, said Philippe Lucas PhD, SABI Mind President. Were very pleased to be working with Optimi to ensure a safe, consistent supply of psilocybin and MDMA to SABI patients qualifying under Health Canadas Special Access Program.

As we continue to establish the logistical channels of our new industry, Optimi is extremely gratified to receive requests such as this, added Ciprick. The knowledge that the substances we produce, natural or synthetic, will be used by patients in a safe environment to further psychedelic science is a vindication of the principles on which this company was established.

Optimi Health recently requested an amendment to its Controlled Substance Dealers Licence from Health Canada which would enable it to utilize its state-of-the-art analytical laboratory for the production of synthetic MDMA, among other substances.

SABI Mind currently operates a best-in-class clinic in the Sunalta area of Calgary, with expansions planned into Edmonton, Alberta and Victoria, British Columbia.

Authorized parties interested in purchasing Optimi psilocybin and functional mushroom products, MDMA, or other synthetic psychedelics are invited to contact sales@optimihealth.ca where a member of the sales team will respond within 24 hours.

ABOUT OPTIMI (CSE: OPTI) (OTCQX: OPTHF) (FRA: 8BN)

Optimi Health Corp. is a homegrown, Canadian success story producing and supplying natural, EU-GMP grade psilocybin and functional mushrooms that focus on the health and wellness markets. Built with the purpose of producing scalable, natural mushroom formulations for transformational human experiences, the Companys goal is to be the number one trusted, compassionate supplier of safe, natural EU-GMP psilocybin throughout the world. With a vertically integrated approach, Optimi is engaged in the cultivation, extracting, processing and distribution of high quality functional and psychedelic mushroom products at its two facilities comprising a total of 20,000 square feet in Princeton, British Columbia.

About SABI Mind

Located in Calgary, SABI Mind supports the careful and necessary mending of mental health and chronic pain through psychedelic-assisted therapies. Founded by a group of Calgary-based entrepreneurs brought face-to-face with the challenges of those suffering from mental health conditions, SABI Mind empowers those discouraged by the conventional medical methods with a patient-centered treatment model supported by experienced psychiatrists, anesthesiologists, therapists, client experience specialists, and other clinic staff specially trained in ketamine-assisted psychotherapy and other psychedelic therapies.

FOR INTERVIEW REQUESTS OR FURTHER INFORMATION PLEASE CONTACT:

Investor Relations Michael Kydd Email: investors@optimihealth.ca Phone: +1 (902) 880 6121 Web: https://optimihealth.ca

FORWARDLOOKING STATEMENTS

This news release contains forwardlooking statements and forwardlooking information within the meaning of Canadian securities legislation (collectively, forwardlooking statements) that relate to Optimis current expectations and views of future events. Any statements that express, or involve discussions as to, expectations, beliefs, plans, objectives, assumptions or future events or performance (often, but not always, through the use of words or phrases such as will likely result, are expected to, expects, will continue, is anticipated, anticipates, believes, estimated, intends, plans, forecast, projection, strategy, objective, and outlook) are not historical facts and may be forwardlooking statements and may involve estimates, assumptions and uncertainties which could cause actual results or outcomes to differ materially from those expressed in such forwardlooking statements. No assurance can be given that these expectations will prove to be correct and such forwardlooking statements included in this news release should not be unduly relied upon. These statements speak only as of the date of this news release. In particular and without limitation, this news release contains forward looking statements pertaining to activities proposed to be conducted under the Companys dealers license and associated business related to Psilocybin and Psilocin and Optimis plans, focus and objectives.

Forwardlooking statements are based on a number of assumptions and are subject to a number of risks and uncertainties, many of which are beyond Optimis control, which could cause actual results and events to differ materially from those that are disclosed in or implied by such forwardlooking statements. Such risks and uncertainties include, but are not limited to, the impact and progression of the COVID19 pandemic and other factors set forth under ForwardLooking Statements and Risk Factors in the Companys Annual information Form dated January 12, 2022, and other continuous disclosure filings available under Optimis profile at http://www.sedar.com. Optimi undertakes no obligation to update or revise any forwardlooking statements, whether as a result of new information, future events or otherwise, except as may be required by law. New factors emerge from time to time, and it is not possible for Optimi to predict all of them or assess the impact of each such factor or the extent to which any factor, or combination of factors, may cause results to differ materially from those contained in any forwardlooking statement.

Any forwardlooking statements contained in this news release are expressly qualified in their entirety by this cautionary statement.

A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/67fd5330-02d3-40bb-af5b-938cb2c94f6d

A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/49bf2da6-a0b2-481e-9cf3-eed6879d5af7

Optimi Health Cultivation and Analytical Facilities

Optimi Health Cultivation and Analytical Facilities

Optimi Health Fruiting Room

Optimi Health fruiting room being prepared for second grow.

2022 GlobeNewswire, Inc., source Press Releases

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Optimi Health Initiates Agreement With SABI Mind For Therapeutic Supplies Of Psilocybin, MDMA - Marketscreener.com

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