psilocybin Archives - Green Market Report

Dave HodesApril 14, 2022
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Public funding for new mental health discoveries that can change the lives of millions of Americans for good? In a word: Absolutely.

Over the last three years, clinical trials of psilocybin and MDMA psychedelics assisted therapy in particular have demonstrated their value in treating various mental health conditions, even hard to treat conditions such as so-called treatment resistant depression. It is believed that this new therapy offers real hope for the hopeless.

The clinical trials excitement is tempered by the fact that there are still many answers needed about how various psychedelic substances work inside the human brain. There is so much more work to do. But that is precisely why more public funding is needed.

To be sure, hundreds of millions of dollars in philanthropic investment are actively making a difference. One example: Stephen Jurvetson, co-founder of Future Ventures and a board member at  SpaceX, is reportedly giving about half of his net worth to fund psychedelic science.

Nonprofit Research

The Psychedelic Science Funders Collaborative (PSFC), a nonprofit organization founded in 2017 created to support scientists and organizations working on psychedelic clinical trials, includes some of the leading funders of psychedelic medicine who are supporting organizations at the cutting edge of psychedelic research. PSFC has funded several organizations at the forefront of the psychedelic field, and, in 2020, completed a $30 million fundraising campaign in partnership with the Multidisciplinary Association for Psychedelic Studies (MAPS) to support the completion of phase 3 clinical trials of MDMA-assisted psychotherapy. 

PSFC’s current areas of focus includes supporting broad and equitable access to high-quality MDMA-assisted psychotherapy post-FDA approval, and supporting the implementation of Oregon’s Measure 109.

It seems that almost every week, another business leader or philanthropist steps up with a psychedelics funding objective—SpaceX founder Elon Musk, Groupon co-founder Andrew Mason, even an anonymous Bitcoin millionaire. But it’s not enough. Deeper pockets are needed for more historic and life-changing outcomes that psychedelics research has just begun to deliver.

A primary source of federal medical science funding comes from the National Institutes of Health (NIH). NIH-funded research has contributed to a 60 percent reduction in the death rates for coronary heart disease and stroke, a 40 percent decline in infant mortality over the past 20 years, and a 30 percent decrease in chronic disability among seniors.

Psychedelics research is at a point where it is ripe for more government funding, as a growing number of U.S. cities and states are taking legislative action to decriminalize or legalize psychedelic use and/or research; and a new Harris Poll reporting that nearly two thirds of Americans who suffer from anxiety/depression/PTSD believe that psychedelic medicine should be made available to patients with treatment-resistant anxiety, depression or PTSD.

Government Funding

And then: The DEA stepped up its allowable production quotas for psychedelics in November citing “a significant increase in the use of schedule I hallucinogenic controlled substances for research and clinical trial purposes.”

There has been a glimmer of hope for public funding in psychedelics. In October, Johns Hopkins Medicine was awarded a grant from the NIH to explore the potential impacts of psilocybin on tobacco addiction. This is the first NIH grant awarded in over a half century to directly investigate the therapeutic effects of a classic psychedelic.

With that announcement comes reference to the stigma problem that began when studies on LSD and other psychedelics that were raging over 50 years ago, in the 1960s and 1970s. LSD became a victim of a politized youth culture at the time that turned the potential therapeutic good of LSD into just another party drug problem. It was made illegal by the DEA as a Schedule 1 drug. Recovering from over 50 years of public disparity has been achieved somewhat, but it is still an ongoing issue with not just LSD but all psychedelics.

It’s clear that today, the NIH needs to get into the psychedelics game in an even bigger way than just its recent grant to Johns Hopkins. The limited support from philanthropic sources has funded the research so far, but these are restricted trials of relatively small samples of patients because of the cost of doing larger studies.

By contrast, NIH is the largest single public funder of biomedical research in the world. Every state and almost every Congressional district has earned a share of this investment. NIH investments in research focused on a particular area has been found to stimulate increased private investment in the same area. A $1.00 increase in public basic research stimulates an additional $8.38 of industry R&D investment after 8 years. A $1.00 increase in public clinical research stimulates an additional $2.35 of industry R&D investment after 3 years.


Dave HodesMarch 30, 2022
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It’s once again a flash from the past—just like with cannabis in 1975, Colorado is leading the country in deciding to decriminalize another psychoactive federally illegal drug. This time, it’s psilocybin. 

Denver became the first city to decriminalize psilocybin in May, 2019, when the city and county of Denver voters enacted Ordinance 301 to make adult personal possession and use of psilocybin the lowest law enforcement priority, and prohibit the city and county from spending resources on enforcing any related penalties. 

Decriminalize Nature Colorado, an educational campaign funded by donations to inform individuals about the value of entheogenic plants and fungi with the intention of proposing a resolution to decriminalize “our relationship to nature,” submitted a proposed ballot initiative to the Secretary of State’s Office on January 28 that sought to decriminalize the possession, use and facilitation of entheogens in the state—a term which is generally regarded as safer “regulator-speak” for psilocybin.

Decriminalize Nature has a track record for this cause—Decriminalize Nature D.C. helped get the psilocybin decriminalization initiative, Initiative 81, passed in D.C. in March, 2021

Another Colorado initiative came from New Approach PAC, backed by major contributors the Van Ameringen Foundation, a private grant-making foundation based in New York, and Dr. Bronner’s Magic Soap, a hemp products maker channeling over $3 million into the PAC. They submitted their own initiative that includes decriminalization measures as well as a legal pathway for psilocybin therapy in Colorado.

In fact, the PAC initially filed two proposed initiatives in December, has since altered both, and tried to court the very activists who are now pushing their own proposal, according to an article in Westword

At one point, it looked like voters would be facing two versions for how to best move forward with psychedelics reform in Colorado: one proposal with carve-outs for state regulation, and one that has none. But it looks as though lawmakers have narrowed down what they want to do. Final initiative language details are being worked out.

New Approach PAC also supported the approved Washington, D.C. initiative 81; plus Oregon’s approved initiative; plus a slew of marijuana legalization laws including California Proposition 64 in 2016.

Colorado officials have given tentative approval to the ballot language of four psychedelics reform measures submitted—Initiatives 49, 50, 58, 59, all titled the Natural Medicine Health Act—but it was always the plan to pursue only one version. The provisions vary slightly in each version of the initiative. Now they’ve requested permission from the state to start signature gathering for Initiative 58.

The initiative states that, if voters approve it in November, 2022, the state will adopt rules by January 1, 2024 to establish qualifications for the education and training of facilitators; adopt rules by September 30, 2024 needed to implement the access program and take applications for facilities; and that, after reviews by the Natural Medicine Advisory Board, other psychedelics than psilocybin may be added by June 1, 2026 (to include ibogaine, mescaline, dimethyltryptamine).

So is this growing decriminalizing movement in cities and states in the U.S. worth it?

Assistant Professor of Law, University of Massachusetts School of Law, Dustin Marlan, discussed several justifications for the decriminalization of psychedelics—medical value, religious freedom, cognitive liberty, and identity politics. 

He then attempted a reframing of the cognitive liberty and identity politics-related justifications under tenets of the neurodiversity paradigm. “It is unclear whether such a brain equality argument would hold clout in a court of law, but to the extent that it gains a following in the popular consciousness, we are more likely to see additional successful ballot initiatives for psychedelic law reform,” Marlan wrote. “This turn of events could shape the end of the unjust prohibition on altered states of consciousness.”


Julie AitchesonMarch 24, 2022
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Medicinal mushrooms have major potential health benefits and are big business for makers of supplements, beauty products, confections and more. These medicinal fungi are finding their way into many of today’s cannabis product line-ups, such as CBD Tea’s CBD Mushroom Defense and the CBDFx line of CBD and mushroom tinctures that boast a supercharged synergy between CBD and mushrooms. The integration of medicinal mushrooms and cannabis has been seamless overall, without many of regulatory snafus that would plague a product made with “magic mushrooms”, aka fungi with the naturally-occurring hallucinogenic compound psilocybin. But that doesn’t mean such products aren’t finding their way into consumers’ hands at a steadily increasing rate.

Though “magic mushrooms” are currently legal in Brazil, Bulgaria, Jamaica, the Netherlands and Samoa and their possession and cultivation has been decriminalized in many other countries, psilocybin is still classified as a Schedule 1 drug in the United States. This means that, by the DEA’s assessment, psilocybin has a high potential for misuse and no currently accepted medical use. This renders psilocybin illegal in all fifty states, though Denver, Colorado and Oakland, California have both signed legislation to decriminalize psilocybin. This means that these cities locales will no longer use city funds to impose criminal penalties on those age 21 or over who use or possess psilocybin. Selling it is still illegal.  In 2020, Oregon became the first state to legalize psilocybin in therapeutic settings, with more than a million Oregonians voting “yes” on Measure 109. Under this measure, only license-holders are able to cultivate psilocybin or provide therapy or own a psilocybin service center. Oregon also passed a measure decriminalizing possession of small amounts of psilocybin. Initiative 81 passed in Washington, DC, which makes prosecuting the cultivation, possession, and distribution of hallucinogens like psilocybin a low priority for law enforcement. 

Given its classification as a Schedule I drug and the steady pace of decriminalization around the U.S., how are these products making their way to market, and what are the implications for businesses and consumers? L.A.-based Psilouette Wellbeing’s Entheogen Mushroom Gummies are the brainchild of Psilouette founder Derek Chase, who created Psilouette’s line of gummies to make the healing powers of mushrooms more accessible to the public. Currently, Psilouette’s website advertises a “Macrodose” gummy with 2,400mg of “soluble fruiting body beta glucans” a “Stamet’s Stack Mircrodose” with 75mg of “soluble fruiting body beta glucans” per 2.5g (the ingredient list specifies only Lion’s Mane extract). They also offer a “Customized Compounding Service”, through which customers can have custom gummies created for their specific needs. While the word “entheogen” (a psychoactive substance that induces alterations in mood, cognition, behavior, or consciousness for the purpose of spiritual development) does appear on Psilouette’s home page, none are specifically mentioned in any of the ingredient lists, nor does the word “psilocybin” appear anywhere on the website. 

Derek Chase believes that psychedelics are among the best tools to help “resurrect” a state of well-being and balanced mental health. “Our focus is really on delivering mental health with the assistance of psychedelics, not psychedelics alone.” Psilouette plans to add therapeutic content and resources to their website and offer them through an eventual brick and mortar location in Oregon. These offerings might include everything from float tanks and virtual reality experiences to more conventional talk therapy. When this content will be offered is still an open question. “The product side is much farther along because it’s simpler and we have manufacturing capability through our cannabis brand,” Chase says, referring to cannabis company Flora + Bast, which has provided a launch pad for Psilouette.  The two companies share facilities and Psilouette uses outreach to Flora + Bast customers to identify those who might be looking for a more targeted and potent remedy for issues like anxiety and stress. 

Through this outreach and, more commonly, word-of-mouth, customers find Psilouette despite the lack of explicit wording on their website. This necessary exclusion is due to Shopify’s rules around what transactions and language are allowed on its platform. Customers are given the opportunity to make a donation and receive a “gift” of product. The suggested donation amount is commensurate with the cost of the actual product, but if a customer cannot afford that, Psilouette often provides the “gift” at low or no cost. After “purchase”, customers are asked how they found out about the product, what they intend to use it for, and recommend a dosage. The product is shipped if the customer “qualifies”. “There is a lot of giving away because most people haven’t tried mushrooms or any psychedelic,” Chase says. “Our interest is really in ushering in this cultural move towards psychedelic medicine.” 

Psilouette’s customer interface raises the issue of how it is ensuring that its consumers are 21 years or older. Psilouette is currently developing “child-resistant” packaging for what Chase describes as “currently a bespoke offering”. According to Chase, their consumer age falls within the 45 to 60 year-old range and the “donation” amount of the product serves to select out those looking for a cheap, illicit high. In terms of regulating safety and standardizing potency, Psilouette is currently applying for a DEA license to use HPLC (high-performance liquid chromatography) for more accurate testing of psilocybin levels in their products. “As of now, we’ve standardized our cultivation and manufacturing to ensure that the experience is similar over time, but we do not currently have the ability to test every round of product.” All of Psiloeutte’s mushrooms are organically cultivated by a staff mycologist in a small facility in Los Angeles, which produces about one hundred pounds of dry weight per month.

In California, an initiative to legalize psilocybin may appear on the ballot as an initiated state statute as early as November 2022, which would legalize all forms of psilocybin-containing fungi as well as decriminalize cultivation, manufacture, processing, distribution, transportation, possession, storage, consumption, and retail sales for adults 21 and older. Until that time, Chase says Psilouette is keeping an eye on Oregon and hoping to apply for a license to open a storefront there when the legal pathway is officially clear. 

Psilouette isn’t the only brand looking to get psilocybin into the mainstream by any creative means necessary. Premium Entheogens is a parent company housing the entheogen brands Illicit, Silent Shaman, Axiom and Sonder. Axiom and Sonder focus on psilocybin products, with Axiom offering microdose capsules and pouches of dried psilocybin mushrooms of different varieties. Sonder also offers various strains of dried psilocybin mushrooms. The customer interface is similar for both, with “psilocybin” clearly listed but only the total dry weight in grams given rather than actual psilocybin content. Payment is conducted through an email money transfer and orders are shipped via expedited mail.

There are cheaper, less glossy options out there for those disinclined to seek out the spiritual framing of entheogens in favor of a trippy high, but the mechanics of acquiring them are also circuitous. The company One UP Mushroom, for example, employs a common workaround, offering a Milk Chocolate Psilocybin Mushroom Bar with 3.5g of psilocybin. This comes as a free gift with the purchase of a “small sticker” for $60.00 on one magic mushroom products website. With spreading decriminalization and the first steps towards legalization being taken in the U.S., more psilocybin products across the spectrum of quality, ethical marketing and responsible use will become available to consumers. This presents an increasing challenge for legislators and business owners alike as regulations attempt to keep up with psilocybin’s exploding popularity.


Dave HodesMarch 17, 2022
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Psilocybin is the focus of more researchers and more business developers than ever before as study after study demonstrate its range of effectiveness. 

In fact, to date, over 27,000 scientific articles have been published on psychedelic drugs, with over 1,000 particularly on psilocybin as of May, 2021, according to one study that also found that psilocybin is the most studied psychedelic right now.

Psilocybin is also one of the top ten drugs used in the world (alcohol is first), according to a global drug survey, doubling in use from 2020 to 2021. 

There are over 40 patents filed since 2019 about various uses of psilocybin formulations and delivery methods (22 in 2021 alone), and 77 published patents since 1958 (35 in 2019 and 2020 alone).

What is being discovered is that psilocybin-assisted psychotherapy has greater promise for a wider range of human health treatments—with more being added all of the time. 

For instance, it can provide long-term relief from cancer-related psychiatric distress, according to a study, where psilocybin-assisted psychotherapy created improvements in psychiatric and existential distress, quality of life, and spiritual well-being. 

Another study, sponsored by Compass Pathways (NASDAQ: CMPS), a mental health care company and developer of the COMP360 psilocybin therapy, was conducted at the Maryland Oncology Hematology (MOH) at the Aquilino Cancer Center. Their study of psilocybin therapy to treat depression in cancer patients found that 50 percent of participants experienced remission in depression symptoms after a single administration of psilocybin therapy.

Cybin is in the discovery phase with the a molecule which is in the same family as MDMA. But it has tryptamine-like properties, like psilocybin, and appears to have strong anti-inflammatory properties. “So that means that in low psychedelic doses, it could have utility for maybe Parkinson’s disease or Alzheimer’s disease or MS,” Doug Drysdale, CEO of Cybin, told Psychedealia. “So there could be broad utility with these molecules, depending on which mix of receptors they hit, and depending on what dose level.”

Psilocybin has been shown to help with addiction, specifically tobacco addiction. “The results of this pilot study cannot be taken as solid evidence for the efficacy of psilocybin for smoking cessation,” researchers concluded in that study. “However, the high rates of abstinence compared with existing medications provide justification for a larger randomized trial the present authors are currently conducting.”

Tobacco cessation researchers are also jazzed about the historic grant from the National Institutes of Health awarded to Johns Hopkins Medicine to explore the potential impacts of psilocybin on tobacco addiction. This was the first NIH grant awarded in over a half century to directly investigate the therapeutic effects of a classic psychedelic.

Clairvoyant Therapeutics is evaluating psilocybin-assisted therapy in a Phase II trial as a potential treatment for alcohol use disorder. Cybin is tackling alcohol abuse treatments as well. 

But it’s not just how psilocybin works within the human body. It’s also about new methods of extraction and synthesizing the psilocybin molecule.

For example, researchers are looking at new extraction techniques using e-coli, according to a 2019 study. Miami University researchers took genes responsible for producing psilocybin, added them to the bacteria E. coli, and created a new strain they called pPsilo16, saying the process was similar to the fermentation process to make beer. “This is the highest psilocybin titer achieved to date from a recombinant organism, and a significant step towards demonstrating the feasibility of industrial production of biologically-derived psilocybin,” researchers concluded.

In addition to having the potential to treat depression, mood and anxiety disorders, psilocybin has also demonstrated analgesic effects as shown by the numerous clinical studies on the treatment of cluster (“suicide”) headaches, intractable phantom-limb pain, and chronic pain. In some cases, psilocybin was comparable to or more efficacious than traditional medications such as opioid analgesics.

Nearly every day, a new announcement about psilocybin hits the news desks. Here’s a sampling:

– March 14. Telescope Innovations Corp., a chemical technology company, announced it has engaged Translational Life Sciences Inc. to evaluate the potential therapeutic effects of Telescope’s proprietary, psilocybin-like novel chemical entities.

– March 14. Numinus Wellness Inc., a mental healthcare company advancing innovative treatments and safe, evidence-based psychedelic-assisted therapies, announced that its research lab, Numinus Bioscience, has been approved by the Public Health Agency of Canada for a Containment Level 2 (CL2) pathogens and toxins license, following upgrading of the facility. The addition will enable the company to, in part, conduct bioassay studies using mammalian cell lines, to analyze the bioactivity of different whole mushroom formulations that contain both psilocybin and other psychedelic compounds.

– March 15. Novamind Inc., a mental health company specializing in psychedelic medicine, announced that it is conducting a phase II clinical trial investigating psilocybin for major depressive disorder, sponsored by the Usona Institute.

– February 10. Mindset Pharma Inc., a drug discovery and development company focused on developing next generation psilocybin-inspired medicines and related technologies, announced that several of its proprietary, novel and diverse psychedelic compounds are demonstrating strong potency and efficacy, superior to psilocybin in in-vivo proof-of-concept studies.

“We’re on the verge of a paradigm shift,” Drysdale said. “We are moving away from giving people a tablet every day for their depression, which is a bit like a set of chemical handcuffs where yes, maybe their depression is a little better, but they also can’t feel joy,” he said. “We are moving away from that to these intermittent treatments with psychedelics, which after one or two treatments could get patients months of benefit, which is completely unlike anything else we’ve ever seen in mental health. So I’m more excited than ever about it, and that data just keeps coming. Hopefully soon the mental health treatment landscape will look very different than it does today.”


Dave HodesMarch 8, 2022
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Oregon made history as the first state to legalize psilocybin for anyone over 21 to use in a therapeutic setting with the passing of Ballot Measure 109 on November 3, 2020

The Oregon Psilocybin Services Section, a new section within the Oregon Health Authority (OHA) Public Health Division Center for Health Protection, will implement Measure 109 and directs the OHA to license and regulate the manufacturing, transportation, delivery, sale, and purchase of psilocybin products and the provision of psilocybin services over a two-year development period, from January 1, 2021, to December 31, 2022.

There’s plenty of time to hash out rules—most are slated to be worked on in May with final rules by the end of the year. And there’s more work to be done about licensing testing labs by early 2023. 

But since the legalization approval by voters, there has been much discussion about what the psilocybin buy-and-use facility looks like; exactly who should be the certified psilocybin services facilitator monitoring the “client” during their session; and how and what a follow-up or integration process should be. 

What seems to be most concerning is the facilitator part of the legalization equation. Anybody can be a facilitator if they have a high school diploma, or its equivalent, without additional degrees or certifications (OHA plans to revisit these qualifications in May). Dr. Saul Levin, chief executive officer and medical director of the American Psychiatric Association, in opposing Measure 109, spelled out the medical community’s issues with facilitators in a letter. “Such treatment should be evidence-based and determined solely by professional standards of care,” Levin wrote.

Though the facilitator will have to go through a training program, a medical license is not required. “We don’t know yet how this is going to work,” psychologist Elizabeth Nielson, co-founder and lead trainer at New York-based Fluence, told Psychedealia. Fluence offers continuing education and certificate programs in psychedelic integration and psychedelic-assisted therapy. “The entire legislation and project, and creating this new (facilitator) credential, is a bit of an experiment. I know that it’s really groundbreaking. It’s really new. It’s really well-intentioned, and it’s got the potential to bring enormous benefit to people. We all have to kind of wait and see how things play out.”

Joshua White, founder, and executive director of the Fireside Project, a psychedelic peer support service, told Psychedealia that he agrees Oregon is an interesting experiment. “I do know that the law requires psilocybin facilitators to obtain a license from the state, and the courses that they have to take in order to get those licenses are pretty regulated in terms of what the courses have to cover, and the duration,” he said. “What I also think is noteworthy and commendable is that Measure 109 is really facilitated psilocybin outside of a clinical medical model. So you could have an agency in Oregon have a guided psilocybin experience for spiritual development for religious reasons. I think it is really important that people be empowered with the choice to have these healing and developmental and transformational experiences without a diagnosis.”

Whatever happens in Oregon, other states are lining up right behind them to legalize psilocybin.

Denver, Colorado became the first city to decriminalize psilocybin in May 2019, followed by Oakland, California (in June 2019) and Santa Cruz, California (in January 2020). 

Washington, D.C. decriminalized psilocybin in November 2020, followed by four other cities, including Seattle, in October 2021.

 Colorado is the next state likely to legalize psilocybin. A national political action committee based in Washington, D.C., New Approach Political Action Committee, which supported both Oregon’s Measure 109 and D.C.’s Initiative 81 decriminalization measures (plus Oregon’s cannabis legalization measure in 2014) has submitted four initiatives to the state.

While psilocybin legalization still has a bumpy road ahead of it, perhaps the first-ever psilocybin legalization effort in Oregon can take cues from the first-ever rollout of legalized cannabis in Colorado—the largely successful so-called Colorado Model—as discussed by John Hudak, deputy director of the Center for Effective Public Management and a senior fellow in Governance Studies at Brookings Institution: “Because legalization is experimental, the state should be committed to understanding what effects—positive and negative—are associated with the policy change. Effective implementation should not mask the need for high-quality, robust, systematic policy analysis, which is as important to good government as the implementation itself,” Hudak wrote in July 2014, nearly two years after voters legalized cannabis in the state. “Still, a strong launch, built on a capable and flexible administrative infrastructure, gives Colorado a leg up as events unfold. If the state can maintain the flexibility, administrative competence, inclusiveness, coordination, and sense of mission that have marked legalization’s rollout, it will be well-positioned to continue its success for some time.”

Sidebar

Oregon’s Ballot Measure 109 and timeline

– November 3, 2020. Voters pass Ballot Measure 109, which legalizes psilocybin for anyone over 21 to purchase and use in a therapeutic setting.

– January 1, 2021. The development phase for Measure 109 begins.

– March, 2021. Oregon Psilocybin Services Advisory Board, appointed by Governor Kate Brown, meets for the first time.

– June, 2021, Oregon Health Authority (OHA) brings on Angela Allbee to manage the newly-created Oregon Psilocybin Services (OPS) Section.

– January 7-February 6, 2022. The OPS Section conducted a community interest survey designed to better understand who may be interested in accessing psilocybin services, service center licensure, facilitator licensure, manufacturer licensure, testing lab licensure, and/or training program approval.

– February, 2022. The Rules Advisory Committees reviewed draft rules for psilocybin products and testing. Community members will be invited to provide comments on the proposed rules during the public comment period scheduled from April 1-April 22, 2022. 

– May 2022. OHA expects to adopt rules about the testing of psilocybin products, and which product forms of psilocybin will be permitted. More testing rules may come later in 2022 as well as rules about dosing, and other rules about the requirements of facilitator trainers.

– June 30, 2022. Oregon Psilocybin Advisory Board will submit findings and recommendations.

– Summer, 2022. A second public listening session is scheduled (the first was in December, 2021). Members of the public are encouraged to attend and share their feedback on the development of the work to build the structure for Measure 109.

– December 31, 2022. All rules for Measure 109 are expected to be adopted.

– January 2, 2023. The OHA will begin accepting applications for psilocybin laboratory testing licenses.

Sources: Ballotpedia https://ballotpedia.org/Oregon_Measure_109,_Psilocybin_Mushroom_Services_Program_Initiative_(2020); Oregon Psilocybin Services Overview https://www.oregon.gov/oha/PH/PREVENTIONWELLNESS/Pages/Oregon-Psilocybin-Services.aspx; Listening session December, 2021 https://www.oregon.gov/oha/PH/PREVENTIONWELLNESS/Documents/M109-Summary-2021-Dec.pdf; Oregon Measure 109 http://oregonvotes.org/irr/2020/034text.pdf; and https://www.oregon.gov/oha/PH/PREVENTIONWELLNESS/Pages/Psilocybin-License-Lab-Testing.aspx


Debra BorchardtFebruary 24, 2022
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COMPASS Pathways plc (Nasdaq: CMPS)  reported its financial results for the fourth quarter and full-year 2021 ending in December and gave an update on recent progress across its business. At this time, Compass doesn’t have any meaningful revenue. However, it has been devoting most of its resources to research & development (R&D) where expenses were $44.0 million for the year versus $23.4 million during the same period in 2020.

The increase was attributable to an increase of $16.1 million, $6.0 million, and $0.4 million respectively in development expenses, personnel expenses and other expenses, partially offset by a reduction of $1.8 million in non-cash share-based compensation, as COMPASS progresses its COMP360 psilocybin therapy in TRD, and continues to explore additional indications and therapeutic approaches. The company is in a comfortable position to continue its research with cash and cash equivalents were $273.2 million as of December 2021 compared with $190.3 million at the end of 2020.

The net loss for the year was $71.7 million, or $1.79 loss per share (after including non-cash share-based compensation expense of $8.6 million) versus $60.3 million or $3.55 loss per share, during the same period in 2020 (after including non-cash-share-based compensation expense of $18.0 million). The net loss for the fourth quarter was $25.7 million, or $0.61 loss per share (after including non-cash share-based compensation expense of $2.8 million), compared with $18.8 million, or $0.52 loss per share, during the same period in 2020 (after including non-cash share-based compensation expense of $1.4 million)

George Goldsmith, Chairman, CEO and Co-founder, COMPASS Pathways, said, “With our end-of-phase II meeting now scheduled with the FDA, we will be finalising our phase III programme design for an expected start in the second half of the year. Moving into phase III is another important step towards providing a much-needed therapeutic option for patients suffering with treatment-resistant depression and extends our leadership in this area of science with the most extensive evidence package to date. At the same time, we continue to broaden our pipeline through a phase II trial in PTSD, ongoing investigator-initiated studies, and development of new compounds through our Discovery Center and our partnership with Dr Matthias Grill of MiHKAL GmbH.”

COMP360 psilocybin therapy in treatment-resistant depression (TRD)

  • Positive results from groundbreaking phase IIb clinical trial; additional data shows patient improvements beyond reduction of depression symptoms, including in positive affect and quality of life
  • Positive results from open-label study of 25mg COMP360 psilocybin therapy as adjunct to SSRI antidepressants in TRD
  • End-of-phase II meeting scheduled with FDA for late April 2022
  • Phase III programme expected to begin in second half of 2022

Dave HodesFebruary 16, 2022
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There has been a proliferation of hemp-infused and cannabis-infused products of all kinds, including beers. Most use low or no THC versions of CBD. Many products, like Ceria Brewing beer, use different dose levels of THC infused in their beer that the consumer can choose (but no alcohol). 

But as psilocybin continues to drift from simply decriminalized into the edges of recreational legality, with people casually micro-dosing in their coffee every morning, the same CBD product expansion thinking is hovering over whether to infuse alcohol with psilocybin as a sort of double whammy trippy buzz drink.

Could a carefully measured microdose of psilocybin infused in an alcoholic drink become a consumer favorite? Should a microdose of psilocybin in any liquid—water, fruit juice, etc.—stay as just another one of the plant-based non-alcoholic drinks that are growing in popularity? Or should everybody just cool it on consuming recreational psychedelic mushrooms infused into anything, and stay with the non-psychedelic mushrooms?

It’s quite a conundrum for the functional food creators because there are literally dozens of studies out there about the dangers of mixing alcohol with psilocybin. For example, one alcohol rehab guide calls it “highly dangerous.” 

The American Addiction Center (AAC) states that, while there might not be any inherently adverse interactions from mixing psilocybin and alcohol, there still are many unknowns involved. “One study found using mushrooms could mask some of the effects of alcohol,” the AAC reported. “Since the effects of one drug can cover up the effects of the other, it could lead to increased consumption of both.”

Ironically, there is some deliberation about psilocybin actually treating alcohol addiction.

Then there is the intriguing viral story about certain South American ancients getting trippily buzzed on a psychedelic beer. The story goes that between 500 and 1100 C.E., in the highlands of Peru an empire called the Wari, who lived there before the Inca, used to mix a strong natural hallucinogen, the vilca seed, with the fermented fruit of a certain tree, for boozy, trippy special event parties. It’s the kind of story that party hearty types like to hear. Why not psilocybin in my beer just like those ancient dudes did?

The exploration of non-psychedelic mushroom-infused teas, drinks, and soups has been heating up recently. They do not make the drinker hallucinate but just give the consumer a dose of one of mushroom’s super powers: immunity balance, stamina, stress and anxiety relief, and skin enhancement. 

So is the anything-infused-into-alcohol movement slowing down, and is psilocybin late to the party? Could be. Consumers today are turning away from alcoholic drinks, as put forward in a book by journalist Ruby Warrington, “Sober Curious: The Blissful Sleep, Greater Focus, Limitless Presence, and Deep Connection Awaiting Us All on the Other Side of Alcohol.” 

And consumers seem to want more of what non-psychedelic mushrooms have to offer. 

Yield Growth Corporation (OTC: BOSQF), a phytoceutical and consumer packaged goods company, is an example of one company that is all-in for mushroom-infused drinks. They just completed the initial development of a formula for a new line of mushroom-infused coffee mixes through their wholly-owned subsidiary, Flourish Mushroom Labs Inc. Flourish Mushroom Labs intends to commercialize the formulas, going to market first with mushroom-based soups and coffees. 

The mushroom coffees will be infused with various wild mushrooms such as Lion’s Mane, Turkey Tail, Reishi, Shitake, Chagas, and Cordyceps.

Califa Farms, makers of plant-free dairy products, is developing a host of mushroom beverages, such as Curious Elixirs, Earth and Star, Four Sigmatic, FreshCap, Health-Ade, Rebbl, Rowdy Mermaid and Woke Up energy shot, with many more to come. 

“There’s so much going on right now. It’s a functional beverage gold rush,” said Duane Stanford, editor of Beverage Digest as reported in a marketing and information publication, The Drum. “What got mushrooms quickly moving up the chain is the fact they get around a lot of the hurdles you see with CBD. They don’t have the same regulatory overhang. Mushrooms are generally recognized as safe under FDA guidelines. As long as you aren’t saying it’s going to cure cancer, you can make claims like, ‘It assists with anxiety and reduces inflammation.’”

While it appears that the legalized recreational psychedelic mushroom product is still working through the regulatory system in the U.S., and there are a huge amount of psilocybin edibles available online under dubious legal structures, there has been a glimmer of the coming psilocybin-infused product push here. 

One company that is working on infusing psilocybin into its coffee is Denver-based Sträva, exploring the benefits and risks of combining micro-doses of psilocybin with their specialty coffee and tea products. 

Sträva CEO, Andrew Aamot, said that the company’s vision is to bring consumers “amazing beverages infused with promising natural compounds,” and, in the case of psilocybin, to “seek physical, mental and spiritual therapeutic benefits without triggering psychedelic ‘trips.’ 

In a press release, Aamot said that just as cannabis has been misunderstood and controversial for decades, psilocybin from mushrooms has been equally polarizing. “Yet proponents of both suggest they each can contribute meaningfully to the human experience. As research is proving, with measured consumption, cannabis and psilocybin can both promote physiological, mental and spiritual health.”

Los Angeles-based Cannabis Global, Inc. (OTC: CBGL) announced in October 2021, that it has launched a new research initiative to develop methods to infuse food and beverage with psychedelic compounds, such as psilocybin, psilocin, baeocystin, norbaeocystin, aeruginascin, among others.

So as psilocybin decriminalizing turns into legalizing recreational use, still not a sure thing in this country yet, chances are good that there will be a psilocybin-infused alcoholic craft drink of some sort. The Wari Peruvian Porter? The Psilo-Tripel? The Psychedelic Saison? For now, consumers who want to try the trippy boozy buzz that the ancients reveled in are stuck making up their own magical, mystery concoctions.


Dave HodesFebruary 9, 2022
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9min8620

As more research has been demonstrating, psilocybin may be one of the best new treatments for not only treatment-resistant depression, but also Alzheimer’s, post-traumatic stress disorder, autism, alcoholism, smoking, and drug addiction, anxiety, obsessive-compulsive disorder, cluster headaches, and more. 

In fact, there are currently 50 psilocybin-related studies in the U.S. either active, completed, or recruiting. Most of the research is done using fairly small control groups of volunteers, and some are heading to their Phase III clinical trial, the last step to becoming an FDA-approved pharmaceutical. In December, COMPASS Pathways plc (Nasdaq: CMPS) announced positive results from its exploratory study of COMP360 psilocybin therapy in conjunction with SSRI use. The study wanted to test whether patients with treatment-resistant depression could tolerate and do well with psilocybin treatments while also taking regular depression medicine.

The list of claims about what psilocybin can treat keeps getting longer, and that is generally seen as a good thing. But it begs the question: Are all these new studies using relatively small study groups enough to quickly launch a new treatment for so many different conditions? In short—is the industry getting ahead of itself?

Research already has demonstrated the safety of psilocybin in regulated spaces facilitated by a medical team over a series of guided sessions. That is where these new treatment discoveries have happened.

But as the popularity of psilocybin grows, especially with new microdosing products making it seem more controllable for the average citizen, psilocybin is moving out of the labs and away from clinical trials to everyday consumers who may not be prepared—or who aren’t getting it for any real mental illness condition, or for any real medical therapy with physician oversight. 

Take for instance Oregon’s Measure 109 passed on November 3, 2020, and may become a model for legalized psilocybin services and sales going forward.

Psilocybin consumers are not patients but “clients.” The client here is just any interested consumer—he or she fills out a simple form that the service center facilitator reviews and the psilocybin experience begins.

The customer is on his own to include any mental health issue information or other similar issues for which he or she is seeking to treat with psilocybin. There is no doctor release or physician direction required. The facilitator is not a health care provider. He or she simply monitors the customer’s psilocybin session, makes sure it’s safe, may or may not ask a few follow-up questions, and then the client is free to go.

What exactly a service center is, and what training is needed for a facilitator, are issues being worked out with the Oregon Health Authority (OHA) under the advice of the 16-member Oregon Psilocybin Advisory Board. They have until the end of December.

Currently, the proposed regulations in the Measure states that the service center facilitator would not be a health care facility, and the facilitator would not have to have a degree from a university, college, post-secondary institution, or other institution of higher education. The facilitator has to pass an OHA exam to be certified.

It all seems a little rushed, given that this is psilocybin, a powerful mental health treatment that causes hallucinations and affects brain chemicals. It may not be ready for prime time in the way that Oregon proposes.

People opposed to the Oregon bill, and the rollout of psilocybin service centers, are saying the state jumped the gun because psilocybin is still being scientifically investigated and not fully understood. Dr. Saul Levin, chief executive officer and medical director of the American Psychiatric Association, wrote a letter in opposition to the bill that, as medical experts in psychiatric care, “we are concerned about determining medical treatment by ballot initiative. Such treatment should be evidence-based and determined solely by professional standards of care.”

A recent study about psilocybin-assisted therapy in medicine concluded that the results of the first clinical trials are encouraging, “albeit there have been some setbacks. For future studies, it will be critical to improve testing procedures. When it comes to mind-altering medications such as psilocybin, conducting thorough double-blind experiments is challenging, and subject selection biases are a concern.”

Researchers are recruiting now for psilocybin studies to treat anorexia nervosa, Parkinson’s disease, bipolar disorder, obsessive-compulsive disorder, body dysmorphic disorder, effects of concussions, cocaine use, migraine headaches, even treatment for work burnout experienced by physicians and nurses with frontline work exposure in the COVID pandemic. There is another study on the horizon to use psilocybin for treating phantom limb pain.

So the research work continues apace. Great. But psilocybin isn’t Cannabis 2.0. As the growing list of mental health conditions that may be treated by psilocybin shows, this is a new, more muscular genie out of the bottle. It could wreak havoc among consumers—aka clients—if not carefully controlled. The real question is: What happens next?


Dave HodesJanuary 13, 2022
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10min12060

On December 20, 2021, breakthrough research at the Usona Institute, a 501(c)(3) non-profit medical research organization based in Madison, Wisconsin, revealed the true crystal forms of pharmaceutical psilocybin. It’s a new discovery of characteristics of the polymorphs of the plant that have always existed but were not detected until now.

But that discovery has ignited controversy within the psychedelics industry about synthetic psilocybin patents being sought by Compass Pathways (NASDAQ: CMPS), one of the leading psychedelics product development companies, using what they said is their original discovery of essentially the same polymorph that the Usona research reported already existed.

The new Usona Institute study laid out the experimental challenges to solve the crystallographic puzzle of synthetic psilocybin, bringing clarity to the polymorphs (unique crystalline arrangements) that naturally occur from the production of synthetic psilocybin. 

Usona claims that the study conclusively shows that three psilocybin polymorphs repeatedly occur from the well-known crystallization process, and that they have appeared in numerous places throughout the history of synthesizing psilocybin since 1959. 

In short, the study finds that there is nothing new to see here.

But Compass Pathways sees it differently. The company said they invented the crystalline form of psilocybin used in their synthesized psilocybin formulations, polymorph A, and want to patent it. Not so fast, the experts says.

The rise of the patent conundrum

The team of Usona chemists and collaborating crystallographers say that they already solved key psilocybin crystal structures using powder X-ray diffraction (PXRD) data collected on psilocybin at the Advanced Photon Source synchrotron at Argonne National Laboratory. 

In the Usona process-scale crystallographic research investigation, three crystalline forms of psilocybin were repeatedly observed: hydrate A, polymorph A, and polymorph B. The crystal structure for hydrate A had already been solved using X-ray diffraction. 

Usona’s study presents key new crystal structure solutions for the two anhydrates, polymorphs A and B, previously unidentified but part of the crystal structure dating back to when the crystalline structure was first reported in the 1970’s. 

Dr. Alexander Sherwood, lead author of the study and medicinal chemist at Usona, said they were just following clues available to any researcher to put together a full, clear picture of the three psilocybin polymorphs. “The process for isolating and crystallizing pure psilocybin has been consistently reproduced since first reported in 1959, and many different clues throughout history pointed to three psilocybin polymorphs resulting from that process,” he said. “The crystal structure solutions unified all the old evidence and data with precision and elegance. Once we put it all into one place, the full picture came together to tell a complete and compelling story about psilocybin crystallization.”

Then.. the twist

That data, that new discovery information from a non-profit company just wanting to advance the science of psilocybin, is creating conflicts between purists who say psilocybin should not be subject to patents and companies looking to build capitalist enterprises based on patenting such new product discoveries.

That’s where Compass Pathways comes in. Compass Pathways has developed a synthesized formulation of psilocybin, COMP 360, which uses crystalline psilocybin, and, in November, 2021, was granted its fifth U.S. patent by the U.S. Patent and Trademark Office (USPTO)—U.S. Patent No. 11,180,517—which covers methods of treating treatment-resistant depression (TRD) with crystalline psilocybin. 

A petition filed December 15 will challenge the patent granted on March 16, 2021. Additional petitions challenging Compass’ patents from the Freedom to Operate (FTO), a non-profit seeking to advance science and education by fighting bad and mistakenly issued patents, are expected.

The December 15 FTO petition quoted expert declarations filed with it from Dr. Sven Lidin (dean at the Lund University in Sweden) and Dr. James Kaduk (professor of chemistry at Illinois Tech and contributor to the Usona study) who explained that “’Polymorph A’ is a mixture of known psilocybin polymorphs, not a new polymorph as claimed. Compass’s patent is therefore invalid as claiming a nonexistent polymorph..”

So can Compass still claim to have identified a new crystalline structure—a so-called novel variant as mentioned in their patent application—for their synthetic psilocybin? Or does this finding by Usona and statements in the filing challenging Compass now negate the Compass Pathway’s synthetic psilocybin patents?

 Usona reseachers also addressed this in their study: “Revision is recommended on characterizations in recently granted patents that include descriptions of crystalline psilocybin inappropriately reported as a single-phase ‘isostructural variant.’”

In other words, the Compass patents using crystalline psilocybin are at best controversial—and at worst, null and void. 

But the Usona Institute v. Compass Pathways disagreement serves to illustrate a deeper and growing issue between non-profit psychedelics companies like Usona who just want to create and advance better therapies to treat human conditions, and for-profit companies like Compass who want to build an enterprise trying to control access and use of a natural product. 

The questions for the psychedelics community are: Who can commercialize, and control, psilocybin? Or.. should that ever happen?

“No one objects to Compass manufacturing and distributing psilocybin for medical uses, and certainly not me,” Carey Turnbull, founder and director of FTO, in a letter from the founder. “On the other hand, Compass has used their resources to try to prevent anyone but themselves from manufacturing and distributing psilocybin. That’s the rub.”

He continues: “(Compass) is attempting to patent things they should know they did not invent. Patents are not a systemic fault of the system; bad patents that attempt to appropriate pre-existing knowledge from the public commons and then ransom it back to the human race are a misuse of that system.”


StaffNovember 2, 2021
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3min37321

Exclusively-natural psychedelic drug discovery company Filament Health Corp. (OTCQB: FLHLF) (NEO: FH)  received authorization from the FDA authorization to initiate the first clinical trial using naturally-sourced psychedelic substances. The news caused the stock to jump over 11% in early trading.

The company said that this approval is the first for the direct administration of psilocin rather than its prodrug psilocybin and will administer Filament’s three proprietary botanical drug candidates. The phase 1 trial is led by the Translational Psychedelic Research Program (TrPR) at the University of California San Francisco (UCSF).

“We are excited to announce this milestone as validation of our ability to cultivate variable psychedelic biomass and transform it into pharmaceutical-grade drug candidates,” said Chief Executive Officer, Benjamin Lightburn. “Our innovative technology has allowed us to create IP-protected botanical drug candidates of oral psilocin, sublingual psilocin, and oral psilocybin, and to enter them into an FDA-approved natural psychedelic clinical trial. Our candidates enjoy significant IP protection, unlike most other psychedelics currently under clinical investigation.”

The phase 1 trial has been designed to include 20 healthy subjects and will examine the effects of Filament’s three proprietary botanical drug candidates: PEX010 (oral psilocybin), PEX020 (oral psilocin), and PEX030 (sublingual psilocin). As a result of the need for psilocybin to convert into psilocin before becoming active in the human body, the direct administration of psilocin may yield several therapeutic benefits such as faster onset time, greater consistency, increased bioavailability, and lessened side effects. These potential attributes are being studied in the authorized trial. In addition, psilocin is an ideal candidate for sublingual delivery because of the bypassing of the gut, where the conversion to psilocybin is thought to primarily occur. To date, synthetic manufacturers have been unable to produce a stable formulation of psilocin and enter it into a clinical trial.

“My team and I are very excited to begin dosing Filament’s drug candidates in our clinic,” said Dr. Josh Woolley, MD/Ph.D., Director of TrPR and the study’s Principal Investigator. “The oral and sublingual administration presents an opportunity to learn about psilocin’s effects compared to psilocybin and perhaps set a new standard for psychedelic assisted therapy.”


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