Category Archives: Psychedelics

About a week after Colorado activists filed revised versions of 2022 ballot initiatives to legalize psilocybin and create healing centers in the state, a second campaign has submitted their own competing proposal to legalize psychedelics.

Activists with Decriminalize Nature Boulder County filed the new, one-page initiative on Friday. It would allow adults 21 and older to possess, cultivate, gift and deliver psilocybin, psilocyn, ibogaine, mescaline and DMT.

Further, the measure says that it would be lawful to conduct psychedelics services for guidance, therapy and harm reduction and spiritual purposes with or without accepting payment. It would not be legal to sell any of the psychedelics, however.

The campaign is being headed by activists Nicole Foerster and Melanie Rodgers, a proponent of Denvers 2019 psilocybin decriminalization initiative who also petitioned for a successful Washington, D.C. decriminalization measure.

Without decriminalization and the security it allows for affected communities to more effectively organize, regulatory models will make it difficult for the most disadvantaged groups of our population to continue to access the natural medicines they safely use to heal, Foerster said in a press release. To address this we are advocating for a simple change to existing laws around these controlled substances.

The new filing is a sign of splintering between Colorado advocates who share the objective of ending psychedelics criminalization and ensuring access but who apparently disagree about the regulatory approach.

The separate, recently revised initiatives filed by the well-funded national New Approach PAC and supported by people like philanthropist David Bronner of the soap company Dr. Bronners is much more thorough and contains key differences from the simple adult-use legalization proposal that have now been introduced.

Under the revised measures, which are titled the Natural Medicine Health Act, there would be a two-tiered regulatory model, where only psilocybin would be legalized and regulated for therapeutic use until June 2026, after which point regulators could expand the policy change to include other psychedelics that are listed in the proposal like ibogaine, DMT and mescaline thats not derived from peyote.

The decision to add additional psychedelics to the program would be made by the Department of Regulatory Agencies in consultation with a Natural Medicine Advisory Board that would be established. The board would be comprised of 15 members, including people who have experience with psychedelic medicine in a scientific and religious context.

There would be no possession limits for the entheogenic substances, unlike the initial measures that were filed by the campaign last month.

These latest filing comes more than two years after Denver became the first city in the U.S. to decriminalize psilocybin mushrooms. Kevin Matthews, who served as campaign director of that local push, is now a chief petitioner for the wider ranging statewide ballot effort. Various activists involved in the 2019 campaign have signaled interest in building upon the reform.

The initiatives must still be assigned an official ballot title and summary from the state before theyre approved to begin signature gathering. The broader measures are scheduled to receive a review and comment hearing on February 3, whereas the new initiative filed on Friday is set to be heard on February 11.

If approved by state officials, activists will need to collect 124,632 valid signatures from registered voters to achieve ballot access.

The Colorado ballot initiatives seek to accomplish something similar to what California activists are actively pursuing. California advocates are in the process of collecting signatures for aballot initiative to legalize psilocybin mushroomsin the state.

Meanwhile in Colorado, Sen. Joann Ginal (D) and Rep. Alex Valdez (D) filed a modest bill this month to create a one-year plant-based medicine policy review panel that would be tasked with studying the use of plant-based medicines to support mental health, according to a summary. The ballot campaign is not affiliated with that legislative effort.

The policy review panel shall submit a report on its findings and policy recommendations to the House of Representatives Public and Behavioral Health and Human Services Committee and the Senate Health and Human Services Committee, or any successor committees; the governor; and the Department of Human Services, it says.

Meanwhile, legislative efforts to enact psychedelics reform are also underway in other states across the country.

For example, a bill to decriminalize a wide array of psychedelics in Virginia was taken up by a House of Delegates panel on Monday,only to be pushed off until 2023. A separate Senate proposal to decriminalize psilocybin alone was defeated in a key committee on Monday.

In Oregon, where voters approved a historic 2020 initiative to legalize therapeutic psilocybin program, as well as another to broadly decriminalize currently illicit drugs, lawmakers introduced a bill last week meant to promote equity into the program.

Two Republican Oklahoma lawmakers recently filed bills meant to promote research into the therapeutic potential of psilocybin, and one of the measures would furtherdecriminalize low-level possession of the psychedelic.

A GOP Utah lawmaker also introduced a bill this month that would set up a task force to study and make recommendations on the therapeutic potential of psychedelic drugsand possible regulations for their lawful use.

In Kansas, A lawmaker also recently filed a bill tolegalize the low-level possession and cultivationof psilocybin mushrooms.

A Republican Missouri lawmaker introduced a bill this month to give residents with serious illnesses legalaccess to a range of psychedelic drugslike psilocybin, ibogaine and LSD through an expanded version of the states existing right-to-try law.

California Sen. Scott Wiener (D) told Marijuana Moment in a recent interview that his bill tolegalize psychedelics possessionstands a 50/50 chance of reaching the governors desk this year. It already cleared the full Senate and two Assembly committees during the first half of the two-year session.

In Michigan, a pair of state senators introduced a bill in September tolegalize the possession, cultivation and deliveryof various plant- and fungi-derived psychedelics like psilocybin and mescaline.

Washington State lawmakersalso introduced legislation this monththat would legalize what the bill calls supported psilocybin experiences by adults 21 and older.

In Vermont, a broad coalition of lawmakers representing nearly a third of the House introduced a bill todecriminalize drug possession.

New Hampshire lawmakers filed measures todecriminalize psilocybin and all drugs.

Last year, the governor of Connecticut signed legislation that includes language requiring the state tocarry out a study into the therapeutic potentialof psilocybin mushrooms.

At the congressional level, bipartisan lawmakers sent a letter to the Drug Enforcement Administration (DEA) this month, urging that the agencyallow terminally ill patients to use psilocybinas an investigational treatment without the fear of federal prosecution.

Schumer Gives Update On Federal Marijuana Legalization And Banking In Meeting With Equity Advocates

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Climate Workforce Would Be Protected From Marijuana Employment Testing Under New Congressional Bill - Marijuana Moment

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Cybin (NEO: CYBN)(NYSE American: CYBN)is starting off the new year right the company has received approval from an Institutional Review Board (IRB) for a feasibility study using Kernels quantitative neuroimaging technology, Kernel Flow. Enrollment for the study begins early this year (https://ibn.fm/XTXAe).

By leveraging the Kernel Flow technology, we may have the ability to measure longitudinal brain activity before, during and after a psychedelic experience, and collect quantitative data as opposed to

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NOTE TO INVESTORS:The latest news and updates relating to CYBN are available in the companys newsroom athttps://ibn.fm/CYBN

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Cybin Inc. (NEO: CYBN) (NYSE American: CYBN) IRB-Approved Study Could 'Lead to New Frontiers,' Begins Enrollment This Year - StreetInsider.com

The Mexican magic mushroom is a psilocybe cubensis, a specie of psychedelic mushroom whose main ... [+] active elements are psilocybin and psilocin - Mexican Psilocybe Cubensis. An adult mushroom raining spores. red and blue color. horizontal orientation

A new study conducted by The Harris Poll and Delic Holdings Corp found that 65% of affected Americans want access to psychedelics for mental health.

Respondents who self-reported that they suffer from a mental health condition say that psychedelic medicine including ketamine, psilocybin mushrooms, and MDMA, should be made available to patients with treatment-resistant anxiety, depression, or PTSD.

The pandemic has skyrocketed the need for psychedelic wellness, says Delic CEO Matt Stang. We're at a tipping point where the data and science regarding psychedelic therapies have become undeniable in treating a variety of serious conditions.

As it stands, ketamine is legal in the U.S. for medical use. Ketamine is an FDA-approved anesthetic and can be prescribed for a myriad of ailments in a regulated setting by licensed clinicians. Psilocybin, like cannabis, is still considered a Schedule 1 drug in the eyes of the federal government. Therefore, its sale and use is illegal, despite some states and cities that have begun to decriminalize mushrooms. Beginning in 2019, psilocybin has been decriminalized in Denver, Oregon, and Santa Cruz. The state of California even has a measure on the 2022 ballot that would decriminalize psychedelic medicine in the state.

Psychedelic wellness companies like Delic are eager for this legal movement. It echoes the beginning of the weed industry we know today, as states began decriminalizing prior to legalization several decades ago. The largest clinical study to date affirms psilocybins efficacy in treatment-resistant depression. Ketamine has even more substantial clinical research backing up its use for depression, anxiety, and PTSD.

A patient at Ketamine Wellness Centers.

Delic acquired Ketamine Wellness Centers (KWC) in November 2021. Today, Delic runs the largest chain of psychedelic mental health clinics in the U.S., operating 12 ketamine wellness clinics. The company has plans to open an additional 15 clinics in the next 18 months. Stang says his team founded Delic in order to improve peoples lives and offer access to lifesaving medicine.

The Harris Poll study found 83% of Americans experiencing anxiety, depression or PTSD would be open to pursuing alternative treatments. Respondents said that if plant medicines were proven more effective than prescription medication with fewer side effects, 66% would try ketamine, 62% would try psilocybin, and 56% would try MDMA.

18% of people surveyed said that traditional pharmaceutical medication did not improve their condition or even made it worse. The survey was conducted from December 6 to 8, 2021, polling 2,037 adults ages 18 and older. Among them, the survey polled 953 people who suffer from anxiety, depression, and/or PTSD.

Delic Labs is developing analytical capabilities that will help form a complete picture of psychedelic medicine and ensure drug safety, says Dr. Marcus Roggen, President & Chief Science Officer of Delic Labs.

In the area of medical developments, psilocybin and other plant-based compounds show great promise, but also have their limitations, says Dr. Roggen. With our medicinal chemistry expertise as the foundation, we will continue to explore these novel psychedelic compounds and other drug candidates with the goal of adding them to this exciting field of medicine.

Psilocybin in Delic's lab.

The group demographics varied. Of the people who participated, 48% identified as male and 50.9% identified as female. In regard to age, we saw a wide variety of respondents with 28.4% aged 18-34; 16.7% aged 35-44; 15.9% aged 45-54; 16.6% aged 55-64 and 21.5% over the age of 65. In regard to race, 61.8% identified as white, 16.5% identified as Hispanic and 11.8% identified as Black, says Stang.

The survey is not comprehensive, and the respondents self-reported, which can leave room for potential bias. This survey is not based on a probability sample and therefore no estimate of theoretical sampling error can be calculated, says Stang.

We truly believe the world will look back on this moment right before full global acceptance and remark how much more effective treatment has become, in a very short time, says Stang. This promising family of new medicines has the potential to be more effective than traditional medicines with minimal side effects.

In 2021, the company hosted its inaugural Meet Delic psychedelic medicine conference, one of the largest psychedelic wellness industry conferences in the world, which welcomed 2,500 attendees. Tickets are on sale for its 2022 event which will take place November 5 and 6, 2022, in Las Vegas, Nevada.

Delic is listed on the Canadian Securities Exchange (CSE:DELC), the OTC Markets Group (OTCQB:DELCF) as well as Germanys largest stock exchange market called the Frankfurt Stock Exchange (FRA:6X0).

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Study Finds 65% Of Americans With Mental Health Conditions Want Access To Psychedelics - Forbes

Mind & Matter is a monthly column by Nick Jikomes, PhD, Leaflys Director of Science and Innovation.

Microdosing is the practice of ingesting small amounts of a psychoactive substanceenough to get some kind of perceived benefit, but not enough to become intoxicated or feel the psychoactive effects of a full dose.

Microdosing psychedelics has become a popular new wellness trend. You can allegedly get various mental health benefits such as enhanced mood and creativity. Everyone from health-conscious young professionals to high-powered tech executives have credited this as a powerful brain hack: a cognitive boost with no obvious side effects.

Psychedelics have long been associated with creativity and have been scientifically shown to stimulate neural plasticity, the ability of brain cells to rewire themselves, which is thought to underlie their therapeutic mental health effects.

This has led to the alluring idea of microdosing: What if you can get the benefits of enhanced neural plasticity without the ego-dissolving hallucinatory experience? Just pop a magic mushroom gummy and watch your spirits lift.

Theres big commercial interest here. In the language of startups, microdosing could increase the Total Addressable Market (TAM) for psychedelics, widening the pool of potential consumers. If microdosing has demonstrable benefits, it could help scale up psychedelic medicine. Large doses of psilocybin may have therapeutic effects, but patients require preparation and supervision before, during, and after their experience. Smaller doses with sub-psychedelic effects dont require such time- and resource-intensive oversight.

Compared to macrodosing with supervision and integration, microdosing more cleanly fits the standard pharmaceutical treatment template in psychiatry: diagnose the patients issue, prescribe a non-ego-dissolving drug, add talk therapy as needed. Repeat.

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How to dose psychedelic mushrooms

Besides, going on a multi-hour psychedelic trip is simply too intimidating for many people.

What if we can turn millions more people on to psychedelics in less time and with fewer side effects by using lower doses of these drugs? And can we sell low-dose consumer packaged goods?

Life advice: When something sounds too good to be true, assume it is until proven otherwise.

Almost all evidence for the benefits of psychedelic microdosing in humans is anecdotal. The few human studies out there rely on self-reported data, which is hard to draw reliable conclusions from, especially when youre measuring something subjective.

People are prone to expectancy effectsthey are biased to report what they expect to experience, especially when they really want a particular outcome. This is why double-blind, placebo-controlled studies are the gold standard.

When evaluating self-reported microdosing data, apply a macrodose of caution. For example, this recent study showed that adults who microdose psychedelics self-report lower levels of anxiety and depression. While thats good to hear, the reported effects were small. Moreover, the data are from people who were motivated by mental health concernspeople who really wanted that result.

These are perfect conditions for expectancy effects. Because the data are self-reported and theres no real control group, we cant bank on these results.

Related

Mushrooms / Psilocybin

An interesting psychoactive phenomenon in themselves, placebo effects are widespread in medicine: A persons expectations can drive measurable physiological change. Placebo effects are common in situations where the measured outcome is subjective, which is exactly what microdosing enthusiasts claimmild subjective effects. Placebo effects are common in the world of pain medicine: Give someone a sugar pill that they think is a pain drug, and they actually experience reduced pain.

Taken to its lowest extreme, microdosing becomes homeopathy: The dose is so low that its zero. Imagine collecting data from health-conscious homeopathy enthusiasts who want to lower their anxiety levels with homeopathy. You give half of them a homeopathic product and the other half a placebo, then ask how they feel. Theyre all likely going to report an improvement.

Indeed, this is exactly what was found in the only placebo-controlled study Im aware of on psychedelic microdosing. The people who microdosed reported improvements, but so did the placebo group, with no difference between them.

Placebo effects are real. But if your mood boost is caused by the mere belief that a 0.1g mushroom chocolate is an antidepressant rather than a pharmacological effect from psilocybin, so what? Theres nothing wrong with a placebo-induced mood boost so long as theres no downside risk.

But there could be downside risks.

I spoke to medicinal chemist Dr. David Olson, whose lab studies the molecular and cellular mechanisms by which psychedelics and other psychoplastogens work in the brain. On the subject of microdosing, he offered the following words of caution:

In the interview, he referenced homeostatic plasticity, a known brain phenomenon, in which our bodies regulate crucial bodily functions to maintain balance, or homeostasis. Think of it as biologys Goldilocks Principlewhen you get too hot, automatic mechanisms kick in to cool you down, such as sweating; when youre too cold, there are automatic mechanisms for generating heat, such as shivering. Our systems have to stay in balance for our cells to work properly; not too hot, not too cold.

When our ability to homeostatically regulate breaks down, many systems can dysfunction. Diabetes is a good example. Normally, blood sugar is tightly regulated. When it spikes after a meal, our body automatically senses this and brings down blood sugar levels to restore balance, or homeostasis.

But the process isnt perfect. Biology is messy. When your body pulls blood sugar back down to normal, it often overshoots. This can result in fatigue, which is why a food coma can follow a big meal.

When this process goes awry, as in diabetes, blood sugar levels drift out of the Goldilocks range for extended periods, which can have a variety of negative physiological consequences.

Related

Psychedelic medicine: The benefits of psychedelics

In the brain, neural plasticity, the ability of brain cells to rewire themselves, is under homeostatic control. Plasticity is crucial for learning, but if your brain became too plasticif you cranked up the plasticity thermostat all the wayyou would, in some sense, have the mind of an infant. Your existing memories would destabilize. You would have difficulty taking coherent action.

Conversely, if you turned the plasticity thermostat in the opposite direction, you would become rigid, with little ability to learn and adapt.

As with blood sugar, so with plasticity: not too much, not too little. Your brain has built-in controls to sense when theres too much growth, and when that happens, it can turn down the growth thermostat, causing neurons to shrivel up by trimming back their connections.

In other words, stimulating the growth of too many neural connections can trigger an automatic process that results in the exact opposite. This is the risk with regular microdosing of psychedelics.

In one experiment, rats were given a small dose of DMT, below the threshold thought to cause psychedelic effects, every third day for several weeks. Similar to single, large doses of psychedelics, antidepressant and anti-anxiety effects were observed. Unlike single doses, which cause robust neuronal growth, small doses of DMT every few days resulted in either no change in growth or a decrease.

The idea here is that if neurons become overstimulated after multiple doses of a psychedelic, the brain might be dialing down its growth thermostat to compensate. Its conceivable this could even make the symptoms of some psychiatric disorders worse, perhaps similar to the food coma thats triggered when your body undershoots blood sugar levels after a meal-induced spike.

A similar theme emerges from animal studies that used large doses of LSD. Intermittent, high doses of LSD given for more than three months lead to persistent behavioral deficits, while a similar dose given over a shorter timespan had antidepressant-like effects.

The dose and the length of treatment are critical for determining outcomes, which can be either beneficial or detrimental.

And theres another potential risk from frequently taking psychedelics.

Psychedelics are most commonly associated with a brain receptor called serotonin 2A (5-HT2A), which is crucial for their mind-expanding effects. But many psychedelics also activate another serotonin receptor, 5-HT2B. This receptor is abundant in heart tissue and is implicated in drug-induced valvular heart disease.

The concern is that, while occasional use of a 5-HT2B drug may not cause any problems, repeated use for extended periods could trigger heart problems, even at a low dose. While this heart issue has not been directly tied to classic psychedelics like DMT, psilocin, or LSD, there is a well-documented history linking valvular heart disease to the long-term use of other drugs that activate this receptor.

One thing thats clear about psychedelics and other psychoplastogens is that both the dose and frequency of exposure matter. Unfortunately, we just dont know enough to give anyone a clear playbook on the benefits and risks of taking different doses of these drugs over different time frames.

We know that single, large doses given under appropriate conditions can be therapeutic. We also know that lots of people say that microdosing is a game-changer, and there are early indications of potential therapeutic benefits. But there may be serious concerns lurking beneath the surface.

I think adults should be treated like adults: They should be informed of the facts and be free to make their own decisions. As for myself, Im going to stick with the occasional macrodose.

To learn more about Mind & Matter and listen to the podcast that inspired this article, visit THIS link.

Nick Jikomes, PhD

Nick is Leafly's Director of Science & Innovation and holds a PhD in Neuroscience from Harvard University and a B.S. in Genetics from the University of Wisconsin-Madison. He is the host of a popular science podcast, which you can listen to for free at: http://www.nickjikomes.com. You can follow him on Twitter: @trikomes

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What are the potential risks of microdosing psychedelics? - Leafly

In this weeks Trade To Black Podcast, Shadd Dales, Benjamin A. Smith and Anthony Varrell discuss a range of issues, ranging from the latest decline in MSOS, atai Life Sciences, crypto/NFTs and more. Our special guest in InMed Pharmaceuticals (Nasdaq:INM) CEO Eric Adams to talk about the rare cannabinoid industry and why its poised to take off in 2022. Grand View Research believes the market will grow at over 20% CAGR over the next five years.

Trade To Black PodcastEpisode 20 CliffsNotes

Cannabis

@3:17 AdvisorShares Pure US Cannabis ETF MSOS is getting smashed along with the broad market meltdown. Are entry points getting to a good place for long term focused investors?

@7:13 This week marked one full year since president Joe Biden took office. To date, he has not come through with any of his policy intentions to decriminalize cannabis and enact expungements for convicted felons of non-violent cannabis crimes. Will we see meaningful reforms in the lead-up to the November midterms?

@10:54 It is very important for cannabis companies to be transparent with their shareholders. Which MSOS companies are doing the best job in this regard?

@12:55 Anthony believes the no. 1 job of a CEO is to keep investors from selling their stock.

Psychedelics

@14:17 The psychedelic sector continues churning out positive news, yet the price action continues to decline. Its at the point where not even one sector company is valued at $1 billion on an undiluted basis. Has the selling gone too far? atai Life Sciences discussed.

@16:25 Anthony is not surprised that the psychedelics market has trended so low. Retail participation is a prime culprit.

@18:09 Benjamin A. Smith theorizes the cause of the steep drawdown in COMPASS Pathways post Phase 2 results released in early November.

@19:34 The future belongs to companies that can produce drugs that are vastly different in qualities from the legacy psychedelics.

@21:01 The selling has been so acute, that sector leader Mindmed has come down to true penny stock status. Benjamin A. Smith is interested in starting positions in the sector.

@22:16 Ray Kurzweil, Neurolink and metaverse discussion.

Crypto/NFTs

@28:10 Bitcoin and Ethereum are crashing. Russias attempt to ban crypto mining in the country was a prime culprit of recent weakness. Whats next for the bellweather cryptocurrencies?

@30:55 Microsoft acquired Activision for $70 billion to build out their metaverse portfolio. Anthony opines on the significance of it all.

@32:50 Anthony breaks down what the metaverse is really about.

@34:10 The NFT market remains very strong despite the selloff in cryptocurrencies. Bored Apes are at an all-time high with big name entertainment stars buying in.

@37:00 Rumor has it that the Super Bowl halftime show could be the first to incorporate virtual reality elements in it.

To view our previous Trade To Black Podcast 19,click here.

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Trade To Black Podcast 20: Is the Selling In MSOS And Psychedelics Getting Overdone? A Frank Discussion - The Dales Report

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

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

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

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

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

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

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

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

Whats the biggest misconception that you hear about MindMed?

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

Whats next for you in the short term?

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

This interview has been edited and condensed for clarity.

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

4. Awakn Life Sciences Signs Memorandum of Understanding with MAPS

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

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

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

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

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

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

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

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

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

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

In the news

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

See more here:

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Go here to read the rest:

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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