Several years after psychedelics began gaining steam as alternative mental health treatments, the U.S. Food and Drugs Administration has finally issued guidance on the management of psychedelic clinical trials. Even though initial results have been incredibly encouraging, significantly more research and clinical trials are needed before psychedelic-based treatments are developed and deployed to the mass market.
The draft guidance published by the FDA in late June 2023 is meant to provide protocols and regulations for future clinical trials involving psychedelics. It offers guidance on the creation of clinical studies to study hallucinogenics such as LSD, psilocybin (magic mushrooms) and MDMA along with their effectiveness in mental health treatment.
According to a statement from an FDA spokesperson, psychedelics present a “very active and challenging area of drug development.” The agency spokesperson noted that there is limited experience in creating programs to study psychedelics for FDA approval due to the novelty of the field.
Compass Pathways, one of the largest companies taking part in psychedelic research, had revealed that it was expecting the draft guidance based on past communications with the FDA. The company is currently running phase 3 studies on the safety and efficacy of psilocybin, the main psychoactive component in magic mushrooms. A Compass Pathways spokesperson said that the company is pleased to see that the draft guidance from the regulatory agency is in line with its own policies, especially on rigor and exceedingly high standards.
Pathways’ clinical trials are already designed with similar protocols in mind and will not need any further change in the face of the draft regulations, the spokesperson said. Researchers in academic institutions studying psychedelics have also praised the draft regulations, stating that they provide much-needed guidance for the nascent but swiftly growing field of psychedelic research.
However, some experts are not pleased with certain requirements included in the draft provisions such as a recommendation that psychedelic clinical trial subjects must be observed by two monitors during treatment. One of the monitors should be a healthcare professional with “graduate-level professional training” and psychotherapy experience and the other should have a degree and at least one year of clinical experience in mental healthcare.
Paul Hutson, PharmD, MS, director of the Transdisciplinary Center for Research in Psychoactive Substances at the University of Wisconsin in Madison, that this will be one of the most disputed aspects of the draft regulations. Hutson explained that the provision could derail efforts to study psychedelics by overburdening research teams.
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Timeka Drew is an operating social equity license holder and seasoned cannabis industry executive. She is the founder and CEO of Biko, a California-born cannabis brand focused on producing luxurious, effective products. She has held executive positions for many respected operators, including 4Front Ventures, Eaze and NUG. Timeka sits on the board of the Cannabis Equity Retailers Association (CERA) and Social Equity LA, and is a proud member of the Social Equity Owners and Workers Association (SEOWA). She serves on the Hall of Flowers Social Equity Committee and has worked with many organizations in support of building equity and community reinvestment programs.
Timeka entered the cannabis industry in California in the early 2000’s as a medical patient and advocate, where she ran a doctor and patient referral service and placed the first advertisements for legal cannabis in Los Angeles. She currently serves as a social equity business coach for the Los Angeles Department of Cannabis Regulation’s Business Licensing and Compliance Assistance program through Oaksterdam University.
Hamilton, Ont. — Zentrela, a leading Canadian neurotechnology company, is proud to announce the launch of an innovative education program focused on providing consumers with reliable information about the effects of cannabis products.
Through cutting-edge brainwave research, Zentrela aims to empower consumers with the knowledge they need to make informed purchase and consumption decisions in the rapidly growing cannabis industry.
Lack of reliable information
As the cannabis market continues to expand, an increasing number of infrequent, inexperienced, and new consumers are seeking reliable information about the potential effects of cannabis products. This critical information gap has left many consumers unsure about the impact of different cannabis products and has hindered their ability to make informed choices.
Unmet consumer need
Until now, this significant consumer need has remained largely unaddressed due to the scarcity of comprehensive, scientific research in this field. Zentrela recognized this issue since the federal Canadian legalization and in 2021 started the world’s largest brainwave study to objectively quantify and classify the psychoactive effects cannabis products have on the brain. As of today, more than 800 consumers of beverages, edibles, pre-rolls and vapes have participated in the Zentrela research project.
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The neurotech tech company is announcing today the beginning of a series publications of scientific articles where they will describe the results of their massive cannabis effect research using their proprietary wearable brain device and Machine Learning algorithms to accurately describe the effects specific products create for consumers. For the first time, new or inexperienced consumers will have neuroscience-backed product effect information to make informed purchasing and consumption decisions.
Unveiling the truth through research
Having successfully piloted their science-driven consumer education approach since 2022 with leading retailers in the Greater Toronto Area and Collective Project, an innovative cannabis beverage brand, Zentrela is now prepared to scale up their program and share their findings with a broader audience of Canadians. This scale-up phase includes publishing the results of their extensive, independent research to address a wide range of consumer questions such as how onset times vary between cannabis beverages, edibles, pre-rolls, and vape products. Zentrela has forged partnerships with age-gated media companies as well as influencers in age-gated social media platforms such as Instagram, Reddit, Twitter, to ensure broad distribution of this scientific content.
Furthermore, Zentrela is partnering with retailers who are committed to educating consumers and helping them make more informed decisions. By leveraging their study publications, Zentrela will provide these retailers with science-backed cannabis product effect information, enabling budtenders to objectively inform consumers and enhance their overall experience. Retailers currently participating in the program include Spirit Leaf, Little Italy and Curious Cannabis. These collaborations will ensure widespread dissemination of accurate information and reach cannabis consumers at point of sale.
Although most cannabis reform activists and industry stakeholders are delighted with nationwide efforts to legalize cannabis and promote social equity, they aren’t happy with the fees and taxes cannabis businesses are forced to pay. Cannabis operators in most states with legal markets have long complained of excessivelyhigh fees and taxes they are required to pay under their respective regulatory policies.
Even though cannabis is still illegal at the federal level, taxes across the country are so high that they exceed taxes for alcohol by a wide margin in many states. These fees significantly limit participation in the market, increase prices for legal cannabis and allow the already massive cannabis black market to continue attracting most of the market.
A group of medical cannabis companies in Oklahoma have teamed up with a cannabis industry advocate to sue the state over the increasingly high fees levied on cannabis businesses.
Regulators recently approved a new fee structure that increased licensing fees for medical cannabis cultivators, processors, laboratories and dispensaries. Cannabis businesses that used to pay a flat $2,500 fee for licenses will now have to pay thousands more per year, with the largest cultivators required to pay up to $50,000 annually to retain their licenses.
The lawsuit claims that these fee increases are in violation of Oklahoma’s constitution and are no different from a “revenue-raising” measure. Oklahoma law requires that revenue bills receive more votes to advance compared to traditional bills. However, the lawsuit argues that since the new cannabis fees did not receive supermajority votes and were passed just as the 2022 session drew to a close, they cannot be codified as law.
Furthermore, the lawsuit explained that it called the fees a revenue-raising measure because the bill did not outline any regulations that would be funded by the extra funding raised by the increased fees. As such, the lawsuit said, the legislation was designed to raise additional revenue for the state rather than being regulatory in nature.
The lawsuit says that the new regulations would have a major financial impact on the medical cannabis industry, costing players in the sector close to $30 million in fees per year.
Oklahomans for Responsible Cannabis Action founder Jed Green and one of the petitioners on the suit says that the lawsuit raises constitutional questions that affect every taxpayer in Oklahoma. He was joined in the petition by medical cannabis cultivator Pharside, medical cannabis dispensary Oklahoma Natural Cures, and cannabis processor Bingo 101.
For enterprises such as IGC Pharma Inc. (NYSE American: IGC), which operate under the drug-development regulations of the FDA, no such disputes over fees can arise because there is a national structure governing the fees drug developers have to pay as they seek permission for each phase of the process that they seek to conduct.
NOTE TO INVESTORS: The latest news and updates relating to IGC Pharma Inc. (NYSE American: IGC) are available in the company’s newsroom at https://cnw.fm/IGC
About CNW420
CNW420 spotlights the latest developments in the rapidly evolving cannabis industry through the release of two informative articles each business day. Our concise, informative content serves as a gateway for investors interested in the legalized cannabis sector and provides updates on how regulatory developments may impact financial markets. Articles are released each business day at 4:20 a.m. and 4:20 p.m. Eastern – our tribute to the time synonymous with cannabis culture. If marijuana and the burgeoning industry surrounding it are on your radar, CNW420 is for you! Check back daily to stay up-to-date on the latest milestones in the fast -changing world of cannabis.
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“We are all born free and spend a lifetime becoming slaves to our own false truths.” ~Atticus
Understand: Your ego is not your enemy. It’s more like a clumsy anchor with too many feelings attached to it. It’s like a whiney, woe-is-me mass of sentimentality constantly tripping over itself. If you are the horse, then your Ego is the cart that you keep ramming into wondering why you can’t get anywhere.
Still, it’s not the enemy. It’s one of the most vital aspects of yourself. The problem is that you are probably its bitch, instead of the other way around. You are its tool, and it leverages you against yourself all the time. It slaps you around. And the crazy thing is that you allow it to. Hell, you probably welcome it. This is because you believe (rather than think) that it knows what you want. It doesn’t. It’s nothing, more than your sense of self-importance. It doesn’t know what you want. It only knows how to keep you safe, comfortable, and secure. It only understands self-preservation.
So the secret to turning the tables on your insecure, uninitiated, tiny ego is to practice self-improvement over self-importance. Practice self-empowerment rather than self-preservation. Self-importance leads to impotence. Self-improvement, on the other hand, leads to liberation and the rise of an initiated, self-actualized ego that’s ready to take on all comers and prepared to overcome itself.
Practice getting out of your own way:
“Be melting snow. Wash yourself of yourself.” ~Rumi
Step one in turning the tables on your ego: get over yourself. Understand that you are a fallible, imperfect, prone to mistakes naked-ape fumbling through the toddler-phase of its species’ evolution. You are a tiny speck of dust in an unfathomably enormous universe that will exist none-seconds compared to the ancient eternity of the cosmos.
That should humble you. But your ego probably won’t allow it to. It’s too damn scary. Too mortal. Too real. So your ego is probably spoon-feeding you a healthy dose of cognitive dissonance to prevent it from getting overwhelmed. Hence the vital importance of practicing getting out of your own way.
Humility is the cornerstone of self-improvement. Humility is the searing pain of seeing the light upon exiting Plato’s Cave. It’s collapsing into a pile of existential angst in the Desert of the Real after transcending the Matrix. Humility is the ultimate psychological leveling mechanism. It puts the ego in check so that you can finally be authentic with yourself.
The beauty of practicing getting out of your own way is that eventually your ego gets used to driving in the back seat. It starts to learn how not to take itself too seriously. It begins to see how everything is connected to everything else. It becomes a vital tool in your arsenal, used to flexibly leverage reality into an understandable construct. In short: it becomes interdependent rather than codependent.
We practice getting out of our own way so that we are humble enough to realize that we’re, paraphrasing Palahniuk, the same decaying organic matter as everything else, but that we’re also unique and fragile snowflakes. And the only way to become more than just a unique and fragile snowflake is to make self-improvement primary to self-preservation.
We must sow a little painful humility if we are to reap the rewards of self-empowerment.
Stop acting like the world owes you something:
“To dare is to lose one’s footing momentarily. Not to dare is to lose oneself.” ~Soren Kierkegaard
Here’s the thing, down and dirty: You don’t deserve a damn thing! Someone told you deserve this or that at some point during your ego’s fragile development and you’ve used it as a prop ever since.
You don’t deserve love. You don’t deserve to be happy. You don’t deserve a job. Hell, you could even earn those things through blood, sweat, and tears, and you would still not “deserve” them. Why? Because the world simply doesn’t work that way. There are probabilities involved. There’s luck involved. There’s vicissitude and unexpected change to consider. And the mother of them all: you simply cannot control other people, unless you become a tyrant.
Only tyrants think the world owes them something.
Your ego is a little bitchy tyrant inside you. And until you have the courage to flip the tables on it, your ego will continue to tyrannize you and everyone around you. It will continue tricking you into thinking you deserve the world. When really you don’t deserve a goddamn thing.
There’s daring, there’s courage, there’s proactive self-improvement, but there is no “deserve.” Toss that hindering sentiment out the window. Defenestrate it along with the outdated notion that “things happen for a reason.”
The beauty of practicing letting go of your sense of entitlement is that eventually you realize that everything is connected to everything else. You see how you are the world, and the world is you. You don’t need anything because it’s already a part of you. Your ego goes from being a self-entitled tyrant to a self-overcoming liberator.
Make mistakes of ambition rather than mistakes of sloth:
“All courses of action are risky, so prudence is not in avoiding danger but calculating risk and acting decisively. Make mistakes of ambition and not mistakes of sloth. Develop the strength to do bold things, not the strength to suffer.” ~Niccolo Machiavelli
When you are your ego’s bitch, you suffer unnecessarily. Your tiny comfort zone is a prison, and metal doesn’t stretch. Bars are not flexible. Sure, inside your prison everything is safe, secure, and comfortable, but it’s all just empty platitudes and sentimental delusions that you keep telling yourself to prevent your prison from turning into a rubber room. But at least a rubber room is flexible.
That’s why the wise have always advised going a little crazy from time to time in order to shake things up and shock the Self into awakening. As Tony Schwartz said, “Let go of certainty. The opposite isn’t uncertainty. It’s openness, curiosity, and a willingness to embrace paradox, rather than choose up sides. The ultimate challenge is to accept ourselves exactly as we are, but never stop trying to learn and grow.”
A mistake of sloth is remaining fortified in the prison of your comfort zone. It’s allowing your ego to continue making you its bitch by bolting the horizon and blocking the door. It’s ignoring all calls to adventure. It’s turning a deaf ear to “a language older than words.” Meanwhile, Rumi is in your soul like a Persian Yoda pleading, “Why do you stay in prison, when the door is wide open?” But when your Ego is boss, self-preservation is your master. You’re in the grips of cognitive dissonance and you can’t see past your need for comfort, security, and safety.
A mistake of ambition, on the other hand, is a leap of courage. It’s a strategic risk based upon passion, perseverance, and love. It’s saying, “Fuck my ego! I’m giving this a shot.” Which gets you out of your own way by launching you past comfort, security, and safety and into some much-needed adventure. It’s heeding the call, listening to the pulse that connects all things, and then acting with deep resolve on a calculated gamble.
The alternative is unnecessary suffering in the prison that your ego has erected. Either way there is suffering, but at least in the suffering that comes from making mistakes of ambition, you are free. As Ajahn Chah said, “There are two kinds of suffering. There is the suffering you run away from, which follows you everywhere. And there is the suffering you face directly, and so become free.”
Create a less shitty life through cyclic self-overcoming:
“In all affairs, it’s a healthy thing now and then to hang a question mark on the things you have taken for granted.” ~Bertrand Russell
So yeah, adventure hurts. The unknown is scary, and unexpected things can happen. Hell, you could even die. Making mistakes of ambition is no walk in the park. Things could go wrong. But so what! There are greater pains. There are worse ways to go down. Like making mistakes of sloth. Growth is painful. Change is even more painful. But remaining stuck in a shitty life of aggrandized ego-fellating is arguably the worst pain of all.
This is where the art of self-overcoming comes in. Self-overcoming is bitch-slapping your ego out of the way, taking the reins of your life into your hands, and proactively going about improving upon who you were yesterday. It’s taking Nietzsche’s idea of the Overman and running with it. It’s a personalized Fibonacci sequence, where your own development is predicated upon an individualized progressive evolution that will ultimately contribute to the evolution of the species.
Self-overcoming is realizing that the human condition is fragile and fallible. And that’s okay. That’s precisely why self-overcoming is necessary. It’s a vehicle that compels us to become robust and wise despite our inherently fragile and fallible natures. The ego wants to keep you safe in your fragile and fallible comfort zone. Self-overcoming tears down the comfort zone and teaches the ego how to become a flexible tool of self-improvement rather than a rigid tool of self-preservation. We’ll still be fragile and fallible, but we’ll also be robust and wise.
Self-overcoming is the daily act of letting your ego know who’s boss. You are! And no amount of comfortable coos and warming sentiments are going to lull you back to sleep. You’re awake. Your comfort zone has been stretched and has gained the flexibility to stretch even further. The tables have been turned. In the poker game of Self, you’ve called your ego’s bluff and now you’re holding all the cards. Your self-preservation has taken a back seat to your self-improvement. There’s an initiation at hand. Your ego is now ready to become a mighty tool for your self-actualization.
Gary Z McGee, a former Navy Intelligence Specialist turned philosopher, is the author of Birthday Suit of God and The Looking Glass Man. His works are inspired by the great philosophers of the ages and his wide-awake view of the modern world.
This article (How to Make Your Ego Your Bitch) was originally created and published byThe Mind Unleashed and is re-printed here under a Creative Commons license with attribution to Gary Z McGee and themindunleashed.com. It may be re-posted freely with proper attribution, author bio, and this statement of copyright.
Starting this week, adults aged 21 years and older in Connecticut have been granted the legal right to grow their own cannabis for personal use, as per the latest provision of the state’s marijuana legalization law. As a reminder of this policy change, the DCP released a notice that emphasized the value of responsible cultivation and provided a thorough rundown of the requirements that must be adhered to.
Some of the key points that adults should be aware of regarding cannabis home cultivation include:
Individuals aged 21 and older can grow a maximum of six marijuana plants, with only three of those plants allowed to be in a mature state for personal use.
Regardless of the number of adults residing together, the household plant limit is capped at 12 plants.
The cultivation must take place indoors, away from public view, in a secure location inaccessible to minors and pets.
After harvesting, adults are strongly advised to store the cannabis in child-resistant packaging to ensure safety.
The legalization law that is being put into effect allowed medical cannabis patients the opportunity to start growing their own plants in October 2021, and that privilege is now being extended to all adult users over the age of 21.
Interestingly, home cultivation legalization comes some six months after Connecticut’s first recreational cannabis retailers opened, resulting in a significant expansion of the market. Recreational sales have risen to previously unheard-of heights and, as of May, have surpassed those for medical use.
Recently, Governor Ned Lamont signed a cannabis omnibus bill that introduces several reforms. Included in this are limitations on consuming hemp-derived goods, the creation of a new Connecticut Office of the Marijuana Ombudsman, and the issuance of permits for cannabis businesses to hold off-site events. Also included in the measure are definitions of edible marijuana products and revisions to the state lottery’s licensing policies.
In the meantime, the governor approved budget legislation last month that includes clauses to give state tax relief to legalized cannabis entities that are now forbidden from taking federal deductions under IRS code section 280E.
Moreover, a bill to improve the state’s cannabis legalization and expungement statute was approved by the House of Representatives in May. The measure calls for the release of people who are currently in prison on cannabis-related offenses as well as requests for judges to impose lighter terms or drop charges for a wider variety of cannabis-related convictions.
The commencement of marijuana home cultivation is likely to create a bigger demand for indoor cultivation equipment in the category of what Advanced Container Technologies Inc. (OTC: ACTX) makes. If this happens, suppliers will likely a spike in sales.
NOTE TO INVESTORS: The latest news and updates relating to Advanced Container Technologies Inc. (OTC: ACTX) are available in the company’s newsroom at https://cnw.fm/ACTX
About CNW420
CNW420 spotlights the latest developments in the rapidly evolving cannabis industry through the release of two informative articles each business day. Our concise, informative content serves as a gateway for investors interested in the legalized cannabis sector and provides updates on how regulatory developments may impact financial markets. Articles are released each business day at 4:20 a.m. and 4:20 p.m. Eastern – our tribute to the time synonymous with cannabis culture. If marijuana and the burgeoning industry surrounding it are on your radar, CNW420 is for you! Check back daily to stay up-to-date on the latest milestones in the fast -changing world of cannabis.
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