Category Archives: Psychedelics

In the 1960s, research surfaced linking psychedelic use to an increased risk of cancer. But a new study published in theJournal of Psychopharmacologyfound no such link. The researchers studied recent data from a large national survey of Americans and found that psychedelic use (e.g., LSD, MDMA, DMT) was not associated with lifetime cancer development.

Lysergic acid diethylamide (LSD) was first associated with cancer risk when a 1967 study reported chromosomal damage in human white blood cells after exposure. A series of subsequent studies were released suggesting that LSD may have carcinogenic potential, and case reports of LSD users developing cancer added to this concern.

Beginning in the late 1960s, concerns were raised by laboratory experiments that LSD and other psychedelics might damage chromosomes and potentially cause hematological cancers such as leukemia and lymphoma, said study author Brian S. Barnett, an assistant professor of psychiatry at the Cleveland Clinic Lerner College of Medicine of Case Western Reserve University.

Once a potential connection between psychedelics and cancer was reported by the media, it became an important factor in psychedelics becoming Schedule 1 drugs and research into their therapeutic applications coming to an end for nearly half a century.

However, multiple flaws have been identified in the concepts and methodologies of these early studies. For example, many of them tested LSD concentrations and durations of exposure that far exceeded reasonable dosages of LSD. Additionally, many studies did not control for use of other drugs alongside LSD.

Today, most of the available evidence suggests that psychedelics do not pose a carcinogenic risk. But Barnett and his colleagues note that research in this area largely faded out with the 70s. Now that much more epidemiological data is available, the researchers aimed to revisit and clarify the link between psychedelics and cancer risk. This topic is particularly relevant, the authors say, in light of the ongoing discussion regarding the therapeutic potential of psychedelics.

With psychedelics now moving rapidly toward FDA approval as medications, I thought it would be interesting to use data from a U.S. government survey of tens of thousands Americans about drug use and health problems to investigate this safety question and see if there actually is any association between psychedelic use and cancer, Barnett explained.

The researchers aimed to expand upon a 2021 population-level study by Simonsson and associates, which explored the link between lifetime psychedelic use and cancer diagnosis in the past 12 months. For the current study, the researchers explored associations between lifetime psychedelic use and lifetime cancer diagnosis. They also differentiated between cancer of any kind and hematologic cancers (e.g., leukemia, lymphoma).

Barnett and his team analyzed data from the 20152019 editions of the National Survey on Drug Use and Health, a nationally representative survey of Americans. Focusing on participants aged 18 and older, the final sample included 210,021 respondents. Importantly, the survey included data on a large number of confounding variables such as age, sex, race/ethnicity, income, educational attainment, lifetime history of HIV/AIDS, and other drug use.

When controlling for confounding variables, the results revealed that lifetime psychedelic use was not associated with lifetime cancer diagnosis nor hematologic cancer diagnosis. This was true for each of the three classifications of psychedelics: tryptamine (5-MeO-DIPT, AMT, DMT), lysergamide (LSD), and phenethylamine (2C-B, mescaline, MDMA, peyote, and San Pedro).

Interestingly, when researchers did not control for confounding variables, they found that lifetime psychedelic use was associated with a lower prevalence of lifetime cancer diagnosis. The authors suggest that this association may have been driven by the lower age of respondents who reported lifetime psychedelic use.

The authors said results support the findings of Simonsson and colleagues (2021), which revealed no significant link between psychedelic use and cancer diagnosis in the past 12 months. The current study extended these findings to include lifetime diagnosis of cancer and hematologic cancer.

However, every scientific study has limitations, Barnett noted. While it is unlikely that the limitations of this study would change the outcome, its important to know that the dataset used for the study does not provide information on the number of times participants used psychedelics (we only knew who used them during their lifetime), doses of psychedelics used, and whether participants psychedelic use preceded their cancer diagnosis or vice versa.

The authors said that more research will be necessary to better understand the physiological safety of psychedelics. Future research in this area would benefit from employing more detailed epidemiological data, the authors wrote, including age of first use for each psychedelic, number of lifetime uses of each psychedelic, time since last use of each psychedelic, age at each type of cancer diagnosis, and information about use of less well-known psychedelics that are gaining increased societal attention, such as ibogaine and ayahuasca.

The study, Is psychedelic use associated with cancer?: Interrogating a half-century-old claim using contemporary population-level data, was authored by Brian S Barnett, Kathleen Ziegler, Rick Doblin, and Andrew D Carlo.

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Large national survey suggests that the use of psychedelics is not associated with lifetime cancer development - PsyPost

Short-acting psychedelics biotech firm Small Pharma Inc. DMTTFreceived a USPTO patent protecting the composition matter of a group of deuterated DMT compounds, with expected exclusivity until April 2041.

We have made significant strides this year progressing our research and development programs and in securing key IP to support and protect them, saidCEO George Tziras.

We secured eight patent grants so far this year, bringing our total from four to twelve. The grant of this second United States patent effectively protects all pharmaceutical formulations of the specified deuterated DMT compounds, enabling us to progress our deuterated pipeline with even greater confidence.

Indeed, the new patent will further strengthen the companys intellectual property position by being the equivalent to an existing European patent, therefore expanding protection for the companys deuterated DMT pipeline in the global market.

Small Pharmarecently released its financial results for the three and six months ended August 31, 2022, as well as business highlights for the period including its two advanced clinical programs and the companys preclinical pipeline.

Its short-acting psychedelic assisted therapies under development are currently focusing on depression treatment with lead candidate SPL026, a proprietary synthetic formulation of DMT. More specifically, Small Pharma is advancing a clinical program of intravenous (IV) SPL026 in conjunction with psychotherapy for the treatment of Major Depressive Disorder (MDD).

Photo courtesy of RF._.studio onPexels and Jynto onWikimedia Commons.

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This Pharma Company Just Scored Another Psychedelics Patent And Set Its Sights On 70 More - Small Pharma - Benzinga

For decades, consciousness researchers have been fascinated by the psychedelic qualities that certain varieties of fungus possess and the remarkable effects they have on the human mind.

Since the early 2000s, a new wave of scientific studies focused on the effects of these hallucinatory compounds have emerged, beginning with Johns Hopkins Center for Psychedelic and Consciousness Research being granted regulatory approval in 2000 to reinitiate research with psychedelics in healthy, psychedelic-nave volunteers.

Six years later, they published the results of their findings, which found long-term positive effects that resulted from as little as a single dose of psilocybin. Subsequent research led to a federal grant in 2021 from the National Institutes of Health to study the possible impact psilocybin might have on helping smokers quit, marking the first time in five decades that such a grant was provided for psychedelic treatment research.

With the growing awareness of psilocybins importance in treating everything from addiction to anxiety and depression, now scientists are trying to narrow down what led certain fungi to take the unique evolutionary path that helped them produce psychedelic compounds in the first place.

Recently, a research team at the University of Plymouth has taken up the case in a new study, which uses novel genetic science coupled with behavioral experiments to help unravel the origins of psychedelic compounds in certain fungi.

Among the theories the team explored included whether hallucinatory compounds might have developed as a unique defense mechanism against invertebrates that rely on fungi as a staple of their diets. Another angle they explored looked at whether some psychedelics were produced in order to manipulate the behavior of insects, not unlike how flowering plants have evolved to work with pollinators in what are often very remarkable ways.

Due to its occurrence in so-called magic mushrooms, psilocybin had been a natural central area of focus that the University of Plymouth team chose to explore. This, along with the compounds similarity to the neurotransmitter serotonin, which is synthesized within our bodies and plays a critical role in conveying information between nerve cells.

John Ellis, Ph.D., Lecturer in Conservation Genetics and one of the researchers supervising the study, says that despite their ubiquity in the natural world, fungi actually present a number of challenges when it comes to their incorporation in studies like the one his team has undertaken.

Fungi generally receive less attention overall than animals and plants, partly because they are less apparent, people interact with them less and they can be hard to study, Ellis recently said in a statement. Ellis also cites the problems associated with the illegality of psychedelic use, which in decades past has required special permits and other preparation in order for studies to occur.

Due to such barriers, some of the most intriguing data on the use of psychedelics is already several decades old.

According to Ellis, there were some very interesting studies in the 1940s and 50s into the use of LSD as a psychotherapeutic treatment for alcoholism and obsessive-compulsive disorder. Around that time, people also became interested in fungi from an anthropological perspective.

One example he provides involves the studies conducted decades ago by the research team of Mara Sabina and R. Gordon Wasson, who traveled to Mexico to observe religious ceremonial practices that incorporated the use of psychedelic fungi.

Around this time, there were also other charismatic individuals, such as Timothy Leary, who advocated the use of LSD more widely by the general public, Ellis says. However, as Leary and others worked to bring more widespread attention to the use of psychedelics, that attention also had the negative effect of drawing attention from lawmakers, whose regulations against psychedelic substances led both to cultural stigmas and also impeded scientific studies of their potential benefits in therapeutic practice.

Fortunately, it seems that many of the old attitudes toward psychedelics and their academic study have changed in recent years, potentially allowing researchers like Ellis to explore their beneficial nature.

More recently, people have returned to that initial research and found that compounds such as psilocybin can have psychotherapeutic benefits, he says.

However, that has not addressed their evolution in nature, he adds, which is what makes the research we are doing so exciting.

With the help of cutting-edge DNA sequencing technologies, the team compared psychoactive and non-psychoactive fungi samples to explore how large a segment of the animal kingdom regularly feasts on psychedelic fungi and how its effects on those species might compare to human experiences with psychedelics.

Along with its focus on DNA sequencing, the research also incorporates gene editing technologies aimed at creating mutated fungi which is incapable of synthesizing compounds like psilocybin.

Fundamentally, Ellis and the University of Plymouth team hope that their research can have the overall effect of helping remove some of the remaining stigmas against psychedelics and their serious study by academics.

I hope our project can change the public perception of magic mushrooms, Ellis says. But beyond that, asking questions about the biological world is a fundamental part of our human nature and this project fits into a long narrative of research asking questions about biodiversity and its evolution.

Micah Hanks is Editor-in-Chief and Co-Founder of The Debrief. Follow his work atmicahhanks.comand on Twitter:@MicahHanks.

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What Made the Mushrooms Magic: Psychedelic Study Explores the Odd Evolution of Mind-Altering Fungi - The Debrief

The Healing Company Inc. (OTC:HLCO), a publicly traded company backed by Dr. Deepak Chopraand psychedelics investor Christian Angermayer among others,has acquired UK plant-based superfood brands Your Super to capitalize on two high-growth wellness sectors:superfoods and plant-based nutrition, which together represent more than $200 billion of global market potential.

The acquisition, financed through a combination of cash and Healing Companyequity, will focus on expanding the impact and accessibility of Your Super's leading healing products portfolio, building on the company's traction to date.

The Healing Company has closed a $150 million credit facility with investment company i80 Group with the aim of further advancing its goal of providing expanded access to integrated healing methods through a community of healthcare brands.

Los Angeles-based health and wellness brand Your Super, whoseprevious investors includePepsiCo PEPand Beyond Meats PowerPlant Partners, was createdafter co-founder Michael Kuechs cancer diagnosis at age 24. Facing this reality, he and his partner and co-founder Kristel de Groot began developing superfood and plant protein mixes to boost his immunity, and theirmission eventually became to improve people's health with the power of superplants.

The certified B-Corp company has proven its ability to grow quickly while maintaining strong margins and a positive EBITDA outlook. In numbers, ithas sold more than 5 million products across the US and Europe, ranking 25th on 2021 Inc.s fastest-growing companies list, with three-year revenue growth of 11,477% and $180 million in cumulative revenue.

Within the wellness industry, which is predicted to reach $7 trillion by 2025, the supplement category has historically shown stability in a downturn, growing 8% through the 2007-2009 recession. The founders see the market as favorable for mergers and acquisitions, with valuations dropping considerably from 2021.

That is, the new credit facility is expected to fuel the company's plans to drive consolidation in a fragmented market, with the objective of buying and scaling more than 15 supplements and nutraceuticals brands in the next few years.

The Healing Companys co-founder and CEO Simon Belsham said he was certain about the acquisition of Your Super, calling it a powerful brand with robust margins and a fantastic product portfolio in a large and growing sector: preventative healthcare.

From the medicinal point of view, the companys chief scientific advisor,Deepak Chopra, added: "Food is medicine, and we now know definitively that plant-based nutrition has immense healing potential as it combats inflammation, which causes more than 80% of chronic disease. Your Super has developed clean, plant-based, superfood mixes that help more people benefit from the healing power of plants, and we're excited to help increase access to their products through this acquisition."

Regarding the new $150 million credit line news, founder and CEO of i80 Group Marc Helwani stated that The Healing Company's targeted acquisition strategy is highly attractive in the currentchallenging economic environment with ongoing declining asset prices and that the company's team is perfectly positioned to capitalize on this reality.

Photo courtesy of The Healing Company.

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Psychedelics And Wellness: The Healing Company Buys PepsiCo-Backed Superfoods Company - (HLCO) - Benzinga

DENVER (KDVR) Colorado voters will soon decide on statewide measures that address things like affordable housing, school meals, psychedelic drugs and alcohol. And of course, there will be several measures on taxes.

There are 11 statewide measures on the ballot this general election.

The proposed amendments to the Colorado Constitution will each require 55% approval, while the remaining measures will each require a simple majority vote to pass, according to the 2022 ballot information book, known as the Blue Book.

The Blue Book breaks down the pros and cons of each measure, and its available in English-language and Spanish-language text versions, and theres also an audio version.

Five of the measures were referred by the state legislature, while the other six were citizen-led. (Heres an easy way to tell, according to the Blue Book: An amendment or proposition placed on the ballot by the legislature is named with a letter or double letters, while citizen-led measures are named with numbers).

Voters have until Monday, Oct. 31, to return their ballot by mail and until Tuesday, Nov. 8, to use a ballot dropbox or vote in person. Here is a rundown of what voters will decide this election.

These measures will each require 55% approval.

Starting in 2025, the 18th Judicial District will split, and Douglas, Elbert and Lincoln counties will move to the newly created 23rd Judicial District. Amendment D would allow the governor to designate judges from the original district to serve the rest of their terms in the new district. It would also require judges to establish residency there.

Amendment E would extend existing property tax exemptions for disabled veterans to the surviving spouse of a U.S. military member who died in the line of duty or from a service-related injury or disease.

Amendment F would reduce the amount of time that a nonprofit can operate in Colorado before it can get a bingo-raffle license. It would also allow bingo-raffle workers to receive compensation, which is not allowed in the state right now.

The rest of the measures on the ballot will require a simple majority vote in favor to pass.

Along with the constitutional amendment that would benefit Gold Star families, several other items on the ballot will deal with taxes. The measures look to taxes to fund other programs, reduce taxes overall or educate people on the impact of tax changes.

Proposition FF would limit state income tax deductions on people who make $300,000 or more to fund healthy, free school meals for students in public schools. The money would also fund grants to help schools buy Colorado food products and increase wages for school food employees. Read more on the free school meals measure here.

Proposition GG would require any ballot initiative that increases or decreases state income taxes to include a table that shows the average tax change for filers across income levels.

Proposition 121 would reduce the state income tax rate from 4.55% to 4.40%. Read more on the proposed income tax reduction in Colorado here.

Proposition 123 would send 0.01% of state income tax toward affordable housing programs. It would also exempt that money from the state revenue limit, so it would reduce the pool of money refunded to taxpayers because of the Taxpayer Bill of Rights. Read more on the affordable housing measure here.

Colorado voters will once again have their say on substances this November, including natural psychedelics and alcohol.

Proposition 122 would decriminalize the personal possession and use of psychedelic mushrooms for people ages 21 and older and allow the creation of healing centers where people could consume the fungi while supervised. It would also open the door for the decriminalization of the psychedelic drugs dimethyltryptamine (DMT), ibogaine and mescaline as soon as 2026. Read more on the move to decriminalize psychedelic mushrooms here.

Proposition 124 would allow the number of liquor licenses a person can have to increase to eight by 2026. The limit would increase thereafter until 2037 when the number of liquor licenses a person could have would be unlimited.

Proposition 125 would allow stores that are licensed to sell beer, like grocery and convenience stores, to sell wine too. Learn more about the measure to allow wine in grocery stores.

Proposition 126 would allow third-party alcohol delivery. FOX31s Gabrielle Franklin spoke to businesses about the potential impact of third-party alcohol delivery.

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What's on the Colorado ballot? Housing, psychedelics, school meals, alcohol, taxes and more | FOX31 Denver - FOX 31 Denver

Miami, Florida--(Newsfile Corp. - October 19, 2022) - DoseConnect, a first-of-its-kind talent company solely focused on psychedelic therapeutics. Blending organizational strategy, systems thinking, and talent acquisition grounded in conscious connection, DoseConnect is built to help companies in this space scale for hyper-growth, and will be sponsoring the Tech Stage Wonderland Miami Conference by Microdose on November 3rd, 2022.

Visit us at the Tech Stage on November 3rd, or through the conference in the Exhibitor Hall to learn more about how our team can help build companies and create conscious cultures from the ground up because we know what it takes to find and land a dream team.

"We are thrilled to launch our services in support of the psychedelic medicine industry and couldn't think of a better opportunity to do this than at Wonderland in 2022" - Dom Farnan, DoseConnect CEO

Get tickets: Use DOSECONNECT20 to save 20% on tickets. Click this link to have it automatically applied: https://tickets.microdose.buzz/attendance/event/index/41737/EN?promocodes=DOSECONNECT20

About DoseConnectDriven towards future healing and wellbeing, DoseConnect is a first-of-its-kind talent company solely focused on psychedelic therapeutics. Blending organizational strategy, systems thinking, and talent acquisition grounded in conscious connection, DoseConnect is built to help companies in this space scale for hyper-growth. Working directly with founders, visionaries and high-level operators, the team at DoseConnect helps companies with everything from human resources systems and compliance to growth culture transformation. DoseConnect is founded by Dom Farnan, CEO and Erica Downing, COO - the dynamic duo behind DotConnect, a 2021 Inc5000 company focused on talent acquisition and retention. For more information, please visit http://www.DoseConnect.io.

Erica Downing(erica@doseconnect.io)

About Wonderland by Microdose Psychedelic InsightsWonderland: Miami will offer the industry a unique in-person convergence of business, science, music, and emerging technologies. The event is a thought-leadership platform and an opportunity to connect with influential leaders in science, policy, and business. It will also act as a launching pad for innovative content connected to the psychedelic medicine space, providing compelling entertainment and collaboration opportunities for attendees.

About Microdose Psychedelics InsightsMicrodose Psychedelic Insights is your guide to the psychedelic medicine industry. With a vision to shift the world's perception of psychedelic medicine, we distribute and create the most compelling content, financial analysis, engaging events, and groundbreaking education to drive the psychedelics industry to the forefront of modern medicine.

To view the source version of this press release, please visit https://www.newsfilecorp.com/release/141126

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DoseConnect to Sponsor the Tech Stage at Wonderland Miami by Microdose - Benzinga

Todays continued rally across equity markets is providing a bullish lift to many investors who have had their sentiment beat down to a great degree this year. While broad-based, certain sectors of the market are rallying more than others today. Among the leading stocks investors are watching are psychedelic companies such asBright Minds (NASDAQ:DRUG). Todays 30% surge inDRUG stock is emblematic of some of the moves were seeing today.

As fellowInvestorPlacecontributor William White pointed out,Mind Medicine(NASDAQ:MNMD) is another big mover, surging 10% higher earlier today. This sector has gained steam from some intriguing comments made by Sen. Cory Booker from New Jersey. In a video posted on Twitter yesterday, Booker outlined his case for why psychedelics could pose therapeutic solutions and should be looked at through a scientific lens.

Bookers view is shared by many investors in psychedelic stocks. However, seeing this rhetoric displayed is something thats certainly raising eyebrows and boosting the sector today.

Lets dive into what investors should make of this news.

Psychedelic drugs such as psilocybin and MDMA have shown some pretty impressive results in International studies on therapeutic solutions for disorders such as post-traumatic stress disorder (PTSD) and depression.

That said, because of laws prohibiting the use of these drugs in the U.S., little research has been conducted stateside. Booker and others are leading the charge to shift the paradigm to a science-first approach to these drugs.

For companies like Bright Minds, a biotech focused on psychedelic therapies for such disorders, todays rhetoric is good news. Potential decriminalization or legalization efforts start with words. And right now, while were still in the very early innings of what will need to be much deeper discussions on the topic, its a start. Indeed, investors have reason to be excited about DRUG stock right now.

On the date of publication, Chris MacDonald did not have (either directly or indirectly) any positions in the securities mentioned in this article.The opinions expressed in this article are those of the writer, subject to the InvestorPlace.comPublishing Guidelines.

Chris MacDonalds love for investing led him to pursue an MBA in Finance and take on a number of management roles in corporate finance and venture capital over the past 15 years. His experience as a financial analyst in the past, coupled with his fervor for finding undervalued growth opportunities, contribute to his conservative, long-term investing perspective.

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What Is Going on With Bright Minds (DRUG) Stock Today? - InvestorPlace

Psychedelics can produce positive changes in attitudes about death and dying and may be a way to help ease anxiety and depression toward the end of life, new research suggests.

In a retrospective study of more than 3000 participants, near-death experiences occurring naturally or via a psychedelic drug had a "remarkably" similar effect on attitudes about death and dying, with most participants reporting less fear and anxiety around death.

"Individuals with existential anxiety and depression at end of life account for substantial suffering and significantly increased health care expenses from desperate and often futile seeking of intensive and expensive medical treatments," co-investigator Roland Griffiths, PhD, Center for Psychedelics and Consciousness Research at Johns Hopkins Medicine, Baltimore, Maryland, told Medscape Medical News.

"The present findings, which show that both psychedelic and non-drug-occasioned experiences can produce positive and enduring changes in attitudes about death, suggest the importance of future prospective experimental and clinical observational studies to better understand mechanisms of such changes as well as their potential clinical utility in ameliorating suffering related to fear to death," Griffiths said.

The results were published online August 24 in PLOS ONE.

Both psychedelic drug experiences and near-death experiences can alter perspectives on death and dying, but there have been few direct comparisons of these phenomena, the investigators note.

In the current study, they directly compared psychedelic-occasioned and nondrug experiences, which altered individuals' beliefs about death.

The researchers surveyed 3192 mostly White adults from the United States, including 933 who had a natural, nondrug near-death experience and 2259 who had psychedelic near-death experiences induced with lysergic acid diethylamide, psilocybin, ayahuasca, or N,N-dimethyltryptamine.

The psychedelic group had more men than women and tended to be younger at the time of the experience than was the nondrug group.

Nearly 90% of individuals in both groups said that they were less afraid of death than they were before their experiences.

About half of both groups said they'd encountered something they might call "God" during the experience.

Three quarters of the psychedelic group and 85% of the nondrug group rated their experiences as among the top five most personally meaningful and spiritually significant events of their life.

Individuals in both groups also reported moderate- to strong-lasting positive changes in personal well-being and life purpose and meaning after their experiences.

However, there were some differences between the groups.

Compared with the psychedelic group, the nondrug group was more likely to report being unconscious, clinically dead, or that their life was in imminent danger.

The nonpsychedelic group was also more likely to report that their experience was very brief, lasting 5 minutes or less.

Both the psychedelic and nondrug participants showed robust increases on standardized measures of mystical and near-death experiences, but these measures were significantly greater in the psychedelic group.

The survey findings are in line with several recent clinical trials showing that a single treatment with the psychedelic psilocybin produced sustained decreases in anxiety and depression among patients with a life-threatening cancer diagnosis.

This includes a 2016 study by Griffiths and colleagues, which included 51 patients with late-stage cancer. As reported at the time by Medscape Medical News, results showed a single, high dose of psilocybin had rapid, clinically significant, and lasting effects on mood and anxiety.

Limitations of the current survey cited by the researchers include the use of retrospective self-report to describe changes in death attitudes and the subjective features of the experiences. Also, respondents were a self-selected study population that may not be representative of all psychedelic or near-death experiences.

In addition, the study did not attempt to document worldview and other belief changes, such as increased belief in afterlife, that might help explain why death attitudes changed.

Looking ahead, the researchers note that future studies are needed to better understand the potential clinical use of psychedelics in ameliorating suffering related to fear of death.

Support through the Johns Hopkins Center for Psychedelic and Consciousness Research was provided by Tim Ferriss, Matt Mullenweg, Blake Mycoskie, Craig Nerenberg, and the Steven and Alexandra Cohen Foundation. Funding was also provided by the Y.C. Ho/Helen and Michael Chiang Foundation. The investigators have reported no relevant financial relationships.

PLOS ONE. Published online August 24, 2022. Full article

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Psychedelics May Ease Fear of Death and Dying

The Drug Enforcement Administration (DEA) is proposing a significantincrease in the amount of researchcannabis allowed to becultivatedin 2023. According to anoticescheduled to be published in the Federal Register on Tuesday, the agency is also looking to boost the aggregate production quota of certain psychedelics likeLSD, psilocin, and mescaline,firstreportedMarijuana Moment.

For 2023,the DEA is proposingthat 6.7 million grams (14,770 pounds) of marijuana be grown for research, more than double the amount suggested for 2022 (3.2 million grams). In January this year, the DEAended a 5-decade federal monopolyon research cannabis production byapproving two companies, Groff North America Hemplex and Biopharmaceutical Research Company (BRC), to cultivate marijuana for research purposes.

This was a major milestone in the cannabis research sphere in that afarm functioning as part of theUniversity of Mississippiwasthe only legal source of federal research cannabissince 1968, despitelawsuitsand years of complaints that Ole Miss's product was not high enough quality to suffice for important research.

With more cultivators gaining DEAauthorization for cultivation, increasing the amount needed for research is achievable.

Whats more, the DEA also raised the quota for all other THC to 15,000 grams from previously 2,000 grams, indicating the popularity and therefore the need for research into cannabinoids likedelta-8 THC, and delta-10.

The agency has been raising production quotas for psychedelics over the last couple of years. For example, last December itincreased its quotafor psilocybin (also known as magic mushrooms), MDMAand DMT for 2022. This move came amid an increase in demand and interest within the scientific community to research the effectiveness of these psychedelic drugs in treatments for mental health disorders.

This time, the DEA proposed to keep the same quote for psilocybin as in 2022,8,000 grams, but it is suggesting to double the production of other important components of magic mushrooms, such aspsilocin from 4,000 to 8,000 grams. As forLSD,the proposed quota for 2023 is 1,200 grams, compared to 500 grams in 2022. The agency also suggested the production of 6,000 grams of5-MeO-DMT,compared to 2,550 grams this year.

Mescalinemanufacturing should go up notablyfrom 100 to 1,200 grams.

There has been a significant increase in the use of schedule I hallucinogenic controlled substances for research and clinical trial purposes.DEA has received and subsequently approved new registration applications for schedule I researchers and new applications for registration from manufacturers to grow, synthesize, extract, and prepare dosage forms containing specific schedule I hallucinogenic substances for clinical trial purposes,the agency stated.

These proposed 2023 quotas reflect the quantities that DEA believes are necessary to meet the estimated medical, scientific, research, and industrial needs of the United States, including any increase in demand for certain controlled substances used to treat patients with COVID-19; lawful export requirements; and the establishment and maintenance of reserve stocks.

At the same time, the DEA proposed keeping the same quotas as this year for psilocybin, MDMA, DMT, MDAand cannabis extract.

Photo: Rob Warner on Unsplash and Mathew Schwartz on Unsplash

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DEA Wants To Boost Production Of Cannabis & Psychedelics For Research In 2023 - Benzinga

Welcome to TDRs review of the Top 5 Psychedelic Developments for the week of October 10. Aside from presenting a synopsis of events, we provide market commentary to summarize the week that was for publicly-listed companies.

5. Atai Life Sciences Announces Positive Initial Results for Phase 1 Trial of KUR-101, an Oral Formulation of Mitragynine for OUD

Atai Life Sciences N.V. (Nasdaq: ATAI) announced positive initial results for their Phase 1 clinical trial of KUR-101. KUR-101 is an oral formulation of deuterated mitragynine, the major active alkaloid of the kratom plant, under development for the treatment of opioid use disorder (OUD).

Initial results indicate that KUR-101 is safe and generally well-tolerated. Results also showed a dose-proportional pharmacokinetic (PK) profile that was unaffected by food. In the single ascending oral dose portion of the trial, no severe or serious adverse events were reported, with most treatment-related adverse events being mild. Changes in respiratory rate following treatment with KUR-101 were comparable to that of placebo-treated patients for the doses tested and comparable across doses.

4. Palo Santo Closes $50M Psychedelic Therapeutics Investment Fund

Palo Santo, a venture capital fund focused on backing and building emerging psychedelic therapeutics companies, recentlyannounced the closing of its $50 million fund.

The oversubscribed fund is positioned to have a transformative impact on the field ofmental health by funding a diverse portfolio of businesses developing innovative psychedelic medicines and therapiestargeting both mental health as well as a range of Central nervous system(CNS) disorders.

The Palo Santo Fundiscurrently investedin over 20 portfolio companies across the psychedelic ecosystem. Moreover, the company combines its investing and portfolio-building experience with the expertise of leading academics and advisors in psychedelic science.

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DEA Proposes Dramatic Increases In Cannabis And Psychedelics Production In 2023 For Research

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3. Psychedelic Sector Dives As Bears Maintain Control

The psychedelic sector dove this past week, as reflected by theHorizon Psychedelic Stock Index (PSYK) ETF(14.67%). The ETF vastly underperformed theNasdaq Junior Biotechnology Index(2.16%) andNasdaq Biotechnology Ishares ETF(0.62%), which both trending inline or better with the the broad indices. TheNASDAQ 1003.16%andS&P 5001.53% fell, where higher-than-consensus Consumer Price Index readings implied additional & robust rate hikes ahead.

Heres how the Health Care (Biotechnology) sector performed:

In the news

Algernon Pharmaceuticals announced that Dr. Rick Strassman, author of the bookDMT: The Spirit Moleculeand Algernon consultant, will be joining CEO Christopher J. Moreau for the Science Keynote Address at Wonderland, the world-leading event in the psychedelic medicine industry.

American Psychedelic Practitioners Association has announced the launch of their organization, establishing safe, ethical and accessible psychedelic therapy and specific focus Psychedelic Assisted Therapy.

Clerkenwell Health, a psychedelic-specialist clinical research organization, has raised 2.1 million in seed funding, bringing the total to date up to 2.5 million, which will be used to get the London-based startup fully operational.

Coloradovoters will decide this November whether to decriminalize the possession and use of some hallucinogenic plants and fungi, including magic mushrooms.

Cybin Inc. and The Chopra Foundation, a not-for-profit organization dedicated to improving health and well-being founded by Dr. Deepak Chopra, join everyone in recognizing World Mental Health Day.

Drug Enforcement Agency is proposing to more than double the amount of marijuana that can be legally grown for research in 2023 and is also increasing quotas for psychedelics like psilocyn, LSD and 5-MeO-DMTwith a 12x bump for mescaline.

Field Trip Health & Wellness announced that a new version of its award-winning app for psychedelic guidance is now available for download on the App Store and Google Play.

Giving lab rats illicit psychedelic drugs may help scientists uncover how it can be used to treat anorexia in humans.

IntelGenx Corp. provided an update on its collaboration with its strategic partner, atai Life Sciences, for the development of novel formulations of pharmaceutical-grade psychedelics based on IntelGenxs polymeric film technologies.

Kratomgrows in severalAsian countriesand has been traditionally used by local communities as anatural home remedy for pain, depression and addiction. Now, several psychedelics companies are developingsubstancesbased on this plant and severalUS stateshave alreadyenactedlegislationthat regulates its production, distribution and sale.

Lobe Sciences has completed the synthesis of bulk L-130, a proprietary form of psilocin, and of the clinical supplies to be used in upcoming trials. The L-130 was manufactured in compliance with U.S. cGMPs (Current Good Manufacturing Practices).

LOVE Pharma provided an update on the advancement of the previously announced trial focused upon clinical applications for psilocybin assisted therapy for addiction to be conducted at Johns Hopkins.

Optimi Health has closed a non-brokered private placement of 5,692,308 units of the company at a price of $0.325 per Unit for gross proceeds of $1,850,000 with Wilson Capital, the Private Equity Division Chip Wilsons family office.

PsyBio Therapeutics has reached an initial agreement with experienced clinical researchers to conduct a clinical trial utilizing PsyBios proprietary biosynthetic psilocybin product upon obtaining all necessary approvals and licenses.

Psychedelic rock band Jefferson Airplane was awarded a star on the Hollywood Walk of Fame.

Red Light Holland announced that Red Light Holland Advisory Board member, Akwasi Owusu-Bempah will participate at Bloomberg CityLab 2022, being held in Amsterdam, The Netherlands, October 9-11, 2022.

Relmada Therapeutics said its therapy to treat major depressive disorder did not meet the main goal of a late-stage study.

Revitalist Lifestyle & Wellness has extinguished its contract with High Standard Capital by issuing 1,282,051 common shares at $0.078 per share. These shares are subject to the Companys filing requirements with the CSE and a hold period of four months and a day from the date of issuance.

Voters in five states will decide on marijuana legalization on their November ballotsand voters in one state will have the chance to enact a historic reform to legalize psychedelics possession.

2. Elon Musk reportedly goes on exploratory journeys, likes to show chart of benefits of MDMA, mushrooms

Elon Musk is no stranger to psychedelic drugs and often likes to discuss the benefits of the substances, according to arecent report from The New York Times.

The billionaire likes to share a chart that shows MDMA and psychedelic mushrooms are healthier than alcohol use, one person who Musk shared the chart with on vacation told the publication.

The Times spoke with over 40 people who have spent time with the richest man in the world over the past decade and a half, many under conditions of anonymity due to concerns of repercussions, as well as non-disclosure agreements that they were required to sign at the parties Musk attended.

1. COMPASS Pathways Announces Phase 3 Pivotal Program Design for COMP360 in Treatment Resistant Depression at Capital Markets Day

COMPASS Pathways plc (Nasdaq: CMPS) announced the Phase 3 pivotal program design for COMP360 psilocybin therapy in treatment resistant depression (TRD) during a virtual Capital Markets Day. COMPASS program will be the first ever Phase 3 program of psilocybin therapy globally, and follows positive results from its Phase 2b study in treatment-resistant depression,presented at the American Psychiatric Association annual meeting in May 2022.

The Phase 3 program is composed of three clinical trials, two pivotal trials and one long-term follow-up, and is expected to commence by the end of 2022. The pivotal program design is as follows:

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TDR's Top 5 Psychedelic Developments For The Week Of October 10 - The Dales Report