Category Archives: Psychedelics

Psychedelics could be the next big thing in medicine. Many companies are researching drugs that could help people with depression and other ailments through the use of ketamine, ecstasy, and psilocybin. And it's not just small companies that are exploring the sector, either. The U.S. Food and Drug Administration (FDA) approved a ketamine-based drug from healthcare giant Johnson & Johnsonin 2019.

However, many companies in the psychedelics sector are in their very early growth stages and aren't generating much (if any) revenue. For growth investors, it may seem like a tempting proposition to buy in now before the sector takes off like cannabis. Is that too big an assumption to make, or can investing in this industry really make you rich?

Image source: Getty Images.

The FDA approved ketamine as an anesthetic in 1970, and it's currently a schedule III controlled substance. However, both psilocybin (which is in "magic mushrooms") and ecstasy fall into the more rigid schedule I classification (as does marijuana), which means the government believes the risk for abuse is high and the medical benefits from the use of such substances is questionable at best. However, the cannabis industry has been growing despite marijuana's inclusion on this list, and companies are currently selling medical-use pot in more than 30 states. So heavy regulation may not be a significant obstacle for the industry, especially if individual states and cities pass legislation allowing the sale of these substances.

Oregon made headlines last year when it became the first state to legalize psilocybin. Washington, D.C., didn't go as far, but it did pass legislation to decriminalize psychedelics. California is currently considering a bill (SB 519, which an assembly committee passed in June) that could decriminalize the possession of psilocybin and ecstasy. Multiple cities, including Oakland, Calif., and Denver, have also made moves to decriminalize psychedelics.

Although the needle is moving toward legalization, investors need to be careful not to assume that psychedelics will follow the same path as marijuana -- in other words, that dozens of states will inevitably end up permitting their use. It is still a long road ahead, and the general public may need some convincing; a poll from earlier this year found that two-thirds of registered voters believe "psychedelic substances do not have medical uses."

The lack of legalization makes it important for companies to spend money on research to prove that these substances work.Compass Pathways (NASDAQ:CMPS), one of the largest public psychedelic stocks, announced last month that it had completed enrollment on a 216-patient phase 2b clinical trial of a psilocybin therapy to treat depression. Later this year, it expects to report on the findings; if they are positive, phase 3 will begin next year.

However, even a successful phase 3 trial still doesn't guarantee the FDA will approve a schedule I substance. Even after all the recent progress in marijuana legislation, there is still only one cannabis-based drug that the agency has approved, Epidiolex (made by GW Pharma, which was bought out this year by Jazz Pharmaceuticals). Simply proving that psychedelic treatments are effective could be just one piece of the puzzle; getting approval for them from the federal government is another, and that could be a long shot until they are legal. In the meantime, businesses are in difficult situations.

One of the biggest reasons to avoid psychedelic companies right now is that they are spending lots of money without any revenue coming through the doors. Compass Pathways reported a net loss of $13 million for the first three months of 2021, incurring expenses but no sales.And over the trailing 12 months, the company has used up $51 million through its day-to-day operations. Given its $180 million in cash and cash equivalents, that isn't a huge concern right now, but without revenue coming in, the prospect of dilution via further share issuance is a real one, and it poses a risk to investors.

Analysts from ResearchAndMarkets project that the psychedelic drug market could grow to a value of close to $11 billion by 2027 from about $5 billion in 2020, marking a compound annual growth rate of more than 12%. There is some great potential there -- the problem is that translating this potential into revenue will ultimately depend not just on a company bringing a successful product to market, but on federal legalization overall. That makes a psychedelic stock like Compass Pathways a riskier investment than biotech, a sector in which legalization is usually not a problem and the biggest challenge is obtaining FDA approval. That set of challenges is risky enough, and psychedelics companies face even greater obstacles.

Investing in this sector is only suitable for those with a high risk tolerance who are prepared to lose a significant amount (if not all) of their money. Remember, it was back in 1996 when California became the first state to pass legislation to permit marijuana for medical use. It has taken a long time for the cannabis industry to get to where it is today, and investors who are assuming that psychedelic drugs will follow a similar path could be waiting for a long time -- and there's no guarantee of widespread legalization.

That's why for the majority of investors, the answer is clearly yes: It is far too early to invest in this sector. While there are some promising opportunities ahead for the industry, that's all that they are right now -- opportunities. If you are looking for some safer growth stocks to invest in, there are much better options for your portfolio over the long term.

This article represents the opinion of the writer, who may disagree with the official recommendation position of a Motley Fool premium advisory service. Were motley! Questioning an investing thesis -- even one of our own -- helps us all think critically about investing and make decisions that help us become smarter, happier, and richer.

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Is It Too Early to Invest in Psychedelic Stocks? - The Motley Fool

By Pat Anson, PNN Editor

A startup pharmaceutical company has announced plans for a clinical trial to see if a psychedelic compound may be useful in treating fibromyalgia.

California-based Tryp Therapeutics is partnering with scientists at the Chronic Pain & Fatigue Research Center at University of Michigan Medical School for the Phase 2a study, which would be the first to evaluate the effictiveness of psilocybin the psychoactive compound in magic mushrooms -- in treating fibromyalgia.

"We are thrilled to collaborate with such forward-looking clinicians and scientists to develop additional treatment options for fibromyalgia," Jim Gilligan, PhD, Tryps President and Chief Science Officer said in a statement.

"The Chronic Pain & Fatigue Research Center at the University of Michigan brings incomparable experience with evaluating treatments for fibromyalgia and other chronic pain indications, and there is nothing more important to our collective team than creating therapies that will address the daily distress of these patients."

The study will evaluate the safety and efficacy of TRYP-8802, an oral formulation of synthetic psilocybin developed by Tryp. The treatment, which will also include psychotherapy, is designed to target pain through neuroplasticity, which alters and reorganizes neural networks in the brain.

Fibromyalgia is a poorly understood disorder characterized by widespread body pain, fatigue, poor sleep, anxiety and depression. Standard treatments for fibromyalgia, such as non-steroidal anti-inflammatory drugs (NSAIDs) and gabapentinoids (Lyrica, Neurontin), often prove to be ineffective or have unwelcome side effects.

"Existing treatment options for fibromyalgia are often ineffective and show significant side effects," said Daniel Clauw, MD, Director of the Chronic Pain & Fatigue Research Center.

Tryp plans to submit an Investigational New Drug application to the FDA for the Phase 2 trial in September. Phase 2 studies typically involve a few hundred people with a disease or condition, and are designed to test the safety and efficacy of a treatment. A much larger Phase 3 study is usually required before the FDA will even consider approval.

Interest in using psychedelics to treat medical conditions has been growing in recent years, primarily as a way to treat depression, anxiety and other mental health issues. Preliminary research suggests that microdoses of LSD, psilocybin and other psychedelics may also be effective in treating pain.

Another pharmaceutical startup Mind Medicine (MindMed) recently announced plans to investigate LSD as a treatment for cluster headache and an unnamed common, often debilitating, chronic pain syndrome.

Tryp Therapeutics is focused on developing psilocybin-based compounds for the treatment of diseases with unmet medical needs. The company recently announced a partnership with the University of Michigan to study synthetic psilocybin as a treatment for neuropsychiatric disorders. Tryp is also working with the University of Florida to investigate psilocybin as a treatment for eating disorders.

LSD, psilocybin and other psychedelics are classified as Schedule I controlled substances, meaning they have a high potential for abuse and currently have no accepted medical use in the United States.

Originally posted here:

Can Psychedelics Be Used to Treat Fibromyalgia? - Pain News Network

NEW YORK, July 21, 2021 /PRNewswire/ -- The early 1970s saw psychedelics and psilocybin products made illegal in the US in the war on drugs. Decades later, new research indicates the medical potential of psilocybin and psychedelics in the treatment of chronic pain and mental illness, which affect approximately 20.4% and 20.6% of the adult population respectively. As psychedelics gain more recognition, companies such as Tryp Therapeutics (CSE:TRYP) (OTCQB:TRYPF), Seelos Therapeutics (NASDAQ:SEEL), Numinus Wellness Inc. (TSXV:NUMI) (OTC:LKYSF), Mind Medicine (MindMed) (NASDAQ:MNMD) (NEO:MMED),and Mydecine Innovations Group Inc. (NEO:MYCO) (OTCPK:MYCOF)are engaging in research initiatives to develop psychedelic-assisted therapies for different mental illnesses and chronic pain conditions.

Fibromyalgia is a disease of the central nervous system that is estimated to affect as much as2% to 8% of the population. It can result in widespread pain, fatigue, memory problems, sleep disturbances, and generally reduced quality of life. The current treatment for the condition includes antidepressants, painkillers, and NSAIDs, although these interventions are often unsuccessful, resulting innearly 30% of patients turning to opioids for pain relief andless than 10% of patients adhering to approved treatments after one year.

Tryp Therapeutics (CSE:TRYP) (OTCQB:TRYPF) BREAKING NEWS: Tryp Therapeutics to Launch World's First Phase 2a Clinical Trial for Fibromyalgia Using Psychedelics - In response to the unmet medical needs in fibromyalgia patients, Tryp Therapeutics seeks to provide psilocybin-based therapies for fibromyalgia. Tryp will be collaborating with the Chronic Pain & Fatigue Research Center in the Department of Anesthesiology at the University of Michigan Medical School, a leading center in chronic pain research. The upcoming Phase 2a trial is believed to be the world's first Phase 2 trial utilizing psilocybin for a chronic pain indication.

The primary objective of the clinical trial is to evaluate the effectiveness of TRYP-8802 8802 (an oral formulation of synthetic psilocybin) and accompanying psychotherapy for the treatment of fibromyalgia. The clinical trial seeks to apply the neuroplasticity benefits of psilocybin to address the source of pain signals in fibromyalgia patients.

The results from the trial will be used in designing a larger Phase 2b clinical trial for fibromyalgia to advance the treatment toward approved use. Tryp Therapeutics intends to submit its IND application to the FDA for the Phase 2a clinical trial in Q3 2021.

"We are thrilled to collaborate with such forward-looking clinicians and scientists to develop additional treatment options for fibromyalgia,"said Jim Gilligan, Ph.D., President, and Chief Science Officer at Tryp Therapeutics. "The Chronic Pain & Fatigue Research Center at the University of Michigan brings incomparable experience with evaluating treatments for fibromyalgia and other chronic pain indications, and there is nothing more important to our collective team than creating therapies that will address the daily distress of these patients."

Earlier in July, Tryp Therapeuticsannounced another partnership with the University of Michigan to evaluate its proprietary psilocybin-based formulation, TRP-8803, as part of its Psilocybin-for-Neuropsychiatric Disorders (PFNTM) program. The series of studies is designed to expand the company's intellectual property portfolio and to prepare TRP-8803 for use in Phase 2b clinical trials.

Companies Conduct Clinical Research into Psilocybin-based Therapies

Clinical stage biopharmaceutical company Seelos Therapeutics (NASDAQ:SEEL)announced that it dosed the first patient in its Part 2 of the registrational Proof of Concept study of SLS-002 for Acute Suicidal Ideation and Behavior in patients with major depressive disorder. Seelos Therapeutics, which develops therapies for central nervous systems disorders and rare diseases aims to change the current standard of care for suicidal patients, which could potentially allow patients to be discharged sooner and treated as outpatients. According to Seelos' Chairman and CEO, the company has gained invaluable information from Part 1 of the study that helped in the design and execution of Part 2. The company intends to continue its discussions with the FDA on the regulatory pathway for SLS-002 (intranasal racemic ketamine).

Numinus Wellness Inc. (TSXV:NUMI) is focused on providing innovative, safe, and evidence-based psychedelic-assisted therapies to promote health and wellness among people. The company recently announced the clearance of its MAPS-sponsored single-arm open-label safety and feasibility study evaluating MDMA-assisted therapy for post-traumatic stress disorder (PTSD). According to the CEO of Numinus, the approval of the study could "potentially advance Canada toward a legal, regulated system for MDMA assisted therapy." After receiving the "No Objection" letter from Health Canada, Numinus is preparing the study by training staff, importing medication, and obtaining ethical approval. During the study, Numinus intends to collect data on the safety and efficacy of MDMA-assisted therapy to support making these therapies available to PTSD patients in Canada.

Meanwhile, clinical-stage biotech company MindMed (NASDAQ:MNMD) (NEO:MMED) ispartnering with Datavant, Inc. where MindMed will use Datavant's linking technology to connect its clinical trial data to external data from other clinical trials and real-world uses. With Datavant's technology, MindMed hopes to prevent data fragmentation and facilitate a deeper understanding of real-world treatment, illnesses, and paths of care. MindMed seeks to gather and relate more data about patients' access to, use, and experience with different treatment modalities over time. Through the linked data, MindMed hopes to enhance clinical trial planning, execution, and commercialization of its psychedelic-inspired therapies.

Mydecine Innovations Group Inc. (NEO:MYCO) (OTCMKTS:MYCOF)is another company seeking to develop psilocybin-assisted psychotherapy for veterans with PTSD. The company announced itsplans to launch its Phase 2a clinical trial on psilocybin-assisted therapy for PTSD in veterans with the hope to achieve safer and accurate psychedelic-assisted psychotherapy results in a supervised setting. Mydecine is waiting for the final approval of its IND before launching the clinical trial, which is scheduled for late Q3 or early Q4 2021.

Psychedelic-assisted therapies are gaining recognition as a possible treatment for mental illnesses, and chronic pain, with companies such as Tryp Therapeutics (CSE:TRYP) (OTCQB:TRYPF) advancing their research into related therapies through upcoming human clinical trials.

For more information on Tryp Therapeutics, click here.

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Psychedelics Gain More Traction as New Research Aims to Address Chronic Pain and Mental Illness - PRNewswire

The anesthesia medication ketamine is showing increased promise as a treatment for people experiencing depression who haven't found relief with other prescription medications.

Though ketamine is known for its recreational use as a party drug, it can also be prescribed legally by doctors. In recent years, ketamine has become more accessible for those struggling with depression. In 2015, there were fewer than 60 ketamine clinics in the U.S. Three years later, there were more than 300, according to the journal of Psychiatry and Clinical Neurosciences.

Generic ketamine isn't specifically approved as a depression treatment, but U.S. doctors are often allowed to prescribe Food and Drug Administration-approved medicines "off-label" for another use.

A growing body of evidence has shown ketamine, which has been used since the 1970s in the field of anesthesia, can be successful in treating depression and suicidal behaviors. In fact, ketamine is part of a growing field of research into whether drugs that have traditionally been viewed as illegal psychedelics or party drugs could, in certain contexts, help people with depression, post-traumatic stress disorder and other behavioral health and psychiatric disorders.

In 2019, the FDA approved Spravato, a ketamine-related nasal spray drug, given in conjunction with antidepressants that has been shown to help people with treatment-resistant depression. But many clinics offer generic ketamine, often in the form of intravenous infusions.

Dr. Steven Mandel, founder and president of Ketamine Clinics Los Angeles, said because ketamine is already a low-cost generic drug, it's unlikely that a pharmaceutical company would pay for the process that would be needed to get the drug approved specifically as a depression treatment.

"For a medicine like ketamine that is already approved and available, adding a new indication for the treatment of depression would probably cost tens of millions -- if not hundreds of millions -- of dollars," Mandel said. "No one wants to spend that money."

A Ketamine IV is prepared at a clinic, March 13, 2019, in Palo Alto, Calif.

But ketamine's unique status can create problems for patients. Ketamine's use for depression is off-label and it is typically not covered by health insurances. Because of this, "there are some access issues," said Dr. Panagiota Korenis, a psychiatrist and associate professor at the Albert Einstein College of Medicine.

"It's often limited to a subset of the population that can pay out of pocket or be a part of a trial," she said.

There are also certain risks associated with ketamine.

"It is a drug that can be abused potentially," said Korenis, who noted that patients typically need to be treated in the clinic and typically cannot take multiple doses of the medication home with them.

Nevertheless, Korenis is hopeful that ketamine may prove itself as another powerful option for those with depression.

"Ketamine certainly is being shown to be a medication of interest and one that has potential for the future," said Korenis.

Experts debate whether ketamine is a psychedelic and able to produce similar altered states of consciousness as MDMA and psilocybin, which have shown healing properties in some studies.

But many clinics are opting to administer ketamine in a manner similar to psychedelics in clinical trials. Ketamine-assisted psychotherapy, or KAP, is a combination of ketamine and therapy that is similar to psychedelic-assisted therapy used in recent carefully controlled clinical trials.

For example, MDMA, also known as molly or ecstasy, is a psychedelic drug that is now being studied in controlled therapy settings as a possible treatment for PTSD. But no psychedelic treatments are FDA-approved, meaning doctors cannot administer them outside of a clinical trial. MDMA is illegal for recreational use in the U.S.

For those who are unable to get into a clinical trial of psychedelics like MDMA and psilocybin, KAP may be the closest legal equivalent.

"Ketamine works for depression and suicidality -- it works quickly, it's safe," said Mandel. "For the other medicines, we just don't know. They seem to have great early promise, but we do need a lot more data and a lot more time before we can fully embrace them."

Psychedelics like MDMA and psilocybin may require a couple of more years until they receive FDA approval, according to Rick Doblin, Executive Director of the Multidisciplinary Association for Psychedelic Studies. In the meantime, Mandel hopes more patients learn about ketamine as an option for depression.

"Ketamine should be available to anyone suffering from these afflictions," said Mandel.

Nicholas Nissen, M.D., is an author, host of the "Brain Health with Dr. Nissen" podcast and a contributor for the ABC News Medical Unit.

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Doctors treating depression see promise in ketamine, a cheap drug already approved for anesthesia - ABC News

In a little over one year, the psychedelics industry has experienced exponential growth.

With more than 40 public companies and 6 listed on the Nasdaq, investors looking to bet on the psychedelic renaissance have a host of alternatives from which to choose.

In this industry. If you miss a day, you miss a year, saidSa'ad Shah, co-founder and managing partner of Noetic, a venture capital firm thatinvests in emerging and early-stage psychedelic-based wellness and pharmaceutical companies.

A rapidly-growing sector can mean great news for investors, but it can also make it difficult tonavigate within the sector, as new companies and lines of business pop up like mushrooms after a summer rain.

For Matias Serebrinsky, partner at PsyMed Ventures, virtually every trend that moved the industry a year ago has intensified.More companies, more funding, established biotech and healthcare players [are] playing a bigger role in the space.

However, as an early-stage investor who also co-hosts the Business Trippodcast,

Serebrinsky saidtheres stilla lot of innovation in the space that has notnecessarily reached retail investors.

Recent developments in the psychedelics sector may lead some to believe that the market is reaching some kind of stability.

But experienced investors say todays public companies are just the tip of the iceberg.

I think that the best companies out there are still private, they're not public, saidShah, whoseVC fund raised over $120 million in the last year alone.

Steve Hawkins, president and CEO of Horizons ETFs and manager of the first psychedelics ETF, saidmore IPOs from larger, well-funded companies are on the horizon.

There are many reasons why companies in the psychedelics space will choose to delay their IPOs. Shah encourages companies in Noetic'sportfolio to remain in the private space for as long as they can afford to.

A large part of the decision to go public versus staying private is about access to capital, Shah explained. For companies that are stirring strong, positive results with a compelling value proposition, its easy to raise private capital, so its in their best interest to delay an IPO for a more opportune time, avoiding operational costs of going public and guarding the flexibility that remaining private offers.

Today there are well over 45 publicly traded entities between the Canadian and the U.S. exchanges, Shah pointed out. When it comes to private companies, there could be well over 400 or 450 private companies, maybe even more than that.

Jeff Siegel, a managing partner at the JLS Fund and co-founder of Green Chip Stocks, said most investors are still in the dark about just how profitable this industry is going to become.

Were talking about a potential disruption of the mental health market that hasnt been seen since the 1970s. Hundreds of billions of dollars are up for grabs, and if these psychedelic molecules prove to be successful, which I believe they will, this industry, and those who invested early, are going to make a lot of money, Siegel said.

As companies in the psychedelics space move up their clinical research pipelines, the most anticipated inflection point will come with the regulatory approval of psychedelics currently under research,Horizons Hawkins noted.

But while the industry waits for MDMA to become the first psychedelic to receive approval sometime in late 2022 or early 2023, could the slow pace of the drug development process usher in a loss of excitement for the sector?

Hawkins saidhe believes well see a number of milestones that will propel positive market trends. Headvises investors not to write-off opportunities because of a loss of novelty.

Whether in the form of more major IPOs, drug stage advancements and approvals, NYSE and Nasdaq cross-listings, positive earningsand increased investor interest, new events can lead to short-term lifts and long-term growth.

One thing to consider is that not all of these companies will have to make it through Phase III clinical trials to be successful,JLS Jeff Siegelsaid.

If the IP is strong and earlier trial data is promising, a company could easily be acquired for a very nice premium. It happens all the time in the biotech space, and really, this is how investors should look at the psychedelics space, anyway. More of a biotech play than anything else, he added.

As far asSiegel is concerned, the psychedelics space is still far frommarket stabilization.

For one, a number of the early, pre-IPO shareholders in this space are still in a lock-up period, so we dont yet know if theres going to be massive dumps of cheap shares when those lock-ups expire, or if those pre-IPO investors are going to stick it out over the long-term.

That uncertainty feeds into instability, which for Siegel means that in the foreseeable future we will likely see far more traders than long-term investors.

Shah agreed.At some point, we may see a shoe drop," saidNoetics Shah.We may see the market take a big correction. It may be led by one or two stocks in the industry that perhaps are not able to continue to really show efficacy or perhaps run into some issues.

However, Shah noted that such an event could benefit the market as it will separate the wheat from the chaff.

Companies with the strongest cash positions will be the ones best fit to endure a dry spell in the market. However, in Shahs view, the biggest thing that will allow companies to continue to raise capital in the private markets is the quality of the science being done and the consistency of the management team.

PsyMeds Serebrinsky encourages investors to go back to the basics.Is there strong data to back a companys claims? Is the founding team experienced and capable of taking these medicines through clinical trials? Do they have a realistic plan and the means to secure funds to make it happen?

JLS Siegel highlights good management, significant cash reserves and strong IP as the winning formula.

Management is the most important. Were seeing a lot of people come into the space who dont know the first thing about psychedelics or what it takes to get any kind of medicine or treatment through FDA trials. Theyre good at raising money, but thats about it. And those are the companies that will make management a lot of money but offer no value to shareholders or the industry, Siegel said.

Different Ball Game From Cannabis

As opposed to cannabis, which is a retail play, psychedelics are a biotech play and a pharma play. It's about clinical trials and new chemical entities, explainedShah, who added thatinvestors need to be very, very careful, becausepsychedelics are a case of buyer beware.

This is an industry that requires domain expertise. And so you either get that advice from outside or you do your own homework and just make sure you understand the space really well. Its a knowledge-based industry, Shah concluded.

Benzinga Photo.

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Will Psychedelics Continue To Grow In 2021? Fund Managers Share Insights And Strategies As More Companies - Benzinga

Cybin Inc. (NEO: CYBN) (OTCQB:CLXPF), a biotech company in the psychedelics space, announced on Thursday a conditional approval to liston the New York Stock Exchange.

A tier 1 listing in the U.S. can open up avenues to new and potential institutional buying, increased retail buying, and help increase the overall visibility of the company, Cybin CEO Doug Drysdale told Benzinga.

The companys over-the-counter shares will uplist into the NYSE Americans Small Cap Equity Market. Cybin shares listed on Canadas NEO Exchange willremain listed there. The Company has reserved the ticker CYBN for the NYSE.

Drysdale said the company expects expanded access to investors to further fuel our mission to develop revolutionary psychedelic therapeutics for patients suffering from mental health conditions."

Approval remains conditional and is still subject to final NYSE approval and the satisfaction of regulatory requirements.

While several psychedelics companies have already listed their stock on the Nasdaq, Cybin will be the first in the sector on the NYSE.

With a market cap of $473 million, Cybin has positioned itself as one of the best-equipped players in the psychedelics space. The companys multiple programs include Phase IItrials for a sublingual formulation of psilocybin in the treatment of major depressive disorder. Psilocybin isthe active ingredient in so-called magic mushrooms.

The company is also carrying out preclinical work on three other novel psychedelic molecules, which could offer increased therapeutic potential for indications such as alcohol use disorder and anxiety.

In a recent report, Stifel gave Cybin a 12-month price target of $12,with a speculative buy rating.

Cybin Stock was $2.98 at the time of this writing.

Photo by Cara Willenbrock on Unsplash

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Cybin Lands Conditional Approval To Become The First Psychedelics Company on The NYSE - Markets Insider

Microdose Psychedelic Insights (Microdose) are set to host their virtual Pyschedelic Capital: July 2021 conference on July 29, 2021. The event is set to play host to a number of companies, drawn from across the psychedelics industry, including, but not limited to, the functional mushrooms and phytopharmaceutical sectors.

Microdose Psychedelic Insights, a cutting-edge media company focused around promoting content, financial analysis, and engaging events focused around the psychedelics industry, have gained renown for their&

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Additional information about the Psychedelic Capital: July 2021 conference, as well as details for registration, can be found on the Psychedelic Capital conference website at https://microdose.buzz/shop/events/psychedelic-capital/psychedelic-capital-jul-2021/

About Microdose Psychedelic Insights:

Microdose Psychedelic Insightsis your guide to the psychedelic medicine industry. With a vision to shift the worlds 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.

About Psychedelic Capital:

This online event programming is dedicated to providing investment grade information for the nascent psychedelic sector and presents a curated group of CEOs, financial experts, thought leaders and investment luminaries from around the globe. Presentations are 30 minutes in length, with 10 minutes always allocated to a one-on-one Q&A session with the audience. Psychedelic Capital features the top companies, latest IPOs, newest opportunities and deepest insights into the emerging psychedelic space.

Contact:Microdose Psychedelic Insightskristina@microdose.buzz

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Microdose Psychedelic Insight's Psychedelic Capital: July 2021 conference to take place on July 29, 2021 - StreetInsider.com

The beefy armed guard at the door of the Church of Entheogenic Plants chuckled at the sight of me, and I guessed what he might be thinking: Whats that 60-something lady doing here?

It wouldnt have been unreasonable to wonderand not just because everyone else waiting to pass through the metal detector that day last winter was roughly 40 years younger than I. Vice News has called the Oakland, CA, church, also known as Zide Door, Americas most prominent magic mushroom club, implying that its religious decor is a ruse to evade state and federal laws against selling psychedelic drugs. In accepting contributions for strains of shrooms with names like Blue Meanies and Penis Envy, Zide Door claims the same exemption that lets the Navajo legally ingest peyote, a traditional sacrament.

Ruse or not, that hasnt offered much protection. In August 2020 police raided the premises and seized about $200,000 worth of cash and drugs. Pastor David Hodges told me he planned to sue the city government for violating his congregants religious freedom.

Potentially breaking the law was not my only concern when it came to trying magic mushrooms. I was an unusually suggestible child in the 1960s, when well-meaning parents scared their kids straight with stories about acid trippers who went blind from staring at the sun, mistook a baby for a turkey and stuffed it in the oven, or woke up convinced theyd turned into a glass of orange juice. In the late 1970s, when many of my college pals were experimenting, I declined even to smoke weed.

But last February, I was standing in front of the church out of desperation, hoping that psilocybin, the active ingredient in mushrooms, would relieve my excruciating pain. I was in my 12th week of a siege of cluster headaches, and I felt as if a Lilliputian with a tiny ice pick were jabbing at the back of my right eye for an hour each day, starting at 5 a.m.

Cluster headache is a rare disorder, estimated to affect roughly one or two in 1,000 people (migraines are at least 120 times as common). Theyd plagued me for a month or so every two years since 2005, and usually prednisone knocked them out. But this time the only thing that brought even brief respite wasno jokesnorting cayenne pepper, which made me sneeze until I felt as if I might pass out. I also worried that it might be corroding the inside of my nose.

Im far from the only person seeking out these long-demonized drugs for medical reasons. Using LSD, psilocybin, and MDMA (Ecstasy) to relieve suffering appears to be on the rise. While most self-experimenters use psychedelics to enhance well-being, a portion self-medicate preexisting mental health conditions, wrote psychiatrist Adam Winstock, M.D., in the Global Drug Survey. His annual polls of more than 500,000 people suggest that the use of LSD and psilocybin among respondents has roughly doubled over just the past five years. An honorary clinical professor at the Institute of Epidemiology at the University College of London, Dr. Winstock joins other experts in comparing the drugs favorably with prescription antidepressants. The benefits are really clear for patients, he says. They want things that work, work quickly, and dont require them to take medications every day.

If youve ever had cluster headaches, you know why theyve been called suicide headaches.

Americans interest in hallucinogens was supercharged by Michael Pollans 2018 best seller, How to Change Your Mind. A year later, Johns Hopkins launched a $17 million center to study a variety of illicit-drug therapies that showed promise in treating disorders such as depression, trauma, anorexia nervosa, tobacco addiction, and even post-treatment Lyme disease. Researchers are excited, even as psilocybin and LSD continue to be classified as Schedule I substances, which are seen as having no medical use, a high potential for abuse, and unacceptable risks even under professional supervision.

But if youve ever had cluster headaches, you know why theyve been called suicide headaches. People in the midst of an attack are believed to die by suicide at roughly three times the rate of the general population, and sufferers describe the attacks as more painful than childbirth, gunshot wounds, and kidney stones, according to University of West Georgia psychology professor Larry Schor, Ph.D., who has conducted a large survey of cluster-headache patients (and suffers from them himself). On average, cluster-headache patients take more than five years to be properly diagnosed, after which even prescribed drugs may fail. Early on, I tried taking sumatriptan, a drug for migraine headaches, and at first it was helpful, but then made my headaches worse, sending me to an emergency room three times. As this latest attack stretched on, I knew I had to try something new.

Researchers first investigated the potential therapeutic benefits of psychedelic drugs in the 1950s and 1960s, when hundreds of Americans, including actors Cary Grant, Rita Moreno, and Jack Nicholson, joined a series of supervised experiments in California. (Grant credited acid with helping him control his alcohol use and cope with the long-unexplained disappearance of his mother when he was a child.) The backlash began after Harvard lecturer Timothy Leary and psychologist Richard Alpert (who became known as Ram Dass) championed wider use of LSD and psilocybin, with Learys call to turn on, tune in, drop out becoming a slogan of the counterculture. President Richard Nixon branded Leary the most dangerous man in America and in 1971 launched the war on drugs.

These days, the hope is that psychedelics may help the many millions of Americans who suffer from depression and other serious mental disorders, particularly when nothing else has worked. The National Institute of Mental Health estimates that 17.3 million U.S. adults have at least one major depressive episode each year, while up to 30% dont receive sufficient help from mainstream anti-depressants. PTSD affects nearly 8 million people, including more than half a million U.S. veterans, while 40 million adults have anxiety. (Some of these rates were higher during the pandemic.) Researchers have been studying psychedelics to alleviate cluster headaches since 2006, but I learned of them through an activist patients group called Clusterbusters, which has touted their use since 2002.

Amid all the hoopla, some people may get a boost from just the idea of psychedelics: More than 60% of participants in a 2020 study said theyd experienced mind-altering effects after taking a placebo. Still, researchers have gathered sufficient evidence of psilocybins power to convince the FDA in 2019 to classify it as a breakthrough therapy for two types of severe depression. That fast-tracked it for approval, similarly to how esketamine (related to ketamine, an illegal party drug) was OKd for treatment-resistant depression that same year.

The treatment of PTSD may be the next potential boon: Some scientists have found MDMA both safer and more effective in treating trauma than conventional antidepressants. In May, a major study published in Nature Medicine provided new evidence along these lines, and late last year Rick Doblin, executive director of the nonprofit Multidisciplinary Association for Psychedelic Studies (MAPS), predicted that MDMA-assisted psycho-therapy for PTSD could win federal approval as soon as next year.

Its not clear just how psychedelics might supply mental and emotional benefitsor, in my case, relieve physical painbut scientists have some ideas. Studies suggest that psilocybin and other psychedelic drugs affect levels of serotonin, a neurotransmitter and hormone involved in regulating mood. MDMA is believed to activate receptors for oxytocin, a peptide linked to trust and bonding, possibly helping soften trauma sufferers defensive shells. So far the explosion of discoveries has involved small studies that need to be expanded and replicated. Yet the drumbeat of positive developments has likely helped increase official tolerance in some parts of the nation.

Many jurisdictions are considering rewriting their laws on psychedelics. In May 2019, Denver became the first U.S. city to decriminalize psilocybin mushrooms, and Oakland, CA, followed suit. Voters in Oregon and Washington, DC, have approved the therapeutic use of psilocybin, while California lawmakers recently took up a bill to decriminalize some hallucinogens. The trend is familiar: Whereas barely 20 years ago cannabis was outlawed everywhere in the United States, today 36 states and four territories have legalized it for medicinal purposes. (Decriminalization doesnt make a drug legal. It simply reduces penalties associated with it. Selling psychedelics is still illegal everywhere, and possession of them can lead to federal prosecution that could result in up to a year in prison and $1,000 or more in fines.)

Of course, breaking the law isnt the only risk involved. Some recreational magic mushroom users have reported frightening bad trips, panic attacks, seizures, and hospitalizations. Scientists and drug aficionados alike warn against casual use, and participants in psychedelic studies to date have all been carefully screened and supervised, with researchers rigorously excluding subjects with preexisting conditions such as heart trouble, schizophrenia, and bipolar disorder. I really worry about people in a time of crisis choosing to take psychedelics without supervision and making themselves worse, says Dr. Winstock, whose surveys indicate that approximately 8% of LSD and psilocybin users had a bad experience over the past year.

Still, in reporting a story for the Washington Post, I learned that many scientists regard psilocybin as one of the least toxic and addictive of all recreational drugs, and that the reports of bad trips involved much larger doses than the therapeutic amount for my cluster headaches. In severe pain, I decided to give it a try.

Psilocybins chemical structure is similar to melatonins, says Yale University neurologist Emanuelle Schindler, M.D., Ph.D., referring to a hormone that regulates circadian rhythm and is taken supplementally for insomnia as well as headache prevention. It is also akin to triptans, which are prescribed to treat one headache at a time. Psilocybin has a longer-term effect, though, notes Dr. Schindler, who is currently working on a study on its effects for cluster headaches.

Over the years, Clusterbusters members have offered invaluable support to Dr. Schindler and other scientists, recruiting patients for their studies and providing them with information from their self-treatment with psychedelics. In 2004, the group convinced Harvard researchers to conduct a pioneering study on psilocybin and LSD. The Harvard team gathered testimonies from 53 cluster-headache patients, most of whom said the drugs had helped. John Halpern, M.D., a psychiatrist who led the Harvard study, told me he has since seen many patients go from being incapacitated to having as close to a functional cure as you can get. The two drugs may prove to be the best we have to offer to cluster-headache patients, he adds, although legally we cant offer them.

The only psychedelic-ish effect that I noticed was that my dogs face was utterly gorgeous.

I followed Clusterbusters recommended protocol of taking small amounts of psilocybinmore than microdoses, but short of what would lead to trippingbrewed in a multi-ingredient tea containing lemon, honey, vitamin C, and a little instant coffee, with three doses spaced five days apart. The first time I didnt feel anything remarkable until the next morning, when I had a more-awful-than-usual headache: the slap-back side effect the website had warned me to expect. Over the next five days, however, I noticed that there were two days when I didnt have a headache at all.

Maybe a little overconfident, I overestimated with my second dose. Twenty minutes after sipping the tea, I found myself staring for half an hour at our backyard pistache tree, which seemed to have grown beckoning silvery branches. I felt as if I could see the tree breathing, which was wondrous. I was back to myself within a couple of hours, and the next morning I had another slap-back headache. But the two mornings after thatnothing. For the rest of the week, the headaches were milder.

Then I took my third dose, measuring carefully this time. The only psychedelic-ish effect that I noticedreally noticedwas that my dogs face was utterly gorgeous. Then I fell asleep next to my husband. I woke up to yet another fierce headache the next morning, but the morning after that I had zero pain. Zero again the next day, and the next. Two months have now passed without my having a single headache.

As the psychedelic-therapy revolution matures, there have been calls to ensure that its potentially powerful benefits are accessible to all. That will require some significant change considering that Black people are much more likely than white people like me to be arrested for possession of any drug, even after decriminalization.

Equity of access to these drugs will address the burden of disease we know is greatest among people of lower socio-economic status, who have higher rates of depression and PTSD, says Dr. Winstock. MAPS has trained scores of therapists of color to prepare for the time when treatment with them becomes legal.

In the meantime, research continues. It doesnt strike me as weird that the same molecule used by someone in a bedroom listening to Pink Floyd can also be a healing drug, says Dr. Winstock. He says that psychedelics capacity to disrupt existing brain networks and allow new pathways and new ways of thinking is why they can have wide potential in so many different conditions.

As for me, I cant say whether my cluster-headache siege ended on its own or whether using shrooms really did do the trick. But I do know that Ive got a plan if the headaches returnand that Ill never look at our pistache tree the same way again.

This article originally appeared in the August 2021 issue of Prevention.

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'I Tried Psychedelics to Treat My Debilitating Cluster Headaches' - Prevention.com

A second California Assembly committee on Tuesday approved a Senate-passed bill to legalize possession of psychedelics like psilocybin and and LSD. But new amendments that add limits on allowable amounts of the substances is creating controversy among advocates.

The Assembly Public Health Committee advanced the legislation, sponsored by Sen. Scott Wiener (D), in a 8-4 vote. This comes weeks after the Public Safety Committee approved the measure.

Wiener has spent significant energy building support for the reform proposal as it has moved through the full Senate and now two Assembly committees, including by holding a recent rally with military veterans, law enforcement and health officials.

SB 519 would remove criminal penalties for possessing numerous psychedelicsincluding psilocybin mushrooms, DMT, ibogaine, LSD and MDMAfor adults 21 and older.

Our racist and failed war on drugs and war on drug policy approach has done nothing to make us safer, Assemblymember Buffy Wicks (D), who presented the bill on behalf of Weiner, said ahead of the vote. But its led to massive public expenditures, torn apart communities, deeply impacted brown and black communities and did nothing to make drug use safer or reduce overdoses. Indeed, the opposite is true.

Its time we stopped this failed mass incarceration strategy and acknowledge that not all substances are harmful or dangerous, she said. In fact, quite the opposite has been found of psychedelics.

Now, as a result of changes approved by the latest panel, the bill includes language laying out the limits for what is an allowable personal possession amount for each substance. Thats led Decriminalize Nature (DN), a group thats worked to enact psychedelics reform across the country, to call for the tabling of the legislation.

Setting allowable amounts is just a creative way to say when can law enforcement arrest you, DN argued.

In a letter about its boards recent decision to switch from a supportive position on the legislation to neutral, DN listed several reasons not to include the possession limits provision. Beyond enabling law enforcement to penalize people possessing certain amounts of entheogenic substances, it also said the measure has sacred value for communities whove used them for centuries and local decriminalization initiatives without possession limits have had no negative impacts.

But other advocates say they are taking a practical position on the revision, accepting the possession limits in the interest of advancing the reform through a legislature that may otherwise defeat the bill if it contained no such restrictions.

David Bronner, CEO of the soap company Dr. Bronners who has contributed considerable financial resources to reform efforts across the country, is one such advocate.

As always, do we let the perfect be the enemy of the good? he said in an email. Senator Wiener is doing an amazing job for us, and we are able to preserve the essential goal that people can heal in ceremony together, and legally produce and consume quantities of the medicine adequate for community-based healing. And theres nothing stopping local city level efforts that have no limiting language whatsoever.

Bronner said that stakeholders discussed the changes extensively, and Decriminalize Nature had full chance to input and review, and we all would have been beyond psyched if their eloquent defense of not having any limits whatsoever could convince the Health Committee chair, but it was unlikely and it hasnt.

As passed in committee on Tuesday, these are the prescribed limits for personal possession that would be legalized:

-2 grams of DMT

-15 grams of ibogaine

-0.01 grams of LSD

-4 grams of mescaline

-2 grams of the controlled substance psilocybin or 4 ounces of a plant or fungi containing the controlled substance psilocybin.

-2 grams of the controlled substance psilocyn or 4 ounces of a plant or fungi containing the controlled substance of psilocyn

-4 grams of MDMA.

It should be noted that while personal possession limits would be imposed under the revision, facilitators could have aggregate amounts for group use, meaning they could possess the allowable amount for each individual involved in a ceremony. And when it comes to personal cultivation, there would not be any limits.

SB 519 still represents protection of community-based healing and the quantities of medicine involved, which is the crucial goal, Bronner said.

Responding to accusations from DN that the possession limits are part of a plot to help deep-pocketed investors corner the market for psychedelics, Bronner said there are no backroom deals going on and that DN has been fully looped real time as weve been navigating this.

While social sharing would have been allowed under the bill as introduced, those provisions were also reframed in the new committee amendment to provide for facilitated or support use so that people could provide the substances to one another in a group context.

The new amendment adopted on Tuesday also requires the state Department of Public Health to develop harm reduction education for the substances.

In the prior Assembly panel, Wiener supported a committee amendment that removed ketamine from the list of psychedelics included in the reform. Thats in addition to a series of technical revisions that were made to the legislation.

The fullSenate approved the bill last month. It now heads to the Assembly Appropriations Committee as its final stop before potentially heading to the floor of that chamber. If approved there, it will have to go back to the Senate for concurrence on recent changes before it can be sent to the governors desk

Wiener has described its prospects going forward as very challenging, but he made the case at a recent press event that it is a necessary policy change to advance mental health reform and end criminalization.

Under the measure, the state Department of Public Health would be required to establish a working group to study and make recommendations regarding possible regulatory systems that California could adopt to promote safe and equitable access to certain substances in permitted legal contexts. Those recommendations would be due by January 1, 2024.

For psilocybin specifically, the legislation would repeal provisions in California statute that prohibit the cultivation or transportation of any spores or mycelium capable of producing mushrooms or other material that contain the psychoactive ingredient.

Thebilloriginally included record sealing and resentencing provisions for people previously convicted of psychedelics possession offenses, but that language was removed in its last committee stop prior to the Senate floor vote as part of an amendment from the sponsor.

Marijuana Moment is already tracking more than 1,100 cannabis, psychedelics and drug policy bills in state legislatures and Congress this year. Patreon supporters pledging at least $25/month get access to our interactive maps, charts and hearing calendar so they dont miss any developments.Learn more about our marijuana bill tracker and become a supporter on Patreon to get access.

Wiener said the reasoning behind that deletion was that the policy ended up generating a huge price tag based on a fiscal analysis, but it could be addressed in separate legislation if the main bill passes.

Speaking at an event hosted by the Psychedelic and Entheogen Academic Council (PEAC) last month, the senator said advancing the legislation would be first step toward decriminalizing all currently illicit drugs.He reiterated that point on Monday, stating that this bill is one step in the direction of ending the failed war on drugs.

While the bill is being described by lawmakers and advocates as simple decriminalization, the official legislative analysis of the proposal states that it would make lawful the personal possession of these substances.

If the bill does ultimately clear the Assembly, it still remains unclear whether Gov. Gavin Newsom (D) would sign itthough the governor has long been an outspoken critic of the war on drugs.

Wiener backed the prior ketamine-related amendment in an effort to build support for the legislation.

There are disagreements within the psychedelic world on it, the senator said at a meeting with activists last month. My view as you keep things in until you have to make a give, and thats one that we could potentially give on. You dont want to spontaneously give on things without getting some ability to move the bill forward as a result.

Mescaline, a psychoactive compound derived from peyote and other cacti, is another controversial psychedelic.

It was specifically excluded from the bills reform provisions in peyote-derived form, but the possession of the compound would be allowed if it comes from other plants such as the Bolivian Torch Cactus, San Pedro Cactus, or Peruvian Torch Cactus.

That decision on the peyote exclusion was informed by native groups who havestrongly pushed back against decriminalizing the cactifor conservationist reasons and because of its sacred value for their communities.

Meanwhile, a group of California activists announced plans earlier this year to put aninitiative to legalize the use and retail sale of psilocybinon the states 2022 ballot. That group, Decriminalize California, said that it would first work to convince lawmakers to pursue reform and then take the issue directly to the people if the legislature fails to act.

The psychedelics effort in the California legislature, whichWiener first previewed back in November, comes as activists are stepping up the push to enact psychedelics reform locally in cities in the state and across the country. The bill notes those efforts in an explanation of the proposal.

The Northampton, Massachusetts City Councilpassed a resolutionin Aprilto deprioritize enforcement of laws against the possession, use and distribution of a wide range of psychedelics such as psilocybin and ayahuasca. Its the third city in the state to advance the policy change, followingSomervilleandCambridge.

These are some of the latest iterations of a national psychedelics reform movement thats spread rapidly sinceDenver became the first city to decriminalize psilocybin mushroomsin 2019.

Besides the cities in Massachusetts, four othersOakland,Santa Cruz,Ann ArborandWashington, D.C.have also decriminalized possession of plant-and fungi-based psychedelics.

In Oregon, Novembers election saw the passage of a historic initiatives tolegalize psilocybin mushrooms for therapeutic purposesand more broadlydecriminalize possession of all drugs.

The governor of Connecticut signed legislation recently that includes language requiring the state to carry out a study into the therapeutic potential of psilocybin mushrooms.

Texas also recently enacted a bill to require the statestudy the medical benefits of psychedelics for military veterans.

A New York lawmaker introduced a bill last month that would require the state to establish an institute to similarly research the medical value of psychedelics.

In Oakland, the first city where a city council voted to broadly deprioritize criminalization of entheogenic substances, lawmakersapproved a follow-up resolutionin December that calls for the policy change to be adopted statewide and for local jurisdictions to be allowed to permit healing ceremonies where people could use psychedelics.

After Ann Arbor legislators passed a decriminalization resolution last year, a county prosecutor recently announcedthat his office will not be pursuing chargesover possessing entheogenic plants and fungiregardless of the amount at issue.

The Aspen, Colorado City Councildiscussed the therapeutic potential of psychedelics like psilocybin and proposals to decriminalize such substances at a meeting in May. But members said, as it stands, enacting a reform would be more better handled at the state level while entheogens remain strictly federally controlled.

Seattle lawmakers also recently sent a letter to members of a local task force focused on the opioid overdose epidemic, imploring the group toinvestigate the therapeutic potential of psychedelicslike ayahuasca and ibogaine in curbing addiction.

Biden Selects White House Drug Czar Who Helped Implement State Marijuana Program And Touted Medical Benefits

Photo courtesy of Wikimedia/Workman.

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California Bill To Legalize Psychedelics Possession Advances Again, With New Amendments That Add Limits - Marijuana Moment

Diti Kohli| Tampa Bay Times (TNS)

Researchers think psychedelic drugs might do more than get you high

Researchers are looking into psychedelics as possible treatments for depression, anxiety and even PTSD.Video provided by Newsy

Newslook

A Tampa, Floria, biotech startup studying whether magic mushrooms could treat illnesses has received $2.5 million from investors led by a Florida venture capital firm.

Psilera Bioscience researches whether there are healing properties in psychedelics, which trigger hallucinations and intensified feelings. Some scientists believe its ingredients DMT, psilocybin and psilocin may alleviate conditions that plague millions of Americans.

Think mental illness, addiction and even Alzheimer's disease.

"Current treatments for those illnesses aren't very effective," co-founder and CEO Chris Witowski said. "Psychedelics haven't been explored as an option since the 1970s. We now have the tools to see how the drugs function in the brain, and analyze if they're actually working."

The unconventional research caught the eye of Iter Investments, an 11-month-old Fort Lauderdale venture capital firm.

Managing partner Dustin Robinson said its portfolio boasts seven psychedelics-focused companies. Most operate outside U.S. borders, but Psilera is uniquely near home.

"I see them as a leading company in the psychedelics ecosystem, right in our neighborhood," Robinson said. "It was an amazing opportunity to operate within Florida."

Baird Inc., JLS Fund, Receptor, What If Ventures, and Psilera founders and board members also contributed to the investment.

Previous coverage: Oregon spearheading drug decriminalization: Here's what you need to know

They are placing a bet on Psilera's "research and development" efforts, Witowski said.

That includes creating analogs, slightly altered psychoactive compounds the startup formulates to see if they can treat nervous system disorders.

Since its inception in 2019, Psilera has also worked with computational chemistry a mixture of computer models and functional MRIs to simulate how those compounds prompt molecular changes.

Its focus has now shifted to developing delivery systems for getting the psychoactive compounds into patients, with five full-time employees and a gaggle of interns dedicated to the task.

The team is in the midst of formulating a nasal gel that would eliminate the use of needles, which have a negative association with drug abuse. It's probably wise, Witowski said, to remove sharp objects during treatment.

"Who wants a needle in their arm when they're hallucinating?" he said.

Transdermal patches also show promise.

Drugs would flow through the skin and to the brain gradually in low doses. The slow process could subdue the psychedelic effects, allowing patients to shorten or forgo experiencing a "trip," or an hours-long sensory episode.

Good trips elicit euphoria and a sense of connection to others. But bad trips can cause mental confusion, anxiety and psychotic episodes that cause people to see bizarre images or experience severe paranoia.

The patch will be tested on around 100 healthy people early next year in a Phase 1B trial, in order to gauge its safety and side effects.

When administered medically, psychedelics can alter how people think and potentially dissipate effects from neurological disorders.

How? "We can't pinpoint it exactly," Witowski said.

But the theory is based upon erasing and re-paving connections between nerve cells, called neural pathways.

The pathways in a patient with a neurological disorder reinforce one pattern of thought. A depressed person, for example, cycles through the same negative ideas about their life. Perhaps they suffer from prolonged loneliness or work stress. Those feelings dwell inside them, day after day.

"It's like if you're out on a sled," Witowksi said. "You slide down one day and then follow that same path because it's already laid. It's just easier because you don't have to go through fresh snow."

Drugs, like DMT or dimethyltryptamine, may simulate a storm. The substance brings on hallucinations and out-of-body experiences.

"Psychedelics lay down a fresh layer of snow," he said. "Now you don't have the same trodden path. It disrupts that introspective voice you have, and this creates an opportunity for clinicians."

Federal level: House votes to decriminalize marijuana at federal level, supported by Oregon Rep. Blumenauer

Psilera researchers believe that, combined with talk therapy, positive and forward-thinking thought patterns can then blossom. This change could potentially relieve triggers and trauma.

It's too early to say which disorder will respond best to psychedelic therapy and to what specific substances, Witowski said.

Other companies are implementing psychedelics to treat traumatic brain injury or to improve emotional well-being. Multiple clinical trials exploring therapeutic uses of psilocybin are underway with approval from the Food and Drug Administration.

And Witowski said a Phase 3 clinical trial into MDMA, commonly known as ecstasy, revealed its possible effect on Post-Traumatic Stress Disorder patients. It could aid those with common PTSD symptoms such as nightmares or unwanted memories of the trauma, the May 2021 study found.

The federal government labels psychedelics as Schedule 1 drugs, meaning they may not be prescribed or used clinically. Like heroin, peyote and LSD, the drugs have a high potential for abuse and no approved medical application, the government says.

Those restrictions have limited research into the substances.

A stain also fell over psychedelics in the 1970s, when recreational use overshadowed its medicinal potential. Thanks to strides in cannabis research and legalization at the state level, "the stigma has been lifted," Witowski said.

The Drug Enforcement Administration has granted a handful of universities permission to research psychedelics.

The University of South Florida is one of them, and Psilera is an early beneficiary.

The company operates as a member of USF Connect's incubator program, which permits nearly 70 startups to take advantage of its research equipment, students and faculty. Its co-founders Witowski and Jackie von Salm completed their doctoral degrees in natural products chemistry from USF.

The university earned DEA approval in February.

"That was a great development for the company," said Michael Bloom, USF vice president for corporate partnerships and innovation. "But it was also great for the university and for the biotech sector in Tampa Bay."

He said Psilera's "work goes beyond a scientific challenge to truly addressing devastating diseases that touch nearly every family in some way." That includes Witowski's.

In the past two decades, his brother cycled through almost every available anti-depressant. His grandmother died after 15 years of battling Alzheimer's.

The majority of Americans know someone who faces similar burdens. One in five people in the U.S. experience mental illness, according to the National Alliance on Mental Illness. The number of substance abuse and Alzheimer's patients is in the millions.

To Witowski, the research offers a path to explore medicinal possibilities for ailments that have proven hard and even impossible to solve.

He partially thanks the pandemic for the recent progress.

"The COVID-19 pandemic almost caused a mental health pandemic concurrently," he said. "In a lot of ways, that could be a catalyst for people to see these drugs more favorably, to see their potential."

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Florida startup treating illness with magic mushrooms receives $2.5 million - The Register-Guard