California Senator Says Bill To Legalize Psychedelics Possession Has ’50/50′ Chance To Pass This Year

A top federal drug official says the “train has left the station” on psychedelics.

National Institute on Drug Abuse (NIDA) Director Nora Volkow said people are going to keep using substances such as psilocybin—especially as the reform movement expands and there’s increased attention being drawn to the potential therapeutic benefits—and so researchers and regulators will need to keep up.

The comments came at a psychedelics workshop Volkow’s agency cohosted with the National Institute of Mental Health (NIMH) last week.

The NIDA official said that, to an extent, it’s been overwhelming to address new drug trends in the psychedelics space. But at the same time, she sees “an incredible opportunity to also modify the way that we are doing things.”

“What is it that the [National Institutes of Health] can do to help accelerate research in this field so that we can truly understand what are the potentials, and ultimately the application, of interventions that are bought based on psychedelic drugs?” Volkow said.

The director separately told Marijuana Moment on Friday in an emailed statement that part of the challenge for the agency and researchers is the fact that psychedelics are strictly prohibited as Schedule I drugs under the federal Controlled Substances Act.

“Researchers must obtain a Schedule I registration which, unlike obtaining registrations for Schedule II substances (which include fentanyl, methamphetamine, and cocaine), is administratively challenging and time consuming,” she said. “This process may deter some scientists from conducting research on Schedule I drugs.”

“In response to concerns from researchers, NIDA is involved in interagency discussions to facilitate research on Schedule I substances,” Volkow said, adding that the agency is “pleased” the Drug Enforcement Administration recently announced plans to significantly increase the quota of certain psychedelic drugs to be produced for use in research.

“It will also be important to streamline the process of obtaining Schedule I registrations to further the science on these substances, including examining their therapeutic potential,” she said.

At Thursday’s event, the official talked about how recent, federally funded surveys showed that fewer college-aged adults are drinking alcohol and are instead opting for psychedelics and marijuana. She discussed the findings in an earlier interview with Marijuana Moment as well.

“Let’s learn from history,” she said. “Let’s see what we have learned from the marijuana experience.”

While studies have found that marijuana use among young people has generally remained stable or decreased amid the legalization movement, there has been an increase in cannabis consumption among adults, she said. And “this is likely to happen [with psychedelics] as more and more attention is placed on these psychedelic drugs.”

“I think, to a certain extent, with all the attention that the psychedelic drugs have attracted, the train has left the station and that people are going to start to use it,” Volkow said. “People are going to start to use it whether [the Food and Drug Administration] approves or not.

There are numerous states and localities where psychedelics reform is being explored and pursued both legislatively and through ballot initiative processes.

On Wednesday—during the first part of the two-day federal event that saw nearly 4,000 registrants across 21 time zones—NIMH Director Joshua Gordon stressed that his agency has “been supporting research on psychedelics for some time.”

“We can think of NIMH’s interests in studying psychedelics both in terms of proving that they work and also in terms of demonstrating the mechanism by which they work,” he said. “NIMH has a range of different funding opportunity announcements and other expressions that are priorities aimed at a mechanistic focus and mechanistic approach to drug development.”

Meanwhile, Volkow also made connections between psychedelics and the federal response to the coronavirus pandemic. She said, for example, that survey data showing increased use of psychedelics “may be a way that people are using to try to escape” the situation.

But she also drew a metaphor, saying that just as how the pandemic “forced” federal health officials to accelerate the development and approval of COVID-19 vaccines because of the “urgency of the situation,” one could argue that “actually there is an urgency to bring treatments [such as emerging psychedelic medicines] for people that are suffering from severe mental illness which can be devastating.”

But as Volkow has pointed out, the Schedule I classification of these substances under federal law inhibits such research and development.

The official has also repeatedly highlighted and criticized the racial disparities in drug criminalization enforcement overall.

Delaware Lawmakers File New Marijuana Legalization Bill With Key Equity Revisions

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Inside PsyMed Ventures’ New $25M Fund For Psychedelics And Mental Health Startups

It started as a shared interest in the science around mental health, psychedelics and a podcast featuring like-minded people, and culminated into a venture firm focused on advancing new approaches to mental health treatments. 

San Francisco-based PsyMed Ventures, founded by Dina Burkitbayeva, Greg Kubin and Matias Serebrinsky in 2020, on Friday announced its new $25 million investment fund. The money will go to early-stage startups, primarily those working on psychedelics, to help treat mental ailments. The fund will also invest in startups working on neurotechnology, digital health and precision psychology, all early, but fast-growing fields of technology in mental health. 

PsyMed has already started making investments to startups, though the founders acknowledge that only about one-third of the $25 million has been officially secured. The trio expects that by the end of March, they’ll have met their fundraising goal and will ultimately help fund between 20 and 25 startups. 

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Among PsyMed’s early investments are biotech companies Freedom Biosciences and Delix Therapeutics, both working on using psychedelics to make new medications. 

Freedom Biosciences was co-founded by Burkitbayeva and John Krystal, chair of psychiatry at Yale University. The biotech company is working on clinical-stage development of ketamine- and psychedelic-focused therapeutics. 

Delix Therapeutics is developing therapeutics with non-hallucinogenic drugs known as psychoplastogens. In layman’s terms, psychoplastogens are meant to help our brains compensate for injuries and diseases, and make new links between the neurons firing signals back and forth. 

The three PsyMed founders spoke to Crunchbase News this week about the fund’s inception, investment strategy and goals for the future of mental health treatments. 

This interview has been lightly edited for length and clarity.

Tell me about how you came together to work on this fund. 

Kubin: We decided to create a syndicate together on AngelList, which has been a really good platform for us because it has given us exposure to two different communities. One is a community of people who are therapists, medicine people, psychiatrists coming from life sciences. But then also we’ve connected with people who are more just interested in technology and startups that see the value of psychedelic medicine. We have invested in 14 companies through our syndicate with over $15.6 million. From that, I believe we have over 300 LPs that have invested with us. We really feel the syndicate has enabled us to create a community of LPs—not just capital, but people, individuals who can support the companies that we’ve been investing in.

How has fundraising gone? 

Kubin: One thing that’s been really neat is some of the people who are investing in our fund have already invested in us through our syndicate. It’s people we’ve been able to build trust and rapport and connection with, and that was a nice validation. … What’s interesting is we’re finding interest from a wide array of investors. Some of these people have benefited from psychedelic medicines themselves. Others see the promise of it, or are following the space and the research. For us, it’s really important to have values-aligned investors who are investing with us because … integrity is super important to us. We recognize this is a very early industry and it’s going to take long-term, committed partners in terms of the founders we back, as well as the people who are supporting us. 

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Psychedelics are still federally illegal, though some states are loosening their laws on their use and the FDA can approve certain applications for them. How does that affect the industry and its investment opportunities?

Burkitbayeva: We’re very aware of the limitations that a scheduled drug such as psilocybin, or MDMA, or ketamine pose in terms of investment and coming to market. With that in mind, … we look at the medical model, not the recreational model. … We invest in companies that would be developing a drug that would go through the FDA approval process, and that’s similar to any other biotech company that’s developing a molecule in oncology or cardiology. If that process is successful, and it’s FDA approved, then that trumps any kind of DEA scheduling. … Otherwise, we believe there’s a possibility that it goes through the FDA process and there could be some descheduling. That would not affect the investment, really. 

What can you tell me about your investment strategy? Why are you focusing specifically on early-stage startups? 

Serebrinsky: That is where we can actually make a difference. That’s where we can help and support entrepreneurs based on our own experience building companies in the past, so that’s number one. Number two is that this is still a very nascent industry. Mental health therapies have been completely underfunded until now, so the companies are just starting as well. … We started with psychedelic medicine and we’ve developed a playbook about how to get involved in this phase, how to invest, how to think through those opportunities. We’re expanding that same playbook to other verticals as well, but based on how established we are in psychedelic medicine, more than 50 percent to 60 percent of our investments in the space will be in psychedelic medicine for the first fund we’re raising. 

What emerging technologies or research in this space do you have your eye on that might be surprising to some people? 

Serebrinsky: Some of the (psychedelic) therapies we are looking at start with depression and anxiety as the biggest markets, but as these medicines are researched more, they’re finding potentially interesting opportunities. Nothing is certain, but they’re looking at potential uses for substance use disorder and things more out there, like Alzheimer’s disease and Parkinson’s. There are companies working on these therapies for things like stroke and organ transplant failure … and eating disorders as well.

Burkitbayeva: I think the mental health treatments space … is going to grow, not just because COVID has had such a hard hit on mental health, … but I think because there was not enough attention, research and investment going into mental health, so we haven’t really diagnosed most of the indications (of mental illness) that are actually out there. We have depression, anxiety, PTSD, OCD, bipolar, but what we’re seeing over and over again in the most cutting-edge research is that there’s so much more granularity to each one of these. 

In the future, when someone goes to a psychiatrist, there will be so many more tools, like neuroimaging tools and other types of biomarkers that we can use to diagnose, but we will also have just a larger number of indications that we’re aware of. So the size of the market is not just going to grow by the number of patients that need help, … but also by how sophisticated the diagnostics space is going to become. … I think psychedelics are probably going to be one of the major treatments, alongside neuro and digital therapeutics. 

Illustration: Dom Guzman

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Startup To Host Psychedelic Trips In The Metaverse

Miami-based psychedelics startup Ei.Ventures announced this week that it has purchased a virtual land estate in The Sandbox, where clinicians will be able to host psychedelic therapy sessions in the metaverse.

The Sandbox, a subsidiary of Hong Kong-based blockchain gaming venture Animoca Brands, is a virtual world where players can create, own and monetize virtual items and experiences as nonfungible tokens (NFTs) on the Ethereum blockchain via the Sandbox marketplace.

The purchase of the 12-by-12 estate in the Sandbox by Ei.Ventures in conjunction with parent company Orthogonal Thinker represents the third-largest land sale in the network of 3D lands known as the metaverse and is valued at $2.22 million. The parcel, covering 144 pieces of virtual land in the 12-by-12 space, will be called PSLY.COM, the name of the soon to be merged company of Ei.Ventures with Mycotopia Therapies.

“PSLY.COM going to be a utopian space in the metaverse, it will be empowering to people in the most-high regard way,” David Nikzad, CEO of Ei.Ventures, writes in an email. “This will be a new way to interact with your friends in general, and provide psychedelic therapy in particular.”

Land Deals In The Sandbox Make Headlines

Land purchases on the Sandbox have made recent headlines, including a November purchase of land on the Sandbox metaverse from Atari for a record $4.3 million, according to a report in the Wall Street Journal. In September, rapper Snoop Dogg announced that he would create his own virtual world, the Snoopverse, within the Sandbox platform. And in December, Forbes reported that Hong Kong property tycoon Adrian Cheng announced that he planned to invest in the Sandbox and acquire one of its largest plots of virtual land.

Nikzad said that after only a week on the Sandbox, he had decided to invest in the platform to advance Ei.Ventures and Orthogonal Thinker’s combined vision of psychedelic therapy, with plans to move into the metaverse over the next 36 months. Ei.Ventures is also developing a psilocybin transdermal patch for use in clinical therapeutic applications.

“The combination of our tech, cannabis, psychedelics, outer space, and crypto-related holdings will all be utilizing this exciting space,” Nikzad said in a January 4 press release. “We are very excited to invite all of our portfolio companies and investors to be part of something extraordinary.”

Virtual Psychedelic Therapy Sessions Planned

While plans for the PSLY.com land on the Sandbox are still in the early stages of development, the company expects to create “wondrous VR experiences of Hawaii, positive psychedelic trips, healing modalities, and much more.” As for applications in psychedelic medicine, the company foresees utilizing the virtual reality nature of the metaverse to facilitate guided or minded therapeutic trips with a therapist in the virtual world. The company plans to offer the services in jurisdictions with legal psychedelic drugs, starting with patients in Jamaica and Oregon.

Nikzad notes that the land deal will eventually give billions of people virtual access to psychedelic therapy, saying “It’s the only way to scale.”

“Health and Wellness is a trillion-dollar market,” Nikzad said. “As we’ve now gone through COVID and are still in the craziness of it, these technologies will become much more important as communications and how financial transactions are handled is changing.”

PSLY.COM will also be the name of company that will be created with the merger of Ei.Ventures and Mycotopia, a company focused on the research, development and commercialization of novel therapeutics based on naturally-derived psilocybin, in a deal that is expected to close by March. Mycotopia CEO Benjamin Kaplan said that as the companies work to close the merger, “we are so heartened by the forward-thinking moves Ei is making to set up PSLY.COM for success in the metaverse and beyond.”

The Promises and Perils of Psychedelic Health Care

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Many recreational drugs known for mind-altering trips are being studied to treat depression, substance use and other disorders. Here’s what you need to know.

Oregon is legalizing mushrooms. Ketamine can be delivered to your home. People are microdosing LSD to treat pandemic-related anxiety and Wall Street is pouring billions into companies that sell mind-altering drugs. It seems like psychedelics — though mostly still illegal — are everywhere.

While the federal government does not recognize a medical use for most of these drugs and says they have potential for abuse, some of the most prominent universities in the world are studying four substances in particular: psilocybin, ketamine, MDMA and LSD. The bulk of available research suggests that these substances hold promise as part of larger treatment plans.

There is also growing evidence that psychedelic drugs operate differently in the brain than addictive drugs, and advocates have been consistently calling for legalization. But psychedelics remain expensive and difficult to gain access to legally, unless you are part of a research study for mental health purposes.

These drugs are not all the same and do come with risks. One quality they share is the ability to create an altered state of consciousness, commonly referred to as a trip. That effect can either provide a sense of perspective — or be downright terrifying.

“You’re not likely to overdose on them, but you can have life-changing negative experiences,” Katharine Neill Harris, a drug policy researcher at Rice University in Texas, said.

To avoid these experiences, while receiving the benefits these drugs can offer, people have started microdosing smaller amounts at regular intervals — but they are often doing so without professional guidance, and some remain uninformed about significant downsides with very little evidence of benefits.

Here’s what researchers are learning about the psychedelic drugs most prominently involved in mental health research.

As the active chemical in magic mushrooms, or ’shrooms, psilocybin is the most studied of the psychedelic chemicals found in plants and fungi, and it’s the most likely to become an accepted mental health therapy soon. After last year’s legalization in Oregon, entrepreneurs began investing tens of millions in psilocybin research there, and other cities and states are following suit.

Potential mental health uses: Research conducted in the last decade suggests that psilocybin, typically taken in pill form, has the potential to treat substance use disorders, including alcoholism and nicotine addiction, as well as depression.

That research isn’t conclusive yet, said Paul Hutson, a professor at the University of Wisconsin-Madison who studies psilocybin and leads the school’s center for psychedelics research. But he anticipates there will soon be enough evidence for the Food and Drug Administration to approve psilocybin capsules to treat at least some of these disorders — most likely in the next five years or so.

In the meantime, clinical trials of psilocybin for a variety of conditions are taking place across the country, though they can be difficult to find or have long waiting lists. Still, it’s safer, Dr. Hutson said, to try psilocybin as part of a study than on your own or in one of the treatment clinics that have popped up. In these trials, patients attend appointments to prepare for and process their psychedelic trip with a professional in an environment where any side effects can be managed.

What it does: According to users who have participated in trials, a mushroom trip may induce euphoria and an increased awareness of parts of their environment. For instance, solid objects might seem to breathe in and out. A trip can last more than six hours, and some people describe a positive “afterglow” lasting for months.

Risks: Psilocybin can cause distressing hallucinations or feelings of panic and anxiety in some patients, especially at high doses. You can’t be guaranteed safety standards — having a trained professional who can reassure you, protect you and even administer drugs during a bad trip — in therapy outside of a research trial, Dr. Harris said.

One use of psilocybin, which should not be confused with standard treatment described above, is microdosing. By taking small doses — perhaps 10 percent of a standard dose — every few days, some people might experience mental health benefits without the high. But microdosing psilocybin can be harmful, and there is some evidence that it can damage the heart over time. Recent research also suggests that the positive impacts of microdosing in humans may be largely caused by the placebo effect.

First synthesized in 1956, ketamine, sometimes called Special K, is used today as an anesthetic by veterinarians and in emergency or combat medicine. Because it is the one psychedelic that’s never been illegal, researchers have been able to explore ketamine’s potential as a mental health treatment — and build a case for its use in humans.

Potential mental health uses: Many brain disorders — like schizophrenia, depression and anxiety — are characterized by atrophy in the prefrontal cortex. The evidence is strong, though not yet conclusive, that ketamine helps people with psychiatric disorders by promoting regrowth over time in neurons in this area. That could help explain the near-immediate feelings of relief that users report, which is one of the reasons it has been used in the treatment of suicidal patients.

Esketamine, a form of ketamine, showed such promise for treating major depression, often faster than other drugs, that the F.D.A. approved its limited use in early 2019.

What it does: Ketamine can create euphoria and provide a sense of detachment from reality. Users taking a low dose might feel as though they’re floating or that their body is numb. Higher doses can temporarily make people clumsy and forget where they are or even who they are. Blurred vision or hallucinations are common.

Ketamine works differently from other psychedelics. Most psychedelics — like LSD, MDMA and those derived from plants — operate by affecting serotonin receptors, which alter mood and happiness. Ketamine affects a different class of brain receptors that are important for learning and memory. Both kinds of receptors are found in the brain’s prefrontal cortex, which might explain why ketamine and the other psychedelics seem to have similar impacts on mental health.

“The prefrontal cortex is a brain region that’s really critical,” said David Olson, a chemistry professor at University of California, Davis, who studies chemicals that affect brain function. “It talks to a whole bunch of brain regions that regulate things like mood, emotion, fear, reward.”

Risks: Ketamine is also known for a specific and scary side effect nicknamed the “k-hole.” It’s rare in clinical settings, but users may feel disassociated from themselves and their surroundings and panic or feel paranoid.

“Turn on, tune in, drop out.” “Lucy in the Sky with Diamonds.” Silicon Valley microdosing. Suffice it to say, LSD, also known as acid, has a storied place in American popular culture.

Potential mental health uses: It’s shown promise for treating alcohol addiction and has been studied for other conditions like depression. As with psilocybin, some new LSD adherents microdose to achieve mental health benefits without the trip.

What it does: LSD users have reported feelings of bliss during their trip, being able to see sound and having mystical experiences as well as a sense of closeness with others.

Risks: Some people experience lasting psychological trauma caused by a bad trip, especially when they take higher doses or use LSD often.

Microdosing LSD may have physical risks, too. In a study on rats, microdosing LSD had the opposite effect of a trip; it made the rats display signs of psychiatric illness, like aggression and poor grooming. Similar to microdosing psilocybin, it may also strain the heart by overworking the neurons around the organ.

“If you’re constantly stimulating these neurons, even with a small dose of these compounds, the neurons just can’t take it,” Dr. Olson said.

A well-known club drug, also known as ecstasy or molly, MDMA has been researched on and off for decades for potential mental health benefits. While the drug remains illegal, the F.D.A. allows its use in research and treatment for life-threatening illness.

Potential mental health uses: In 2010, results from a study on treatment-resistant PTSD renewed interest in MDMA research. Since then, it has also been explored as a treatment for other conditions like substance use disorder or social anxiety in autistic adults, although it has more potential to cause damage than some other psychedelics.

What it does: MDMA is often known by its street name — ecstasy — from the feeling of euphoria and connectedness it promotes in users.

Risks: MDMA can cause lasting kidney and organ damage as well as heart arrhythmias during a trip, especially in patients with related pre-existing conditions.

***

Psychedelic drugs aren’t simple substances. More time and research will provide answers about their effects on the brain and whether it’s possible to use them for medical treatments. For now, Dr. Hutson cautioned that evidence supports psychedelic treatments only in cases where other forms of treatment haven’t worked.

“They’re not a panacea that everybody is going to respond to,” he said.

Kat Eschner is a science and business journalist based in Toronto. She is a contributing editor for Popular Science and a contributor to Fortune magazine.

Psychedelic Drug From Magic Mushrooms – Psilocybin – Can Be Safely Administered With No Detrimental Effects in Healthy People

Psychedelic Drug

New research from the Institute of Psychiatry, Psychology, & Neuroscience (IoPPN) at King’s College London, in partnership with COMPASS Pathways, has established that psilocybin can be safely administered at doses of either 10mg or 25mg to up to six participants simultaneously.

The research, published in The Journal of Psychopharmacology, is an essential first step in demonstrating the safety and feasibility of psilocybin – a psychedelic drug isolated from the Psilocybe mushroom – for use within controlled settings alongside talking therapy as a potential treatment for a range of mental health conditions, including treatment-resistant depression (TRD) and PTSD

Post-traumatic stress disorder (PTSD) is a psychiatric disorder that develops in some people who have experienced or witnessed a shocking, scary, or dangerous event.

“>PTSD.

Current treatment options for these conditions are ineffective or partially effective for many people, resulting in a significant unmet need. Early research has indicated a potential for psilocybin therapy to treat these groups, but no trials have been undertaken at the scale needed for regulatory approval to make the therapy available.

The trial is the first of its kind to thoroughly investigate the simultaneous administration of psilocybin. 89 healthy participants with no recent (within 1 year) use of psilocybin were recruited. 60 individuals were randomly picked to receive either a 10mg or 25mg dose of psilocybin in a controlled environment. In addition, all participants were provided with one-to-one support from trained psychotherapists. The remaining 29 participants acted as the control group and received a placebo, also with psychological support.

Participants were closely monitored for six to eight hours following administration of psilocybin and then followed up for 12 weeks. During this time, they were assessed for a number of possible changes, including sustained attention, memory, and planning, as well as their ability to process emotions.

National Institute for Health Research Clinical Scientist Dr. James Rucker, the study’s lead author from King’s IoPPN and honorary consultant psychiatrist at South London and Maudsley NHS Foundation Trust said: “This rigorous study is an important first demonstration that the simultaneous administration of psilocybin can be explored further. If we think about how psilocybin therapy (if approved) may be delivered in the future, it’s important to demonstrate the feasibility and the safety of giving it to more than one person at the same time, so we can think about how we scale up the treatment. This therapy has promise for people living with serious mental health problems, like treatment-resistant depression (TRD) and PTSD. They can be extremely disabling, distressing, and disruptive, but current treatment options for these conditions are ineffective or partially effective for many people.”

Throughout the study, there were no instances of anyone withdrawing from the study due to an adverse event, and no consistent trends to suggest that either of the psilocybin doses had any short- or long-term detrimental effects on participants.

Professor Guy Goodwin, Chief Medical Officer, COMPASS Pathways, said: “This study was an early part of our clinical development program for COMP360 psilocybin therapy. It explored the safety and feasibility of simultaneous psilocybin administration, with 1:1 support, in healthy participants, and provided a strong foundation to which we have now added positive results from our phase IIb trial in 233 patients with TRD, and from our open-label study of patients taking SSRI antidepressants alongside psilocybin therapy. We are looking forward to finalizing plans for our phase III program, which we expect to begin in Q3 2022.”

The investigators have since completed Phase II of the study, which has explored the efficacy and safety of psilocybin in people living with TRD and PTSD, and are analyzing the data.

Reference: “The effects of psilocybin on cognitive and emotional functions in healthy participants: results from a phase 1, randomised, placebo-controlled trial involving simultaneous psilocybin administration and preparation” by James J Rucker, Lindsey Marwood, Riikka-Liisa J Ajantaival, Catherine Bird, Hans Eriksson, John Harrison, Molly Lennard-Jones, Sunil Mistry, Francesco Saldarini, Susan Stansfield, Sara J Tai, Sam Williams, Neil Weston, Ekaterina Malievskaia and Allan H Young, 4 January 2022, Journal of Psychopharmacology.
DOI: 10.1177/02698811211064720

Washington City Votes To Decriminalize Psychedelics

City leaders in Port Townsend, Washington voted this week to decriminalize entheogenic plants and fungi, joining a growing list of communities that have relaxed their policies on psychedelic drugs.

Under a resolution adopted unanimously by the city council on Monday, laws against natural psychedelic drugs such as psilocybin mushrooms, peyote, and ayahuasca will be among the lowest law enforcement priorities in the city. The measure also expresses the city council’s support for decriminalization of psychedelics by the State of Washington and at the federal level.

City staff modeled Port Townsend’s psychedelics decriminalization resolution after one approved by the Seattle City Council in October, making it the largest U.S. city to make such a move. Denver was the first major municipality to decriminalize psychedelics in 2019, and similar measures have been passed by Oakland, Washington, D.C., and Cambridge, Massachusetts. And in November, voters in Oregon approved a ballot measure that decriminalized psilocybin and legalized the compound for therapeutic use.

Activists Advance Decriminalization

The Port Townsend Psychedelics Society (PTPS), a group dedicated to decriminalizing entheogenic plants and exploring their potential for healing, also contributed to the drafting of the resolution. The city now “maintains that the abuse of controlled substances should be understood primarily as a public health issue,” the text of the resolution reads, according to a report by Marijuana Moment.

Before the council voted on the measure, PTPS activists recommended changes to an early draft of the resolution. Under amendments supported by the group, the text of the resolution was changed to make entheogens “among the lowest” law enforcement priorities, instead of a “low” priority.

“After two and a half years working on this issue, we are extremely excited that the City of Port Townsend has passed a resolution supporting the decriminalization of entheogens,” Erin Reading of PTPS told Marijuana Moment after the vote. “We received only support in the passing of this resolution and are grateful for the vibrant community that has congealed around this work.”

“Now, we can focus more of our energy on the other facets of the PT Psychedelic Society which include increasing accessibility to these medicines, providing educational workshops and trainings, developing support structures (such as our monthly integration groups), and strengthening community connections,” she wrote in an email.

Psychedelics As Medicine

Researchers continue to study the potential medicinal applications of psilocybin and other natural psychedelic drugs, which are often also referred to as entheogenic plants and fungi. Research published last year in the journal JAMA Psychiatry found that psilocybin-assisted psychotherapy was a quick-acting and effective treatment for a group of 24 participants with major depressive disorder. A separate study published in 2016 determined that psilocybin treatment produced substantial and sustained decreases in depression and anxiety in patients with life-threatening cancer.

Greg Rovner, CEO of Heally, a California-based telemedicine platform for psychedelic clinics and patients looking for alternative medicine treatment, applauded the unanimous decision to decriminalize entheogenic plants and fungi by city leaders in Port Townsend.

“This is a great first step that we believe will significantly reduce the number of people arrested for possession of entheogenic plants, as we’ve seen in Oakland, Denver and the whole state of Oregon,” Rovner wrote in an email. “We’re seeing an upswelling of grassroots support for psychedelics and hope it will lead to the end of federal prohibition and create more opportunities for medical research into the benefit of psychedelics.”

Ketamine, Psilocybin and the Rise of Missouri Psychedelics

Inside the salt room, Scott Mickey flew above the bright expanse of his own consciousness. His eyes were closed. A weighted blanket pressed his body into a recliner. In his arm, an IV delivered a few dozen milligrams of ketamine to his bloodstream.

His mind was somewhere else.

“I ain’t gonna lie, I was very skeptical,” recalls Mickey, a 45-year-old business owner who runs a chain of head shops in rural Missouri. Before ketamine, the Rolla native had spent much of his life gripped by a deep social anxiety that made crowded indoor spaces, even a trip to the grocery store, intolerable to the point of breakdown.

He had gone to a psychiatrist. They prescribed him the antidepressant Xanax, but he says it felt like “wrapping your head in a blanket.” So, one day this past October, he went to a different doctor, one located in a compact strip mall opposite the Saint Louis Galleria in St. Louis.

Ketamine is undergoing something of a renaissance. First synthesized in 1962, the substance has been used for decades as a surgical anesthetic, and not just because of its ability to safely render a person unconscious. For reasons scientists are still studying, the introduction of ketamine releases the mind to dissociate — that is, to be blissfully unaware, in all sensation and memory, of the physical trauma happening to their body.

However, with smaller amounts of ketamine, a person can experience that disassociation without the amnesia. That experience, as shown in the growing body of scientific research and widening availability of treatment options, acts as a profoundly effective antidepressant.

But it’s not just ketamine that holds such promising possibilities for treatment. Currently, a combination of state and federal laws block patients from using an even more powerful line of psychedelics, substances that have long been used in indigenous rituals and which are well known to the crowd of self-experimenting “psychonauts” for their mind-expanding effects.

For Mickey, attending music festivals in his twenties had brought him into contact with hallucinogens like LSD and magic mushrooms, but it had been many years since he had taken a psychedelic trip. That day at the clinic in St. Louis, as the salt vapors flowed, he found himself settling into a comfortable chair and listening to the music coming from the wall speakers, the melody soft and meditative.

“I was sitting there, they started the IV, and I just got this little bit of a tiredness that came over me,” he says now. “It was like, ‘Oh, I could probably lay back and get comfortable.’ When I laid my head against the pillow, it was like a light switch. It was, boom, there I was, flying. And there was no fear to it.”

He remembers looking down at an endless landscape beneath him. He says, “I started thinking about my anxiety — why do I get uncomfortable in various situations? I flew close to the ground and saw this dark spot in the center of this snow-covered region. I instantly knew that it was either trauma or something that had happened in my life that created that inside of me.”

As easy as thinking, Mickey flew down to the dark spot, and “exchanged energy.” The spot turned light, and, he says, “as it happened, I would feel the release of this incredible weight.”

Today, he describes it as one of the most powerful sensations of his life. He was sold.

“Once I had tried it once, I was like, ‘Alright, I’ll take the package.'”

After decades of legal restrictions and fear mongering, Americans are finally coming around to the notion that psychedelics are legitimate medicine. Even as the law and science lag behind, people in Missouri like Scott Mickey are already embracing ketamine; and these aren’t hippies or followers of the sort of LSD utopia envisioned by Timothy Leary in the 1960s — these are simply people in pain.

During a recent visit to the Radiance Float + Wellness clinic in Richmond Heights, psychiatrist Dr. Zinia Thomas walks through a short hallway to the salt room, the same room in which Scott Mickey tuned in, dropped out and started flying through his mind. The back wall, built of rock salt bricks, is lit with cool blue lights. A flier on a table features a friendly message, “Enjoy your K-Cation,” beneath a photo showing a line of multicolored cottages on a perfect beachfront.

Thomas founded the clinic in 2017, one year before then-President Donald Trump signed the federal Right to Try Act that made some classifications of drugs, including ketamine, open to therapeutic use if patients had exhausted FDA-approved treatment options.

At first, Thomas says she considered ketamine treatments as an option of last resort. But two key events shaped her current stance that ketamine is for everyone.

First came Missouri’s legalization of medical cannabis. In 2020, Thomas began prescribing medical marijuana licenses to hundreds of patients across the state through virtual appointments. Quickly, she says, it became clear that people were seeking more substantial relief than even high-potency cannabis could offer.

“They wanted it to cure their depression, PTSD, their pain, migraines. They wanted it to cure everything,” she says. “People put so much hope in it, but this is just a plant.”

Thomas says she began suggesting ketamine as a possible treatment for her medical marijuana patients’ more serious health needs. Around the same time, the pandemic hit — and with it, the crush of isolation, job stress and the ever-present tragedy of the rising death toll. She believes the pandemic inflamed a mental-health crisis that was already burning out of control.

“Even high-functioning people have suffered so much loss in the pandemic,” she notes. “I just thought, ‘Why should you have to fail other antidepressants before trying something like ketamine?'”

Finding the Light at the End of the Tunnel with Advanced Wellness and Pain

“The light at the end of the tunnel” is a phrase I found myself turning to much more frequently since 2020. Nobody is walking out of the events of the last 18 or so months unscathed, but the hope is that we emerge wiser for the wear.

The problem with the light at the end of the tunnel is that, by definition, you rarely see it when you embark on this journey. You have no choice but to dive headlong into darkness, hoping that the light will be there to greet you soon.

There’s no sugar-coating it: this is hard – to get in the car, fasten your seatbelt, put the keys in the ignition and depart without any sense of where you’re going or who you’ll be when you get there. It’s during these times we most often could use a hand.

Not a helping hand; no, we can make it ourselves. Not a guiding hand, either – the road is long but we know we’re on the right path. What we need most is a handshake, someone who’s been down this road before who can assure us that, yes, it is difficult but in time we will emerge on the other side bathing in the light of new hope that was once just a far-off glimmer.

That, more than anything else, is the goal of the providers at Advanced Wellness and Pain. It was made abundantly and refreshingly clear to me over our recent Zoom call – the new normal, it seems – that their mission is to create a treatment center that patients can trust. Trust not just to be experts in their fields, but also trust to know they have been there, and they understand.

Advanced Wellness and Pain was born out of its founders – James Leathem, DO, Gregory Wong, MD, and Deepak Sharma, MD, MBA – and their understanding that 2020 exposed us to the gaping wounds of our healthcare model; their understanding that not only do we need new treatments, but most importantly we need providers who understand them and how they make patients feel.

Continue reading for our full conversation about their backgrounds, their commitment to patient care, and the new clinic facility they have moved to.

What separates Advanced Wellness and Pain from other clinics?

First, we are three board-certified physician anesthesiologists who directly participate in each patient’s care. We intake each patient and directly administer the ketamine ourselves. In addition, we optimize dosing both during and between infusions. We will often micro-bolus patients during their infusion to achieve optimal ketamine experiences in our clinic. Then, depending on the patient, we will escalate our dosing to achieve dissociative experiences by their 5th or 6th infusion.

The most important distinction is that we have worked tirelessly to create a comprehensive integrated program that helps our patients create life-long results for their mood, chronic pain, and substance abuse disorders. Furthermore, we have a unique partnership with a psychedelic integration coaching company. We are the only ketamine clinic in the state of Arizona with this partnership. They are experts in psychedelic integration and help our patients prepare, process, and integrate their ketamine experiences into their lives. We also collaborated to author a ketamine preparation and integration workbook that combines our knowledge and expertise. This helps to create a more consistent experience for our patients and encourages them to be an active participant in their healing journey. 

This is key for immediate and long-term results. It’s common for patients to be confused with some of the ideas they encounter during or after their infusion sessions. Our coaches are able to help clarify and assist our patients by insightfully unpacking their revelations in the 24-48 hours post-infusion. Coaching them with integrative and cultivative techniques are critical and necessary for sustained results. On top of that, we teach meditation, mindfulness, breathwork, journaling, visualization, and other life hacks to sustain a positive mindset. This has allowed us to create a success rate of over 95%, compared to the reported national average of 70%.

How much time do you spend taking care of each individual patient?

The time involved for our first infusion session is two hours, subsequent sessions are one-and-a-half hours. In addition, there are three hours of 1:1 integration coaching. The induction or stabilization phase of six infusions, over the course of two to three weeks, involves over 12 hours of time with each individual patient.

What can you tell me about your commitment to patient care?

Our commitment to patient care is unprecedented and another key to what sets us apart from other facilities. Not only is our set and setting pushing beyond typical expectations, but our patients have messaging access to us at any time of the day as part of our program. They will have two, often three physicians interacting with them during any visit. We converse with our patients before starting each infusion and after each infusion to help them optimize their sessions.

There is a lot of excitement around our ongoing clinical study for first responders affected by PTSD that started earlier this year and should be completed by this year’s end. The early data has been fantastic and we should be publishing our results soon.

How does the new office facility help you treat your patients?

We just built a brand-new beautiful state-of-the-art clinic in Scottsdale, Arizona. It was designed specifically for ketamine infusion treatments in order to optimize the patient’s setting, which is crucial to the experience. We have five private rooms with integrated healing music, LED color lighting, vibro-acoustic meditation cushions, zero-gravity chairs, and exquisite artwork. We have created the safest setting for our patients to heal from within.

Can you each tell me a little bit about your background and expertise?

James Leathem, DO

 I completed my Osteopathic Medical Degree at Midwestern University in Glendale, Arizona in 2011. I have been an anesthesiologist since 2015 and trained at Michigan State University. In hindsight, I was lucky to have trained at a very ketamine-centric program. Not all anesthesia programs embrace the use of ketamine equally. We embraced a multimodal approach and ketamine was often part of the anesthetic plan. That is the beauty of anesthesia, it is both an art and a science. In my professional opinion, I think ketamine often improves the anesthetic picture for the patient.

When I was a medical student, having to decide which specialty to pursue, I was conflicted between anesthesiology, family medicine, and psychiatry. Ironically, what I do now is essentially a merger of those three fields. I have administered ketamine to thousands of patients in my career, perfecting my understanding of its dosing and pharmacodynamic effects.

I do a thorough medical history on my patients so I can better understand them from a bio-psycho-social-spiritual point-of-view. I have a passion for exploring consciousness and helping others to evolve their perspective. I also recently became a certified psychedelic integration coach in order to strengthen my ability to care and connect with my patients.

I realize we are all a work-in-progress and societally we are amidst a mental health crisis in the United States. I want to be a part of the solution by catalyzing the healing of patients through the careful administration of psychedelics, ketamine being the only currently-legal psychedelic. We are likely to see a lot of changes in the next two-to-four years involving psychedelic medicines, also known as entheogens, due to the tireless efforts of MAPS.

These are exciting times and I feel fortunate, through the use of my knowledge and skills, to play an integral role in the healing journeys of my patients. Providing hope and attaining positive results for those that have tried so many other options and have been labelled as “treatment-resistant” is truly fulfilling.

Deepak Sharma, MD, MBA

I completed a dual degree in medicine and business at Drexel University in Philadelphia in 2012. I did my residency training at Mount Sinai Morningside-West Hospital in New York City and have been an anesthesiologist since 2016. In my training, we frequently administered ketamine infusions in the operating room as a multimodal approach to managing surgical pain. Patients required significantly less amounts of opioids to control their pain after surgery because of ketamine. 

Our pain management service also administered ketamine infusions to treat patients with Complex Regional Pain Syndrome (CRPS). Most of these patients had accompanying mental health problems, such as anxiety and depression. They would notice that after ketamine infusions, not only would their pain reduce, but their anxiety and depression would also diminish. Had I not been exposed to the powerful benefits of ketamine in my training, I would likely not have gone down this path of becoming a psychedelic medicine physician today.

Unfortunately, most practitioners don’t get enough exposure to ketamine so they have misguided opinions about its value. Even more unfortunately, I’ve found in my career as an anesthesiologist that the healthcare industry has misguided opinions about the value of anesthesiologists and physicians as a whole.

After working in multiple large organizations, both corporate and academic, I realized that I was just a cog in the wheel of a massive machine. I had very little autonomy over how I practiced and I was constantly under pressure to produce. Quantity mattered more than quality to the CEOs. This is the current state of healthcare: big conglomerates merging to form even bigger entities; controlled by private equity forms; managed by bloated administrative staff; with doctors, nurses, and other providers serving as the labor force.

But most of us providers put up with it because of the competitive salary. Kevin O’Leary, a prominent businessman and television personality on Shark Tank, once said that “a salary is the drug they give you to forget your dreams.” That phrase really stuck with me. Although I’ve given up the comfort of a salary to start this venture, I feel much more spiritually satisfied that I’m part of this revolutionary psychedelic movement and that I’m helping to build a resource for struggling patients.

I’ve struggled in many instances in my own personal life, and I know how it is to feel incapacitated from stress, anxiety, and depression. In fact, residency was so stressful that two of my colleagues I trained with committed suicide. It was through my own journeys with psychedelics that I was able to gain a new perspective on life and be resilient enough to persevere through adversity.

My mission now is to show others this new perspective. Helping others navigate through their mental blocks and potentially saving lives in the process is exactly what I want to be doing.

Gregory Wong, MD

I graduated from the Chicago Medical School in 1992 and completed my anesthesia training at the University of Arizona in Phoenix in 1996. I trained using ketamine frequently during high risk obstetrics cases. Although many people believe that ketamine is a dangerous drug, it is actually one of the safest anesthetics that we have available to use. Ketamine’s safety profile makes it one of the preferential drugs during emergency surgeries. 

Over time, us anesthesiologists found secondary benefits that began showing up during patient’s times of stress. We discovered that at low doses of ketamine, patients’ pain syndromes as well as depression were improved. The secret is that when ketamine is used at low doses, it partially blocks the NMDA receptor. This has a very different effect than when given at large doses as in a typical anesthetic. It literally causes neuroplasticity, or new neural pathways.

When used properly, this allows our patients to heal from within. As we have all become more aware of the mental health and substance abuse crisis in our country, I believed it was important for me to take an active role as a physician leader for a solution. The ability to shape the future of patient care through psychedelic medicine is both an intriguing and extremely rewarding practice. We are in the middle of a paradigm shift in mental health care.

We are offering our patients the chance of healing and repairing past emotional traumas with our ketamine-based wellness program. It is unlike typical pharmacologic antidepressants and central nervous system medications that function more like a band-aid than a healing process. Although quite a few ketamine clinics have opened up over the last two or three years, we are still at the infancy of psychedelic medicine. The clinical trials of MDMA and psilocybin show us that new legal compounds will be available in the next two-to-four years.

Our clinic’s plan is to demonstrate how these compounds are even more useful when combined with an integration process. This is precisely why we launched our own clinical study using ketamine and integrative coaching for PTSD patients over a multi-month time frame. For this reason, I feel we run one of the top ketamine clinics in the country. We have scrutinized every aspect of the process and worked to optimize the patient experience.

The results have produced an amazingly high success rate of over 95%. This is well above the national average, so I know our clinic is performing at a very high level.

What led you to start a ketamine clinic?

Our anesthesia business slowed down quite a bit during the COVID crisis in 2020. We saw the amount of mental health illness rising in our country. We looked at the landscape of care and thought we could do an exceptional job of taking care of patients with ketamine, since we were all experts using ketamine in our combined 40+ years of clinical anesthesia practice. We saw that mental health/depression is predicted to be the leading cause of disability by 2030. This led us to believe that we could be leading contributors to shaping psychedelic medicine treatment in the future and evolving the paradigm surrounding mental health care.

What lessons have you learned about mental health during your time at Advanced Wellness and Pain?

We learned that there are a lot of people suffering with their mental health and COVID exacerbated the problem for many. We also learned that most ketamine clinics are not supporting their patients optimally during their acute phase of care. Most do not offer services beyond just the infusion of ketamine itself.

Ketamine is not a magic bullet. Rather, it is a powerful tool and catalyst to healing when set and setting are optimized, the ketamine is precisely dosed, and the patient receives proper preparation and integration coaching. We have had several patients receive care from us after having received ketamine infusions elsewhere. They all resoundingly confirmed we have a truly unique process.

We realize that having strong mental health is a result of conscious daily practice. You have to be an active participant in your healing. Just like we need a good diet and exercise to optimize  our physical health, we need a good diet and exercise for our mental health. In this case, diet is composed of our social media feed, news, screen time, human interactions/relationships, nature exposure, sleep and consumption of psychotropic substances; and exercise is daily meditation, mindfulness, breathwork, activities, guided journaling, and recognizing your internal narrative.

We also offer patients infusions of essential vitamins, minerals, anti-oxidants, and NAD+ to further optimize the patient’s internal milieu as they heal.

We personally guide our patients through this often anxiety provoking or confusing foreign process. It is paramount to a patient’s success. Asking a patient to navigate their subconscious when they have debilitating depression or general anxiety is a huge task to ask someone to conquer on their own.

What should I ask you about that I didn’t know enough to ask?

A question that many people probably wonder about a physician who administers ketamine to help others heal would be, “have you ever tried the infusion yourself?” The short answer is yes. You can only lead someone as far as you have gone yourself.

In our professional opinion, you can read about ketamine all you want. Unless you have personally experienced it in an optimized safe-setting, you will not fully understand its effects on the mind and its healing potential. It is our understanding that less than 10% of ketamine practitioners have in fact tried an infusion themselves. Maybe most won’t be honest and admit it. Maybe it’s higher than 10%.

Regardless, if I were a patient, I would want to go to a doctor who has actually journeyed with the medicine. Otherwise, how do you truly relate? The experience at times is ineffable. Would you take swim lessons from an instructor who can’t swim? I think not. In our professional opinion, you must have walked the walk in order to fully understand the unique healing potential of ketamine and the potentially transformational impact of the psychedelic medicine renaissance that is before us.

In Conclusion

To learn more about Advanced Wellness and Pain’s innovative treatment options, visit their website here or call them at (480) 546-5615.

Simone Biles Ignites a Movement: How One Voice Sparked a Fire for the Future of the Olympic Torch

How the Public Views Our Olympic Athletes

Most stories stemming from the Olympics share the impossible-sounding feats performed by the best athletes from countries around the world, and the most iconic are ones where said athletes push through pain, tragedy, and mental blockades.

Kerri Strug, a retired American gymnast from Arizona, once part of the 1996 Olympic team dubbed the ‘Magnificent Seven’, won gold for Team USA after completing her vault routine with an injured ankle. Thanks to her, the country won the team competition for the first time ever.

Michael Phelps remains one of the most decorated Olympians ever, and has his sport to thank for making him a household name. He’s earned 23 gold medals, 3 silver, and 2 bronze for a whopping total of 28. He is the face of the sport, and his accomplishments are the drive for many who are striving to be the next Phelps.

What many don’t know is Phelps struggled to find his own identity after retiring from the sport in 2016. In his HBO Sports documentary, “The Weight of Gold,” he says, “Yeah, I won a s–t ton of medals. I had a great career. So what? I thought of myself as just a swimmer. Not a human being.”

Remember Strug? She was a teenager during the ‘96 Olympics, where she injured her ankle on her first vault attempt. It was thought that her next attempt was the difference of gold or silver for Team USA. The weight of the country was on her shoulders, or so she thought.

“Do we need this?” she had asked her coach, desperate to find an alternative that didn’t mean landing hard on her injured foot. She was given no way out and had to be carried off the mat after her second attempt—where she stuck the landing.

It was because of that final vault that won her country gold that she left the Olympic Games a hero, but she was soon forced to retire after struggling to keep up thanks to her injured foot.

Glamour Magazine collaborated with Elite-level gymnasts prior to their participation in the Olympic Prelims of June 2021 for a documentary called, “Defying Gravity: The Untold Story of Women’s Gymnastics” where they reveal that Strug never needed to compete in that final vault. Team USA had already won the gold. Her sacrifice was for naught.

These are the stories that people take away from the Olympics. We cheer for the medal ceremonies and shed tears for the sob stories, but it’s the sacrifices that stick with us, for better or for worse. These sacrifices of self, of health, of mental toughness have been viewed as strength.

Strug and Phelps rocked the boat by speaking out about their mental health post-Olympics, but then Simone Biles appeared, and she’s set on capsizing it.

The Greatest of All Time

Simone Biles is an American gymnast from Texas who got an early start in the sport, beginning when she was around six years old. With a combined total of 32 Olympic and World Championship medals under her belt, Biles is tied with only one other person as the most decorated gymnast of all time. She has four skills named after her, a feat that only occurs if the gymnast performs it at a major international competition, like the Olympics. With her capabilities she is, quite literally, considered to be the greatest athlete of all time.

She was a no-brainer for Team USA, and her scores blew her fellow competitors out of the water at the June Preliminaries. With Biles on the team, America could rest easy knowing no other country had the talent to compete for gold.

Then Tokyo happened, and Biles messed up on vault, which is one of her personal favorites.

Announcers were unable to hide their shock, the crowd emitted worried gasps, and her teammates tried to look away.

She unexpectedly withdrew from the women’s team finals following the vault event, citing mental health concerns as well as fear for her safety should she continue on. Biles admitted that she had lost sense of where she was in the air after launching herself from the vault, which is a major deal in a sport where landing on your feet means everything.

The world watched on, scouring social media while waiting for Biles herself to comment on what had happened. As many speculated that she was embarrassed by her blunder and came to their own conclusions that she was selfish not to continue, many more stepped forward to rally around their Olympic hero.

She eventually did release a statement, tweeting, “the outpouring of love & support I’ve received has made me realize I’m more than my accomplishments and gymnastics which I never truly believed before [white heart emoji].”

Biles returned to the floor days later, after finding refuge in a private Japanese gym to prepare for her Olympic comeback, for the beam event where she earned a bronze medal to add to her repertoire.

What This Means Moving Forward

Hours after being awarded her seventh Olympic medal, Simone Biles said that her biggest takeaway from the 2020 Olympics was to “put your mental health first.” Often this is an epiphany that doesn’t befall athletes until long after they’ve stepped away from the spotlight, their sport, the Games as a whole.

But with Biles still in the running and rumored to be preparing for the 2024 Olympics, with this movement encouraging others to speak up about their own mental health, it’s possible we’ll see less Phelps’ and Strugs’– people who lose themselves in the sport with no resources to fall back on.

We’ll see athletes at their physical best, wowing audiences and inspiring future generations who watch on from their television screens.

We’ll see them with broad smiles as they stand on podiums, cross finish lines, prepare for their dives.

We’ll see less of our heroes crashing and burning, and watch as their names trailblaze the path for those who will come after them.

For more reasons than just what she can do in the air, Biles continues to show she is, in fact, one of the greatest of all time.