Missouri Patients Could Use Psychedelic Treatments Under New GOP ‘Right-To-Try’ Bill

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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Peter Thiel-Backed Psychedelics Company Gets FDA Approval To Study Ketamine Therapy

The U.S. Food and Drug Administration has authorized German psychedelics startup Atai Life Sciences to conduct a clinical trial on a nonpsychedelic form of ketamine for treatment-resistant depression.

The company will study R-ketamine, an enantiomer of ketamine, the FDA-approved dissociative anesthetic that is used for general anesthesia and off-label as a popular treatment for depression.

R-ketamine’s promise is that it may not produce a psychedelic experience while still providing rapid antidepressant effects. If proven in clinical trials, R-ketamine could be a new medication for people with treatment-resistant depression and safe enough to use at home, not in a clinic under medical supervision like ketamine and Spravato, another form of the drug that has been approved by the FDA.

Atai’s majority-owned subsidiary Perception Neuroscience will launch the first in a series of clinical trials on R-ketamine early this year in the U.S. The first trial will be a drug interaction study.

Florian Brand, the CEO and cofounder of Atai, which is backed by billionaire Peter Thiel and is publicly traded on the Nasdaq, says that if the trials successfully show that R-ketamine is a fast-acting antidepressant safe enough for at-home use, it “would be a big game changer for patients.”

Perception Neuroscience has already launched two studies on R-ketamine abroad.

The phase 1 trial, which was conducted in New Zealand with 58 adults who received different doses of an intravenous infusion of R-ketamine in February, found that their compound, which they refer to as PCN-101, was “safe and well-tolerated” at all doses up to 150mg. Participants reported no serious adverse effects. The second stage of the study compared PCN-101 to S-ketamine, which is the ingredient in Spravato. The results showed that Perception’s compound required substantially higher doses to induce similar psychedelic experiences than S-ketamine.

In September, Perception was approved to launch a double-blind, placebo-controlled phase 2a trial in patients with treatment-resistant depression in Europe. The study plans to enroll 93 patients who will receive either a placebo, a 30mg dose or a 60mg dose of R-ketamine, which will be given intravenously. The trial will be studying if the drug is safe and effective in reducing depressive symptomology. Results should be ready by the end of 2022.

Terence Kelly, the CEO of Perception Neuroscience, which is based in New York, says that he is encouraged by how R-ketamine is progressing through the regulatory process. “We believe that PCN-101 has the potential to offer a differentiated therapeutic effect, in terms of both efficacy and ease of administration, for clinicians and patients,” Kelly said in a statement.

Srinivas Rao, Atai’s chief scientific officer, says that the psychedelic experience is important for many of the drugs the company is pursuing, but R-ketamine’s nonpsychedelic properties is what makes it a potential disruptive medication for treatment-resistant depression.

“At-home use—that’s the key,” says Rao. “Everything else that we’re looking at, like psilocybin, must be administered in the doctor’s office. This is obviously important for those compounds. But if we can get something that can be administered at home as a rapid-acting agent, that’s a potential much larger market and certainly broadens the appeal of the compound.”

Big Pharma has already taken interest in R-ketamine. In March 2021, Otsuka Pharmaceutical announced a $20 million licensing agreement to develop and commercialize Perception’s R-ketamine compound in Japan as a potential treatment for major depressive disorder and treatment-resistant depression. Otsuka will have exclusive rights to PCN-101 in Japan. If Otsuka successfully brings the drug to market, Perception will receive royalties on sales.

The opportunity for a new blockbuster medication to treat conditions like depression, anxiety and post-traumatic stress disorder is huge. Prescription sales for depression is estimated to be $50 billion a year globally, while the mental health market is worth about $100 billion in annual sales. While biotech analysts say that FDA-approved psychedelic-assisted therapy could seize $10 billion in annual sales by targeting the treatment-resistant depression subcategory, the real opportunity lies in replacing drugs like Prozac, Zoloft and other selective serotonin reuptake inhibitors.

An estimated 100 million people have treatment-resistant depression around the world, which is a sizable market for R-ketamine.

“What excites us, certainly, is what you call blockbuster potential,” says Brand. “We’re really interested in large unmet needs, large markets, large opportunities.”

Atai is also the largest investor in Compass Pathways, a U.K.-based clinical stage company that is developing a patented form of psilocybin to be used in conjunction with therapy for treatment-resistant depression. In November, Compass Pathways’ much-anticipated FDA-approved phase 2b clinical trial found that patients who took a single psychedelic dose of psilocybin, the main ingredient in “magic mushrooms,” in conjunction with therapy reported almost immediate and significant reduction in depressive symptoms that lasted weeks compared with patients who were given a 1mg dose, which is so low it’s essentially a placebo. 

Atai, through another majority-owned subsidiary, is building a suite of second-generation psychedelics that feature a shorter-lasting two-hour trip.

Brand says that when it comes to treatments that involve a psychedelic experience, the length of the psychedelic experience itself is an obstacle to mainstream adoption.

“We’re all about scale,” says Brand.

By modifying psychedelic molecules to shorten the trip, more patients might try it and insurance companies could be more willing to cover the treatment.

Brand and many others in psychedelic medicine believe that the no-trip treatment will have a prominent place in the future of the industry.

“We have a vision for precision psychiatry,” says Brand. “Ultimately, the goal is to identify which type of treatment is the right one for which patient. Not everyone will necessarily always want to do psychedelic agents like psilocybin. For some, it might be the appropriate treatment, but it’s not really feasible for everyone.”

Rao says the future is in choices. Finding a medication that helps patients with treatment-resistant depression is particularly difficult considering that these patients have tried many different drugs without success. About 30% of people with depression find no success with available treatments. Rao says if R-ketamine is approved it would become another tool doctors can use.

“It depends on where you are in your disease process—you may need esketamine, or you may need psilocybin or DMT, or something else to induce and then you could maintain with R-ketamine,” says Rao. “But we don’t yet know how things will shake out.”

Could a VR “trip” offer a sober shortcut to the healing potential of psychedelics?

Especially amid the existential dread of our current COVID hellscape, people have increasingly turned to psychedelics as portals to empathy and enlightenment. Tech bro hype aside, though, they’re not for everyone. Tripping isn’t recommended for those with severe heart disease or who show signs of schizophrenia and related disorders. Many others are simply unprepared for the intensity of a full-blown trip.

But what if you could unlock the same altered state of consciousness that psychedelics do — as well as their potential to treat PTSD, major depressive disorder, and other mental health conditions — whilst completely sober?

Some virtual reality experiences could offer just that. The extremely buzzy meditation app Tripp allows you to float through celestial bodies, fractals, and other awe-inspiring scenes. The University of Sussex’s Hallucination Machine mimics the swirling hallucinations triggered by classical psychedelics like psilocybin (the main compound in shrooms) and LSD. Meanwhile, Atlas V’s Ayahuasca, Kosmik Journey immerses users in pulsing, kaleidoscopic images, similar to those created by the hallucinogenic brew.

While tripping sans drugs is an intriguing possibility, I can’t help but be skeptical. Sure, VR can replicate the auditory and visual aspects of a trip. But what about its intensely spiritual, ineffable profundity, which also seems important for the psychological healing that psychedelics promise? I spoke with Matthew Johnson, a professor of psychiatry and behavioral sciences at Johns Hopkins Medicine, about the extent to which VR apps can mimic psychedelics — and their therapeutic potential.

To definitively respond to this line of inquiry, “what you’d really need is the study comparing the two [psychedelics and VR] head to head,” says Johnson, who researches the effects of psychedelics. Even studies that look at them separately, but under similar conditions, would provide more clarity. Scientists still have yet to conduct them, though, Johnson tells Mic.

Dried psilocybin mushrooms on white surface on black background
Raphael Rangel / 500px/500Px Plus/Getty Images

But as it stands, “I highly doubt whether an app alone is going to approximate the magnitude of the efficacy of psychedelic therapy,” he says. That’s partly because VR can only directly manipulate the perceptual, but not the emotional, aspect of a trip.

It’s the emotional aspect — especially the mystical experience observed at higher doses, which can include revealed truth and ineffability, among other powerful qualities — that seems to underpin psychedelics’ therapeutic potential. Studies have correlated it with long-term positive outcomes for treatment-resistant depression, lowered depression and anxiety in cancer patients, and greater likelihood of quitting smoking, for example.

People have highly emotional experiences on 5-MeO-DMT (derived from the venom of the Bufo alvarius toad), even if it’s less visual than DMT (the main active ingredient in ayahuasca) — suggesting that “maybe you won’t get a meaningful effect from just the perceptual effects,” Johnson says. “But perhaps you do.” It’s also possible that the perceptual effect contributes to the emotional effect. At this point, we just don’t know.

That said, the therapeutic results have been so large in preliminary studies of psychedelics that “even if you had an effect that was a quarter of that size, that’s still important to pursue,” Johnson says. To his knowledge, no studies have investigated whether VR can offer the same mental health benefits psychedelics have shown.

For people advised to steer clear of psychedelics, VR may offer a safer alternative, unless it does end up closely mimicking a trip, in which case it, too, could spur a panic reaction. But that seems less likely, Johnson says — and you can always remove the headset if it all feels like too much. In contrast, you’re stuck tripping, no matter how badly you want to stop. VR would also allow you the flexibility to program your experience, maybe transition to a beautiful field of flowers to calm yourself down, or crank up the intensity if you’re ready. “You want to test these things, but it’s reasonable that it [VR] would be, relatively speaking, safer than psychedelics,” Johnson says.

Trippy VR experiences might seem like psychedelics lite.

While Johnson believes it’s worth testing VR experiences that seek to recreate a psychedelic trip on their own, he’s also exploring using them alongside psychedelic therapy. In a study slated to start in a month or two, he and his colleagues will compare participants’ self-reports about their creativity and engagement with their professional work during portions of psilocybin-assisted therapy sessions with and without VR.

Rather than an app designed to mimic a trip, Johnson and his team will experiment with various images to see how they influence participants’ psychedelic experiences. (Maybe, say, exploding fireworks won’t have an effect, but nature scenes will.) They hope to determine whether VR can enhance them — in other words, whether participants will find these experiences more meaningful with VR than with psilocybin alone.

In a similar vein, Tripp and PsyAssist — a company acquired by Tripp that creates digital psychedelic therapy tools — plan to release a product that would let providers and patients use VR, augmented reality, and mobile technology in ketamine-assisted therapy, Forbes reported in August.

While trippy VR experiences might seem like psychedelics lite, the bottom line is that they come with both promise and risk, just like the real thing, according to Johnson. To an optimization-obsessed generation constantly in search of “brain hacks,” a sober shortcut to the healing potential of psychedelics has massive appeal. But “we need to follow the data,” Johnson says, “rather than what we hope is going to work.”

Cannabis And Psychedelics Experts Reflect On Cali Sober For Dry January

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Welcome to Dry January, the month many stop drinking alcohol to give their bodies a rest from toxic compounds consumed en masse over the holidays. If you’re in recovery or, like me, practicing a lifestyle that favors cannabis and psychedelics over alcohol and harder substances, also known as “Cali sober,” every month may be dry for you. For those new to this term, drug and culture journalist Mary Carreon sums up the Cali sober concept eloquently. 

Mary says it’s easy to get caught up in the trendiness of Cali sober, noting the phrase sounds like “designer sorbet rich people buy at Erewhon.” She recognizes that celebrities talk about it, radio stations “like KIIS FM” air songs about it, and we’ve seen the concept swirling around the media landscape a few times. But, she believes the root of why people are fascinated by the Cali sober lifestyle is because “it honors nuance and flexibility, and flips the concept of abstinence on its head, reducing the idea of abstinence to nothing more than a theory.” She shares that the perspective shift alone “can help people reclaim their autonomy and independence, two things that are often stripped from people who go through recovery.”

Mary finds that Cali sober as a trend is annoying, “but making it a practice — like meditation or mindfulness or exercising — can help people repossess their power, which is critical when making lifestyle shifts away from substances or habits or friends (or all of the above) that don’t contribute to making you the best version of yourself.” And, she acknowledges that being Cali sober isn’t for everyone (see Demi Lovato’s recent change of heart), noting that “sometimes abstinence is the most empowering path to becoming your optimal self… it doesn’t matter what road you take because the end goal is doing whatever is ideal for your longevity, and that should be the number one priority.” Agreed. In the end, it’s about saving lives. 

Cali sober is trending in pop culture alongside Dry January, so today I’m providing a platform for six accomplished thought leaders in cannabis and psychedelics to share insights and strategies on Cali sober for inspiration on staying balanced year round — Christina DiPaci is the CEO of one of the largest independent craft cannabis farms in California; Zeus Tipado is not only a neuroscientist but also the creator of Stonedgamer and MiddleEasy; David Bienenstock is a popular podcaster and author of How to Smoke Pot (Properly): A Highbrow Guide to Getting High; Shelby Hartman has created a media company and education platform at the forefront of the rapidly growing psychedelic movement; Payton Nyquest’s company combines the latest advances in psychedelic medicine with evidence-based care and a holistic, integrated approach; and Mary Carreon is an award-winning journalist, editor, podcaster, and copywriter who’s written for Snoop Dogg’s Merry Jane, Billboard, DoubleBlind, the LAnd, and more.

Let’s keep the conversation going with an open mind. Let’s explore and normalize innovative ways to thrive. 

Paradiso Gardens Founder & CEO Christina DiPaci

“I am in full support of conscious, intentional drug consumption. Cannabis can be a wonderful alternative to alcohol, (did I mention without the hangover?!), but we have to be careful not to have elitism in our preferred drug use. Do what works for you and don’t judge other people’s drug use! Check out Dr. Carl Hart’s Drug Use for Grown-Ups: Chasing Liberty in the Land of Fear. A scientist and a professor of psychology specializing in neuroscience at Columbia University who’s known for his work on drug abuse and addiction, Dr. Carl Hart presents a powerful argument for how adults can use substances and live a happy and meaningful life.”

Neuroscientist Zeus Tipado

“I’ve seen all the altered states that alcohol has in store for me, and it doesn’t appeal to me anymore. With cannabis and psychedelics, I can have my entire perception and its fundamental constructs completely altered, and the next day I’m perfectly fine with no hangover. That’s appealing to me — I can’t throttle my subjective experience in that way with alcohol. As far as the physiological effects of alcohol — I don’t really vibe with it. At the beginning of the pandemic, my best friend died of alcohol poisoning. He was the closest person on this planet that I would have called a brother. Dead, from a drink you can buy at a grocery store. A product advertised across the world in Superbowl commercials. His struggle with alcohol (and the constant struggle of other friends) is one of the reasons I also remain Cali sober. It’s not my place to dictate which lifestyles people should adopt. The Cali sober lifestyle works for me because alcohol no longer holds priority in my entertainment and leisure. Fortunately in California, the environment is slowly adapting to the Cali Sober lifestyle. Alcohol-free, cannabis-infused beers are popping up. Cannabis smoke lounges are also appearing, unfortunately at a staggeringly slow rate due to city burearcy — which brings up my next point. The only force preventing the full adoption of the Cali sober lifestyle is the government of California itself. Perhaps the state of California is against the Cali sober lifestyle.”

Great Moments in Weed History Co-Host & Co-Creator David Bienenstock

“When Abdullah Saeed and I had David Crosby as a guest on our podcast, we realized that he’s been ‘California sober’ for many years without ever being aware of the term. And while he personally finds the word sober a bit misleading in this context, he also confirmed that going California sober has worked for him. After famously struggling with drugs like cocaine and heroin, Crosby was first completely abstinent from all intoxicants including cannabis for more than a decade before successfully reintegrating cannabis back into his life. This is a complex issue, and it’s important to keep a focus on individualist care and not one-size-fits-all solutions, but David Crosby is just one example of many people I’ve encountered through my reporting and advocacy work who are pursuing this path with success.” 

DoubleBlind Co-Founder & CEO Shelby Hartman

“There is hardly any rigorous research looking at microdosing psychedelics, or taking small amounts of psychedelics. But, much like we had in cannabis before recreational legalization, we do have thousands and thousands of people saying it has changed their lives. One of the reasons is that when people microdose LSD and psilocybin they often report that they just want to make the healthier decision, the decision that is more aligned with their body’s needs. Dr. James Fadiman, microdosing pioneer, often says that when people microdose they just “want the salad.” I’ve experienced this myself. It’s hard to explain, but on days when I microdose psilocybin, I often find myself habitually reaching for the unhealthy snack or glass of wine and then finding that I genuinely don’t want it. That’s the magic of Cali sober, I think. Not that it’s a cop out for people who can’t actually be sober, but that cannabis and psychedelics, in this context, are seen as supportive medicines that help people make the right choices for themselves.” 

Numinus CEO Payton Nyquest

“For personal health reasons, I’ve never been a heavy drinker to start with, and I’ve reduced my consumption over the years as I tried various therapies and wellness practices. I’ve consistently found that abstinence helps me maintain clarity of mind and keeps me grounded emotionally and spiritually. Today, I’m very happy with a lifestyle that lets me be present as a father, husband and business leader, and to make conscious choices. Integrating regular therapy, including the responsible use of psychedelics, has been a key component in my health journey. I see a similar societal shift happening – I’m not surprised by the move away from alcohol consumption. At Numinus, we believe that psychedelic-assisted psychotherapy (PAP) is transformative and a core part of this shift. We know current healthcare isn’t equipped to handle climbing global rates of mental illness, addiction, and trauma. Ongoing studies show the benefit of PAP in treating many conditions, including substance use disorder, which could include alcohol abuse. In PAP, trained psychedelic therapists help patients by combining traditional psychotherapy with psychedelic medicine, making both components equally critical. It is a trauma-informed practice, meaning patients work through past experiences or traumas in a safe therapeutic container and integrate that learning into everyday life. Through this treatment, we aim to help our patients make more informed choices and build sustainable lifestyle habits.”

Drug & Culture Journalist Mary Carreon

“Abstinence doesn’t work for me. Rigid frameworks have never worked for me. My personality is too indulgent and I love party environments. I’m not exaggerating when I say I live for wild, adventurous times with my crew of close friends. I’ve always been this way! But my life moves too fast and too much is on the line now to be hungover (from anything), which is why I regularly replace alcohol with mini-doses of mushrooms when I go out. They never make me feel hungover, and they give me a way to let loose and still have a good time without getting drunk. I’m a better human on mushrooms (and cannabis or other psychedelics) than alcohol, even though I think most people would classify me as a “happy drunk.” I’m just more conscious and available, I don’t forget what I’m saying half way through a sentence, and I’m more willing to connect with others and maintain all boundaries. To be clear, I’m not Cali sober right now. I went wine tasting last week and drank a hard kombucha last night. I also foresee more wine nights during holidays. Cali sober is something I oscillate to and from for periods of time for my mental, emotional, and spiritual health. And even during the phases when I’m not Cali sober, it still provides a framework for responsible partying, which has been my undying ethos for over a decade. Drugs don’t have to consume you. They don’t make you a bad person, nor do they make you incapable of achieving the highest success. As Dr. Carl Hart says, “using drugs can help us in our pursuit of happiness.” When done responsibly, drugs can actually help us be the best versions of ourselves.”

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

Marijuana Moment is made possible with support from readers. If you rely on our cannabis advocacy journalism to stay informed, please consider a monthly Patreon pledge.

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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.”