Monthly Archives: July 2021

Psychedelic drugsonce promising research subjects that were decades ago relegated to illicit experimentation in dorm roomshave been steadily making their way back into the lab for a revamped 21st-century-style look. Scientists are rediscovering what many see as the substances astonishing therapeutic potential for a vast range of issues, from depression to drug addiction and acceptance of mortality. A frenzy of interest has captivated a new generation of researchers, aficionados and investors, triggering some understandable wariness over promises that may sound a little too good to be true. But late last year the highly respected institution Johns Hopkins Universitythe U.S.s oldest research universitylaunched a dedicated center for psychedelic studies, the first of its kind in the country and perhaps the worlds largest. With work now underway, the center is aiming to enforce the strictest standards of scientific rigor on a field that many feel has veered uncomfortably close to mysticism and that has relied heavily on subjective reports. Early results have been promising and seem poised to keep the research on a roll.

Psilocybin (a psychoactive compound found in certain mushrooms) and LSD were widely studied in the 1950s and 1960s as treatments for alcoholism and other maladies. They later gained a reputation in the media and the public eye as dangerous and became strongly associated with the counterculture. Starting in 1966, several states banned their use. In 1968 LSD was outlawed nationwide, and in 1970 Congress passed the Controlled Substances Act, classifying that drug and psilocybin, along with several others, as having a high potential for abuse and no accepted medical use. But in recent years a rapidly growing number of studies reporting encouraging results in treating depression, addiction and post-traumatic stress disorder (PTSD) have brought them back out of the shadows, spurred on by positive media coverage.

In a major boost to the reviving field, Johns Hopkinss Center for Psychedelic and Consciousness Research is exploring the use of psychedelicsprimarily psilocybinfor problems ranging from smoking addiction to anorexia and Alzheimers disease. One of the remarkably interesting features of working with psychedelics is theyre likely to have transdiagnostic applicability, says Roland Griffiths, who heads the new facility and has led some of the most promising studies evaluating psilocybin for treating depression and alcoholism. The myriad applications suggested for these drugs may be a big part of what makes them sound, to many, like snake oilbut the data [are] very compelling, Griffiths says. And psychedelics may not only hold hope for treating mental disorders. As Griffiths puts it, they provide an opportunity to peer into the basic neuroscience of how these drugs affect brain activity and worldview in a way that is ultimately very healthy.

As author Michael Pollan chronicles in his 2018 best seller How to Change Your Mind, researchers were examining the therapeutic effects of psychedelics in the 1950sa decade before then Harvard University psychologist Timothy Leary and his colleague Richard Alpert started their notorious study in which they gave psilocybin to students (ultimately leading to Learys and Alperts dismissal from the university). In the 1950s1970s, studies conducted with LSDwhich acts on the same brain receptors as psilocybinreported strong results in treating substance use disorders, including alcohol and heroin addiction. But when LSD became illegal in 1968, funding for this work gradually dried up. Most psychedelics research stopped or went underground.

Griffiths and some of his colleagues helped revive the field around 2000, when they obtained government approval to give high doses of psilocybin to healthy volunteers. The researchers published a foundational study in 2006 showing a single dose was safe and could cause sustained positive effects and even mystical experiences. A decade later they published a randomized double-blind study showing psilocybin significantly decreased depression and anxiety in patients with life-threatening cancer. Each participant underwent two sessions (a high-dose one and a low-dose one) five weeks apart. Six months afterward, about 80 percent of the patients were still less clinically depressed and anxious than before the treatment. Some even said they had lost their fear of death.

Armed with these promising results, Griffiths and his colleagues turned their attention to other clinical applications. They decided to investigate tobacco addictionin part because it is much easier to quantify than emotional or spiritual outcomes. Johns Hopkins researcher Matthew Johnson led a small pilot study in 2014 to see whether psilocybin could help people quit smoking. It was an open-label study, meaning the participants knew they were getting the drug and not a placebo.

The work followed a classic model for psychedelic therapy in which the participant lies on a couch and wears eyeshades while listening to music. Researchers do not talk to or guide subjects during the trip, but before each session, they do try to prepare people for what they might experience. In Johnson and his colleagues study, participants also underwent several weeks of cognitive-behavioral therapy (talk therapy aimed at changing patterns of thinking) before and after taking psilocybin. The drug was given in up to three sessionsone on the target quit date, another two weeks later and a third, optional one eight weeks afterward. The subjects returned to the lab for the next 10 weeks to have their breath and urine tested for evidence of smoking and came back for follow-up meetings six and 12 months after their target quit date.

At the six-month mark, 80 percent of smokers in the pilot study (12 out of 15) had abstained from cigarettes for at least a week, as verified by Breathalyzer and urine analysisa vast improvement over other smoking cessation therapies, whose efficacy rates are typically less than 35 percent. In a follow-up paper, Johnson and his colleagues reported that 67 percent of participants were still abstinent 12 months after their quit date, and 60 percent of them had not smoked after 16 months or more. Additionally, more than 85 percent of the subjects rated their psilocybin trip as one of the five most meaningful and spiritually significant experiences of their lives. The team is currently more than halfway through a larger, five-year study of 80 people randomized to receive either psilocybin or a nicotine patch at the new Johns Hopkins center. Recruitment for the study is ongoing.

The exact brain mechanism by which the therapy appears to work remains unclear. At the psychological level, Johnson says, there is evidence that the sense of unity and mystical significance many people experience on psilocybin is associated with greater success in quitting, and those who take the drug may be better able to deal with cravings. At the biological level, he adds, scientists have hypothesized that psilocybin may alter communication in brain networks, possibly providing more top-down control over the organs reward system. A team led by Johns Hopkins cognitive neuroscientist Frederick Barrett is now investigating further by using functional magnetic resonance imaging to measure brain activity before and after patients undergo the therapy.

Like any drug, psilocybin comes with risks. People with psychotic disorders such as schizophrenia (or a strong predisposition for them) are generally advised against taking the hallucinogen. People with uncontrolled hypertension are advised to abstain as well, because psilocybin is known to raise blood pressure. Although it appears to be one of the safest recreational drugs and is not considered addictive, there have been reports associating it with deathsbut these may have been the result of multiple drugs, impure substances or underlying medical issues. In the smoking study, a third of participants experienced some fear or anxiety at a high dose of the psilocybin, Johnson says. But he adds that the risks can be minimized by carefully selecting participants and administering the drug in a controlled environment.

The smoking study results are promising, but Johnson says its relatively small size is a limitation. Also, subjects in such studies cannot comprise a completely random sample of the population, because it would be unethical to recruit people without telling them they may be taking a psychedelic drug. Thus, participants tend to be people who are open to this category of experience and, potentially, more apt to believe in its efficacy. And it is also hard to tease apart the effects of psilocybin from those of the cognitive-behavioral therapy in the smoking study, Johnson notes. He and his colleagues at the new center plan to conduct a double-blind, placebo-controlled studythe gold standard for medical investigationsin the future. Johns Hopkins researchers are also starting or planning studies using psilocybin therapy for a wide range of other conditions, including opioid addiction, PTSD, anorexia, post-treatment Lyme disease syndrome, Alzheimers disease and alcoholism in people with depression.

David Nichols, a professor emeritus of pharmacology at Purdue University, who was not involved in the recent Johns Hopkins studies but had synthesized the psilocybin used in Griffithss 2006 and 2016 papers, has been conducting research on psychedelics since the late 1960s. Back then, you probably could have counted on one hand the number of people in the world that were working in this field. There wasnt any money; there was no interest. [Psychedelics] were just looked at as drugs of abuse, he says. Now theres a whole society set up to study these, with probably 150 international scientists working on it.

Nichols says he has supported Griffithss and Johnsons work since its early days, as they gathered the initial data that excited wealthy donors enough to fund the latest research. Philanthropic funding is the way its going to beuntil the National Institutes of Health decide that this is a field worth funding, he says. There are still too many political considerations that are keeping that from happening, but eventually, well get there. Well get institutional support. Were just not there yet.

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Johns Hopkins Scientists Give Psychedelics the Serious ...

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Post-traumatic stress disorder is a crippling, hard-to-treat psychiatric affliction, and the U.S. spends billions annually on veterans who have it. Now theres new hope for sufferers: psychedelics.

This past Monday in Nature Medicine, researchers reported on a treatment combining psychotherapy with doses of MDMAthe illegal drug known as Ecstasy or Molly. In a Phase 3 trial, the therapy was effective in reducing PTSD symptoms and improving daily functioning in 42 participants. Two months after their last session, two-thirds of the MDMA-treated patients no longer met the PTSD diagnosis, compared with a a third of those treated with placebos.

The Food and Drug Administration has approved a handful of antidepressants as PTSD treatments, which provide relief for only about half of patients. The Nature authors speculate that MDMA-assisted sessions produce a window of tolerance, in which patients can revisit traumatic memories with less shame and anger, and without being overwhelmed by PTSD symptoms.

When people see these results, there will be tremendous interest in it, says Amy Emerson, chief executive of the MAPS Public Benefit Corp., which ran the trials. Drug activist Rick Doblin founded the Multidisciplinary Association of Psychedelic StudiesMAPSto pursue the scientific study of banned psychoactive drugs in 1986. Mondays news lifted shares of some psychedelic drug start-ups, even though they werent involved in the MDMA study: Compass Pathways rose 5% that day, to $35.77 and Field Trip Health gained 13%, to $5.18. Doblin jokes about his 35-year effort: Were the oldest start-up in the world.

Its Tax Day 2021. Federal income tax filings for individuals for the 2020 tax year are due today, four-and-a-half weeks later than usual.

The National Association of Home Builders releases its NAHB/ Wells Fargo Housing Market Index for May. Consensus estimate is for an 81.5 reading, slightly lower than the April figure. Home builders remain very bullish on the housing market.

The Federal Reserve Bank of New York releases its Empire State Manufacturing Survey for May. Economists forecast a 25 reading, less than Aprils 26.3, which was a three-and-a-half year high for the index.

Home Depot, Macys, Take-Two Interactive Software, and Walmart announce quarterly results.

Raytheon Technologies holds its 2021 investor meeting.

Novartis hosts a conference call to discuss its cardiovascular drugs.

The Census Bureau reports new residential construction data for May. Expectations are for a seasonally adjusted annual rate of 1.7 million housing starts, while building permits are seen coming in at 1.75 million. Both estimates are a tick lower than the March data.

Analog Devices, Cisco Systems, JD.com, Keysight Technologies, Lowes, Synopsys, Target, and TJX Cos. report earnings.

The Federal Open Market Committee releases the minutes from its late-April monetary-policy meeting.

Fortive webcasts its 2021 virtual investor day.

Applied Materials, Hormel Foods, L Brands, Ralph Lauren, and Ross Stores hold conference calls to discuss earnings.

Sysco hosts its 2021 investor day.

Altria Group, McDonalds, and Morgan Stanley hold their annual shareholder meetings.

The Conference Board releases its Leading Economic Index for April. Consensus estimate is for a 1.1% month-over-month increase, after a 1.3% gain in March. Following a stronger than expected gross-domestic-product growth rate in the first quarter, the Conference Board is now projecting a real GDP growth rate of 6.4% for 2021.

Deere and V.F. Corp report quarterly results.

IHS Markit reports both its Manufacturing and Services Purchasing Managers Indexes for May. Economists forecast a 60.5 reading for the Manufacturing PMI and 64.7 for the Services PMI. Both estimates are roughly even with the April data, which were multiyear highs for both indexes.

Write to Bill Alpert at william.alpert@barrons.com

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Psychedelics Get a New Look, and PTSD Sufferers Might Have ...

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Shares of Seelos Therapeutics (NASDAQ:SEEL) were jumping 11.4% higher as of 12:28 p.m. EDT on Tuesday. The gain came after the company announced that it has been included in the Defiance Next Gen Altered Experience ETF (NYSEMKT:PSY). This is the first exchange-traded fund (ETF) focused on psychedelics-related stocks listed on a U.S. exchange.

It's good news any time a small biotech stock is included in an ETF. As investors buy the ETF, the fund will buy more shares of the individual stocks that it holds. However, it's still too early to know for sure the full impact that the inclusion of Seelos in the Defiance Next Gen Altered Experience ETF will have. This ETF only began trading on May 28, 2021.

Image source: Getty Images.

Still, the launch of this new ETF should help further validate the emerging psychedelics industry. Seelos stands as one of the leaders in psychedelics, with two clinical-stage candidates in its pipeline targeting four indications.

This wasn't the first time that Seelos has been included in a psychedelics-focused ETF, though. In January, the company announced that it was one of 17 businesses included in the Horizons Psychedelic Stock Index ETF, which is traded on Canada's NEO exchange.

The main thing to watch with Seelos is its pipeline progress. Seelos recently announced positive results from part 1 of an open-label study evaluating SLS-002 (ketamine) in treating acute suicidal ideation and behavior in patients with major depressive disorder. It's also conducting clinical studies of SLS-005 (trehalose) in treating neurodegenerative disease amyotrophic lateral sclerosis (ALS), rare genetic disease Sanfilippo syndrome, and rare genetic muscle disorder oculopharyngeal muscular dystrophy (OPMD).

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

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Why Seelos Therapeutics Stock Is Jumping Today | The ...

Investors are opening their minds and wallets to the possibilities of psychedelic-assisted therapies.

Three biopharmaceutical companies aiming to make psychedelic drugs to treat mental health disorders have gone public in recent months: Peter Thiel-backed Atai Life Sciences IPO'd in June and now has a market cap of $2.6 billion; MindMed went public in April and now has a market cap of more than $1 billion; and Compass Pathways IPO'd in November, with a current market cap of nearly $1.5 billion.

Together the three companies have more than nine psychedelic therapy drugs in their pipelines. And that's not to mention the work being done by many more private biotech and telemedicine companies like Y Combinator-backed Gilgamesh Pharmaceuticals, as well as start-ups like Mindbloom, which is already treating patients with ketamine-assisted psychotherapy. (Ketamine is not a psychedelic but is considered a dissociative anesthetic that can lead to a distortion of sights, colors, sounds, self and environment).

All this means that tripping on mind-altering drugs like MDMA could become a regular part of therapy to treat conditions from depression to post-traumatic stress disorder, addiction, chronic pain and obsessive-compulsive disorder in the next two to five years.

Here's what that could look like and what the research says.

Psychedelic drugs are substances that alter perception and mood and affect a number of cognitive processes. The classic psychedelics include MDMA aka "ecstasy" or "molly," LSD, psilocybin or "mushrooms," ayahuasca and ibogaine.

Used in conjunction with therapists, research has shown that psychedelics can help treat historically difficult-to-treat conditions by essentially "reshaping" the way "parts of the brain talk to each other," says Jennifer Mitchell, a neuroscientist and professor in the departments of neurology, psychiatry and behavioral sciences at the University of California San Francisco.

Researchers provide therapeutic support in the treatment room at one of the study sites for MAPS-sponsored clinical trials of MDMA-assisted therapy for PTSD.

Courtesy of MAPS.

"Psychedelics allow for processing in a way that enables subjects to let go of things that had previously plagued them," she says.

As Mitchell explains it, when people are young, their brains go through critical periods of learning and development that then become closed off as they age. Researchers believe that psychedelics "open those closed critical periods for just a tiny window of time," she says.

"When that critical period is open again, you want to make the most of it, and make that potential change as positive as possible," she says.

With psilocybin, for instance, it is believed the drug boosts connectivity in the brain and increases "neuroplastic states," which are the brain's ability to reorganize and adapt, says Dr. Stephen Ross, associate professor of psychiatry at the NYU Grossman School of Medicine, who has been conducting clinical trials on psilocybin-assisted therapy for the past 16 years.

A recent Yale University study conducted on mice, for instance, found that a single dose of psilocybin led to an immediate increase in connections between neurons that lasted for a month afterwards.

When on psychedelics, "parts of the brain that don't normally speak to each other start to communicate with each other, and it appears to reset brain patterns in some way," he says.

MDMA-assisted therapy could be approved by the FDA for medical use as early as 2023, while other psychedelics, notably psilocybin, are waiting in the wings for their turn to be evaluated for medical purposes.

If and when psychedelic-assisted therapy is FDA-approved, it will be far more complex and medicalized than just someone taking mushrooms recreationally in the woods.

"You don't just get thrown into it," Mitchell says. "It's not Burning Man or something. It's very thoughtful."

First, patients will have to be carefully screened to be eligible.

"It's not for everybody," says Dr. Corine de Boer, chief medical officer at Multidisciplinary Association for Psychedelics Studies, a nonprofit research and educational organization. For example, the treatment isn't suitable for people who have a history of psychosis or cardiovascular issues. (And at the moment, psychedelics are not being studied on people with milder mental health conditions or people without clinically diagnosable conditions.)

For those who do qualify, psychedelic-assisted therapy sessions will be "a synergy between the participants, the therapists and the drugs," de Boer says.

Research-grade capsules for use in MAPS-sponsored clinical trials of MDMA-assisted therapy for PTSD.

Courtesy of MAPS.

Before any drugs are administered, clinicians meet the patient to talk about what might come up for them for example, a traumatic incident or painful memories from childhood, or for a terminally ill patient, they may review how the disease has affected their lives.

The sessions, during which the patient takes psychedelic drugs, can be pretty labor intensive and long (about eight hours), Mitchell says. A single dose of MDMA acts for six hours and a half-dose is given about 90 minutes into the session.

To ensure that the patients have a comfortable setting in which to trip, providers set up a space that resembles a living room or bedroom and give the patients eye shades and a playlist with soothing music before taking the drug. Patients are invited to "go inward" and think about the topics that they discussed in the preparatory sessions.

"Whatever comes up for them is whatever the medicine decides, based on their own history and [brain] circuitry," Mitchell says.

Patients might talk about the topics that come up, and the therapists are there to help them accept and listen to whatever ideas come to the surface, rather than prompt them with questions. "As you could imagine, there's a lot of emotions," Mitchell says.

Patients are conscious and can comfortably eat, drink and use the bathroom, though are escorted by two staff members when they stand or walk, Mitchell explains.

The following day there will be an "integration session," in which the therapists talk to the patient to help them make sense of the experience. The patient might circle back to the reasons why they pursued the treatments in the first place and discuss what they felt or saw during the experience, for example.

Mitchell says there's an important transformation that takes place when people take psychedelics in this clinical setting. "It's amazing how much lighter and freer people appear to be following the even the first session," she says.

Indeed, in a recent MDMA study, depression was offset or significantly attenuated after three doses that were each administered about a month apart.

The expectation is that these treatments will eventually be covered by health insurance. Getting insurance to cover treatment is also contingent upon the compounds getting rescheduled from their current classification as Schedule I drugs under the Controlled Substances Act. (Experts anticipate MDMA could be rescheduled in the next two years.)

Naturally, there are risks to the treatment. People who have psychotic disorders as well as those who have hypertension are not recommended for psychedelic-assisted therapy. Outside of a clinical trial, many psychedelics, such as psilocybin and MDMA, are classified as Schedule I drugs under the Controlled Substances Act.

But "in the next three to five years, psychiatry is going to be profoundly altered" by psychedelic-assisted therapy, says Ross.

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Psychedelic trips could soon be part of therapy heres what those sessions will look like - CNBC

An amendment to protect all state and tribal marijuana programs from federal interference now has 15 cosponsors after its bipartisan proponents circulated a letter to build support this week. But a Republican opponent of reform is pushing a dueling proposal to end a more modest, longstanding rider thats provided protections for medical cannabis states alone.

The pro-reform amendmentwhich could receive a vote on the House floor next weekis being led by Reps. Earl Blumenauer (D-OR), Tom McClintock (R-CA), Eleanor Holmes Norton (D-DC) and Barbara Lee (D-CA). The hope is to attach the proposal to 2022 fiscal year spending legislation for the Commerce, Justice, Science, and Related Agencies (CJS).

Meanwhile, Rep. Doug LaMalfa (R-CA) is taking the unusual step of filing a competing measure that would cease federal protections for states with medical cannabis legalization on the booksincluding his ownthat have been in place and renewed annually on a bipartisan basis since 2014.

Given Democratic control of Congress and the increasingly cross-party nature of support for marijuana reform overall, advocates arent necessarily concerned about LaMalfas amendment. But while the GOP congressman has earned a reputation as a staunch reform opponent, going so far as to recently bulldoze illicit cannabis grow sites in California alongside local police, his proposal to end protections for the states decades-old medical cannabis program has raised eyebrows.

On the other end, pro-reform lawmakers explained in a Dear Colleague letter this week that the appropriations revision theyre proposing would add language preventing the Department of Justice from using any funds appropriated by Congress to enforce federal laws regarding activities that are legal under state, territorial, or tribal law with regard to marijuana, regardless of whether the marijuana laws are recreational or medicinal.

This language has been proposed in past sessions as well,passing the House last yearand in 2019. But it was not attached to final appropriations legislation sent to the presidents desk under GOP control of the Senate. Now that Democrats have a slim majority in the chamber, advocates are optimistic that it could finally be enacted.

In addition to the four main sponsors of the amendment, its now been cosponsored by Democratic Caucus Chairman Hakeem Jeffries (D-NY) and Reps. Carolyn Maloney (D-NY), David Joyce (R-OH), Diana DeGette (D-CO), Dina Titus (D-NV), Donald Beyer (D-VA), Jan Schakowsky (D-IL), Mike Thompson (D-CA), Pramila Jayapal (D-WA), Ed Perlmutter (D-CO) and Don Young (R-AK)

As it stands, the spending bill rider that LaMalfa is attempting to strike offers the protection only to states with medical cannabis programs. This new broader amendment from reform supporters would expand that protection at a time when more and more states are opting to legalize marijuana for adult use. Four statesConnecticut, New Mexico, New York and Virginialegalized for recreational purposes this year alone.

Heres the text of the proposed amendment:

1 SEC _. None of the funds made available by this Act to the Department of Justice may be used, with respect to any of the States of Alabama, Alaska, Arizona, Arkansas, California, Colorado, Connecticut, Delaware, Florida, Georgia, Hawaii, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Montana, Nebraska, Nevada, New Hampshire, New Jersey, New Mexico, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, SouthCarolina, South Dakota, Tennessee, Texas, Utah,Vermont, Virginia, Washington, West Virginia, Wisconsin, and Wyoming, or with respect to the District of Columbia, the Commonwealth of the Northern Mariana Islands, Guam, Puerto Rico, or the United States Virgin Islands, to prevent any of them from implementing their own laws that authorize the use, distribution, possession, or cultivation of marijuana.

1 SEC __. None of the funds made available by this Act to the Department of Justice may be used to prevent any Indian tribe (as such term is defined in section 4 of the Indian Self-Determination and Education Assistance Act (25 U.S.C. 5304)) from enacting or implementing tribal laws that authorize the use, distribution, possession, or cultivation of marijuana.

The first time the House passed the more sweeping protections to cover state recreational marijuana laws was in 2019, andmembers approved it along largely bipartisan lines.

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

LaMalfa also filed a second amendment to the CJS bill thats aimed at including marijuana grow sites in the eligible category for [Drug Enforcement Administration] reimbursement of state, units of local government, or tribal governments for expenses incurred to clean-up and safely dispose of substances which may present a danger to public health or the environment found at illegal marijuana grow sites.

An additional LaMalfa amendment to a separate funding bill for the State Department is meant to express the intent to direct the Department of State to issue a report on the connections between international criminal organizations and illegal marijuana grows within the United States.

On the CJS bill, Rep. Jay Obernolte (R-CA) also filed an amendment intended to support efforts to eliminate illegal marijuana grows in South Eastern California.

The appropriations process this session has seennumerous drug policy reform provisionsincluded in bill text and attached reportsincludingprotecting banks that work with marijuana businesses, encouraging government agencies toreconsider policies that fire employees for useandexplore research into the medical value of psychedelicsandstopping immigrants from being deported for cannabis, amongother issues.

Separately, the full House of Representatives couldvote next week on amendments to large-scale minibus appropriations legislationthat would make it so marijuana possession or consumption could not be used at the sole basis for denying people access to public housing.

For the CJS appropriations bill where the new marijuana state protection language could be attached, amendments were due to be submitted by Friday afternoon. The House Rules Committee is set to make a rule next week, after which point the legislation and any amendments that are deemed in order will move to the floor for votes.

Kansas City Mayor Files Ordinance To Ban Pre-Employment Marijuana Testing For Most City Workers

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AOC Promotes Research On Benefits Of Psychedelics Like Psilocybin And MDMA With New Amendment - Marijuana Moment

What makes a drug a drug?

Its strange to say, but we dont really have a good definition of the term. You could say a drug is any substance that transforms our subjective experience of the world, but food does that, too. So whats the difference?

In this country, it turns out the difference is pretty arbitrary. Drugs are whatever the government says they are. And for a long time, the government has classified them in a deeply dishonest and cynical way. We call this absurdity the drug war.

But heres the good news (especially if youre one of the groups victimized by it): The drug war is dying. You can see it in the marijuana legalization movement and you can see it in the so-called psychedelic renaissance. The country will have to think seriously about what comes next. How will our taboos shift? What sorts of reforms will we need? What kind of cultural infrastructure should we build?

Michael Pollan is perhaps best known for his 2006 book The Omnivores Dilemma, but his 2018 work How to Change Your Mind did more than any other to vault psychedelics into the mainstream, and it remains one of the best explorations of the therapeutic potential of psychedelics.

Pollans latest book, published in July, is titled This Is Your Mind on Plants. This one is about psychedelics too, but its a much broader look at our all-too-human obsession with psychoactive plants not just hallucinogens, but also caffeine and opium and why our culture has such a fraught relationship with them.

So we talk about all that, and we explore what we can learn from other cultures about how to use psychedelics, and why he thinks these plants are powerful antidotes to our disconnected lives.

You can hear our entire conversation (as always, theres much more) in this weeks episode of Vox Conversations. A transcript, edited for length and clarity, follows.

Subscribe to Vox Conversations on Apple Podcasts, Google Podcasts, Spotify, Stitcher, or wherever you listen to podcasts.

Ill start with a deceptively simple question: What is a drug?

Its deceptively simple because its very hard to say. I think of it as something we ingest that changes us in some way, but of course you could also say that about sugar or chicken soup. I went to the Food and Drug Administration, who youd think would have nailed this down a long time ago, but they basically decided that a drug is a substance that is not food, that is called a drug by the FDA. Thats how they define a drug.

Its still not at all clear to me what makes a drug a drug and food food.

There are a lot of cases right on the edge. Sugar is a great example. If youve got kids and youve watched how they respond to sugar, theres no question its a drug. But then what about a placebo? That is something that you ingest that changes you, but its not a drug in the pharmacopeia. So its a mess. All of this shows that theres something very arbitrary about illicit versus licit drugs. An illicit drug seems to be whatever the government has decided is illicit.

Well get to that, but lets step back a little. Humans have always and I mean always loved drugs. Why do you think were so determined to change our own consciousness? What is it about ordinary states of consciousness that bores us, or scares or limits us?

Ive been interested in this question for a very long time, as long as Ive been writing about the relationship between plants and people. Its very curious that this appears to be a universal desire of our species, to change consciousness, that were not satisfied with everyday normal consciousness. You alluded to one reason, which is boredom. I think that people seek novelty, and they seek novelty in states of mind as well as places and activities, so thats one.

The relief of pain is another, and thats one of the most important things weve used drugs for. For most of the history of what we now call medicine, pain relief was about all you could get out of it. Opium was the greatest drug in the pharmacopeia because it could relieve pain. And other drugs, whether they act directly on pain or not, distract you from pain, and thats often just as good. Cannabis works that way for some people. It doesnt really diminish pain, but at certain doses you just dont give a shit about the pain.

But I think that there are more interesting reasons that we use drugs. One is, the novelty they contribute is useful to us as a species. The way I describe it in the book is that theyre mutagens in a cultural sense. In the same way that mutations in DNA lead to variation and every now and then produce useful traits that then give an advantage to the individuals or the species that acquire them, drugs have a similar mutating effect on cultural memes. They give people ideas, they plant metaphors, images, all these things that feed into cultural evolution in a way similar to the way mutation and variation feed into biological evolution. Thats pretty speculative, and I dont know that I could prove it scientifically, but I think thats part of whats going on.

The other important things that drugs do is increase sociality. Drugs like alcohol make people more fluid socially, more interested in other people. MDMA does this, too. Activities that make us more sociable creatures are very important to our success as a species.

Our popular conception of drugs seems so flat in comparison to what youre saying now.

During this last 50 years of the drug war, weve lost track of this. Weve really simplified our view of drugs into good and evil. We tend to moralize them, and weve lost track of the fact that something that could be dangerous used in a certain way could also be incredibly helpful in another way.

The Greeks really got it with their word for drugs; they called them pharmakon. That could mean both a blessing and a curse depending on the context, and context is everything when it comes to drugs. There was also a third meaning of pharmakon, which was something like scapegoat. Thats very revealing. A drug was something you could blame things on. And God knows weve done that.

Id argue that our most incontestable right as human beings is the right to experiment with our own consciousness, with our own minds. Why do you think the state is committed to policing how and whether we do this?

I think its because the state regards drug use as a tremendous threat. There are certain drugs that contribute to the smooth working of society, like coffee today. But I wrote about coffee in the book, and there were lots of problems when coffee first showed up in Europe. King Charles II wanted to ban it briefly because he didnt like all the political conversation going on in the coffeehouses. He felt threatened. He thought it was a seditious beverage, but that didnt work. It was already too popular, and he backed down.

In general, though, a drug like caffeine is making us better workers, more focused, less drunk. Its a great drug for capitalism. Capitalism loves caffeine. You need no better proof of that than the existence of the coffee break as an institution. Heres a case where your employer gives you a drug free of charge and then gives you paid time in which to enjoy it. Thats all you need to know about whos benefiting from caffeine.

But then you have something like LSD or psilocybin, which the government took a very strong interest in, even though theyre virtually nontoxic and nonaddictive. But they were disruptive to society in the 60s. Nixon believed that the reason young boys werent willing to go to Vietnam was because of drugs and specifically because of LSD. It may have contributed to their willingness to defy authority. These are substances that, taken in the right context, do encourage independent thinking of various kinds.

Here was a rite of passage, but, unlike most rites of passage, LSD didnt fold the person more tightly into society. It had the opposite effect. It made this young person feel that they were in a whole other culture and wanted to dress differently, talk differently, have different mores. We called it the generation gap. And you had this very interesting and historically pretty novel split in the values of two different generations.

When Nixon decided to launch the drug war in 1971, he did it because he thought these drugs were threatening his political agenda and he may well have been right.

Oh, he was most definitely right, and it speaks to a broader point you were hinting at earlier: One way to determine what a society really values is to look at the drugs it condones and condemns. And its awfully revealing that our society says bourbon and caffeine are good but somehow DMT or psilocybin are bad.

Yeah, but its very interesting that those same chemicals are good in other cultures in other contexts. For example, one of the reasons I was so interested in writing about mescaline is that its a psychedelic, like LSD, but the way its used in the Native American church, where its a legal sacrament, is the most conservative way imaginable. It is used to enforce social cohesion and help heal traumas. Its this very conservative model of psychedelic use. And that told me that theres nothing inherently disruptive about psychedelics its how theyre used.

That will surprise a lot of people. Can you say a bit more about how a drug like mescaline is used to reinforce, as opposed to disrupt, social bonds and values in these communities?

Well, the Indigenous use of psychedelics goes back at least 6,000 years. Thats the oldest evidence we have for the use of mescaline in the form of peyote, the cactus that produces mescaline. These cultures have had a lot of time to experiment with these drugs and figure out what theyre good for. And in most of them its always a social application. They dont use psychedelics alone. Its always in a group setting and theyre approached with great solemnity and ritual, which I think is incredibly important. They dont use these drugs (or medicines) for thrills. Its for communal healing.

Why didnt that happen here?

One of the most striking things about psychedelics is when they showed up in the West, beginning with Albert Hofmanns discovery of LSD in 1938, they were novelties. We didnt look to traditional cultures to understand them, probably out of condescension. So these powerful substances arrived without an instruction manual.

So we just started that process of trial and error that other cultures may have gone through 10,000 years ago. We began in the 50s and 60s, and there was a little bit of research into their potential as medicines, but we didnt know how to use them. We tried lots of things, and some of it was disastrous, and people got into serious trouble.

But now were in the midst of this renaissance in psychedelic research, and its leading to new ways to use these drugs therapeutically that I think the government will actually support very soon. Thats a huge turnaround. And maybe that will change our understanding of psychedelics from something that disrupts our society to something that helps smooth the operation of society, because right now mental health difficulty is whats disrupting our society.

Well, the good news is that the dumb taboos created by the drug war are dying and the laws are starting to evolve, which raises the question: What comes next? How do we fold these substances into society?

Thats a fascinating question. What does the peace look like after the drug war? I dont have the answers, but I have some glimmers of answers. I think that in a way the drug war made things easy, because we didnt have to have this conversation it was either the drug was illegal or it was legal, and we let the government decide. These questions will fall to individuals and cultures when the drug war ends.

One of the really interesting developments to watch is the formation of these new psychedelic churches, around psilocybin or DMT or ayahuasca. Theyre popping up all over the place. People are forming churches because they think its going to give them some legal protection, and it may. The jurisprudence of the Supreme Court around religious freedom is so expansive that its going to be an exploding cigar in front of Sam Alito or John Roberts when the court has to consider the rights of the Church of Lysergic Acid or something. Theyre going to be hard-pressed, given the precedents that theyve laid down.

A theme in this book and your last one is that human beings have become too separated from nature. I obviously agree and Id argue that this is maybe the most consequential fact of the post-industrial world. Are you still hopeful that a psychedelic renaissance is at least part of the solution to this problem?

Look, all my writing has been about bringing nature back into peoples lives and realizing how plants affect us and how we affect them. That reconnection is a big part of my life. Our distance from nature, which is even more pronounced in younger generations whove grown up with social media, is an enormous threat. And Im really interested in any research that explores whether psychedelics help with that. I do think psychedelics are an antidote to our mediated lives and our addictions to phones and screens and everything else that comes between us and the natural world.

Psychedelic takes you off screens. Your phone is not going to be part of the experience, and it is very much about reconnecting to the body, to the contents of the mind, to your memories, and to nature. I had very profound experiences in nature on some of my psychedelic experiences. But again, I was already well-disposed, as a gardener, to love my plants. What I wasnt ready for was to have my plants return my gaze in the garden and announce themselves to me in a way they never had before, as agents with their own perspective and subjectivity. I know this sounds absolutely crazy, but my plants were more alive than theyd ever been.

These are products of nature. This is nature talking to us. And yes, LSD was invented in a lab, but its based on a chemical produced by fungus. Its extraordinary that the plant world might be offering us an antidote to the flight from nature. These plants call us back to nature, and nothing seems more valuable right now than something with that power.

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Michael Pollan on psychedelics and Americas dysfunctional relationship with drugs - Vox.com

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

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

Image source: Getty Images.

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Companies Conduct Clinical Research into Psilocybin-based Therapies

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

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

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

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

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

For more information on Tryp Therapeutics, click here.

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

By Pat Anson, PNN Editor

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

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

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

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

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

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

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

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

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

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

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

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

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