It’s possible that I shall make an ass of myself. But in that case one can always get out of it with a little dialectic. I have, of course, so worded my proposition as to be right either way (K.Marx, Letter to F.Engels on the Indian Mutiny)
Intensity of psychedelic experiences after taking psilocybin does not depend on body mass index, study suggests
Researchers in the United Kingdom studied whether the effects of psilocybin, a naturally occurring hallucinogenic drug, depend on the body mass index of the person, thereby requiring higher doses for the same effect in heavier people. The results showed that the overall intensity of psychedelic experiences after consuming a 25 mg dose of psilocybin was unaffected by differences in body mass indices of respondents. The study was published in the Journal of Psychopharmacology.
Psilocybin is a psychedelic drug obtained from certain sorts of fresh and dry mushrooms (“magic mushrooms”). In the human body, it acts as a serotonin type 2A (5-HT2A) receptor agonist, activating serotonin receptors on brain cells, mostly in the prefrontal cortex region of the brain. In this way, it reduces the energy needed for the brain to switch between different activity states.
Although illegal in the United States and considered a Schedule I substance by the Drug Enforcement Administration (high abuse risk, no medical use), there is a recent increase of interest for its potential use in psychiatric treatment. However, due to its legal status, research on dosing of the drug has, so far, been limited and it is unknown whether the dosage needs to be scaled to achieve the same psychedelic effect for people of different body weight or a fixed dosage can be used for everyone.
“There is already a lot of research supporting the importance of the acute experience in psilocybin-assisted therapy, and that this is not solely dependent on the dose used. The acute experience is also shaped by extra-pharmacological factors; commonly referred to as the set and setting,” explained study author Meg J. Spriggs, a research associate at the Centre for Psychedelic Research at Imperial College London.
“While body weight adjusted dosing is the ‘gold standard’ in pharmacological research, it was unclear from previous research whether bodyweight adjustment is necessary in psilocybin-assisted therapy, given what we know about these extra-pharmacological factors. Here, we wanted to test whether the acute experience and outcome are impacted by a participants BMI when using a fixed 25 mg dose (a ‘therapeutic’ dose) of psilocybin.”
“As we look towards a future where psychedelic-assisted therapy may become accessible, we need to be thinking about how to facilitate safe and equitable clinical roll out,” the researcher said. “Bodyweight adjustment is standard practice in research, but it adds practical and financial complexity to standardization, validation and large-scale distribution. A greater understanding about whether fixed doses can be used will help facilitate this transition to the clinic.”
Spriggs and her colleagues analyzed data from three different studies using psilocybin. Two of the studies were clinical studies on potential use of psilocybin for treating depression and the third was a study on healthy volunteers who have never taken a psychedelic drug before aiming to examine long-term psychological and brain changes. The researchers analyzed data on the effects of a 25 mg dose of psilocybin from all three studies. The three studies included 77 participants. Average age was 43 years.
The researchers measured body weight and height of participants to calculate their body mass indexes. Body mass index is calculated by dividing the body weight of a person expressed in kilograms by the square of the person’s height in meters. It is used to indicate whether a person is underweight, normal-weight or overweight.
Participants also completed an assessment of the altered states of consciousness related to the psychedelic state they were experiencing after taking the psilocybin dose (The Altered States of Consciousness Questionnaire, ASC), of emotional breakthrough experienced during the psychedelic state (Emotional Breakthrough Inventory, EBI) and of well-being (Warwick-Edinburg Mental Well-being Scale).
“Body mass index does not predict overall intensity of the altered state, mystical experiences, perceptual changes or emotional breakthroughs during the acute experience. There was weak evidence for greater ‘dread of ego dissolution’ in participants with lower body mass index,” Spriggs and her colleagues wrote. However, further analysis suggested that even this link with body mass index disappeared when age and sex of participants are taken into account.
“While mystical-type experiences and emotional breakthroughs were strong predictors of improvements in well-being, BMI was not,” the researchers concluded.
“This helps us understand that psychedelic-assisted therapy is more than just pharmacology, it is psycho-pharmaco-therapy,” Spriggs told PsyPost. “The drug is only one aspect of the therapy ‘package,’ which also includes extensive psychological preparation before, and integration after, the dosing session which takes place in a supportive and therapeutically-oriented environment.”
This research further demonstrates that there is more than just the ratio of dose-to-bodyweight in determining the acute experience and the outcome.
“This is a great demonstration of where ‘support for the null hypothesis’ is really important. Using standard (‘frequentist’) statistical methods, the results of this study are non-significant — meaning that there is no evidence for the effect of BMI, and so the results are inconclusive. A common problem in science is that null results are often not published. Not only does this mean that the wider science community cannot learn from null findings, but it can put pressure on researchers to ‘find’ significant results if they want a study to be published.”
“Here we took a different statistical approach (Bayesian statistics) that allowed us to draw conclusions about evidence in support of the null hypothesis. i.e., we can say that there is evidence against BMI being a predictor of acute experience and outcome. So, what would typically be a null result is actually really informative. I hope that this helps people to look at science in a different way, and inspires scientist to explore new statistical approaches.”
The study results provide strong evidence that scaling psilocybin dose according to body weight is not necessary and that a fixed dosage for all persons is sufficient to achieve acute psychedelic experience. However, it also has certain limitations. Notably, only the 25 mg dosage was studied and it is possible that effects of different dosages would depend on body weight. Also, there were much more obese participants than underweight ones.
“Fixed vs bodyweight adjusted dosing also has implications for clinical applications in populations where BMI is part of the diagnostic criteria, e.g., anorexia — I am currently working on a trial of psilocybin-assisted therapy for anorexia at Imperial College London,” Spriggs noted.
was authored by Meg J. Spriggs, Bruna Giribaldi, Taylor Lyons, Fernando E. Rosas, Laura S. Kärtner, Tobias Buchborn, Hannah M. Douglass, Leor Roseman, Christopher Timmermann, David Erritzoe, David J. Nutt, and Robin L. Carhart-Harris.
When Jaclyn Downs, a 43-year-old nutritionist in Lancaster, Pennsylvania, stumbled upon the concept of microdosing psilocybin, or taking a tiny amount of a psychedelic for a subtle effect, she immediately recalled an incident in college where friends made tea with “magic mushrooms,” which contain the drug. Downs had only one sip, but she spent the rest of the night feeling grounded, peaceful, and present. Looking back, she realized what she had experienced was a microdose.
Three years ago Downs began microdosing to prepare for certain situations, such as when she had to stay later at a social event than she might want to. The drug soothed her angst and made her a better conversationalist, she says. Six months ago, she began a more structured routine, taking a tincture of microdose psilocybin every three days. It has made her calmer and more accepting, she says, especially when her six- and nine-year-old daughters argue with one another or push back on her requests. “Before I was more reactive—getting angry or irritated—but now I respond more evenly,” Downs says. “The general atmosphere of our home is more positive.”
Diana Bui, Wendell Phipps, and Carlyn Hope Davis went hiking in the Pacific Palisades after microdosing and then chose to roller skate at their favorite location on Venice Beach.
In recent years, psychedelic drugs have evolved from a taboo topic to one gaining acceptance in mainstream quarters of society. Psychedelics are even heading for general medical approval, having been designated as a “breakthrough therapy” by the U.S. Food and Drug Administration.
But many who are intrigued by the promise of psychedelics—a category that includes psilocybin, lysergic acid diethylamide (LSD), ayahuasca, mescaline, and other substances that alter consciousness—are eager to reap the benefits without having to take a dose strong enough to provoke an hours-long journey down the rabbit hole. A growing number are turning to microdosing, regularly ingesting five to 10 percent of the mind-bending amount in a quest to enhance well-being, improve work, or diminish depression and other psychological demons without triggering the drug’s full effects.
Many people who microdose consume foods or teas containing psychedelic drugs, which can trigger warm emotions and pleasure. Here a baker spritzes cookies with a microdose of a psychedelic brew including MDMA—also known as ecstasy or Molly—as well as LSD and 2C-B, a synthetic drug first synthesized in the 1970s.
But experts say there is little scientific evidence so far to support this approach.
“As far as we know, there are not many risks associated with microdosing. But it’s not at all clear, aside from user testimonials, that there are benefits,” says John Krystal, chair of psychiatry at the Yale School of Medicine, who has closely followed the field.
A key reason is that microdosing, as it is done in real life, is challenging to study. Users generally consume a dose for one or two mornings, skip the next one or two, and repeat this regimen for months or years. Because psychedelics are illegal, U.S. law prohibits researchers from giving them to people to take on this schedule at home. But providing the drug and overseeing users day after day in a laboratory isn’t practical, says Albert Garcia-Romeu, a researcher at the Center for Psychedelic and Consciousness Research at Johns Hopkins Bayview Medical Center in Baltimore.
That presents a problem for both the scientists and the microdosers. When active users respond to surveys about their experiences for observational research, the scientists can’t be sure each person is taking the same amount. After all, there aren’t standardized products a person can pick up at the local pharmacy. It’ s especially challenging for someone to determine an exact psilocybin microdose from a batch of dried mushrooms or a lick of an LSD tab, says Jerome Sarris, executive director of the Psychae Institute in Melbourne, Australia.
Alli Schaper is cofounder and CEO of Supermush, which sells various mouth sprays made from non-psychedelic mushrooms called cordyceps. Here, Schaper chills out at her home in Marina Del Rey, Los Angeles, after taking a microdose of psilocybin.
No one knows how many people in the U.S. currently microdose, although its popularity seems to be growing. An analysis in 2018 of a Reddit discussion group devoted to microdosing recorded 27,000 subscribers; in early 2022, the group had 183,000. At a recent business conference focusing on psychedelic drugs in Miami, when audience members were asked how many currently microdose, hundreds of hands went up.
“When it first became popular about a decade ago, microdosing was hush hush, with tech entrepreneurs and businesspeople the primary users,” says Steven Holdt, the 24-year-old founder of Tune In Psychedelics, an app that lets microdosers track their dosing schedules and record drug effects for their own information. In the past few years, a broad range of people have jumped on board, Holdt says, thanks to podcasts on the topic, articles in mainstream newspapers, and writer Ayelet Waldman’s popular book, A Really Good Day, which chronicled how microdosing LSD lifted her intractable depression.
he Hillbilly is one of the most common varieties of magic mushroom. The psychedelic pan-tropical giant grows wild in states lining the Gulf Coast, and is found in Central and South America, the Caribbean, and Southeast Asia. This one was grown in the Hollywood Hills of Los Angeles.
Erica Zelfand, a naturopathic physician in Portland, Oregon, says dozens of her patients currently microdose, mostly in a bid to improve their depression or attention deficit disorder. Zelfand supports their efforts but makes it clear they are lab rats in a grand experiment. “I let them know that we don’t have the research yet. And we especially don’t know the long-term risks,” she says. To help build a body of knowledge, she encourages patients to report their experiences on crowdsourced research sites like microdose.me or microdosingsurvey.com.
An earthy platter showcases the many shapes of the Hillbilly mushroom. The psychedelic effects of these fungi can kick in as quickly as 15 to 30 minutes after a microdose, peak in 60 to 90 minutes, and mostly disappear after about six hours.
None of the current studies on microdosing reach standards that enable scientists to draw firm conclusions. But results from recent studies using a single high-dose psychedelic have illuminated the mental-health potential of these long-shunned drugs. One potent dose of synthetic psilocybin along with psychological support improved treatment-resistant depression, according to unpublished results from a randomized study of more than 200 people released in November by the company Compass Pathways, whose proprietary formulation is one of the F.D.A. breakthrough-therapy designees. And in May 2021 scientists reported in the journal Nature that a high dose of MDMA (aka Molly or Ecstasy, which is not a classic psychedelic but produces a similar effect) greatly diminished severe post-traumatic stress disorder (PTSD).
The doctor-patient relationship is all about trust, and for good reason: your life, health, and wellbeing are literally in their hands. Experts say that a key part of building that trust lies in open communication, yet there's one conversation doctors and patients are evidently failing to have. A 2013 Harvard study has found that many doctors may be misinterpreting your wishes and acting against your best interest when it comes to prescriptions. A quick conversation to set the record straight could have a major impact—not only on your health, but on your finances, too. Read on to find out which prescription you should never let your doctor write, and how to fix the problem if they already have.
But these results can’t be generalized to microdoses, says Matthew Johnson, acting director of the Johns Hopkins Center, which has conducted numerous studies on high-dose psychedelics.
A review of psychedelic research that Sarris published in January 2022 underscored problems facing studies that seek to discover both micro- or high-dose effects of a psychedelic drug: few large randomized trials have been done in humans.
Studies of medications in people typically begin with what is known as a phase one clinical trial, designed to determine levels of safety and tolerability in a small number of people. Such a study has not yet been undertaken for microdosing, although the drug manufacturer Diamond Therapeutics announced in November that it is about to embark on such a trial, minutely escalating the quantity of psilocybin until the ideal microdose, one that causes positive effects with the fewest negative ones, is found.
A handful of laboratory studies that included a small number of healthy people have sought to uncover the effects of microdosing after taking one or a few doses. A 2020 review published in Therapeutic Advances in Psychopharmacology counted 14 of these small experimental studies, with most finding that microdosing LSD or psilocybin yields subtle positive changes to emotions and to thought processes involved in problem-solving. The reviewers noted that some users did feel anxious or overly euphoric. Since all studies were done in healthy individuals it isn’t known whether microdosing might consistently benefit people with mental-health concerns.
One European study of 30 people, published in April 2021, found that people who microdosed psychedelics for several weeks were more in awe when viewing videos and artworks than during the weeks they took a placebo. But the study was flawed because many people were able to figure out what they were taking based on side effects like increased sweating so the researchers were unable to separate people’s actual experiences from their expectations. Placebo effect?
Larger studies have primarily asked current users about their experiences. One tapped more than a thousand microdosers who reported increased energy, better work results, and more positive moods. Another compared 4,000 microdosers to a similar group of nonusers and found that among people with prior mental-health issues, those who microdosed reported having lower levels of anxiety and depression.
But in addition to the issue of users taking non-standardized doses, participants were all microdosing before the studies began, so they may have been biased. “We have to be cautious about not overinterpreting the encouraging retrospective reports that have appeared in the literature,” Yale’s Krystal says. “The concern about first-person experiences is that there is often tremendous potential for placebo effects to color the interpretation.”
In fact, the best study of microdosing to date shows just this effect. This was a “citizen science initiative” involving some 200 LSD and psilocybin microdosers. Some of the participants were chosen at random by scientists at Imperial College London to swap their drugs for placebos, with neither group knowing for sure which they were getting. After a month everyone was surveyed about their well-being, life satisfaction, cognition, and other factors. Psychological outcomes improved significantly for people taking the psychedelics—but they also did for those downing the placebos.
This was a clever way to study a large number of microdosers in the current regulatory environment, says Garcia-Romeu, who helped to evaluate the research for the journal eLife. The fact that so many placebo-takers reported benefits “calls into question the whole phenomenon of microdosing,” he says.
Nonetheless, imaging studies do make clear that something is happening.
In one, 20 healthy people were scanned with an fMRI several hours after taking a microdose of LSD or a placebo. The amygdala, considered the emotion center of the brain, changed how it interacted with other brain regions in the microdosers, indicating the potential to better regulate negative emotions, says study coauthor Katrin Preller, a neuropsychologist at the University of Zurich. In fact, those whose brains experienced the improved connectivity also subjectively reported feeling more upbeat, Preller says. Another study used electroencephalography (EEG) to measure brain activity in 22 LSD microdosers and documented more activity in the brain than usually occurs during rest, something also seen with high-dose psychedelics. The effects of microdosing
Despite the paucity of research, people are turning to microdoses for a variety of reasons. Holdt says microdosing psilocybin helps him have fun around other people. He suffers from social anxiety, so without the drugs his mind constantly ruminates about all the things he might say or do. “Microdosing helps me stop that inner monologue so I can be more comfortable and present,” he says. He has had the same effect using high-dose psychedelics, which he first experienced in high school, but says the subtler effects of microdosing make it easier to incorporate into everyday life. “You don’t need to take a day off work or have someone watching you [to make sure a trip doesn’t turn ugly],” he says.
Many microdosers find it helps them with work. Dusty, a 40-year-old audio engineer in Philadelphia (who asked that only his nickname be used), says the tiny bit of LSD he takes once each week boosts his productivity, desire to collaborate, and creativity on the job. For example, when setting up sound systems for live concerts, “there are a million little problems that you need to solve every day, and there’s not always a good road map,” he says. On days he microdoses, he’s noticed he has “a little extra excitement to solve a problem that leads to long-term solutions, rather than just making it work for now.”
Others microdose to self-treat mental-health conditions. Karen Gilbert, a 69-year-old retired nurse in Lopez Island, Washington, is hoping microdosing psilocybin, which she started in November, might help with the depression she has suffered for more than two decades. One of Zelfand’s patients, Gilbert says she noticed a difference almost immediately. “For the first time in a long time I am excited about the projects I want to do, which are feeling like opportunities rather than obligations,” she says.
Zelfand herself tried microdosing a few times but didn’t enjoy the effects. “I don’t feel well when I do it. It seems to make me a little edgy,” she says.
Some of Zelfand’s patients have had similar unwanted experiences. People with general anxiety disorders and, especially, bipolar disorder should probably avoid microdosing because it can lead to agitation or mania, she says.
Even if microdosing proves to be safe and effective, some experts fear widespread recreational use could render it useless later in life if it turns out to be valuable for important mental-health purposes but people are tolerant to it after frequent use. “If we introduce more of these types of substances, that might undercut their therapeutic efficacy when we really need them for medicine, such as for end-of-life distress,” says Conor Murray, a neuroscientist at UCLA who conducted the EEG research.
And while they don’t trigger the same wild thoughts and images as taking high doses of these drugs do, some microdosers have reported some impairment, Johnson says. “If this turns out to be the case, it may be hard to drive, take care of your toddler, or make important decisions at work.”
Plus, of course, psychedelics are illegal, which means there’s no quality control on supply. What’s more, “people have lost their jobs because they’re microdosing, and they can and do get incarcerated,” Garcia-Romeu says.
But even those who are concerned about the growing use of psychedelics say microdosing may eventually prove beneficial for some people. Johnson from Johns Hopkins thinks depression might be relieved by microdosing—although he’s much more jazzed about the prospect that a person could get more relief after one or two high-dose sessions, something his research is bearing out.
Krystal believes until more is known about microdosing, people should hold off. “Right now, it should only be done in the context of experimental research,” he says. “There, protections can be in place, and the data generated will inform our understanding about these doses and drugs.”
Additional microdosing studies could also yield insights about our brains. For example, experts don’t fully understand the role of another serotonin receptor activated by psychedelics, 5-HT2A, Johnson says. “We have a whole lot to learn about [this receptor]. Is it involved with naturally occurring mystical experiences like near death experiences, even alien abduction encounters?” he wonders. “How can we use microdosing research to understand more about the nature of the human mind?”
Wednesday, April 28, 2021
HIPSTER CAPITALI$M
Trumpy Billionaire Peter Thiel Is Behind the Next Psychedelics IPO
On Tuesday, New York-based company MindMed will start trading on the Nasdaq, becoming the second psychedelic company ever to go public on a major American exchange. The debut comes six months after Compass Pathways, a drug developer focusing on the psychoactive compound in shrooms, became the first, reaching a market cap of $1.33 billion.
A third company is set to follow suit. Just last week, self-described “drug growth platform” Atai Life Sciences filed an S1 application with the Securities and Exchange Commission, announcing plans to raise $100 million in an initial public offering. The German developer was founded by prodigious meme investorChristian Angermayer—a COVID skeptic who has psilocybin’s molecular structure tattooed on his forearm. In something of a mind-bending ouroboros, Atai is also the largest shareholder in Compass Pathways.
In May, Atai Life Sciences closed a financing round of $24 million backed by billionaire right-wing donor and Trump backer Peter Thiel. The German American PayPal co-founder, who later launched the big data firm Palantir, has funded a range of controversial projects––research into seasteading, various experiments in “life extension,” and the lawsuit that bankrupted Gawker.
“ATAI’s great virtue is to take mental illness as seriously as we should have been taking all illness all along,” Thiel told CNBC at the time. “The company’s most valuable asset is its sense of urgency.”
Like Thiel’s Atai, MindMed is ultimately a biotech company, focused on developing medicines derived from the compounds in shrooms (psilocybin), acid (LSD), molly (MDMA), DMT, and Ibogaine, which some believe may be useful in treating opioid addictions. It has been trading as a penny stock under the ticker “MMEDF” and for the past year, on the NEO Exchange in Canada, after arranging a reverse takeover with a British Columbia-based gold mining company.
The IPOs are riding a wave of increasing interest in developing long-restricted substances for medical application, particularly in the treatment of mental health disorders. In 2018, the FDA granted “breakthrough” status for a psilocybin-derivative called COMP360, just months before they approved Johnson and Johnson’s ketamine-derived treatment. Last year, the state of Oregon legalized psilocybin use for therapy, and several states have passed bills to decriminalize it.
Matt Zemon, who co-founded a health platform called Psychable, which connects users to legal medical providers of psychedelic treatments, told The Daily Beast that the FDA had opened the door to more research into their efficacy.
“From our perspective, we believe we’re in the middle of a psychedelic renaissance,” Zemon said. “Research now shows the transformative power of psychedelics...The response to ketamine has been showing us that people want something different, there hasn’t been a drastic change in medical treatments for mental health treatments in decades.”
But the psychotropic trading rush also arrives in the second year of what writer David Nickles dubbed, in the academic drug outlet Psymposia, the “Corporadelic Era”—a transition from an open science approach to psychedelic research to a private one, circumscribed by proprietary concerns and patent competition.
“There are groups that believe that this should be done all under a nonprofit or an open source philosophy,” Zemon said. “There are other groups that feel like to invest what needs to be invested, they need to have patents and the ability to have long term profits from them.”
This transition has been poorly received by many proponents of psychedelic treatments. A major flashpoint in the debate took place in February, when Compass Pathways filed a patent application for psychedelic therapy using the shrooms compound psilocybin. The developer attempted to stake ownership on a range of basic uses to “treat depression and other various disorders,” suggesting to some that almost any outside application of the drug might violate the patent.
As reporter Shayla Love noted in VICE, Compass had tried to claim ownership of aspects of psilocybin therapy that went beyond the chemical composition of its drug to the basic ways the psychedelic might be administered. If other providers offered shroom therapies in “a room with a substantially non-clinical appearance,” or one that comprised “soft furniture,” or was “decorated using muted colors” ––they’d risk running afoul of Compass’ patent. Other potential violations included rooms with “high resolution sound systems” or “a bed or a couch” or “wherein the subject listens to music.”
The other psychedelic developers have signaled support for Compass’ approach. In an open letter to VC investor Tim Ferriss from March, Atai Life Sciences co-founder Christian Angermayer defended the use of patents in psychedelic drug development. Patents, he wrote, “represent the best means of accelerating patient access and optionality in the midst of a mental health crisis.”
MindMed has made similar moves. Last year, the company announced a multiyear partnership with a Swiss lab, granting them exclusive rights to the lab’s research into LSD and related compounds. When co-CEO Jamon “JR” Rahn derided the movement to decriminalize psychedelics in an interview with Forbes, prominent psychedelic commentator Mike Margolies suggested the executive wanted to restrict others’ access to the compounds.
“@JamonRahn, Director of @mindmedco, wants to ‘develop IP’ securing his company's exclusivity to sell LSD and simultaneously maintain prohibition,” Margolies wrote, in a tweet later noted by Psymposia.
MindMed and Atai Life Sciences did not immediately respond to the Daily Beast’s requests for comment.
Psylocibin mushrooms. Health Canada has said requests for psychedelics will be considered on a case-by-case basis for a 'serious or life-threatening condition' and where other conventional treatments have failed.
Psychedelic therapy professionals warn new regulations set to roll out next year in Alberta could limit access and add hurdles for patients
Nick Kadysh, board chairman of Psychedelics Canada, a trade association for the legal, medicinal and for-profit segment of the psychedelics industry, said while it’s a good sign the province is making regulatory decisions, they lean heavily on the use of psychiatrists.
“Any clinic has to have a psychiatrist responsible,” he said in a recent interview with Postmedia. “Any patient has to talk to a psychiatrist before getting access to these therapies and we just know that there is an incredibly long wait time for psychiatry services in Alberta. So it becomes a patient access issue.”
The Alberta government announced the new rules on Oct. 5 for psychedelics such as psilocybin, psilocin, MDMA, LSD, mescaline (peyote), DMT, 5 methoxy DMT, and ketamine. The province says they are meant to provide safeguards and medical oversight, coming into effect next January.
While some clinical trials have shown promising results for the use of psychedelics as a treatment for mental health conditions, the drugs are illegal in Canada. However, health practitioners and researchers can apply for permission from Health Canada to use psychedelics in research or for therapeutic use in special circumstances. The same rules still apply in Alberta under the new regulations.
The provincial rules differ based on the level of risk involved. With few exceptions, clinics offering psychedelic-assisted treatment must be licensed and have the medical oversight of a psychiatrist.
With only psychiatrists providing oversight and not other professionals like anesthesiologists, neurologists, and general practitioners, access could be limited, said Liam Bedard, coordinator of Psychedelics Canada.
“There are a number of qualified practitioners that can oversee these therapies and by mandating that only psychiatrists can manage them, it’s creating bottlenecks in accessing these potentially very valuable therapeutic tools,” he said.
In a statement, Alberta mental health and addictions spokesman Eric Engler said the regulation does not limit the prescription of psychedelic drugs to only psychiatrists. Others can prescribe them, after and with ongoing consultation with a psychiatrist.
“A psychiatrist is required to oversee services for psychedelic-assisted psychotherapy, as they are the most highly trained and experienced regulated health professionals in the diagnosis and treatment of psychiatric disorders,” Engler said.
“Alberta is setting a deliberately high bar to protect patients, since the evidence for use of these drugs in the treatment of psychiatric disorder is still emerging and not without risk.”
At SABI Mind, intramuscular injections of ketamine are used to treat people for mental health conditions like trauma, depression, or chronic pain conditions, said Philippe Lucas, president and CEO of the psychedelic-assisted psychotherapy clinic group that has a location opening in Edmonton in November.
The new regulations do not apply to all uses of ketamine, since it is approved for use outside of psychedelic-assisted therapy, such as an anesthetic for pain management.
SABI Mind also has an in-house psychiatrist and therefore won’t be severely affected by the new regulations. However, Lucas said it can currently take between six and 18 months for a patient with a referral to see a psychiatrist in Alberta, a problem paired with the fact that only a handful in the province would be comfortable considering psychedelics as a treatment option.
“When we’re talking about hundreds, if not thousands, of patients needing to now line up to see one of those 10 or 12 psychiatrists that are willing to prescribe or consider psychedelic-assisted psychotherapy, you can see how this will inevitably create bottlenecks,” Lucas said.
Leah Mayo, the Parker Psychedelic Research Chair at the University of Calgary, said the regulations are like “putting the cart before the horse” since the field is still evolving with research still being done on who can be treated, the frequency of treatment, and dosing.
“While it’s good to kind of advance the field and increase access to these compounds, I still think we’re so early on that I mean, we don’t even know what populations should be getting these medications,” she said.
Dr. Robert Tanguay, a psychiatrist specializing in addiction medicine and vice-president of the Newly Institute, a network of medically-assisted psychotherapy clinics, attended the province’s announcement of the new rules on Oct. 5. He said they protect individuals from unregulated individuals providing non-evidenced-based treatment.
“I think at the end of the day, it moves us forward and increasing the amount of access and putting structure behind what we’re supposed to be doing, and most importantly, protecting those individuals who are under the influence while in treatment,” Tanguay said.
In a statement at the time of the announcement, the College of Physicians and Surgeons of Alberta supported innovative approaches to health care and noted protecting the public while guiding regulated members remains a focus to ensure safe, high-quality innovation.
Despite criticisms, the Alberta government is credited for trying to get ahead of the curve.
“I think that they are trying to get ahead of the eight-ball and trying to design regulations for these therapies as they progress, which is great. That’s actually very, very forward-thinking,” Kadysh said.
New Alberta opioid program could increase barriers and harm, health professionals say
“We definitely need to watch the risks of diversion, it's very important to reduce diversion. But there's also a duty to ensure that our clients don't have any harm come their way and get destabilized.”
Mike Ellis, associate minister of mental health and addictions, left, listens to Dr. Robert Tanguay, co-chair, Alberta Pain Strategy and co-lead, Rapid Access Addiction Medicine Program, Alberta Health Services. The two were speaking at a news conference to announce new rules for the use of high-potency opioids on Oct. 5, 2022.
PHOTO BY GREG SOUTHAM /Postmedia, file
Health-care professionals say new provincial regulations for high-potency opioids may increase barriers and harm to patients seeking treatment. On Oct. 5, the Alberta government announced the narcotics transition services program where opioids such as hydromorphone, diacetylmorphine (heroin) and fentanyl are offered at licensed opioid dependency program (ODP) clinics run by Alberta Health Services.
The changes mean community health professionals can no longer prescribe and pharmacists will no longer be able to dispense high-potency opioids for treatment. Patients must instead be referred to the ODP clinics by a health-care professional or self-refer.
While the goal is to transition the patient to opioid agonist therapy medication, like suboxone, and provide access to other wraparound supports, a patient cannot be discharged from the program if they are unable to make the transition
The province estimates fewer than 350 people in Alberta are currently prescribed high-potency opioids for severe addiction and will be affected by the changes.
Elaine Hyshka, associate professor at the University of Alberta’s School of Public Health, said that means 350 people who are getting treatment and likely doing well will now be abruptly forced to alter their lives.
“You have to change to a new clinic, where you’re going to have to go likely multiple times per day to get your dose and structure your whole life around that new routine,” she said. “And best of luck to you that you continue to be stable and in your recovery. That to me is really fundamentally unfair to those patients.”
Dr. Monty Ghosh, an internist and addiction specialist at the U of A, echoed concerns that clients will have to travel to a brick-and-mortar facility, as opposed to a pharmacy or have a take-home option.
“That would pose a barrier for numerous individuals if they have cognitive concerns, behavioural concerns, developmental delay,” he said. “Having to come three times a day might be problematic for individuals.”
The new program is only for the most severe cases of opioid addiction and is an extremely specialized service, said Eric Engler, spokesman for the mental health and addictions ministry, in a statement.
“The medications that may be provided as part of this program can be extremely dangerous, especially if they are diverted into the community,” Engler said. “This service will only be provided to those with the most severe cases of opioid addiction, in a supervised setting, with no opportunity for diversion of dangerous opioids to the community. The risk of these drugs being diverted is simply too high to offer this service in any other way.
But Hyshka said it’s “very problematic” that the province is “cracking down” on prescribing high-potency opioids when there isn’t a lot of evidence it is causing problems.
Out of the 884 drug poisoning deaths recorded between January and July this year, 20 were from pharmaceutical opioids.
Diversion is still a real concern, Ghosh said. But the crux of the issue is the risks of diversion need to be weighed with the risk of harms associated with destabilization that the new rules may cause.
“We definitely need to watch the risks of diversion, it’s very important to reduce diversion. But there’s also a duty to ensure that our clients don’t have any harm come their way and get destabilized.”
Individuals who treat chronic pain with pharmaceutical opioids are an example of providing take-home high-potency drugs without concerns of diversion, Ghosh said. (Chronic pain patients are not affected by the new regulations.)
“There are some substance users who are more or less the same as well,” he said. “So where does this land for them? And does this create a system of more stigma for these individuals?”
Dr. Ginetta Salvalaggio, an associate professor with the U of A’s department of family medicine, said continuity and relationships help people stay on their medications long term.
“What we’re doing here is a very top-down approach, sending people to people they don’t know,” she said. “This is not the sort of program that would be designed by people who use drugs.”
Engler said clients are encouraged to maintain relations with their existing care team, and the new standards require AHS to take steps to maintain those connections, too.
There are some positives to the program. Hyshka said clinics providing diacetylmorphine is an addition that has not been offered before in Alberta.
For Ghosh, one of the positives is increased access to high-potency opioids, not just in Edmonton and Calgary, but across the provincial health zones.
“In addition to this, there’s a strong emphasis on providing wraparound services for clients,” he said. “So making sure they get access to other wellness supports to support their housing, their income support, their mental health issues. These are all being provided as part of the service, which is fantastic news.”
The framework also includes a process to protect individuals who can’t transition off the high-potency opioids to more stabilized versions like suboxone.
“That’s really helpful and it really moves us in the right direction and it provides an outlet in some respects for safe supply,” Ghosh said.
(RNS) — Decades after being forced underground by the war on drugs, psychedelics are going mainstream. Researchers are rediscovering the possibilities of using psilocybin, ketamine, MDMA and LSD as tools in treating depression, addiction and psychological distress.
Oh, and they may spark a spiritual awakening, too.
In his new book, “God on Psychedelics,” Don Lattin, a veteran religion journalist, investigates how some religious groups are encouraging chemically induced revelatory experiences of human interconnectedness and unity.
Lattin, who for years covered religion for the San Francisco Chronicle and has written six other books, mostly about psychedelics, said things are changing fast. Though mostly illegal for recreational use, universities around the world are studying psychedelics in clinical studies, and some states are taking notice: Oregon last year approved the adult use of psilocybin, the hallucinogen in “magic mushrooms,” though it is still hammering out the rules for its production and sale.
Five years ago, people — and particularly clergy — didn’t want to be quoted about their experiences with psychedelics. Now they’re far more open. Lattin said tripping is being explored in congregational settings and in chaplaincy.
RNS caught up with Lattin, who lives in the Bay Area, to talk about his new book. The interview was edited for length and clarity.
Your book introduces readers to the term entheogen — drugs taken for religious or spiritual purposes. Are psychedelics really God-enabling drugs?
They can be. “Psychedelic” means “mind-manifesting,” while entheogen refers to “the divine within.” I write about rabbis, priests and other clergy who do see entheogens as a way to renew the faith. Then there are the “nones” — people of no particular faith — who are consciously using psychedelics as a spiritual practice. Some are affiliated with new religious movements, including two originating in Brazil that use ayahuasca, a tea brewed from two plants native to the Amazon. A lot of ayahuasca or magic mushrooms churches based in the U.S. are underground, but some are going public as the legal situation shifts. They see sacred plant medicines as sacraments.
Another congregation I profile is called Sacred Garden Church. It seeks divine communion with different kinds of psychedelic drugs and sees itself as a “postmodern church” that follows the “path of least dogma.”
You point out that psychedelics don’t always induce feelings of unity with all humankind. They can also be terrifying, right?
Aldous Huxley, the famous British writer who wrote “Brave New World” and “The Doors of Perception,” called them heaven and hell drugs. They can give you a taste of heaven and they can send you right to hell, too. It really depends on the intention and context.
Even people who use these substances cautiously and carefully to open up to greater spiritual awareness or psychological insight may have very difficult experiences. You can have a bad trip. You can feel like you’re dying. You can feel like you’ve lost your body. You can feel you’re going crazy. These drugs can fuel feelings of unity, awe, compassion and gratitude. They can also induce paranoia, grandiosity and existential dread. But with an experienced guide, it can be fruitful. It’s like in therapy — trauma from your past can come up. Having someone help you through those feelings in a safe, contained environment can be really helpful.
Author Don Lattin. Photo courtesy Deanne Fitzmaurice.
It’s been eight years since scientists at New York University and Johns Hopkins University recruited clergy for a study to see if psilocybin deepened their spiritual lives. Will it ever be published?
It’s taking longer than most people thought, but researchers expect to publish a paper sometime this year. I tracked down four or five people in the study who were comfortable talking about their trips. Some people, like an Episcopal priest I write about, saw his psychedelic experience as “a second ordination” — for the first time, he felt the power of the Holy Spirit as bodily energy. Before, his faith was all in his head, too intellectual. Psilocybin inspired him to start an organization called Ligare, which is already having church retreats where other clergy can have these experiences. Currently, they can only do that in the Netherlands or a handful of other countries with less repressive drug laws.
But now Oregon and Colorado have legalized magic mushrooms and are regulating supervised psychedelic sessions. Under federal law, hallucinogens are only clearly legal in clinical trials or among churches that get a formal exemption, such as the Native American Church, or certain ayahuasca fellowships. But more than 20 cities in the U.S. have directed their police departments to stop arresting people for using certain types of drugs and plant medicines, so the legal situation is rapidly changing.
Is ‘mystical’ really the right word to describe the experience of psychedelic drugs?
Researchers have surveys they give people to measure if they had a mystical experience: Did you feel a sense of unity with the cosmos or with nature or other people? Did you feel awe and wonder? Mystical experiences are not always positive, but they’re profound, soul-shaking experiences that can crack people open. Then there’s the question as to whether psychedelics produce just altered states of consciousness, or whether they encourage altered traits of human behavior. Do they make us more aware and compassionate? I think that’s an important question, but not everyone does.
Mysticism itself can be dangerous to religious orthodoxy, no matter how it’s induced. The mystic often challenges the religious authorities of the time. That explains the hesitancy that many Christian leaders have toward mysticism, especially when it’s drug-induced. Some may also feel that it’s too much of a “short cut” to God.
What are the chances of finding a church that does psychedelics?
I bet you could, or at least a spiritual retreat center where you could experience this. Informed insiders estimate there are hundreds of these psychedelic churches. Some are very small — maybe a dozen people. Others may have 100 members. Then there are people who go down to Peru or Mexico or Brazil and work with shamans or indigenous medicine people and come back and start their own groups. Some are sincere. Others are charlatans.
There are several national networks of people lobbying now to reform drug laws. In Oakland, the city council passed a law a few years ago directing the police department to make these drugs their lowest priority. Sacred Garden Church came out of that local campaign. But this is not just happening in pockets of woke enlightenment like Berkeley, Boulder or Boston. There are big psychedelic churches in Utah, Arizona, Florida. It’s happening all over.
A lot of these new psychedelic churches keep certain Christian elements, right?
Yes. Take Santo Daime, one of the syncretic religious movements I profile in the book. It’s a mixture of folk Catholicism, spiritualism, African and Indigenous religion. You’ll see a Christian cross in their ceremonies, but also the Star of David. Many people in Santo Daime still consider themselves Christian or Catholic. What I found interesting was the large number of people in these groups in the U.S. who were raised Jewish. They probably wouldn’t call themselves “Christian,” but might say they are connecting to “Christ consciousness.”
You tried to join a couple of these psychedelic churches, but in the end, you went in a different direction. Describe the group you belong to.
“God on Psychedelics: Tripping Across the Rubble of Old-Time Religion,” by Don Lattin. Courtesy Lattin
It’s just a meditation group that I started working with about a dozen years back. We meet at a retreat house in Oakland run by a Catholic religious order. But it’s not Catholic. It has nothing to do with psychedelics. We employ a mix of contemplative prayer and Buddhist meditation. Many of us — but not all — are also involved in 12-step recovery groups. On some days, we’ll hear a dharma talk from a teacher from the San Francisco Zen Center who is also a recovering alcoholic. On another day, we’ll employ a lectio divina reading, perhaps a passage from the gnostic Gospel of Thomas, or a Rumi poem.
This is something I was already involved with before I started experimenting with psychedelics again as part of my research for my previous book, “Changing Our Minds — Psychedelic Sacraments and the New Psychotherapy.” I joined these psychedelic fellowships as a reporter, as a participant/observer who was sincerely open to the possibility of becoming a member. In the end, I decided none of them were for me.
I don’t really see psychedelics as a lifestyle. A lot of people may have one or two experiences with psychedelics. They will call it one of the most significant experiences of their lives. But it’s not like they want to do this every weekend, or even every month. I’m in that camp. There’s a famous line by the spiritual commentator Alan Watts, “Once you get the message,” he said, “hang up the phone.”
Bringing psychedelic medicine from the margins to the mainstream
BY ROBERT BAUER, THE HILL OPINION CONTRIBUTOR - 12/31/23
Getty Images
Research into the therapeutic benefits of psychedelic drugs is nothing new. In fact, research extends back 80 years with the discovery of lysergic acid diethylamide (LSD), when the Swiss chemist Albert Hofmann, looking to synthesize a migraine treatment, created the derivative of the ergot fungus. It wasn’t until several years later that he accidentally dosed himself and realized LSD’s psychedelic effect.
This initial research kicked off a wave investigating the therapeutic potential of psychedelics, but with the emergence of the secretive and unethical research by the Army and CIA and the rise of the counterculture, the federal government stepped in. The Controlled Substance Act subsection of the Comprehensive Drug Abuse Prevention and Control Act of 1970 classified LSD, heroin, marijuana and a few other drugs as having “a high potential for abuse, no current medical use, and a lack of safety for use under medical supervision,” classifying them as Schedule I substances and effectively killing research because of the hoops scientists would need to jump through, with both the U.S. Food and Drug Administration (FDA) and the Drug Enforcement Administration (DEA).
It would be nearly three decades before psychedelic medicine research re-emerged in a meaningful way, when researchers at Johns Hopkins obtained regulatory approval to reinitiate research in healthy, psychedelic-naïve volunteers. A subsequent study examining psilocybin administered in a supportive setting is widely recognized for igniting the current period of psychedelic research. This seminal study, which demonstrated long-term benefits of psilocybin (e.g., positive mood, life satisfaction, prosocial behavior) in healthy participants, is just one of many studies that have since confirmed the low toxicity and minimal addiction potential of psychedelics.
In the intervening years, legislative reform regarding psychedelics began to gain momentum. According to a study in JAMA Psychiatry, from January 2019 to September 2022, 25 states considered 74 bills to reform existing laws restricting access to psychedelic drugs or proposed further research into reform legislation. Ten of those bills were signed into law by seven states, with the vast majority (90 percent) specifically referring to psilocybin and 36 percent of the bills also including 3,4-methylenedioxy-methamphetamine (MDMA).
The foundation laid by Johns Hopkins has, over the last 20 years, spurred a wave of interest — and progress — into the benefits of psychedelic medicines.
In October 2022, mental health company Compass Pathways announced initiation of the first Phase 3 program of psilocybin therapy globally for treatment-resistant depression. Initiation of the program followed positive results from the company’s Phase 2b study, presented at the American Psychiatric Association annual meeting in May 2022. Likewise, earlier this year, the Multidisciplinary Association for Psychedelic Studies announced results of its Phase 3 clinical trial of MDMA-assisted therapy, which demonstrated statistically significant improvements in PTSD symptoms after three sessions.
This past June, the FDA published a new draft guidance to highlight considerations to researchers investigating the use of psychedelic drugs for potential treatment of medical conditions. This represented the first draft guidance that presents considerations for designing clinical trials for psychedelic drugs. It recognizes the interest in exploring their therapeutic potential, but also the unique challenges throughout the drug development process, including clinical trial conduct, data collection, subject safety and new drug application requirements.
Further, the draft guidance notes that, for psychedelics that are currently Schedule I controlled substances, activities associated with investigations under an Investigational New Drug Application must comply with applicable DEA regulatory requirements. Importantly, in providing a pathway for the research, this is a tacit signal that the FDA is also indicating to the biopharmaceutical industry that there is ultimately a pathway to approval. With the first approval possibly coming as soon as 2024, there will surely be increased interest in the space, even if it doesn’t translate into an immediate wave of approvals.
Yet, challenges remain.
These challenges are often logistical in nature. Given the psychedelic experience that accompanies treatment, which can last up to 12 hours in some cases, conducting clinical research is labor and resource intensive. FDA’s guidance requires two people to monitor clinical trial participants. One of these monitors needs to be at least a Ph.D.-level researcher and the secondary monitor still needs to have experience in the mental health space. This is something that will likely extend into treatment once these medicines are approved. Uptake could be a similar challenge, as it could require two people to guide patients through their psychedelic experience to make sure they remain safe, and if there are any adverse effects, that they can support them along their journey.
This is also new ground for the FDA, and the agency will likely take a very cautious approach to safeguard patients and minimize the risk for unforeseen treatment-emergent safety concerns. Compounding the challenge of uptake is that manufacturers and investigators will need to go through the process of securing DEA clearance to be authorized to administer these drugs in the research setting.
Despite decades of research, the FDA’s draft guidance is finally bringing psychedelics research into the light. As the space continues to progress, there could be a move toward fine tuning the experience for patients. That may mean minimizing the psychedelic effects of these drugs without compromising their therapeutic benefits or being more selective in the receptors researchers target to reduce their adverse potential. Along with this evolution, a meaningful step that could bring us closer to realizing the full potential of these important therapeutics would be for the Department of Health and Human Services (HHS) to initiate a review to consider recommending rescheduling of the individual drugs or the entire class. The precedent for such a move was recently set when HHS recommended in August 2023 to have cannabis moved to Schedule III from its current Schedule I. Doing so would greatly ease access for further research and eliminate the administrative burden on prospective researchers and the DEA that is currently required to review the paperwork from each researcher for each trial they plan to conduct.
In researching her new book, about the therapeutic applications of MDMA, author Rachel Nuwer dove into MAPS. She discovered the group was supported by some surprising benefactors.
This includes Elizabeth Koch, the daughter of Charles Koch of Koch Industries, which is one of the largest private American companies. Besides their massive fortune, Charles Koch and his brother David are known for funding conservative movements, like the Tea Party.
Nuwer explained in her book that though it may be counterintuitive, many public figures with conservative ties, like Elizabeth Koch, invest in socially liberal groups like MAPS. Advertisement
Read below for the story of how Elizabeth Koch came to support psychedelic therapy in an excerpt from Rachel Nuwer's new book "I Feel Love."
When it's sold on the street, MDMA is sometimes distributed in pills like these.
Reuters/ DEA
The moment I walked through the door of the loftlike space, the slender forty-five-year-old greeted me with a hug, a blanket, and not one but two very LA-appropriate canned drinks ("energy booster" and "prebiotic popping soda") from the office's meticulously organized fridge. Elizabeth's bubbly enthusiasm and disarming warmth immediately put me at ease, and within minutes I felt as though I were chatting with an old friend.
Elizabeth's uncanny ability to endear herself to others is a skill she has been cultivating nearly her entire life, and it's actually a symptom of her trauma. In hearing her story, I would learn that MAPS's fundraising success doesn't just boil down to Doblin's prowess as a salesman, or to wealthy people simply loving MDMA, but to the fact that trauma and suffering are universal.
Not even the most privileged individuals in the world are immune to mental anguish, and they can face the same limitations as the rest of us in finding relief for that pain. Elizabeth's "fall from Eden," as she described her index trauma, occurred when she was five years old.
After a close friend of her parents severed his spine by diving into a shallow pond, the family went over to pay their respects to the now wheelchair-bound man. The atmosphere in the house was oppressively somber, so to lighten the mood for her little brother, Elizabeth began singing the Humpty Dumpty song.
In one refrain, though, she absentmindedly replaced "Humpty Dumpty" with the name of the paralyzed man. Suddenly, all the tension in the room was directed at her. "I see my dad looking over his shoulder and giving me this death stare," she recalled.
Charles Koch, Elizabeth Koch's father, who owns Koch industries. At the time of writing, his estimated net worth is $62.5 billion USD.
When the family got home, Elizabeth's father sat her down. "You kids don't get it," she recalled him saying. "You have everything that everyone wants, and you'll be hated for it your entire life. Your job, always, is to be the nicest person in the room, and the hardest worker in the room — the one who picks up garbage that everyone leaves behind. You have to be aboveboard because if you aren't, you'll not only be hated by everyone else but also by yourself."
Looking back on this incident with an adult's perspective, Elizabeth now understands that her father was trying to protect her. "He was absolutely terrified that my brother and I would grow up to be spoiled, piece-of-shit monsters," she said. As a five-year-old, however, she interpreted his lecture to mean that she could only be loved if she were good.
That pivotal message came to hold sway over nearly every facet of her personality and life.
In "The Myth of Normal," Gabor Maté wrote, "A child who does not experience himself as consistently and unconditionally lovable may well grow to be preternaturally likable or charming" — which was exactly the path Elizabeth followed.
It started with a nightly ritual: before bed, she would review everything she had said and done that day to make sure she had been the nicest person and the hardest worker, and that she hadn't accidentally hurt anyone's feelings. If something bad happened to her — say, she tripped and skinned her knee — she would tell herself that it was because the universe was punishing her for not being good enough.
In classrooms, during extracurricular activities, or on sports teams, she would always beeline for whichever kid she thought would hate her the most — usually the one who appeared to have the least money, or the one who looked the least like her — and try to win them over by telling them funny stories about her family's dysfunction.
Over the years Elizabeth rose to the top of her class, won competitions for her writing, and made many friends, but she lacked joy. "I have to do this to prove that I deserve to be alive," she would tell herself each time she accomplished something.
"I have to earn my existence."
Her paranoia about what others thought of her intensified, as did her unhappiness. She realized she needed help and began trying various mental health solutions, including yoga, silent meditation retreats, and, briefly, medications. Advertisement
She read books about Buddhism and neuroscience and gained glimpses of insight. But no amount of knowledge, learning, or practice brought genuine relief.
MDMA, also known as ecstasy, initially became popular as a club drug.
When a friend suggested in 2016 that she try psychedelic-assisted therapy with a "consciousness cowboy" he knew — an ex-military man who called himself Doug the Lovebunny — she agreed. Doug filled a silver balloon full with "some kind of vapor smoke," Elizabeth recalled, and instructed her to breathe in and hold it.
She had no idea what she was in for: he had given her 5-MeO-DMT, a short-acting but incredibly potent tryptamine. The ego-abolishing drug dissolved Elizabeth in totality. It was terrifying.
Doug the Lovebunny hadn't prepared Elizabeth for this harrowing and destabilizing experience, and he did not provide any support or integration for her afterward. For weeks, she would wake up in the middle of the night, she said, "scrambling to try to grab hold of my body."
She wanted to know more about what she was going through, and research led her to MAPS. She attended a psychedelics conference in Los Angeles, where she was moved and inspired by the firsthand accounts shared by war veterans who had taken part in the MDMA-assisted clinical trials for PTSD.
"I Feel Love" by Rachel Nuwer was published in June and describes the fascinating transformation of how we've come to use the psychedelic drug MDMA.
Bloomsbury Publishing
MDMA sounded a lot more user friendly than 5-MeO-DMT — and perhaps, Elizabeth thought, it could help her, too. So in spring 2018, she found "someone off grid" who agreed to give her MDMA-assisted therapy following the MAPS protocol.
Elizabeth wound up doing three sessions, and through that process, she saw the vast amount of pain she had been harboring throughout her life.
"I had been terrified of joy," she said. "The medicine showed me the degree to which all this buried stuff that I hadn't even been able to see was causing me to be reactive and feel constantly trapped, overwhelmed, and miserable."
The MDMA sessions (one of which she also paired with psilocybin) helped Elizabeth let go of the "intense self-hatred" she had been burdened with since she was five years old, she said, and to feel sympathy and love for herself. She's since become one of MAPS's top five donors.
"MDMA is not going to save the world," Elizabeth said. "But together with conversations and experiences of going inward and self-investigating, I think it can help."
Following that thread, in 2018, Elizabeth founded a company, Unlikely Collaborators, that aims to bring people together who seem like they're on opposite sides of an issue, and then work with them to reveal their shared humanity and commonalities.
If and when MDMA-assisted therapy gains FDA approval, Elizabeth also envisions Unlikely Collaborators providing community-oriented group integration services.
Peyote is the darling of the psychedelics renaissance. Indigenous users say it co-opts ‘a sacred way of life’
Flowering peyote plant (Photo: Hans B | CC BY-SA 3.0)
BY ANNETTE MCGIVNEY, THE GUARDIAN
On the first day of autumn, evening temperatures near Window Rock, Arizona, were brisk. Beneath the late September sky, a traditional round hogan in this remote corner of the Navajo Nation was enveloped in darkness. Ten tribal members gathered inside.
This article was originally published in The Guardian and is used with permission.
After a dinner of mutton and fry bread, the group settled in a circle around a wood stove radiating with burning juniper, preparing to ingest what the Diné(Navajo) call azeé – the medicine.
Most people know azeé as peyote: a small, button-like cactus famed for its powerful psychoactive and healing properties. The cactus is extremely rare in the United States – it grows wild in only one part of Texas – and has been integral to traditional Indigenous American practices for thousands of years.
The goal of this ceremony was to guide Diné college students on their spiritual path. One young man struggling with alcohol abuse was especially in need of the medicine.
“When this is over, you will feel like a washrag with all the gunk wrung out of it,” the man’s grandmother told him.
Tonight, the ritual would be no different from what it was a century ago. There would be peyote songs and drumming. Margie Whitney-Silva, a certified spiritual leader known as a roadman, would supply the peyote in the form of a tea brewed from the cactus, carried in a large pickle jar. Eagle-feather fans and gourd rattles would be used as the jar was passed around.
During the 19th and first half of the 20th centuries, Indigenous Americans risked being thrown in jail for participating in such ceremonies because peyote was illegal under US law. Today, it is just the opposite. Peyote and mescaline – the hallucinogenic substance found inside the cactus – have become a darling of the psychedelic renaissance.
Peyote, mescaline and other hallucinogenics such as LSD, MDMA, ayahuasca and magic mushrooms are being touted for their capacity to revolutionise the treatment of PTSD, addiction and other health problems. In recent years, progressive politicians, doctors, community groups and Silicon Valley investors alike have thrown their weight behind decriminalization bills in dozens of US states and cities.
Their goal to spread the benefits of psychedelics may be well-intentioned, but for Indigenous Americans, the boom has a dark side that rarely comes up in venture capital pitches. Many Diné tribal members are describing this moment as a “peyote crisis” that threatens to appropriate and commodify their sacred way of life.
Their concerns are multifold. Decriminalizing peyote could fuel poaching and a black market for the slow-growing cactus, whose limited habitat is already threatened by climate change and development. A sudden surge in demand might completely wipe out peyote from its natural environment, traditional practitioners say.
Then there are the deeper concerns about turning peyote and mescaline into an on-demand drug. Members of the Native American church of North America, an inter-tribal religion that revolves around the ancient practice of peyotism, are alarmed by pharmaceutical ventures seeking to create mescaline in a lab, in much the same way opium from the poppy flower was synthesized to create fentanyl.
Non-Indigenous leaders in the psychedelic space insist they are respecting Native American spirituality by using synthetic mescaline instead of the real thing. Dozens of Indigenous Americans interviewed for this story see it otherwise.
“How would Christians feel if Jesus Christ was cloned?” asked Justin Jones, a Diné peyote practitioner and legal counsel for the Native American church of North America, a non-profit organization that advocates for more than 300,000 members. “And while the real Jesus is protected, people could do whatever they wanted to the clone.”
At its core, the push to medicalize and mass-produce peyote and mescaline goes against the Indigenous American worldview of interconnectedness. There are no English words that describe how the spiritual character of peyote is inextricably intertwined with its hallucinogenic properties, the land where it grows and the Indigenous Americans who consume it, says Jones. In the Navajo language, Jones describes this harmonic oneness as azee’ hinááh biníłch’idiyin, be’adínídíín.
Creating synthetic mescaline in a lab or growing peyote in a greenhouse is a violation of natural law, and interrupts the unique symbiotic relationship with the plant. “What western scientists call mescaline is for us the essence of the medicine,” said Jones. “It is the soul of it and what makes it holy.”
Traditional peyote practitioners emphasise that they are not against the use of all psychedelics to innovate new treatments for addiction and PTSD. After all, their experiences prove just how powerful a healing tool these substances can be.
But they question why peyote and mescaline need to be used when a variety of other tools – especially psilocybin and MDMA – have proven effective. In rushing to medicalize peyote, which has a unique history and a sacred role for tribes, the decriminalisation movement risks perpetuating more harm in the name of doing good, they say.
“I’m all for healing,” said Cora Maxx-Phillips, a social worker, member of the Navajo Nation human rights commission and board member of the Council of Peyote Way of Life Coalition, a grassroots group in the Navajo Nation.
“But don’t do it at the expense of our people, who are trying to survive the multigenerational trauma inflicted upon us. Please, leave us alone.”
A fight for tradition
The ceremony near Window Rock was a private, emotionally grueling ritual that lasted all night.
Before the ceremony, Boyd Tsosie, another roadman who led the ritual, said the experiences of ancestors from three or four generations prior might surface. There would be little discussion; the goal was for each person to embark on their own inner journey in a kind of spiritual vision quest where the plant itself was the guide.
Tsosie emphasized that the practice of peyotism is as much about the ceremony as it is about the psychological effects. “We don’t view peyote as a substance the way non-Natives think about drugs,” said Tsosie. “There is no hallucination, no trip. The medicine is not used to numb the body like with other drugs, but to teach us.”
The gathering was sponsored by a local Diné chapter of the Native American church. Diné peyote practitioners and church members across the west describe peyote as one might a beloved family member. For them, peyote is a sentient being, a wise elder, a savior. They say the medicine is a gift from the creator that has made it possible to survive the traumas of colonization.
Fear and anger about what outside forces might do were palpable inside the hogan. Synthesizing, commodifying and enriching oneself at peyote’s expense is no way to treat a relative.
“We just have a sliver left of what we hold dear,” said Tsosie. “And we are praying and fighting to hang on to it.”
The way modern tribal members tell it, their ancestors were drowning in sorrow as a result of federal policies to seize their homeland and sacred sites, force their children into boarding schools and forbid the practice of traditional ceremonies. Peyote was sent by the creator as a kind of life raft that traveled from tribe to tribe, and those who jumped on, survived.
Radiocarbon studies of peyote buttons have dated the ritual use of Lophophora williamsii by Indigenous peoples back more than 5,000 years, but peyotism did not reach the Diné and other Plains tribes until the mid- to late 1800s.
Then in 1883, Congress passed the Religious Crimes Code, outlawing Indigenous American spirituality on the grounds that it hindered the federal policy of forced assimilation. In addition to peyote ceremonies, the sun dance and ghost dance were only practiced in secret, with violators subjected to jail time and the withholding of food rations.
Frank Dayish, 65, grew up on the north-western corner of the Navajo reservation and is descended from generations of peyote practitioners. He remembers how, when he was a young boy, tribal law enforcement would show up at his home and seize his community’s supply of peyote.
“The Navajo Nation police put all the peyote in a pile and poured gasoline on it and burned it,” said Dayish. “After they left, my father and his brothers would try to salvage what was too green to burn.”
The religious crimes law would not be repealed until 1978, when Congress passed the American Indian Religious Freedom Act (Airfa). But Airfa did not specifically address the use of peyote, which the federal government still classified as a highly addictive, schedule 1 drug. To distinguish themselves from the experimental hippies in the 1970s, Indigenous American peyote practitioners banded together to form a religion called the Native American church, demanding the same protections for their religious beliefs as anyone else in the US.
After decades of lobbying by Native American church groups, a 1994 amendment to Airfa finally gave protections to Indigenous American peyote users by stipulating that peyote can only be consumed by a “federally recognized tribal member” and “in connection with a traditional Indian religion”. The amendment also authorized tribal members to legally transport peyote across state lines.
“That was a huge victory for us,” said Dayish, who was president of the Native American church of North America at the time and heavily involved in lobbying for the amendment.
However, the hard-won exemption soon had unintended effects. Non-Indigenous New Age groups, such asJames Mooney’s Oklevueha church and the Peyote Way Church of God,began offering access to the sacred cactus by claiming to follow the Native American church religion or their own brand of peyote religion.
In a precedent-setting 2004 case, the Utah supreme court ruled that Mooney was allowed to distribute peyote to his church members under the Religious Freedom Restoration Act. The result was to embolden psychedelic activists, who established plant-medicine churches on the grounds of religious freedom and to invigorate the decriminalization movement.
Today, one of the largest groups behind this movement is called Decriminalize Nature. The organization has 50 chapters across the United States, each comprising grassroots plant-medicine activists who advocate for legislation at state and local levels. Their logo features a peyote button, with a website that urges humanity to “draw upon the ancient wisdom of all our ancestors who lived from the Indigenous Worldview upon this Earth”.
Aikutzi Valadez, a member of Decriminalize Nature’s board, believes anyone should be allowed to grow peyote in private greenhouses for their personal use in order to increase supply and protect the cactus from being depleted in its native habitat. Valadez resides in California but is a member of the Huichol tribe in Mexico, which practices peyotism. She said that because she is not enrolled in a federally recognized tribe in the US, current drug laws prevent her from being able to engage in traditional peyote rituals where she lives.
“Native American church members need to look at the big picture,” she said. “If they are concerned about peyote becoming commodified, the solution is to make it widely available so it’s not just the pharmaceutical companies that have access. We are trying to liberate peyote because it is Mother Nature’s plant and should not be criminalized.”
This anti-corporate, nature-based ideology is appealing to many liberal-minded activists. But the philosophy of Decriminalize Nature, and groups like it, illuminates a tension at the heart of the peyote debate. Native American church leaders say groups describing themselves as culturally progressive are not only ignoring the requests of tribal governments but have done little to consult them on how peyote should be used by non-Indigenous people – if at all.
While the group’s policy is positioned as a “working plan” to help Native American church members and other Indigenous peyote practitioners protect their sacred medicine, Kevin Feeney, a cultural anthropologist at Central Washington University, sees echoes of the US’s colonial past in such efforts.
“There is the sentiment within the movement that decriminalizing these plants will result in this rosy, kumbaya situation where we all get to take peyote,” said Feeney, who has written extensively on peyote issues. “They are saying, let bygones be bygones … But, really, they are only asking Native people to be OK with this history.”
An $11bn industry
The psychedelics drug market is expected to be worth more than $11bn by the end of the decade. And while the use of psilocybin and MDMA in a clinical setting are farthest along, mescaline is the dark horse that some of Silicon Valley’s biggest investors are betting on.
One company riding the wave is Journey Colab, a pharmaceutical startup that’s developing psychedelic drugs and therapies. Since its founding in 2020, the company has raised more than $12m from high-level investors including Sam Altman, the founder of ChatGPT and an avid psychedelic proponent.
Journey Colab’s founder, Jeeshan Chowdhury, says people describe him as a “Silicon Valley tech bro”. He’s also a physician and the son of Indian immigrants.
He says he was intrigued by mescaline when he started the company. “The elders and respected leaders in the psychedelic space all told me mescaline was their favorite,” he said.
Peyote has long had a certain cachet in the psychedelics world. The English writer and philosopher Aldous Huxley first coined the term “psychedelic” in his 1954 essay The Doors of Perception to describe a mescaline trip. The perpetually intoxicated gonzo journalist Hunter S Thompson further popularised the drug in works like Fear and Loathing in Las Vegas.
While mescaline was studied for its therapeutic benefitsin the 1950s and 1960s, it became overshadowed by LSD, which was cheaper and more accessible. Today, multiple companies, including several in Canada – where there are fewer restrictions on mescaline – are developing mescaline-based products and growing peyote in greenhouses.
The Canadian company Lophos Pharma, for instance, describes itself as “North America’s largest cultivation and research facility for peyote cactus” and is working on genetically modifying peyote to “decrease the peyote growth timeline from 13 years to as low as 3 years”.
Chowdhury says he set out to do things differently, and was influenced by Altman’s OpenAI model, which strives to share technological benefits with society at large. Alongside its drug development, Journey Colab set aside 10% of its founding equity for Indigenous groups, such as the peyote practitioners in the Native American church, as part of what it calls the Reciprocity Trust. Journey Colab has also signed a “patent pledge” that promises to use only synthetic mescaline in its products, and to not directly utilize any Indigenous resources.
Chowdhury says the fund is about respecting Indigenous American use of peyote and sharing financial benefits with Indigenous populations. “I believe if you have used any psychedelic personally or they are in any part of your professional career, we all owe our relationship to these medicines to the Indigenous communities who have stewarded this knowledge for generations,” Chowdhury said.
Native American Church prayer tipi near Potomac Park on the National Mall in Washington, D.C. (Photo by Darren Thompson for Native News Online)
However, he admits he did not consult with US Indigenous American peyote practitioners or leaders of the Native American churchbefore establishing the Reciprocity Trust. Nor did he get their opinion about creating a company that revolves around synthetic mescaline. He says he wants to give back because he believes it is the right thing to do, but he also believes that because Journey Colab’s synthetic mescaline product is not directly derived from peyote, it is not appropriating Indigenous Americans’ sacred medicine.
“There is absolutely no use of peyote or any botanical material in the construction of our synthetic mescaline,” he explained.
This is of little comfort to peyote practitioners. Aside from the spiritual implications, there is no guarantee other companies won’t try to obtain patents for mescaline that may contain some degree of organic material, or attempt to patent aspects of Indigenous American ceremonies as part of clinical treatments.
According to Chowdhury, establishing how and when the Reciprocity Trust will distribute company profits is currently on hold. Leaders of both the Peyote Way of Life Coalition and the Native American church of North America have been reluctant to engage with Journey Colab regarding the Reciprocity Trust, which is featured prominently in the company’s marketing material.
“Our unwritten spiritual laws don’t allow us to receive benefit from the extraction of our holy medicine or from our sacred heritage molecule that the pharmaceutical companies are trying to appropriate,” said Ryan Wilson, a peyote practitioner with the Oglala Lakota tribe and chair of the Native American church of North America’s legislative committee. “We don’t sell our way of life.”
While psychedelics have created a new gold rush, cultural anthropologist Feeney says the drive is about more than money.
“If someone’s goal is to have a psychedelic trip, then why do they need to use peyote or mescaline when there are so many other equally effective options like LSD or psilocybin?” he said. “I think it comes down to what non-Natives in the United States associate with the American Indian. They want a psychedelic trip and they want something that feels traditional, authentic and Earth-based.”
The proliferation of non-Indigenous ayahuasca ceremonies and plant-medicine retreats show just how mainstreamed Indigenous spirituality has become. Ayahuasca used to be largely off-limits to tourists and required an arduous trip into the South American jungle with the permission of a tribal community. Today it’s possible to attend luxury ayahuasca retreats in places like New York, New Mexico and Florida that cost thousands of dollars and promise access to Indigenous wisdom and sacred ceremonies alongside yoga, massage and other perks.
As a white person who is disconnected from his own European ancestry and Catholic religion, Feeney says he understands the desire to find meaning through Indigenous spirituality.
“There is a common emptiness among the European diaspora in this country,” Feeney added. “But, we can’t continue to perpetuate the harms of colonization by trying to fill that hole with Indigenous people’s culture.”
Back on the reservation, the peyote ceremony was drawing to a close. Diné participants greeted the rising sun with drumming and singing as shafts of white light pierced the hogan’s east-facing door.
Coals from the woodstove that had burned all night were used to form a giant heart on a square of dirt inside the structure. It was a testimony to the 12-hour spiritual marathon the participants had completed.
Hostess cupcakes and coffee were passed around. A rooster crowed. Eventually people made their way outside, where Native American church volunteers were cooking breakfast. Navajo was spoken more than English.
The student struggling to overcome alcohol abuse reported that he felt “energized and happy” as he held his girlfriend’s hand. They said the power of the experience was not just about ingesting peyote but also receiving support from their community and connecting to a tradition passed down by their ancestors.
Margie Whitney-Silva stood outside the hogan hugging the pickle jar to her chest. About half of the peyote tea had been consumed.
Having inherited the role of Native American church roadman from her father, Whitney-Silva takes the responsibility of “protecting the medicine” very seriously. She has been facilitating peyote ceremonies on the Navajo Nation for nearly two decades, ever since she first heard the sacred cactus singing to her from inside her deceased father’s medicine box.
When Whitney-Silva had arrived at the ceremony the night before, she said, she had been filled with grief. Her husband had died suddenly just a few weeks prior.
“I thought I was going to collapse, but then I heard the singing,” she said. “Our medicine is like a beating heart. As long as you have it, you will be OK.”
