FDA Calls Psychedelic Psilocybin a ‘Breakthrough Therapy’ for Severe Depression

By Yasemin Saplakoglu

The FDA is helping to speed up the process of researching and approving psilocybin, a hallucinogenic substance in magic mushrooms, to treat major depressive disorder (MDD).

For the second time in a year, the U.S. Food and Drug Administration (FDA) has designated psilocybin therapy — currently being tested in clinical trials — as “breakthrough therapy,” an action that is meant to accelerate the typically sluggish process of drug development and review. It is typically requested by a drug company and granted only when preliminary evidence suggests the drug may be an enormous improvement over already available therapy, according to the FDA.

Last year, the FDA granted “breakthrough therapy” status to psilocybin therapy in the still-ongoing clinical trials run by the company Compass Pathways, which are looking into psilocybin’s potential to treat severe treatment-resistant depression, or depression in patients who have not improved after undergoing two different antidepressant treatments, according to New Atlas.

Now, the FDA has granted another “breakthrough therapy” status to the psychedelic treatment, this time for a U.S.-based clinical trial conducted by the nonprofit Usona Institute, according to a statement from the company. This clinical trial, which includes 80 participants at seven different sites across the U.S., focuses on the efficacy of treating patients with MDD with a single dose of psilocybin.

There are more than 17 million people in the U.S. who have major depressive disorder, or severe depression that lasts more than two weeks, according to the statement. Psilocybin, with a single dose, could profoundly impact the brain and have long-lasting impacts after wiping away depressive symptoms, according to the statement.

The phase 2 trial is expected to be completed by early 2021, and with the help of this status, Usona expects it to quickly move into a larger phase 3 trial, according to New Atlas. Around one in three treatments previously given a Breakthrough Therapy status have moved on to get market approval, New Atlas wrote.

“What is truly groundbreaking is FDA’s rightful acknowledgement that MDD, not just the much smaller treatment-resistant depression population, represents an unmet medical need and that the available data suggest that psilocybin may offer a substantial clinical improvement over existing therapies,” Dr. Charles Raison, the director of clinical and translational research at Usona, said in the statement.

This isn’t the first time that a psychedelic has been researched for its potential in treating depression. In March, the FDA approved a nasal spray depression treatment for treatment-resistant patients based on Esketamine, a substance related to ketamine — an anesthetic that’s also been used as an illicit party drug. But much is still unknown even of this approved drug. Though fast-acting, it’s unclear how Esketamine changes the brain and thus what its long-term effects will be, according to a previous Live Science report.

https://www.livescience.com/psilocybin-depression-breakthrough-therapy.html

Parents have started using LSD and ‘magic’ mushrooms because they say it helps them be more present with their kids

In September, the Brooklyn Psychedelic Society hosted a “Plant Parenthood” event to educate moms and dads on how psychedelics can make a person a better — and more present — parent.

Psychedelics have been shown to help people battling depression and anxiety by disrupting ruminative thought patterns, and enabling people to connect more deeply to the world around them.

A number of parents at the “Plant Parenthood” event said that psychedelics have helped them to overcome childhood trauma and keep it from interfering with how they relate to their own children now.

When Nina’s baby turned 1 last year, Nina quit her job working as a therapist. She realized she could no longer cope, let alone help her patients get through trying times.

Nina was still battling postpartum depression. When she held her daughter, she wanted to feel at peace the way she had always envisioned. But, instead, she was awash with dark memories of her traumatic childhood and sexual assault.

That’s when Nina started microdosing with LSD and mushrooms. It’s also when she finally started to feel some relief.

“I realized how much I was reliving my childhood trauma through my own child,” Nina, who asked to use just her first name to protect her family’s privacy, told Insider. “It was affecting my mothering skills. I wanted the cycle of trauma to end with me.”

Nina, who lives in Brooklyn, New York, grew up homeless and often felt responsible for her mother’s hardships. She felt guilty that her mother endured a difficult pregnancy with her, and she constantly worried about her mother’s financial struggles.

Now, the 31-year-old microdoses a couple of times a week in sub-perceptual doses — very low amounts that don’t cause a user to experience a traditional “trip.” The precise amount is determined based on a person’s tolerance and body weight.

Nina said the experience has helped her to let go of some of her pain and refocus energy towards her daughter.

The mother of one is hardly alone in examining how psychedelics could help her become a better parent. Insider met Nina at a September event in Brooklyn called “Plant Parenthood,” which was an opportunity for moms and dads to learn more about the benefits of psychedelics.


The Brooklyn Psychedelic Society hosted an event last month to teach about the benefits of psychedelics. Jodie Love

Organized by Brooklyn Psychedelic Society, a group that educates about psychedelics, the event drew about 30 parents. Panelists, which included a poet, a church founder, and a lactation consultant, spoke from personal experience about how psychedelics can help people to overcome trauma, battle addiction, treat anxiety and depression, and simply feel more present.

Psychedelics help to disrupt ruminative thought patterns

Research into how psychedelics can be incorporated into a therapy setting began in the 1990s.

Psychedelics have been shown to disrupt the way people who are distressed think, and allow them to break out of depressive thought patterns. Psilocybin, which is similar in chemical makeup to LSD,targets the “default mode network” in the brain, and essentially causes that part of the mind to go “offline,” author Michael Pollan wrote in his book, “How to Change Your Mind,” which was excerpted in the Wall Street Journal.

In turn, the user is able to more effectively connect to other people and the world around them.

“All these disorders involve uncontrollable and endlessly repeating loops of rumination that gradually shade out reality and fray our connections to other people and the natural world,” Pollan wrote. “The ego becomes hyperactive, even tyrannical, enforcing rigid habits of thought and behavior — habits that the psychedelic experience, by loosening the ego’s grip, could help us to break.”

More than 30 million Americans are psychedelic users, according to a 2013 study published by the National Center for Biotechnology Information. That figure has remained consistent since the 1970s, Matthew Johnson, associate professor of psychiatry at the John Hopkins Center for Psychedelic Research, told Insider.

Johnson said that many of his patients who have used the mind-altering drugs report feeling more present and having a better ability to refocus their priorities, especially when it comes to familial relationships.

Despite the purported benefits, Johnson doesn’t encourage the use of these substances to help with improving parenting techniques. However, he confirmed that the drugs are physiologically safe for most people: They’re non-addictive and it’s nearly impossible to overdose.

People with heart conditions, however, run the risk of experiencing elevated blood pressure and cardiac arrest. The drugs are also unsafe for people who have schizophrenia, bipolar disorder, and other psychotic disorders, because they can lead to a psychotic break.

That being said, anybody who takes a high enough dose can have a “bad trip” which, though relatively rare, can lead to potentially dangerous behaviors. “I have a file folder full of cases where people have gotten into accidents or killed by the police because they were out of it and broke into a neighbor’s house,” Johnson said. Anxiety and depression can be exacerbated, even though there are anecdotes stating the opposite.

Experts across the board stress the importance of parents hiring a babysitter to care for their children while they’re using psychedelics.

A number of parents at the Brooklyn event agreed that the drugs have helped them to relate to their children in a deeper way.

“Psychedelics have cleared the path between me and my son,” Nicholas Powers, a poet and journalist, said during the event. “This helps me listen to him.”

Others had similar experiences to Nina, saying that psychedelics allowed them to overcome issues from their childhoods, and keep them from interfering with their relationships with their children.

This was the case with Danny Allan, a 42-year-old filmmaker and father of one. Allan said he and his wife take a “hearty” dose of mushrooms once every few months. They aim to mimic indigenous shamanic ceremonial practices and used Ayahuasca, a drink used for spiritual purposes by Amazonian tribes, once during a retreat in Peru.

Allan said using these drugs has helped him to work through the issues he had with his own mother growing up. As a child, Allan often felt that his mother was detached and that having children disrupted the lifestyle she actually wanted. When he was a teenager, Allan’s mother changed gears and became more religious, and more controlling.

As a result of his experience, Allan said he was at times smothering to his 8-year-old son, because of his mother’s aloofness. At other times, he was detached in response to her controlling behaviors.

He said psychedelics have helped him to find an even ground with his child.

“When you do that internal work with the help of psychedelics, you can heal from childhood wounds,” Allan said, “and make your parenting decisions with love and empathy.”

https://www.businessinsider.com/how-psychedelics-like-mushrooms-lsd-help-parents-relate-to-kids-2019-10

These fungi drug cicadas with psilocybin or amphetamine to make them mate nonstop


The cicada-infecting Massospora cicadina fungus makes an amphetamine called cathinone, which spurs cicadas to mate and spread fungal spores. Other species of the fungus produce psilocybin, more often found in hallucinogenic mushrooms.

A cicada-infecting fungus produces drugs that make the insects literally mate their butts off.

Massospora fungi make either a drug found in hallucinogenic mushrooms or an amphetamine found in khat leaves, plant pathologist Matthew Kasson of West Virginia University in Morgantown reported June 22 at the ASM Microbe 2019 meeting.

The fungi may use psilocybin, which causes people to hallucinate, or the amphetamine cathinone to suppress cicadas’ appetites and keep the insects moving and mating even after they lose big chunks of their bodies. The finding marks the first time that researchers have discovered a fungus, other than mushrooms, producing psilocybin, and the first organism outside of plants to make an amphetamine.

Massospora fungi are transmitted sexually from cicada to cicada. Huge plugs of fungi form on the insects’ abdomens, and during mating, parts of the abdomens may break away, Kasson said.

Losing body parts would surely slow most organisms down, and yet for the fungal-infected cicadas, “two-thirds of their body might be missing, and they would be whistling as they walk down the street,” Kasson said. The infected insects mate nearly nonstop, spreading the fungi to partners, he and colleagues report June 25 in Fungal Ecology.

Overall, the team discovered 1,176 small molecules in fungus-infected cicadas, including the two psychoactive drugs. The researchers aren’t sure how the fungi produce the drugs, which in other organisms require enzymes that seem to be missing from Massospora. So the fungi may be using new ways to make the compounds, Kasson said. The team is also trying to determine what the other molecules do to influence cicada behavior.

These fungi drug cicadas with psilocybin or amphetamine to make them mate nonstop

A Growing Push To Loosen Laws Around Psilocybin, Treat Mushrooms As Medicine


A growing body of research suggests psychedelic mushrooms may have therapeutic benefits for certain conditions. Now a movement seeks to decriminalize them.

Douglas rattles around a collection of glass jars in the storage closet of his Denver apartment. They’re filled with sterilized rye grains, covered in a soft white fungus — a mushroom spawn. Soon, he’ll transplant it in large plastic bins filled with nutrients such as dried manure and coconut fiber.

Over the course of two weeks, a crop of mushrooms that naturally contain psilocybin, a psychoactive ingredient, will sprout. The species he grows include psilocybe cubensis.

“I mean, it’s a relatively quiet thing to do. There’s just lots of waiting,” says Douglas, which is his middle name. He didn’t want to be identified because this is an illegal grow-and-sell operation; psychedelic mushrooms were federally banned in 1970, along with several other hallucinogens.

“Mushrooms are really easygoing, especially psilocybin,” he says. “They kind of just grow themselves.”

Denver is at the forefront of a national movement that seeks to access these mushrooms, largely for medicinal use. On Tuesday, voters are weighing in on a ballot measure to decriminalize them. And while that may sound ambitious, a campaign in Oregon is gathering signatures for a ballot measure in the 2020 election and seeks to legalize mushrooms with a medical prescription for use in approved clinics.

In Iowa, Republican lawmaker Jeff Shipley recently proposed two bills: one removing psilocybin from the state’s list of controlled substances, and the other legalizing it for medical use. And last year, a campaign in California did not get enough signatures to qualify for the ballot. The group that led the campaign hopes to try again in 2020, according to their Facebook page.

For Douglas, it’s a sign that change is on the horizon, one that could have implications for his business, which he says he runs for the supplemental income, but also because he believes mushrooms are beneficial.

“Cultivating psilocybin and offering medicine to people to change their lives, that will be my mission, or my way of serving others,” he says.

With his DIY setup of glass jars, large plastic bins and a pressure cooker for sterilization, Douglas can produce up to $1,000 of mushrooms a month. He learned how to do this thanks to Internet videos. He purchased his first mushroom spores online and received them in the mail; companies legally are allowed to sell spores since they don’t contain psilocybin.

If the Denver ballot measure passes, adults 21 and older who are caught with psilocybin mushrooms, or even growing them for personal use, would become the “lowest law enforcement priority” for local police. Plus, the city and county of Denver would be barred from spending any money to prosecute psilocybin cases.

The notion that state laws around mushrooms could be loosened up, much like they have been for cannabis, is not without controversy. Matthew Johnson, who has spent the past 15 years researching psychedelics at Johns Hopkins University in Baltimore, says decriminalization of illegal drugs is generally a good thing, but he wouldn’t support policy that encourages people to use psilocybin without professional supervision.

“(This therapy) needs to be done by appropriately trained and credentialed medical and psychological professionals,” he says.

Research suggests that psilocybin is not addictive, causes few ER visits compared to other illegal drugs and could be used to treat a number of ailments. Johnson believes the most promising research is on treating anxiety and depression in cancer patients. In a study he conducted with other researchers at Johns Hopkins, he says they found even a single dose can positively affect an individual for several months.

“It’s really unprecedented in medical history to see effects for depression that are caused by a single medication,” he says.

Preliminary research has been conducted for other potential uses, including curbing nicotine addiction and for treatment-resistant depression. And while Johnson believes psilocybin could one day become a groundbreaking treatment, he’s emphatic about the potential risks involved.

“The most common side effect is the so-called ‘bad trip,’ ” he says. “(It) can be well-managed in a medical research setting, but that sometimes leads to dangerous behavior when out in the wild.”

Under the influence of psilocybin, people can panic and put themselves in unsafe situations; there have been fatalities, he says.

Johnson says he thinks that, in as little as five years, research on psilocybin will lead to the first medication approved by the Federal Drug Administration. Once that happens, he thinks the government will have to remove it as a Schedule 1 drug — a substance like heroin that the DEA considers to have “no accepted medical use and a high potential for abuse.”

Until then, Deanne Reuter, the assistant special agent in charge at the DEA’s Denver office, says the agency will continue prosecuting cases of psilocybin possession and trafficking.

“Any controlled substance is a concern,” she says. “It’s obviously on a Schedule 1 for a reason.”

Reuter admits they don’t see many cases of psilocybin trafficking. Typically, they’ll bust a drug dealer carrying several types of narcotics, including mushrooms.

“The trafficking of psilocybin seems to be like a small, niche kind of community,” she says.

Douglas would agree. He has little competition and knows most of the people he sells his product to. Still, he knows the work he does it risky.

“With decriminalization and stuff I can operate a little bit more freely, have to worry less,” he says.

If the Denver ballot measure passes, it wouldn’t protect someone like him, who’s selling mushrooms for profit. Still, he says it’d be a step closer to a future where he can freely provide people with something he believes in.

https://www.npr.org/sections/health-shots/2019/05/07/720828367/a-growing-push-to-loosen-laws-around-psilocybin-treat-mushrooms-as-medicine

Possible reason why ‘magic’ mushrooms evolved

By Rafi Letzter

“Magic” mushrooms seem to have passed their genes for mind-altering substances around among distant species as a survival mechanism: By making fungus-eating insects “trip,” the bugs become less hungry — and less likely to feast on mushrooms.

That’s the upshot of a paper published Feb. 27 in the journal Evolution Letters by a team of biologists at The Ohio State University and the University of Tennessee.

The researchers studied a group of mushrooms that all produce psilocybin — the chemical agent that causes altered states of consciousness in human beings — but aren’t closely related. The scientists found that the clusters of genes that caused the ‘shrooms to fill themselves with psilocybin were very similar to one another, more similar even than clusters of genes found in closely related species of mushrooms.

That’s a sign, the researchers wrote, that the genes weren’t inherited from a common ancestor, but instead were passed directly between distant species in a phenomenon known as “horizontal gene transfer” or HGT.

HGT isn’t really one process, as the biologist Alita Burmeister explained in the journal Evolution, Medicine and Public Health in 2015. Instead, it’s the term for a group of more or less well-understood processes — like viruses picking up genes from one species and dropping them in another — that can cause groups of genes to jump between species.

However, HGT is believed to be pretty uncommon in complex, mushroom-forming fungi, turning up much more often in single-celled organisms.

When a horizontally transferred gene takes hold and spreads after landing in a new species, the paper’s authors wrote, scientists believe that’s a sign that the gene offered a solution to some crisis the organism’s old genetic code couldn’t solve on its own.

The researchers suggested — but didn’t claim to prove — that the crisis in this case was droves of insects feasting on the defenseless mushrooms. Most of the species the scientists studied grew on animal dung and rotting wood — insect-rich environments (and environments full of opportunities to perform HGT). Psilocybin, the scientists wrote, might suppress insects’ appetites or otherwise induce the bugs to stop munching quite so much mush’.

https://www.livescience.com/61877-magic-mushrooms-evolution.html

Johns Hopkins clinical pharmacologist Roland Griffiths talks about a major new study hinting at psychedelic drugs as therapeutic powerhouses

By Richard Schiffman

In one of the largest and most rigorous clinical investigations of psychedelic drugs to date, researchers at Johns Hopkins University and New York University have found that a single dose of psilocybin—the psychoactive compound in “magic” mushrooms—substantially diminished depression and anxiety in patients with advanced cancer.

Psychedelics were the subject of a flurry of serious medical research in the 1960s, when many scientists believed some of the mind-bending compounds held tremendous therapeutic promise for treating a number of conditions including severe mental health problems and alcohol addiction. But flamboyant Harvard psychology professor Timothy Leary—one of the top scientists involved—started aggressively promoting LSD as a consciousness expansion tool for the masses, and the youth counterculture movement answered the call in a big way. Leary lost his job and eventually became an international fugitive. Virtually all legal research on psychedelics shuddered to a halt when federal drug policies hardened in the 1970s.

The decades-long research blackout ended in 1999 when Roland Griffiths of Johns Hopkins was among the first to initiate a new series of studies on psilocybin. Griffiths has been called the grandfather of the current psychedelics research renaissance, and a 21st-century pioneer in the field—but the soft-spoken investigator is no activist or shaman/showman in the mold of Leary. He’s a scientifically cautious clinical pharmacologist and author of more than 300 studies on mood-altering substances from coffee to ketamine.

Much of Griffiths’ fascination with psychedelics stems from his own mindfulness meditation practice, which he says sparked his interest in altered states of consciousness. When he started administering psilocybin to volunteers for his research, he was stunned that more than two-thirds of the participants rated their psychedelic journey one of the most important experiences of their lives.

Griffiths believes that psychedelics are not just tools for exploring the far reaches of the human mind. He says they show remarkable potential for treating conditions ranging from drug and alcohol dependence to depression and post-traumatic stress disorder.

They may also help relieve one of humanity’s cruelest agonies: the angst that stems from facing the inevitability of death. In research conducted collaboratively by Griffiths and Stephen Ross, clinical director of the NYU Langone Center of Excellence on Addiction, 80 patients with life-threatening cancer in Baltimore and New York City were given laboratory-synthesized psilocybin in a carefully monitored setting, and in conjunction with limited psychological counseling. More than three-quarters reported significant relief from depression and anxiety—improvements that remained during a follow-up survey conducted six months after taking the compound, according to the double-blind study published December 1 in The Journal of Psychopharmacology.

“It is simply unprecedented in psychiatry that a single dose of a medicine produces these kinds of dramatic and enduring results,” Ross says. He and Griffiths acknowledge that psychedelics may never be available on the drugstore shelf. But the scientists do envision a promising future for these substances in controlled clinical use. In a wide-ranging interview, Griffiths told Scientific American about the cancer study and his other work with psychedelics—a field that he says could eventually contribute to helping ensure our survival as a species.

[An edited transcript of the interview follows.]

What were your concerns going into the cancer study?
The volunteers came to us often highly stressed and demoralized by their illness and the often-grueling medical treatment. I felt very cautious at first, wondering if this might not re-wound people dealing with the painful questions of death and dying. How do we know that this kind of experience with this disorienting compound wouldn’t exacerbate that? It turns out that it doesn’t. It does just the opposite. The experience appears to be deeply meaningful spiritually and personally, and very healing in the context of people’s understanding of their illness and how they manage that going forward.

Could you describe your procedure?
We spent at least eight hours talking to people about their cancer, their anxiety, their concerns and so on to develop good rapport with them before the trial. During the sessions there was no specific psychological intervention—we were just inviting people to lie on the couch and explore their own inner experience.

What did your research subjects tell you about that experience?
There is something about the core of this experience that opens people up to the great mystery of what it is that we don’t know. It is not that everybody comes out of it and says, ‘Oh, now I believe in life after death.’ That needn’t be the case at all. But the psilocybin experience enables a sense of deeper meaning, and an understanding that in the largest frame everything is fine and that there is nothing to be fearful of. There is a buoyancy that comes of that which is quite remarkable. To see people who are so beaten down by this illness, and they start actually providing reassurance to the people who love them most, telling them ‘it is all okay and there is no need to worry’— when a dying person can provide that type of clarity for their caretakers, even we researchers are left with a sense of wonder.

Was this positive result universal?
We found that the response was dose-specific. The larger dose created a much larger response than the lower dose. We also found that the occurrence of mystical-type experiences is positively correlated with positive outcomes: Those who underwent them were more likely to have enduring, large-magnitude changes in depression and anxiety.

Did any of your volunteers experience difficulties?
There are potential risks associated with these compounds. We can protect against a lot of those risks, it seems, through the screening and preparation procedure in our medical setting. About 30 percent of our people reported some fear or discomfort arising sometime during the experience. If individuals are anxious, then we might say a few words, or hold their hand. It is really just grounding them in consensual reality, reminding them that they have taken psilocybin, that everything is going to be alright. Very often these short-lived experiences of psychological challenge can be cathartic and serve as doorways into personal meaning and transcendence—but not always.

Where do you go from here?
The Heffter Research Institute, which funded our study, has just opened a dialogue with the FDA (Food and Drug Administration) about initiating a phase 3 investigation. A phase 3 clinical trial is the gold standard for determining whether something is clinically efficacious and meets the standards that are necessary for it to be released as a pharmaceutical. Approval would be under very narrow and restrictive conditions initially. The drug might be controlled by a central pharmacy, which sends it to clinics that are authorized to administer psilocybin in this therapeutic context. So this is not writing a prescription and taking it home. The analogy would be more like an anesthetic being dispensed and managed by an anesthesiologist.

You are also currently conducting research on psilocybin and smoking.
We are using psilocybin in conjunction with cognitive behavioral therapy with cigarette smokers to see if these deeply meaningful experiences that can happen with psilocybin can be linked with the intention and commitment to quit smoking, among people who have failed repeatedly to do so. Earlier we ran an uncontrolled pilot study on that in 50 volunteers, in which we had 80 percent abstinence rates at six months. Now we are doing a controlled clinical trial in that population.

How do you account for your remarkable initial results?
People who have taken psilocybin appear to have more confidence in their ability to change their own behavior and to manage their addictions. Prior to this experience, quite often the individual feels that they have no freedom relative to their addiction, that they are hooked and they don’t have the capacity to change. But after an experience of this sort—which is like backing up and seeing the larger picture—they begin to ask themselves ‘Why would I think that I couldn’t stop cigarette smoking? Why would I think that this craving is so compelling that I have to give in to it?’ When the psilocybin is coupled with cognitive behavioral therapy, which is giving smokers tools and a framework to work on this, it appears to be very helpful.

You are also working with meditation practitioners. Are they having similar experiences?
We have done an unpublished study with beginning meditators. We found that psilocybin potentiates their engagement with their spiritual practice, and it appears to boost dispositional characteristics like gratitude, compassion, altruism, sensitivity to others and forgiveness. We were interested in whether the psilocybin used in conjunction with meditation could create sustained changes in people that were of social value. And that appears to be the case.

So it is actually changing personality?
Yes. That is really interesting because personality is considered to be a fixed characteristic; it is generally thought to be locked down in an individual by their early twenties. And yet here we are seeing significant increases in their “openness” and other pro-social dimensions of personality, which are also correlated with creativity, so this is truly surprising.

Do we know what is actually happening in the brain?
We are doing neuro-imaging studies. Dr. Robin Carhart-Harris’s group at Imperial College in London is also doing neuro-imaging studies. So it is an area of very active investigation. The effects are perhaps explained, at least initially, by changes in something [in the brain] called “the default mode network,” which is involved in self-referential processing [and in sustaining our sense of ego]. It turns out that this network is hyperactive in depression. Interestingly, in meditation it becomes quiescent, and also with psilocybin it becomes quiescent. This may correlate with the experience of clarity of coming into the present moment.

That is perhaps an explanation of the acute effects, but the enduring effects are much less clear, and I don’t think that we have a good handle on that at all. Undoubtedly it is going to be much more complex than just the default mode network, because of the vast interconnectedness of brain function.

What are the practical implications of this kind of neurological and therapeutic knowledge of psychedelics?
Ultimately it is not really about psychedelics. Science is going to take it beyond psychedelics when we start understanding the brain mechanisms underlying this and begin harnessing these for the benefit of humankind.

The core mystical experience is one of the interconnectedness of all people and things, the awareness that we are all in this together. It is precisely the lack of this sense of mutual caretaking that puts our species at risk right now, with climate change and the development of weaponry that can destroy life on the planet. So the answer is not that everybody needs to take psychedelics. It is to understand what mechanisms maximize these kinds of experiences, and to learn how to harness them so that we don’t end up annihilating ourselves.

https://www.scientificamerican.com/article/psilocybin-a-journey-beyond-the-fear-of-death/

Psilocybin Study Results Hailed as Potentially Groundbreaking Treatment for Anxiety and Depression

Two new randomized and controlled trials show that just one dose of psilocybin—the compound in psychedelic mushrooms—can produce dramatic and long-lasting improvements in depression and anxiety symptoms.

The findings, published in The Journal of Psychopharmacology, are being hailed as unprecedented and potentially transformative for the treatment of psychiatric disorders.

“These findings, the most profound to date in the medical use of psilocybin, indicate it could be more effective at treating serious psychiatric diseases than traditional pharmaceutical approaches, and without having to take a medication every day,” said George R. Greer, MD, Medical Director of the Heffter Research Institute, which funded and reviewed the studies.

Psych Congress Steering Committee member Andrew Penn, RN, MS, NP, CNS, APRN-BC, said that if the findings can be replicated in larger studies, “we may be living witnesses to an event in psychiatry that is no less significant than when Alexander Fleming discovered penicillin.”

“These studies represent a new dawn of hope for our profession and our ability to help some of our most desperate patients, those whose lives are disrupted not only by cancer, but by the existential distress of dying, not only find relief from their suffering, but to find meaning in their illness,” said Penn, Psychiatric Nurse Practitioner at Kaiser Permanente in Redwood City, California.

The 2 studies were led by researchers at Johns Hopkins University School of Medicine in Baltimore, Maryland, and the New York University (NYU) Langone Medical Center in New York City. The participants in both trials had life-threatening cancer diagnoses and related mood disturbances.

Fifty-one adults participated in the double-blind Johns Hopkins study. They received a capsule of psilocybin in what is considered a moderate or high dose (22 or 30 mg/70 kg) during 1 of 2 treatment sessions. At the other session, they received a low dose of psilocybin as a control.

Researchers reported they had considerable relief from their anxiety or depression symptoms for up to 6 months. About 80% of the participants continued to show clinically significant decreases in symptoms 6 months after the final treatment session.

“The most interesting and remarkable finding is that a single dose of psilocybin, which lasts four to six hours, produced enduring decreases in depression and anxiety symptoms, and this may represent a fascinating new model for treating some psychiatric conditions,” says Roland Griffiths, PhD, professor of Behavioral Biology in the Departments of Psychiatry and Behavioral Sciences and Neuroscience at the Johns Hopkins medical school.

The NYU double-blind crossover study involved 29 participants, who all received tailored counseling, a 0.3 mg/kg dose of psilocybin at one of 2 treatment sessions, and a vitamin placebo at the other session. Eighty percent of the participants experienced relief for more than 6 months, researchers reported.

“That a drug administered once can have this effect for so long is unprecedented. We have never had anything like it in the psychiatric field,” said Stephen Ross, MD, principal investigator of the NYU study and director of substance abuse services in the Department of Psychiatry at the Langone Medical Center.

Psych Congress co-chair Charles Raison, MD, said he has “had the privilege of being involved in the next stages of the work to explore whether psilocybin holds true potential for treating depression and anxiety.”

“This has given me an insider’s view of this area of research and from that perspective I think there is a very good chance that psychedelic medicines—which were abandoned long ago by psychiatry—may hold promise as some of the more powerful treatments for emotional disorders that we will identify in the 21st century,” said Dr. Raison, Professor of Human Development and Family Studies and of Psychiatry at the University of Wisconsin-Madison.

The Journal of Psychopharmacology published 11 commentaries with the study results, which generally support the research into psilocybin and its use in a clinical setting, according to a Johns Hopkins statement.

Penn noted that “few mental health professionals trained in the last 4 decades know anything about these drugs, beyond their use as an intoxicant.”

“When the sun set on psychedelic drug research amidst the hysteria of the ‘drug war’ begun in the 1960s, the promise of these compounds, including psilocybin, was almost lost to history,” Penn said.

– Terri Airov

http://www.psychcongress.com/article/psilocybin-study-results-hailed-potentially-groundbreaking

Psychedelic Therapy and Bad Trips


Synthetic psilocybin, a compound found in magic mushrooms, has been administered to cancer patients in a study at New York University. Researcher Anthony Bossis says many subjects report decreased depression and fear of death after their session. Although some patients do not report persistent positive feelings, none report persistent adverse effects. Photo: Bossis, NYU.

By John Horgan

Bossis, a psychologist at New York University, belongs to an intrepid cadre of scientists reviving research into psychedelics’ therapeutic potential. I say “reviving” because research on psychedelics thrived in the 1950s and 1960s before being crushed by a wave of anti-psychedelic hostility and legislation.

Psychedelics such as LSD, psilocybin and mescaline are still illegal in the U.S. But over the past two decades, researchers have gradually gained permission from federal and other authorities to carry out experiments with the drugs. Together with physicians Stephen Ross and Jeffrey Guss, Bossis has tested the potential of psilocybin—the primary active ingredient of “magic mushrooms”–to alleviate anxiety and depression in cancer patients.

Journalist Michael Pollan described the work of Bossis and others in The New Yorker last year. Pollan said researchers at NYU and Johns Hopkins had overseen 500 psilocybin sessions and observed “no serious adverse effects.” Many subjects underwent mystical experiences, which consist of “feelings of unity, sacredness, ineffability, peace and joy,” as well as the conviction that you have discovered “an objective truth about reality.”

Pollan’s report was so upbeat that I felt obliged to push back a bit, pointing out that not all psychedelic experiences—or mystical ones–are consoling. In The Varieties of Religious Experience, William James emphasized that some mystics have “melancholic” or “diabolical” visions, in which ultimate reality appears terrifyingly alien and uncaring.

Taking psychedelics in a supervised research setting doesn’t entirely eliminate the risk of a bad trip. That lesson emerged from a study in the early 1990s by psychiatrist Rick Strassman, who injected dimethyltryptamine, DMT, into human volunteers.

From 1990 to 1995, Strassman supervised more than 400 DMT sessions involving 60 subjects. Many reported dissolving blissfully into a radiant light or sensing the presence of a loving god. But 25 subjects had “adverse effects,” including terrifying hallucinations of “aliens” that took the shape of robots, insects or reptiles. (For more on Strassman’s study, see this link: https://www.rickstrassman.com/index.php?option=com_content&view=article&id=61&Itemid=60

Swiss chemist Albert Hofmann, who discovered LSD’s powers in 1943 and later synthesized psilocybin, sometimes expressed misgivings about psychedelics. When I interviewed him in 1999, he said psychedelics have enormous scientific, therapeutic and spiritual potential. He hoped someday people would take psychedelics in “meditation centers” to awaken their religious awe.

Yet in his 1980 memoir LSD: My Problem Child, Hofmann confessed that he occasionally regretted his role in popularizing psychedelics, which he feared represent “a forbidden transgression of limits.” He compared his discoveries to nuclear fission; just as fission threatens our fundamental physical integrity, so do psychedelics “attack the spiritual center of the personality, the self.”

I had these concerns in mind when I attended a recent talk by Bossis near New York University. A large, bearded man who exudes warmth and enthusiasm, Bossis couldn’t reveal details of the cancer-patient study, a paper on which is under review, but he made it clear that the results were positive.

Many subjects reported decreased depression and fear of death and “improved well-being” after their session. Some called the experience among the best of their lives, with spiritual implications. An atheist woman described feeling “bathed in God’s love.”

Bossis said psychedelic therapy could transform the way people die, making the experience much more meaningful. He quoted philosopher Victor Frankl, who said, “Man is not destroyed by suffering. He is destroyed by suffering without meaning.”

During the Q&A, I asked Bossis about bad trips. Wouldn’t it be awful, I suggested, if a dying patient’s last significant experience was negative? Bossis said he and his co-researchers were acutely aware of that risk. They minimized adverse reactions by managing the set (i.e., mindset, or expectations, of the subject) and setting (context of the session).

First, they screen patients for mental illness, eliminating those with, say, a family history of schizophrenia. Second, the researchers prepare patients for sessions, telling them to expect and explore rather than suppressing negative emotions, such as fear or grief. Third, the sessions take place in a safe, comfortable room, which patients can decorate with personal items, such as photographs or works of art. A researcher is present during sessions but avoids verbal interactions that might distract the patient from her inner journey. Patients and researchers generally talk about sessions the following day.

These methods seem to work. Some patients, to be sure, became frightened or melancholy. One dwelled on the horrors of the Holocaust, which had killed many members of his family, but he found the experience meaningful. Some patients did not emerge from their sessions with persistent positive feelings, Bossis said, but none reported persistent adverse effects.

Bossis has begun a new study that involves giving psilocybin to religious leaders, such as priests and rabbis. His hope is that these subjects will gain a deeper understanding of the mystical roots of their faiths.

http://blogs.scientificamerican.com/cross-check/psychedelic-therapy-and-bad-trips/

More People ‘Microdosing’ on Psychedelic Drugs

by Tia Ghose

For Martijn Schirp, it’s a way to make an ordinary day just a little bit better.

A former poker player and recent graduate in interdisciplinary science in Amsterdam, Schirp has been experimenting with a new way to take psychedelic drugs: Called microdosing, it involves routinely taking a small fraction of a normal dose of lysergic acid diethylamide (LSD) or magic mushrooms.

Microdosing has gained a cult following amongst a small group of hallucinogen enthusiasts like Schirp, who now writes at HighExistence.com. Proponents report improvements in perception, mood and focus, minus the trippy tangerine trees and marmalade skies normally associated with psychedelics.

Schirp said he prefers to microdose when he’s immersed in creative or contemplative activities, such as writing, painting, meditating or doing yoga.

“It’s like the coffee to wake up the mind-body connection. When I notice it is working, depending on the dosage, time seems to be slowing down a bit, everything seems covered with a layer of extra significance,” Schirp told Live Science in an email.

Given his positive experiences with higher doses of psychedelics, “microdosing offered a way to get a taste of this without [the experience] completely overwhelming me,” Schirp said.

But while the effects Schirp and others describe are plausible from a physiological perspective, microdosing is uncharted territory, said Matt Johnson, a psychologist at Johns Hopkins University in Baltimore, Maryland, who has studied the behavioral effects of psychedelic drugs. Scientists have yet to run a clinical trial to assess the effects (or lack thereof) of microdosing. Johnson added that taking a smaller dose of a psychedelic is safer than taking a large dose, but the way people tend to do it — regularly taking small doses every several days — could have long-term side effects.

Just a little bit

The idea of taking small doses of psychedelics has been around for a while. The inventor of LSD, Albert Hofmann, was known to microdose in his old age and told a friend that microdosing was an under-researched area. But microdosing gained greater visibility when James Fadiman, a psychologist and researcher at Sofia University in Palo Alto, California, described it in his book “The Psychedelic Explorer’s Guide” (Park Street Press, 2011).

Since then, Fadiman has received about 50 anecdotal reports from microdosers around the world. Most report positive, barely perceptible shifts while microdosing, Fadiman said.

“What people say is that whatever they’re doing, they seem to be doing it a little better,” Fadiman told Live Science. “They’re a little kinder, a little bit nicer with their kids.”

People with creative jobs report improved focus and an ability to enter the state of flow more easily. Some report a desire to eat healthier or start meditating, Fadiman said.

“It’s like they tend to live a little better,” Fadiman said.

Still others report taking the teeny doses of psychedelics for psychiatric conditions, said Brad Burge, the director of marketing and communications at Multidisciplinary Association for Psychedelic Studies in Santa Cruz, California, where scientists study the effect of psychedelics on medical conditions such as PTSD.

“I’ve heard anecdotally of people using it for depression, seasonal affective disorder, anxiety, OCD [obsessive compulsive disorder],” Burge told Live Science. “With microdoses, the point would be to create subtle changes in people’s psychopharmacology or experience, in much the same way as most traditional pharmaceuticals are used now.”

Plausible mechanism, no evidence

The effects people report with microdoses of LSD, psilocybin, DMT or other “classic” psychedelics aren’t completely implausible, Johnson said. All of these drugs work by activating a particular receptor in the brain known as the serotonin 5HT-2A receptor. This receptor fuels the release of the “feel-good” brain chemical, serotonin, which creates a domino effect in the brain that leads to many other brain changes.

At high doses, these drugs temporarily, but radically, reshape brain networks; for instance, one study found that magic mushrooms create a hyperconnected brain. But antidepressants like Prozac also target serotonin receptors, so it’s possible that a low, constant dose of a psychedelic might work in a similar manner, Johnson said.

Still, there’s absolutely no evidence to suggest microdosing works as people claim it does, Johnson said. The effects described are so subtle — on par with having the caffeine in a cup of coffee — that they “fall within that category of barely perceptible, and it’s right in the range where people can so easily fool themselves,” Johnson told Live Science. That means microdosing is particularly susceptible to the placebo effect, in which people taking a sugar pill who believe they’re taking a drug report perceptible effects, he said.

To prove that microdosing has an effect, psychedelics researchers would need to do a double-blind study, in which neither the people administering the drug nor the recipients know whether a particular participant is getting a microdose of a psychedelic or something inert, like a little sugar dissolved in water, Johnson said. Some groups of people are allegedly doing these trials — but because LSD is illegal, and is only approved for research use in a few small trials in a few locations, all of these people are off the grid and not publicizing their efforts, Fadiman said.

Unknown side effects

What’s more, microdosing could have side effects, Johnson said. The few microscopic grains of LSD — just 10 micrograms — typically used to microdose are too tiny to measure even on a professional laboratory scale, Johnson said. To get around this, people who microdose typically take a blotter paper laced with one hit of LSD, soak it in water and then drink some of the water. But since LSD is an illegal substance procured on the black market, there’s really no way to know exactly what you’re getting, Johnson said.

Even in the lab, with carefully measured doses of drugs administered in a controlled environment, Johnson has found substantial variation in the way that people react to the same dose. Combined, those two uncertainties mean people may not be able to reliably microdose, he said.

“Someone might be expecting a kind of sparkly day, just a really productive day at work — and next thing you know, they’re grasping hold to their office chair wondering why the world is dissolving,” Johnson said.

Schirp, for instance, has occasionally had negative microdosing experiences.

“At times, the experience was still too overwhelming to be productive — I just wanted to lay down or take a walk,” Schirp said.

Beyond that possible experience, the long-term risks of the drug are unknown. The risk of taking a single, tiny dose of LSD or psilocybin is going to be smaller than the risk of taking one big hit, Johnson said. But even the most dedicated psychonauts don’t typically trip daily or even weekly, Johnson said. By contrast, people who are microdosing report using the drugs every three or four days, he said.

Such frequent use could have unknown, long-term side effects, he said.

“You’re tinkering with the system that is involved with depressive systems, but in unexplored ways,” Johnson said.

http://www.livescience.com/51482-more-people-microdosing-psychedelic-drugs.html

Meet the Man Trying to Use Ayahuasca to Treat PTSD

Deep in the Amazon rainforest, a group of veterans chokes down a gritty, gut-wrenching shot of liquid absolution. They try to drink away their severe mental disturbances, but not the way you drink away your ex-girlfriend with a bottle of whiskey. They’re looking for a cure. Their leader: 27-year-old retired infantryman Ryan LeCompte. Their goal: to hallucinate away their terrible memories.

From a few fringe psychiatrists to veterans like LeCompte, there is a budding belief that extreme hallucination can save our brains from themselves. Several organizations, including the Multidisciplinary Association for Psychedelic Studies (MAPS), and adventurous doctors around the world test out psychedelics such as MDMA, psilocybin and ayahuasca for possible medical uses.

Ayahuasca is a devilish brew. It’s made of vines and roots found in the Amazon; drinking it equals a heavy psychedelic experience and profuse vomiting. “As the shapes and colors continued to move about, they sometimes converged to create the face of a woman, who of course I immediately labeled as Aya,” says an ayahuasca user on the underground drug website Erowid. Aya is known as the spirit or soul of the ayahuasca world. LeCompte described having kaleidoscope vision during his ayahuasca trip, and he even began to dance and went to look at leaves and other pieces of the nature around him at points.

Ryan LeCompte is a scruffy former Marine who, today, is studying at the eccentric Naropa University in Boulder. The school was founded by Tibetan Buddhist teacher and Oxford University scholar Chögyam Trungpa and includes schools such as the Jack Kerouac School of Disembodied Poetics. The beat poets used to flock to there. It’s a Buddhist-inspired school infamous for attracting people who are looking for an alternative education in an attractive location.

For his part, LeCompte didn’t ever face a PTSD diagnosis during his time in service. But he’s lucky, because many of his peers did. What he did experience still shook him. In 2008, while stationed in 8th and I Marine Barracks in Washington, D.C., LeCompte walked into the room of a good friend in his barracks one morning to find Sgt. Jorge Leon-Alcivar dead—a suicide. He was not the only Marine LeCompte encountered who would take his own life. At least 22 veterans kill themselves every day. Leon-Alcivar’s death was the final straw, and three years later LeCompte retired from the Marines to start fighting PTSD. He received his End of Active Service honorable discharge after four years in the Marines and didn’t look back.

LeCompte began traveling to the VA hospital in Birmingham, Alabama, where he was living, to learn what was ailing disturbed veterans and soldiers. He hung around in waiting rooms, cautiously approaching the soldiers, wheedling their stories out. But it didn’t take much persuasion; the men were “so beat,” he recalls, that they opened up to him instantly. This took course over several years, during his free time, while he did contract work building helicopters.

Soon, LeCompte had amassed the information from about 100 cases in Birmingham; Veterans spilled almost everything to him: their meds, their dosages, their choice of therapy. It all added up. Over and over again, he discovered his peers were taking the same types of medicines such Zoloft and Paxil, in the same dosages, 50 to 200mg of Zoloft a day or 20 to 60mg of Paxil a day were common, and with the same form of EMDR therapy. EMDR is a somatic therapy that follows eye movements and dream states.

LeCompte didn’t see anything wrong with the therapy. How about the drugs? Yeah, it’s probably the drugs. LeCompte’s complaints ring of an old story these days in American psychiatry: we’re too drugged up, we’re overdosed and overdiagnosed. It’s a complaint plenty of professionals agree with, but only a handful of psychiatrists are taking alternate routes. “There are some veterans who actually do respond to those meds, but it’s rare,” Dr. Sue Sisley, an expert on PTSD in veterans who has studied treating the illness with marijuana, told ATTN:. “The vets who respond to the standard FDA approved meds like Zoloft or Paxil is probably less than 10 percent. The rest come in looking like zombies.”

LeCompte had tried almost all the drugs they were offering, from “highly addictive anxiolytics like Klonopin, and … Prozac as an anti-depressant and Ambien for a sleep aid,” he said. “These different drugs sort of mixed together in a cocktail just as a recipe for disaster,” he said. He never tried to contact U.S. Veteran’s Affairs to inform them of these problems, because he didn’t think they would do anything about it. VA psychiatrists like Dr. Basimah Khulusi of Missouri have been fired for simply refusing to increase medication dosages that they didn’t think their patients needed shows the kind of system LeCompte was dealing with.

LeCompte looked into how these drugs work and found they’re just mind blockers, they’re not helping you deal with your problems. “Medications do not entirely eliminate symptoms but provide a symptom reduction and are sometimes more effective when used in conjunction with an ongoing program of trauma specific psychotherapy,” according to the VA website.

LeCompte looked at research from people like Julie D. Megler, watched videos of the academic conferences focusing on psychedelics called Psychedemia from Penn State and went on websites like Erowid to look at ayahuasca experiences people had posted to the site. What did he learn? “Something like ayahuasca or MDMA is used to bridge severed connections in the brain that trauma plays a big part in creating,” he said.

“Ayahuasca opens the limbic pathways of the brain to affect the emotional core of the trauma in a way similar to affective psychotherapy for trauma, and also impacts higher cortical areas … to allow the patient to assign a new context to their trauma,” wrote brain experts J. L. Nielson and J. D. Megler, in the book The Therapeutic Use of Ayahuasca.

Soon, LeCompte started having conversations with veterans and began informing people of the possible benefits of ayahuasca, wondering if anyone else was daring enough to start considering the idea of drinking a shot of psychedelics for their PTSD. LeCompte had never tried ayahuasca, but he was willing to try anything to help his comrades. Eventually he heard of an ayahuasca retreat, the Phoenix Ayahuasca retreat in Peru, where he could test out his medicine.

It took him six months to do what any sane person would do before planning a group outing to South America to hallucinate in a forest together… he started a nonprofit. Its name? The Veterans for Entheogenic Therapy. Other vets started to find him; some were suicidal, exhausted by the daily challenge of deciding whether or not they wanted to be alive. He didn’t know them, but he felt he intimately understood – or at least sympathized with – their minds. He rounded up a trip: five other vets, and him. MAPS helped pay for two of the trips for veterans who couldn’t afford it, and the rest paid for themselves.

The prep was strangely regimented: LeCompte had to ensure the veterans were off their medication for a month leading up to the trip; anti-depressants plus ayahuasca equal a lethal mix. That task amounted to phone therapy and keeping a close eye on everyone: He called the guys every day, even their friends and family, to make sure the men had quit their pills, he said. But he made it work. The families may have thought the idea was strange, but LeCompte says none of them tried to stop their family members because of their knowledge that the drugs weren’t helping treat the PTSD symptoms, and they just wanted to help their family.

The veterans flew into Iquitos, Peru, from Lima – from Iquitos, they sat in a van all the way to the Amazon, winding past motorbikes and rickshaws “on back roads in the middle of bum fuck,” LeCompte says.

Then their lives collided and things got weird.

They were stationed for 10 days at Phoenix Ayahuasca. The camp was little more than a set of huts in the jungle, made from wood and leaves. They would drink the ayahuasca on ceremony nights and be led through their experience by the shaman, and they would stay in their personal huts on days off to reflect on their experiences alone.

LeCompte said the ayahuasca drink “tastes like shit.” The shaman leading the experience dressed in all white scrub-like clothes, like a nurse lost in the jungle. After you drink the brew, the shaman’s job is simply to observe. He diagnoses: Is anyone losing it? Some people have been known to begin convulsing. Is this the moment they need to hear a song that will send them burrowing into a different dimension? “I don’t know how he does it. It’s beyond my rational mind,” LeCompte said. “It” amounts to singing, blowing smoke on trippers’ faces and using instruments like a rattler to change their state of mind.

For his part, LeCompte only wanted two out of the four drink ceremonies, since they were so powerful. It certainly wasn’t about the PTSD for LeCompte; he was trying to get past his experiences of fallen friends and broken relationships. He says just returning home to family and friends from military service or an ayahuasca trip is a difficult experience of its own. “You’re a changed person and there’s no doubting or denying that.”

“Most people get a cut, and they put a bandaid on it,” he said. “These people have had these wounds for so long that they’ve become infected. The infection can’t be fought off with a bandaid.” LeCompte sees ayahuasca as an antibiotic, not a bandaid.

LeCompte is now planning to do an official study to look at how ayahuasca could treat PTSD, which will serve as his thesis for Naropa University. It is being sponsored by MAPS, and it will focus on 12 veterans with treatment resistant PTSD who will try using ayahuasca to treat it. The plan is to conduct the study over 10 days in early 2016. LeCompte is currently running an Indiegogo campaign to fund research and education around the medicinal use of ayahuasca.

http://www.stumbleupon.com/su/2KDuBh/:1EfXhqlsu:Y+0NYw4t/www.attn.com/stories/2301/semicolon-tattoo-mental-health