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This article was made possible thanks to research from Calyx Law, the Emerge Group and Psilocybin Alpha.

As psychedelics like LSD, ayahuasca and magic mushrooms come rushing back into the public conversation, a few simple questions come up after discussing the potential of these substances in treating a wide variety of mental health disorders:

Contents

What Are Psychedelics?

Are Psychedelics Legal In The U.S.?

Where Are Psychedelics Allowed In The U.S.?

Where Are Psychedelics Being Considered For Legalization?

Wait, What Are Psychedelics?

Psychedelic is a broad term that encompasses a few different substances, some of which enjoy decriminalization or low-level law enforcement in certain jurisdictions around the country.

Psychedelics are usually described as drugs capable of producing non-ordinary states of consciousness.

While there are hundreds of natural and synthetic substances that can fall into the general definition of mind-altering drugs, most people refer to some compounds in particular when speaking of psychedelics:

LSD, or Lysergic Acid Diethylamide. Street names: acid, mellow yellow.

Psilocybin, a compound naturally produced by Psilocybe mushrooms. Street names: magic mushrooms, shrooms.

Mescaline, naturally found in the Peyote and San Pedro cacti.

DMT, or dimethyltryptamine, is a compound found in ayahuasca, a traditional Amazonian concoction used in shamanic rituals.

Ibogaine, naturally produced by the iboga plant, a shrub native to West Africa.

5-MeO-DMT, a psychedelic toxin produced by the Sonoran Desert Frog and some plants. Street name: toad venom.

MDMA. This empathogen can be considered a drug of a different category from the classic psychedelics listed above, but its often grouped within this definition. Street names: ecstasy, molly.

Are Psychedelics Legal In The U.S.?

As a general rule, all of the substances listed above are considered Schedule 1 substances by the federal government and are therefore illegal to produce, sell, possess or consume without special government authorization.

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Although scheduled, every one of these substances is currently under clinical research and most are expected to become approved in the coming years as psychiatric medication for specific mental health indications.

In the meantime, some U.S. jurisdictions have passed legislation reducing law enforcement of some psychedelic substances, allowing for the use and possession of small amounts of these drugs.

Exception: The Case Of Ketamine

Ketamine is a dissociative drug originally approved as an anesthetic in 1970. In recent decades, its psychedelic-like effects were discovered to produce a reduction in depression symptoms.

While ketamine is only officially approved as an anesthetic, physicians are allowed to prescribe it off-label for the treatment of depression and other mental disorders.

This has placed ketamine at the forefront of the psychedelics movement, as a prescribable drug that can be legally administered at clinics under physician supervision.

Where Are Psychedelics Allowed In The U.S.?

Using Psilocybin Alphas Psychedelic Legalization & Decriminalization Tracker, we compiled a list of U.S. jurisdictions where psychedelics are allowed.

Oregon

In November 2020, Oregon became the first U.S. state to eliminate criminal penalties for all illegal drugs including cocaine, heroin, oxycodone and methamphetamine, as well as every psychedelic substance like LSD, psilocybin and MDMA.

Possession of small amounts of these substances were made a Class E violation, instead of a misdemeanor. This reduces penalties to a $100 fine or the option to enlist in one of the states Addiction and Recovery Centers.

Additionally, in the same 2020 ballot Oregonians voted to launch a program for the therapeutic use of psilocybin, creating the countrys first state-licensed psilocybin-assisted therapy system.

The program, currently in development, will allow patients over the age of 21 to buy, possess and use psilocybin under the supervision of trained facilitators, while manufacture, delivery and administration of psilocybin will be allowed at supervised, licensed facilities.

California: Santa Cruz and Oakland

While the state of California still places a ban on scheduled psychedelic molecules, two cities within its borders have passed resolutions preventing the city from spending resources in imposing criminal penalties for the use and possession of entheogenic plants and fungi.

In both Santa Cruz and Oakland, personal use, possession and cultivation of plants like iboga, mescaline cacti, the ingredients in ayahuasca as well as psilocybin mushrooms are classified among the lowest law enforcement priorities. In Oakland, purchasing, transporting and distributing these natural psychedelics fall into the same category.

District of Columbia

Similar measures were passed in Washington D.C., where psychedelic plants and fungi became decriminalized in November 2020.

Non-commercial planting, cultivating, purchasing, transporting, distributing, engaging in practices with, and/or possessing entheogenic plants and fungi are considered lowest enforcement priorities by the DC Metropolitan Police, banning the investigation and arrest of persons 18 years of age or older for these practices.

Colorado: Denver

Denver became the first U.S. jurisdiction to reduce penalties on psilocybin mushrooms in May 2019. Psilocybin mushrooms are among the lowest law enforcement priority, preventing law enforcement from using Denver city funds for criminalizing the personal use and possession of these fungi.

Michigan: Ann Arbor

Ann Arbor is currently the only city in the American Midwest where cultivating, purchasing, transporting, distributing, engaging in practices with, or possessing natural psychedelics is not criminalized.

Entheogenic plants or plant compounds, which are on the Federal Schedule 1 are a lowest law enforcement priority, meaning that city funds or resources shall not be used in any investigation, detention, arrest, or prosecution and that the district attorney must cease prosecution of persons involved in the use of entheogenic plants or plant-based compounds.

Massachusetts: Somerville, Cambridge and Northampton

In January 2021, the Boston suburb of Somerville passed a legislation wherein no city funds or resources shall be used to assist in the enforcement of laws imposing criminal penalties for the use and possession of entheogenic plants by adults.

Soon after, neighboring cities of Cambridge and Northampton adopted the same legislation, which states that the investigation and arrest of adult persons for planting, cultivating, purchasing, transporting, distributing, engaging in practices with, and/or possessing entheogenic plants shall be amongst the lowest law enforcement priority, calling upon the District Attorney to cease prosecution of persons involved in these practices.

Where Are Psychedelics Being Considered For Legalization?

Federal legislation decriminalizing psychedelic substances does not appear to be on the horizon despite the approval of specific psychedelic substances for medical use via the FDA clinical trial pipeline.

In late July, Rep. Alexandria Ocasio-Cortez reintroduced an amendment to remove federal barriers to research the therapeutic potential of psychedelic substances. The measure was widely rejected by the House, although floor support grew from a previous introduction of the same measure in 2019.

However, several U.S. states have recently passed legislation that calls for research around psychedelic molecules. Other states have bills in congress that could enact further measures around psychedelic legalization.

In California, a bill is being considered that would remove penalties for the possession, personal use and social sharing of certain natural and synthetic psychoactive drugs including psilocybin, DMT, ibogaine, mescaline, LSD, ketamine and MDMA.

The bill passed a Senate vote and is currently on track to the Assembly floor. In a recent interview with Benzinga, Sen. Scott Wiener, the bills main sponsor, said he is in favor of full drug decriminalization and this measure is a first step toward that goal.

In 2021, Connecticut and Texas approved bills that launched working groups to study the medical use of psilocybin. In Texas, MDMA and Ketamine are also being studied for the same purpose, with military veterans as the main target group for these therapies.

A similar resolution to study the therapeutic potential of psilocybin was introduced in Hawaii, where a separate senate bill to deschedule psilocybin is also under consideration. In an interview, Hawaii Senator Stanley Chang told us that the goal of the bill is to remove psilocybin and psilocin from the list of Schedule I substances and require Hawaiis Department of Health to establish treatment centers for the therapeutic administration of these compounds.

Measures involving the decriminalization of psychedelics have also been introduced in a number of other state legislatures, including Florida, where a psilocybin legalization bill died in the senate. In Illinois, a bill to loosen restrictions on entheogenic plants was introduced but never made it to a floor vote.

Iowa, Maine, Missouri, Vermont and New York currently have active bills in their legislature that could bring different levels of decriminalization to certain psychedelic substances. In the Empire State, a bill introduced by Assemblywoman Linda Rosenthal would establish a psychedelic research institute and a therapeutic research program to study and provide recommendations on the use of psychedelic substances.

As investors, scientific institutions and the general public grow more knowledgeable and interested in the medicinal potential of psychedelics, more states and jurisdictions are expected to roll out further bills and legislative moves that will hopefully open access to psychedelics in different ways across the country.

Ms contenido sobre psicodlicos en Espaol en El Planteo.

Photo: Morgan Lane on Unsplash

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Are Psychedelics Legal In The US? Where Are They Decriminalized? A Deep Dive Into The Legal Status of Psilocybin, MDMA, LSD, Ketamine And More - Yahoo...

Posted: Jul 30, 2021 / 10:41 PM CDT | Updated: Jul 30, 2021 / 10:41 PM CDT

(NewsNation Now) If youre like most Americans, something or someone probably set you off today. If youre like many Americans, your day was a bummer. But if you are like 1/5 of the country, your day was clinically awful. Thats because 21% of us suffer from depression, anxiety, addiction or PTSD.

Americans spend a staggering $240 billion per year on mental health services. But if what youre doing isnt working, or if youre looking for a better option, a better day?

A whole new field of psychiatric science is opening up to help Americans amid a mental health crisis and an ongoing opioid epidemic. Hold on to your hat, because the science involves drugs like LSD, ecstasy, magic mushrooms and ketamine to name just a few.

Theyve been demonized for decades but many now think its time to reexamine them.

Watch Banfieldweeknights at10/9con NewsNation.

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Banfield: Experts weigh in on the often misunderstood world of psychedelics - NewsNation Now

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This is a promising step forward in our mission to get safe, natural psychedelics into the hands of everyone who needs them, as soon as possible.

Author of the article:

Vancouver-based Filament Health, a natural psychedelic drug development company, has expanded the scope of its research.

The company was already federally licensed to work with psychoactive mushrooms, but an amendment to its Health Canada Dealers Licence will now allow Filament to possess, produce, research, export and import all remaining controlled natural psychedelic substances, including N,N-dimethyltryptamine (DMT) and mescaline.

This licence amendment significantly increases the scope of our work with natural psychedelics, said Filaments director of research, Ryan Moss. By studying untapped psychedelics in a scientific setting, we believe we can unlock and standardize their healing power. This is a promising step forward in our mission to get safe, natural psychedelics into the hands of everyone who needs them, as soon as possible, Moss said.

Filament plans to produce natural extracts of these substances at its facility in Metro Vancouver and enter them into clinical trials to demonstrate safety and efficacy.

The benefits of these valuable plants are well-documented; we will be among the first to purposefully explore their pharmaceutical applications, said company CEO Benjamin Lightburn.

In June, the company announced its natural psilocybin extracts would be administered in clinical trials in collaboration with the Translational Psychedelic Research Program at the University of California, San Francisco, later this year.

Another Vancouver-based company, Algernon Pharmaceuticals, is also studying DMT, a psychedelic compound that is part of the tryptamine family, alongside substances like psilocybin, ketamine and LSD, as a possible treatment option for stroke.

The Phase 1 clinical trial, which will seek to establish dosages and the safety of the treatment, is set to begin later this year with U.K.-based Hammersmith Medicines Research, a contract research organization that specializes in clinical pharmacology.

One of the consultants on the trial is Dr. David Nutt, a psychiatrist and a neuropsychopharmacology professor at Imperial College London and formerly the U.K. governments top drug adviser.

The idea is, can we stimulate neurogenesis without being psychedelic? Dr. Nutt told The GrowthOp earlier this year. I think thats a really clever idea. No one knows. But if it works, its very exciting.

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Most of us have an idea or think we have an idea of what psychedelics do to us. At their trippy best, drugs such as LSD and magic mushrooms can lead you to feel at one with the universe and awash with creativity. It was under the influence of LSD and peyote derived from cactuses that author Ken Kesey, for instance, wrote One Flew Over the Cuckoos Nest, tipped paint into a stream and dipped T-shirts in it (creating tie-dye), and discovered the world was a hole filled with jewellery.

There are, of course, bad trips, the extremes of which are perhaps best described by the late Boston crime boss James Whitey Bulger who, while incarcerated in an Atlanta penitentiary in 1957, was forcibly injected with LSD as part of the United States Central Intelligence Agencys now infamous behaviour control experiments. We experienced horrible periods of living nightmares and even blood coming out of the walls, Bulger wrote.

In 1963, psychology professor Timothy Leary, who had started listing his profession on academic forms as ANGEL, was booted out of Harvard University for his research into psychedelics, notably LSD and psilocybin, the active ingredient in magic mushrooms. He gave the psilocybin to undergraduate students when the university had agreed he could only give it to graduate students in his studies as a tool in psychotherapy and mind expansion. While psychedelics were a hallmark of the counter-cultural hippie movement, by 1970 they had been criminalised, thanks to US president Richard Nixons war on drugs.

In Australia, psychedelics were used by doctors to treat various psychological conditions none of it systematically documented but they began to be criminalised from 1970 onwards and remain, mostly, illegal. So, how is it that were now in the middle of a psychedelic renaissance?

In March 2021, the Australian federal government announced it would provide $15 million for clinical trials to determine whether psilocybin and MDMA could help treat debilitating mental illness. In July, a new privately funded research centre was launched in Melbourne to develop psychedelic medicines. Meanwhile, leading research is underway in a Melbourne hospital into the use of psilocybin to treat end-of-life anxiety and depression in terminally ill patients.

These trials follow an enormous amount of psychedelics research over the past 20 years, in the US and Europe, which has led to promising findings about the role they might play in treating conditions ranging from severe depression and post-traumatic stress disorder (PTSD) to addiction, Alzheimers disease and anorexia nervosa. In fact, in 2021 there were about 100 psychedelics trials worldwide, at prestigious institutions such as Johns Hopkins University in the US, which launched a Centre for Psychedelic and Consciousness Research in 2020, and Imperial College London, which opened its Imperial Centre for Psychedelic Research in 2019.

What are these studies hoping to find? Could these mind-altering drugs be the long-sought answer to alleviating suffering caused by mental illnesses where other treatments have failed? Do they reveal the secrets of the universe? And what are the risks?

Psychedelics refer to a broad range of pharmacological compounds that include LSD (d-lysergic acid diethylamide), psilocybin, ayahuasca (pronounced aya-washka, a South American psychoactive brew traditionally used in shamanistic ceremonies), MDMA (known as ecstasy) and ketamine (often called Special K). Broadly speaking, they work by simulating, suppressing or modulating the activity of the various neurotransmitters in the brain the bodys so-called chemical messengers which carry messages between nerve cells, keep our brains functioning and affect various psychological functions such as fear, pleasure and joy. This leads to a temporary chemical imbalance that can result in, among other effects, euphoria and hallucinations.

The term psychedelic from the Ancient Greek words psyche (soul) and deloun (to make visible, to reveal) was coined in the 1950s by British psychiatrist Humphry Osmond, who was part of a small group of psychiatrists researching the therapeutic potential of LSD in treating alcoholism and other mental disorders.

Its like 10 blind people feeling an elephant from different angles none of them has the full picture.

But even today, researchers dont know exactly how psychedelics do what they do to our brains. Its like 10 blind people feeling an elephant from different angles none of them has the full picture, says University of NSWs Dr Colleen Loo, a professorial fellow at the Black Dog Institute who is the foremost Australian researcher of the use of ketamine. Ketamine is a powerful animal and human anaesthetic that is legal in Australia, with limitations, and is being used to tackle depression thats resistant to other treatments. One thing researchers know is that ketamine promotes the growth of nerve cells that have shrunk in the brains of people with depression.

The fact that the broader picture is far from complete isnt a red flag in itself, given we commonly take medicines even though doctors dont know exactly how they work. In a sense, knowing how it [a drug] works becomes probably less important if we know that something works, and if we know that treatments safety profile, says Dr Vinay Lakra, president elect of the Royal Australian and New Zealand College of Psychiatrists.

For one thing, psychedelics have been shown to increase cognitive flexibility. This doesnt so much refer to the more spectacular effects of psychedelics we often hear about, but rather the way that psychedelics disrupt our default mode network the part of the brain that is active when we are at rest, where we think about the future and the past and incorporate things that have happened to us. It is central to defining who we are.

Psilocybin is the active ingredient in magic mushrooms. Credit:Getty Images

In many people, the stories they tell themselves are embedded in rigid and destructive patterns of thought: people with depression or anxiety often tell themselves theyre worthless and unlovable. Those who have experienced trauma often feel a sense of survivors guilt.

Psychedelics, in conjunction with psychotherapy, temporarily short-circuit these ruminative, and frequently negative, mental loops. In doing so, they help provide new perspectives on old problems. Michael Pollan, a Berkeley journalism professor who chronicled his encounters with psychedelics in a 2018 book How to Change Your Mind, spoke to one man who had quit smoking after a psychedelic trip because I found it irrelevant.

People often see patterns and geometry, or weird sort of things ... they might feel like theyre warping, melting or dissolving.

Many trippers also describe a temporary breakdown of identity, erasing the distinction between self and non-self, which also seems to have benefits. As people involved in a psilocybin smoking cessation trial variously recounted to Pollan, I died three times. I sprouted wings. I flew through European histories. I beheld all these wonders. I saw my body on a funeral pyre on the Ganges. And I realised, the universe is so amazing and theres so much to do in it that killing myself seemed really stupid.

Other people in clinical psilocybin trials report radically heightened senses, says Dr Margaret Ross, chief principal investigator of a psilocybin-assisted psychotherapy study at St Vincents Hospital in Melbourne. Music can sound amazing, or people can see music, she says.

Their visual field is often impacted; they see all the colours, people often see patterns and geometry, or weird sort of things. They can also experience their body very differently, they might feel like theyre warping, melting or dissolving.

[Theyre] kind of at one with the universe, if you like, says Dr Paul Liknaitzky, a research fellow at Monash University who is the lead investigator on four psychedelics trials, and exist beyond space and time and thought, and these are often called mystical experiences. Its a little like what astronauts report from looking at the Earth from outer space this enormous perspective on life that allows people to no longer fear death, or no longer fear anything, because theyve got a different perspective on things.

Timothy Leary, the former LSD experimenter, in his home in California in 1992 with video images projected over him. Leary died of cancer in 1996.Credit:AP

This is why, says Liknaitzky, psychotherapy-assisted psychedelics are being trialled to treat so many different problems, from end-of-life anxiety and terror to nicotine and cocaine addiction, to PTSD. The drugs address more fundamental aspects of psychological distress than just the symptoms although its no reductive pill-popping exercise.

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The clinical trials always include multiple psychotherapy sessions to help address fears and personal history, and to help the patient make sense of their psychedelic experiences. No current trials or experiments simply use the drugs by themselves; in many, the therapy incorporates lifestyle changes such as better eating and exercise.

One woman who participated in a psilocybin trial to combat nicotine addiction at Johns Hopkins but who ended up confronting long-held grief about the breakdown of her marriage and a miscarriage told Dr Albert Garcia-Romeu, It really helped me move forward.

It was almost like a letting go of some grief that had been in there, that she may not have wanted to deal with, or acknowledge, says Garcia-Romeu, who is involved with numerous psychedelics trials.

Another woman with terminal colon cancer reported that taking psilocybin enabled her to enjoy her final months of life when she was otherwise paralysed from making even the most mundane plans, so mired was she in fear. I felt this lump of emotions welling up almost like an entity, she told researchers in the Harbor-UCLA Medical Centre trial.

I started to cry. Everything was concentrated and came welling up and then it started to dissipate and I started to look at it differently. I began to realise that all of this negative fear and guilt was such a hindrance to making the most of and enjoying the healthy time that Im having.

The same, its been reported, can go for LSD. The New York Times reported on a trial using LSD-assisted talk therapy for people with end-of-life anxiety: One 67-year-old man said he met his long-dead, estranged father somewhere out in the cosmos, nodding in approval.

Its not all sunshine, rainbow-enveloped self-acceptance and tripping across the cosmos, though. The work can be confronting, as with much therapy. One woman who had been sexually assaulted by her father as a child, and who was suffering from PTSD as a result, ended up transferring her anger and sadness onto a male psychotherapist who was guiding her through an MDMA trial in the US. She was actually quite distressed the next day when she realised what had happened [during the trip], says Dr Stephen Bright, senior lecturer of addiction at Edith Cowan University, who witnessed the session. But, despite her embarrassment at lashing out, the treatment lessened her PTSD symptoms. (PTSD symptoms include anguish-inducing flashbacks and hypervigilance.)

Credit:Getty Images

All of a sudden, it hasnt got that kind of counter-culture tag, says Ross. She points to testimonials from high-profile, respected journalists and writers such as Pollan, who was in his 60s when he wrote his book about trying psychedelics. I felt my sense of self scatter to the wind, Pollan told National Public Radio, almost as if a pile of Post-Its had been released to the wind but I felt fine with it. Then I looked out and saw myself spread over the landscape like a coat of paint or butter. Pollan says the drugs act upon the self that talks to the self.

The year before, author Ayelet Waldman published a memoir about how microdosing on LSD saved her marriage, by, among other things, easing her depression and bipolar disorder. It changes the profile of who would use something like this, says Ross, whose study focuses on whether psilocybin alleviates anxiety and depression in terminally ill patients.

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Brain sciences and scans that reveal brain activity have also been trending over the past decade, lending legitimacy to psychedelics studies, says Garcia-Romeu. If you can measure something in the brain then you can point to a mechanism, and so understanding the biological and brain-based mechanism is an important part of validating this work from a kind of more hard science perspective, if you will, he says. (Some researchers now refer to their trials as anti-Leary as Learys studies were largely anecdotal.)

This modern research dovetails with a growing dissatisfaction within the scientific and medical communities with current treatments for depression and anxiety.

Although antidepressants work for many people, they dont for large portions of the population. And they really dont offer much for people with terminal illnesses experiencing end-of-life anxiety and depression, says psychiatrist Justin Dwyer, who is leading the St Vincents Hospital psilocybin trial, along with Ross.

For giving people this sense of reconnection, of oneness with family, of meaning, of purpose, of feeling as though theres much more to them than their illness, antidepressants do nothing.

For one thing, he says, antidepressants often take weeks to work, and frequently cause nausea, which might interact with pain medication, and have a sedating effect when people are most longing for connection.

Credit:Getty Images

A groundbreaking study from Johns Hopkins in 2016 found that, of 51 cancer patients suffering psychosocial distress, 80 per cent who received psilocybin (with psychological support) had significant reductions in depressed mood and anxiety. Data suggests the treatment lowers anguish for as long as six to nine months afterwards, says Garcia-Romeu.

A 2020 study from Johns Hopkins showed that psilocybin, taken by people with major depressive disorder, showed effects four times greater than standard antidepressants. And another Johns Hopkins psilocybin study, from 2014, reported that of 15 participants, 80 per cent abstained from smoking over six months. A year later, 67 per cent of participants still abstained. (This compares to a 35 per cent success rate for patients taking Varenicline, a prescription medication widely considered to be the most effective smoking-cessation drug.)

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As for treating PTSD, a study from the non-profit Multidisciplinary Association for Psychedelic Studies (MAPS) in California found that, of 107 participants with chronic, treatment-resistant PTSD (who suffered, on average, for nearly 18 years), 61 per cent no longer qualified for PTSD after three sessions of MDMA-assisted therapy. At the 12-month follow-up, 68 per cent no longer had PTSD.

And what of LSD? The 12 people who participated in one Swiss trial of LSD-complimented talk therapy as they neared the end of their lives reported positive results. Their anxiety went down and stayed down, psychiatrist Dr Peter Gasser has said.

Participants ... experienced an immediate boost in mood and a feeling of connection ... as well as significant drops in depression and stress but no drop in anxiety. They also reported a significant increase in neuroticism.

And that microdosing that Ayelet Waldman found so life-changing? There are few studies of microdosing but one of the first, from Macquarie University in NSW in 2019, found mixed results. Ninety-eight study participants who took super low doses of various psychedelics over six weeks including psilocybin, LSD and mescaline experienced an immediate boost in mood and a feeling of connection with their surroundings as well as significant drops in depression and stress but no drop in anxiety. They also reported a significant increase in neuroticism a tendency to feel sad, angry, anxious or vulnerable although a subsequent study by Macquarie found its microdosers experienced a decrease in neuroticism.

Almost none of these clinical trials has yet moved to phase three, which typically lasts between one and three years and confirms safety and effectiveness on large populations, comparing the drugs to standard therapies. MAPS in California published the results of its phase-three trial of MDMA-assisted psychotherapy to treat severe PTSD in 2021. Ninety people participated in the trial. Two months after treatment, 67 per cent in the MDMA group no longer qualified for a diagnosis of PTSD compared with 32 per cent in the placebo group.

Professor Michael Farrell, director of the National Drug and Alcohol Research Centre at the University of NSW, is glad that research is being done on psychedelics but cites the lack of large-scale trials so far as one reason to be cautious. Small trials make it difficult to prove cause and effect, for example. When people say that theres now very strong evidence [for psychedelics benefits], I wouldnt agree with that.

Wayne Hall, an emeritus professor at the National Centre for Youth Substance Use Research at the University of Queensland, agrees, saying that any new drug can have a placebo effect among participants and practitioners who are really convinced of the value of what theyre giving. But he says, It is pretty promising that theyve [researchers] managed to get clinically significant effects in the trials that they have with numbers as small as they have thats encouraging. Larger trials will give a clearer picture of who will likely benefit from psychedelics, and under what circumstances.

Credit:Getty Images

Psychedelics might not generally, as many experts put it, follow the cycle of abuse they dont typically lead to addiction, cravings or withdrawal. Apart from anything, unlike addictive drugs such as heroin, which triggers euphoria (at least at first) or benzodiazepines, which melt anxiety, psychedelics have unpredictable and often frightening effects, says Bright, which means people rarely take them as often as one would need to in order to become addicted.

That said, the risks are myriad and taking psychedelics can have tragic results. In rare instances, some psychedelics can evoke a lasting psychotic reaction, more often in people with a family history of psychosis. (Participants in clinical trials, who must be above the age of 18, are screened for a family history of psychosis, schizophrenia and other conditions including bipolar disorder and complex trauma, which could lead to damaging outcomes.)

MDMA, which is a stimulant the MA is for methamphetamine elevates heart rate, blood pressure and body temperature. So, if youre in a panic state, that would increase your panic state, says Dr Monica Barrett, a social scientist at the University of NSW and the lead Australian research for the Global Drug Survey, a London-based research company that monitors drug use. In rare cases, MDMA can lead to serotonin syndrome, which causes overheating and can kill, as has been seen at music festivals. And, of course, when people take psychedelics in a non-clinical setting, the hallucinations can lead them to take potentially fatal risks such as walking into traffic or jumping from a high place in the belief that they can fly.

Their PTSD could actually become worse because theyre being retraumatised rather than reprocessing their trauma.

Then theres the reality that many psychedelics being offered by a burgeoning number of sometimes-untrained underground psychotherapy practitioners outside clinical trials are not using pharmaceutical-grade drugs. Thats Russian roulette, says Bright. Their PTSD could actually become worse because theyre being retraumatised rather than reprocessing their trauma. [And] it creates a lot of suggestibility, so you could brainwash people.

Bright remembers one woman who presented at a Victorian clinic he worked at who had been sexually assaulted two years prior to showing up but had no PTSD before she used psilocybin one day at home with her partner. She freaked out, her partner called a paramedic, she was taken to the hospital, the psychedelics were reversed with an anti-psychotic and she developed PTSD and a drinking problem.

Recreational users who take high doses of ketamine over long periods report a condition called ketamine bladder: the organ becomes so inflamed the lining dies off. Sometimes, the entire bladder needs to be removed. Ketamine also features a risk even in a clinical setting of relapse. He said hed had this amazing experience, says Colleen Loo, recalling a male participant in the first Australian clinical trial of ketamine for depression. Within four hours of taking the drug, he started changing before her eyes, as many who take ketamine do: faces brighter, more reactive. Theyve got a spring in their step, she says. But by the end of the week, the effects had worn off. The anti-depressant qualities of ketamine often fade after a few days, and treatment, due to governmental restrictions, is allowed for only two months at a time. He said something to me Ive never forgotten, that the devastation of the relapse was bigger than the elation of getting well, says Loo.

For other people, she says, ketamine provides welcome, temporary relief as a treatment of last resort when all else, including antidepressants and psychiatric therapy, have failed. Its not an easy treatment to manage, she says, but shes been completely astounded by its impact on some patients. Its truly amazing ... You could see the same person yesterday, and today [after treatment] a completely different person.

Credit:Getty Images

In July, a $40-million global institute was launched to develop new psychedelic medicines and psycotherapeutic treatment models to go with them. The Psychae Institute, in Melbourne, is funded by a North American biotechnology company and aims to connect leading researchers from across the globe, including Swinburne University, the University of Melbourne and the Florey Institute of Neuroscience and Mental Health. The company, which has been vetted by the universities and Agriculture Victoria, wants to remain private as part of its strategy to secure private investment.

Australian experts say that, after years of trailing in the psychedelics research race, they are swiftly catching up. In 2021, six clinical trials of MDMA or psilocybin were planned or underway, including one at St Vincents Hospital in Melbourne, which is testing psilocybin for treatment-resistant depression and end-of-life anxiety and depression. This study would expand on previous research, as its being conducted with terminally ill patients who have a number of diseases and conditions, whereas the 2016 Johns Hopkins trial, its most important predecessor, treated only patients with cancer. If a trial eventually leads to treatment approval, the approval is only for the illnesses that its been trialled on.

Ross, who has long worked in palliative care as a clinical psychologist, hopes the St Vincents Melbourne study confirms the Johns Hopkins findings because people are not coming along to us saying, Im depressed and anxious [at end of life]. What theyre doing is saying, Im terrified. Ive lost all sense of meaning and purpose in my life. I feel completely unmoored from everything that gives me a feeling of identity. They may have limited time left and theyre spending it anguished and pulling away from people.

Early in 2021, Australias drug regulator, the Therapeutic Goods Administration (TGA), rejected a push by the not-for-profit organisation Mind Medicine Australia to allow psychiatrists to prescribe MDMA and psilocybin because of lack of evidence as to its efficacy. It was an interim decision, and the TGA has since sought independent review of the evidence. Many local researchers were relieved. There are a lot of evangelistic claims being made but this is no silver bullet, says Bright about psychedelics, adding that the hype could encourage people to embark on unsafe experiments in non-clinical settings. Desperate people will do desperate things they will go, How will I find this?

Parts of the US are embracing psychedelics. In 2019, the city of Denver decriminalised magic mushrooms ...

However, Bright adds that, historically, the TGA has followed rulings by the US Food and Drug Administration and, increasingly, the FDA is supporting psychedelics. In 2017, it granted breakthrough therapy status to MDMA-assisted psychotherapy, meaning it will develop and review it faster than other candidate therapies for PTSD. Bright predicts the FDA will approve MDMA-assisted psychotherapy for PTSD in the US by 2024, with Australia following suit after that. Garcia-Romeu predicts that, in the US, laws allowing psilocybin-psychotherapy assisted treatment for depression will probably be five years [away], maybe.

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In the meantime, parts of the US are embracing psychedelics. In 2019, the city of Denver decriminalised magic mushrooms, or psilocybin, after a referendum. In 2020, Oregon became the first US state to vote to legalise psilocybin for therapeutic use.

Garcia-Romeu is wary about people believing that psychedelics might offer a magic pill that will solve all their problems.

I always say, This is not going to pay your bills, its not going to wash your dishes, or fix your relationship with your estranged family members.

You dont just take a pill, and all of a sudden youre in fantastic shape.

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At one with the universe: How can psychedelic drugs help treat suffering? - Sydney Morning Herald

What connects a nocturnal bonfire ritual in the Peruvian rainforest with Wall Street? The potent psychedelic compound N, N-dimethyltryptamine, better known as DMT.

Starting Wednesday, Mind Medicine Inc., a Nasdaq-listed biotech company will launch a clinical research study on DMTalso known as the active ingredient in ayahuasca, an Amazonian hallucinogenic potion.

DMT produces intense alterations of consciousness and deep out-of-body psychedelic experiences.

The compound, which has been used ceremonially for centuries by native tribes from the Amazon basin, is believed to offer outstanding capabilities in the treatment of mental health conditions like depression and anxiety.

MindMed as the company is colloquially known is launching a phase 1 clinical trial on DMT, with an eye set on understanding its safety profile, dosage parameters, pharmacokinetics and pharmacodynamics.

In the phase 1 clinical trial, DMT will be administered intravenously.

MindMeds clinical research program into DMT is a first for any of the few (but rapidly growing) psychedelics companies listed on the major U.S. exchanges.

However, as substantial as the news might sound for a small biotech company like MindMed, the weight of the announcement is not being placed on DMT itself, but on the companys ability to produce an extensive and diversified pipeline of psychedelic molecules, which at this point already includes LSD, MDMA and a proprietary analog of ibogaine called 18-MC.

This continues to show our expansion beyond just the programs we've already got in our development pipeline. It's more evidence of the value of our collaboration with Dr. Liechti and University Hospital Basel, said CEO Rob Barrow in an exclusive interview.

At the core of MindMeds expansion strategy lies a research partnership with the Liechti Lab at University Hospital Basel in Switzerland, an institution with unique expertise and legal leeway in the research of psychedelic molecules.

The new DMT trials will be conducted as an investigator-initiated study by Dr. Liechti, handing the findings exclusively to MindMed.

The exec. said that the new program highlights the companys edge, as it is able to research a wide variety of psychedelic molecules without having to deploy significant efforts on new infrastructure or personnel.

This is really a great case study in how we can be very effective, efficient and timely with assessing a new drug program, Barrow said.

The company is not letting its excitement behind the new program to guide decision-making. Conversely, MindMeds approach into the DMT business is rigorous and evidence-based.

While anecdotal evidence has placed DMT and ayahuasca at the center of attention when discussing the therapeutic potential of psychedelics, the company will use this study as a starting point for assessing its future DMT strategy.

For these reasons MindMed is still cautious not to announce any formal development program to achieve FDA or EMA approval on DMT.

This gives us a jumpstart effectively in terms of understanding the pharmacokinetics and pharmacodynamics, ultimately to craft a development approach for ourselves if we choose to do so, said Barrow.

The study will begin enrolling 30 healthy volunteers for a randomized 5-period crossover, double-blind, placebo-controlled trial.

In the traditional Amazonian setting, ayahuasca is prepared as a mixture of several plants that ... [+] allow DMT to be metabolized by the body.

I think a lot has stagnated on this idea that there's one treatment indication for psychedelics, says Barrow, emphasizing that these molecules have a broad potential beyond just depression and anxiety.

The exec thinks that as the space progresses and science gets more sophisticated with the study of these substances, we may find that the various components that have been historically assumed as essential in psychedelics therapy aren't actually essential to the safety and effectiveness of the molecules.

This could lead to the discovery of new indications and new methods for using the same molecules.

The CEO says his company is not jumping to any assumptions when it comes to the way psychedelics must be administered. In this particular study, DMT is administered intravenously, which also indirectly tests the parameters under which a lot of organizations are claiming you must administer psychedelics.

The more robust we can be, the more different versions of set and setting or treatment administration parameters we can test throughout our studies, the better sense it gives us in terms of how essential those elements are, he said.

While not in liberty to disclose any specifics, Barrow anticipates that the companys DMT program is one in many early-stage clinical investigations into classic psychedelic molecules, to be announced in the near future.

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Nasdaq-listed MindMed Launches Human Trials OnDMT, The Psychedelic Ingredient In Ayahuasca - Forbes