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Psyched Wellness: Amanita muscaria for the masses

Psyched Wellness is working with the Amanita muscaria mushroom to bring a legal tincture to market.

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Psyched Wellness: Amanita muscaria for the masses

Psyched Wellness CEO Jeff Stevens speaks to Psychedelic Health about how the company has launched the first legal Amanita muscaria extract available for sale in the United States.

The Amanita muscaria mushroom – also known as the fly agaric – is famous the world over for its striking looks. Often present in folklore and fairy tales, the iconic red and white mushroom has been consumed for centuries in traditional settings.

Amanita muscaria is mainly known for the psychoactive compounds ibotenic acid and muscimol. Deaths from Amanita muscaria are extremely rare, but it can make people very ill if not prepared properly. There is currently very little research into the mushroom, meaning the current scientific understanding of Amanita mascaria’s therapeutic benefits is limited. 

Psyched Wellness is now working with the mushroom to investigate its properties on the likes of sleep, anxiety and inflammation. 

The company is one of the first to commercialise a legal Amanita muscaria extract – ‘Calm’. Primarily composed of muscimol, Psyched says the product aims to promote feelings of relaxation and calmness, without producing any psychedelic effects.

See also  Amanita muscaria extract shows immune priming activity

Psyched Wellness’ CEO Jeff Stevens told Psychedelic Health that the company identified Amanita muscaria as its mushroom of choice as muscimol has never been scheduled as a drug. This enables the company to work with the compound as a food supplement by obtaining a Generally Recognized As Safe (GRAS) approval from the US Food and Drug Administration (FDA).

“We have done two years of scientific studies in our preclinical trials, which included toxicology, safety studies, and a whole host of other studies, to compile all of that data to submit it to get a GRAS approval,” said Stevens.

“We compiled a dossier that was peer-reviewed and approved. So, the path we chose rather than going to clinical trials to develop a drug, was to find a way to bring some of these really exciting and special compounds to market.

“The mushroom itself is legal. But to convert that into a product for human use, and human consumption is illegal unless you do the work that we’ve done. We spent time getting the scientific data, to present that data and get approvals.

“We’re so excited about Calm coming to market. It’s our flagship product. It’s a tincture in a 30 mil bottle, and we recommend one to two milliliters per dosage that fall within our GRAS approval range. There’s room to go higher if you just so if you so desire, but it it’s designed to be microdose, so we use it to promote relaxation and restfulness.”

Human clinical trials have not yet been carried out on Calm, but Stevens says preclinical data suggests that muscimol could potentially help with the likes of pain, anxiety and sleep. 

See also  Amanita extract could boost antiviral immune response in the brain

“We recognise that globally, there’s a sleep issue whether you’re aged 15, 95 or in between. We wanted to do something that we felt could help the most amount of people,” said Stevens. 

“When you look at people struggling with the stresses of the world – coming out of Covid-19 and inflation and all of the things that are happening now – having something that can help you relax that you can take 30 minutes before you go to bed is beneficial.”

The wellness opportunities of psychedelics

Highlighting the changing attitudes of mainstream media towards psychedelics, Stevens says that as the psychedelic industry matures, there needs to be a recognition of the health and wellness opportunities as well as the medical opportunities that these compounds can provide. 

“People – such as Prince Harry – are talking about how they’ve used psychedelics and how it’s benefited them from an anecdotal standpoint, and that’s being backed up now scientifically with results that are coming through from clinical studies,” said Stevens.

See also  Preliminary data demonstrate neuroprotective properties of amanita extract

“Psyched Wellness is in a unique situation because we’re not working with a scheduled drug. We’re a food supplement.

“I really think that as we progress as an industry, we should start talking about the fact that these are actually health and wellness opportunities.”

Calm is Psyched Wellness’ flagship product and the company’s research and development team is now working to bring other methods of delivery to market. The tincture is currently sold in 40 different states through the company’s online channels, but Stevens says it intends to open brick-and-mortar stores in the future.

Psyched Wellness is also carrying out studies with the National Research Council of Canada on the anti-inflammatory qualities of AME-1 – the company’s proprietary extract of Amanita muscaria from which Calm is derived.

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Evegreen

Can Psilocybin Be Safe and Effective for Anorexia? Shortwave Life Sciences Is Leading a Study To Find Out

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Psilocybin continues to gain momentum as a possible alternative to mental health treatments that leave large numbers of patients without recovery. 

Shortwave Life Sciences is a company that’s currently working on a feasibility study to prove whether psilocybin can be delivered safely, accepted by patients and integrated smoothly into clinical practice, for the treatment of anorexia.

The company presented its most recent findings at the latest edition of PSYCH Symposium 2025, in a panel called “Designing Breakthroughs: A New Human Study for Anorexia Treatment,” led by Chief Medical Advisor Dr. Nadya Lisovoder.

Psilocybin for Anorexia: An Integrated Perspective

According to Lisovoder, anorexia nervosa carries the highest mortality of all psychiatric disorders, driven by both medical complications and suicide.

In an interview, Lisovoder told Psychedelic Health that “the illness itself is exceptionally complex” because “it is a multifactorial condition that involves emotional, cognitive and physiological mechanisms at the same time.”

For that reason, not much therapeutic innovation has been seen in trying to combat the condition since developing a single medicine that can influence all of these layers has been extremely difficult.

“Most traditional treatments focus on one pathway only. In anorexia, that is rarely enough. The psychological patterns, the fear circuits, the rigid thinking styles and the metabolic consequences all reinforce each other. Treating just one aspect does not shift the illness in a meaningful way,” says Lisovoder.

That has led Shortwave to develop an integrated perspective. 

“Our approach aims to engage several relevant receptor systems and neural pathways simultaneously, addressing the mental and emotional dimensions of anorexia in a more complete way,” she told us.

By doing so, Shortwave aims to create conditions that can also support improvement in the underlying physiology, because in this illness the mental state and the physical state are deeply interconnected.

Scientific evidence may support Shortwave’s thesis. A systematic review published in the British Medical Journal in 2024 found that psilocybin could be as effective as escitalopram, a selective serotonin reuptake inhibitor (SSRI), in treating depressive symptoms.

“Psilocybin is considered a promising candidate for conditions defined by rigid cognition and compulsive patterns because it can temporarily soften the fixed neural networks that shape these behaviours,” said Lisovoder.

Research also shows that it creates an increase in neuroplasticity, allowing the brain to form new associations and to respond more flexibly to emotional and environmental cues. In disorders where people become locked into narrow patterns of thought or behaviour, like anorexia, this short period of increased adaptability may provide a meaningful therapeutic opportunity.

These same principles are relevant to anorexia nervosa, where inflexible thinking, heightened fear responses and avoidance-driven routines play a central role.

“Even a modest shift in these underlying circuits can support change when combined with the right clinical framework,” says Lisovoder.

A Unique Formulation 

Shortwave’s plan is to build on the known effects of psilocybin but not rely on it alone. Its formulation includes an additional component intended to influence complementary pathways, reflecting the company’s view that complex psychiatric and neurological conditions are best approached through more than one mechanism.

To administer the treatment, the company is developing a psilocybin-based buccal film designed specifically for patients with severe anorexia nervosa, addressing both biological and practical barriers to treatment.

Patients with anorexia can have their gastrointestinal function compromised. For this reason, Shortwave chose a method of administration that bypasses the gut altogether: a buccal film allows the active components to be absorbed by oral mucosa in the cheek and enter directly into the bloodstream. 

“Non-invasive, easy to administer format increases acceptability in a population that often avoids medications, procedures and anything perceived as forceful,” says Lisovoder. 

Shortwave’s Feasibility Study On Psilocybin for Anorexia

A safe and credible feasibility study in anorexia nervosa must begin with a clear focus on safety, Lisovoder says.

The first aim is to confirm that the treatment can be given without harm, with careful monitoring and a responsible medical framework. Because anorexia involves both medical fragility and deeply rooted cognitive and emotional behaviours, the protocol has to keep the burden on participants as low as possible, supported by a psychiatric and nutritional environment that understands the condition well.

Recruitment is often challenging in this field, which makes partnerships with established eating disorder centres essential. The company is in partnership with Sheba Medical Centre in Israel, whose eating disorders unit is recognised internationally for its clinical and research expertise, with a large and diverse patient population and a highly experienced psychiatric and medical team.

“Having an established collaboration with such a centre allows us to design studies with real clinical insight, consult with leading clinicians, and recruit participants more efficiently and responsibly,” said Lisovoder.

Lisovoder is hopeful for the treatment, beyond the results of the feasibility trial. She says there is a possibility that this line of research could help shift the way we think about eating disorders more broadly.

“For many years, these illnesses have been approached mainly through behavioural and psychological frameworks, which are important but do not fully reflect the underlying biology. The emerging science suggests that patterns of fear, avoidance, cognitive rigidity and altered reward processing all play a role, and that these patterns can be influenced at the neurocircuit level. If we can show that targeted modulation of these circuits contributes to meaningful change, it may open the door to a more integrated model of care,” she told us.

Such a shift would not replace psychological treatment, but rather add a biological dimension that has been missing, concludes Lisovoder

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Is Ketamine Therapy Only Reaching The Wealthy? Dr. Celia Morgan On Expanding Equitable Access

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Dr. Celia Morgan is one of the UK’s leading figures in ketamine and psychedelic research, especially in the domain of addiction and mental health.

Based at the University of Exeter, she holds the Chair of Psychopharmacology and leads trials exploring how ketamine, paired with psychotherapy, can break cycles of relapse in substance misuse.

Morgan has led some of the largest clinical trials on ketamine-assisted therapy for alcohol use disorder and will be speaking at the upcoming PSYCH Symposium: London 2025, to be held at Conway Hall on December 4.

“I think that the most promising findings from our work with ketamine are of the sense of agency and autonomy in their recovery that the people we are working with experience,” she told Psychedelic Health in a written interview.

Still, she thinks several key challenges need to be tackled for these treatments to be able to reach more people. One of the biggest of such challenges is ensuring equitable access to these treatments.

“We see a relatively homogenous and privileged group in most studies, our work has tried to address this,” she said.

Building the infrastructure to safely deliver these treatments in public healthcare systems is another big challenge for the industry, she said.

Yet the healthcare sector can also take advantage of Ketamine’s regulated status to allow for a faster roll-out, when compared to other psychedelics like MDMA or psilocybin.

“Some of the recent recommendations by the Royal College fo Psychiatrists are steps on the way towards more widespread use,” she said.

What distinguishes Morgan in the psychedelics field is her dual commitment. She studies the risks and harms of recreational ketamine use while simultaneously designing controlled, clinical applications for it.

One of her flagship projects is Exeter’s KARE trial (Ketamine for Reduction of Alcohol Relapse), which blends ketamine infusions with psychotherapy for patients with alcohol use disorder. Early published data show dramatic improvements in abstinence rates during six-month follow-ups, far exceeding baseline relapse rates. Morgan has also worked on trials for gambling disorder and other behavioral addictions, expanding the frontier of what ketamine-assisted therapy might treat.

Morgan also plays a role in academia’s response to the psychedelic renaissance, she’s a co-lead on Exeter’s postgraduate certificate in psychedelic studies, a program designed to train clinicians, researchers, and therapists in the science and ethics of psychedelic medicine.

“I think its important to keep on with our efforts to study, regulate and roll out these treatments principally for the patients who might benefit from psychedelics as I have seen first hand in my work,” she said.

Picture is extracted from an interview with Dr. Morgan at PSYCH Symposium’s 2022 edition.

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Speaker Spotlight: Professor David Nutt Talks About Most Significant Developments in Psychedelic Regulation

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Professor David Nutt stands out as a leading figure in modern psychedelic science, tirelessly pushing the boundaries of how drugs such as psilocybin, MDMA, LSD, DMT, and ketamine, are understood, regulated, and used in therapy. 

Since 2008, he is the Edmond J. Safra Chair in Neuropsychopharmacology at Imperial College London and in 2010, he founded Drug Science, a charity that “works to provide an evidence base free from political or commercial influence, creating the foundation for sensible and effective drug laws.”

​He decided to found the organisation after his removal from his post as the government’s Chair of the Advisory Council on the Misuse of Drugs in 2009.

On December 4, Drug Science will co-host PSYCH Symposium: London 2025, where Prof. Nutt and other key figures in the psychedelics space will meet for a day of lectures, panel discussions and industry networking.

Landmark Research in Psychedelic Therapy

In recent decades, Nutt has been central to studies showing that psychedelics can do more than produce altered states. These compounds may help “reset” rigid brain-patterns linked with depression, addiction, PTSD, and other disorders. 

Under his direction, some of the first modern brain-imaging studies with psilocybin were conducted, showing how the compound disrupts rigid patterns of connectivity in the brain and enhances communication between regions normally kept apart. His team also ran early clinical trials in patients with treatment-resistant depression, where just two guided psilocybin sessions produced rapid and, in some cases, lasting reductions in depressive symptoms. 

In an interview with Psychedelic Health, Prof. Nutt said he’s currently dividing his time between his post at Imperial College London, his work with Drug Science, and his endeavours at Solvonis, a company developing new studies with ketamine and MDMA alternatives for addiction.

Earlier this year, Solvonis completed the purchase of Awakn Life Sciences, where Nutt served as Chief Research Officer.

Moving the Needle On Psychedelics Regulation

Nutt is outspoken about how law and regulation have stifled psychedelic research. He has repeatedly called for reform to the scheduling of substances like psilocybin and LSD, arguing that many legal controls are more political than scientific. His 2009 dismissal from the UK Government’s Advisory Council on the Misuse of Drugs came after controversy over his claims that some illegal drugs are less harmful than alcohol.

While the UK is slowly moving towards removing barriers for research with psychedelic substances, the country still lags behind others in Europe and the English-speaking world. Prof. Nutt says he finds the rescheduling of psilocybin and MDMA therapy in Australia one of the most significant developments in the regulatory landscape of recent years.

Germany’s landmark step to introduce compassionate access to psilocybin for patients with treatment-resistant depression, a first in the European Union, also stands out for him, as well as the recent decision from the Czech Republic’s lower house to allow the medical use of psilocybin.

Nutt told us he continues to strive for the regulation and equitable access of psychedelics because he believes they’re are “the most exciting new treatments for mental health disorders and addictions in half a century.”

Psychedelic Health is the official media partner for PSYCH Symposium: London 2025.

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Psychedelic Health is a journalist-led news site. Any views expressed by interviewees or commentators do not reflect our own. We do not provide medical advice or promote the personal use of psychedelic compounds. Please seek professional medical advice if you are concerned about any of the issues raised.

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