Alberta’s new policy on psychedelic drug treatment for mental illness: Will Canada lead the psychedelic renaissance?


Erika Dyck, 

Professor and Canada Research Chair in the History of Health & Social Justice,

 University of Saskatchewan

THE CONVERSATION
Sun, January 15, 2023 

Psychedelics are being held up as a potential solution to the growing need for mental health treatment. But, magic mushrooms are not magic bullets.

 (AP Photo/Peter Dejong)

Patients in Alberta will now be able to legally consider adding psychedelic-assisted therapy to the list of treatment options available for mental illnesses.

Alberta psychiatrists and policymakers suggest that they are getting ahead of the curve by creating regulations to ensure the safe use of these hallucinogenic substances in a therapeutically supported environment. As of Jan. 16, the option is available only through registered and licensed psychiatrists in the province.

Alberta’s new policy may set a precedent that moves Canadians one step closer to accepting psychedelics as medicinal substances, but historically these drugs were widely sought out for recreational and non-clinical purposes. And, if cannabis has taught us anything, medicalizing may simply be a short stop before decriminalizing and commercializing.

Psychedelic drugs — including LSD, psilocybin (magic mushrooms), MDMA (ecstasy) and DMT (ayahuasca) — are criminalized substances in most jurisdictions around the world, but some people are suggesting it is time to re-imagine them as medicines. A few places are even considering decriminalizing psychedelics altogether, claiming that naturally occurring plants like mushrooms, even “magic” ones, should not be subject to legal restrictions.

In the wake of cannabis reforms, it appears that psychedelics may be the next target in the dismantling of the war on drugs. Canada made bold strides internationally with its widespread cannabis decriminalization, but are Canadians ready to lead the psychedelic renaissance?

Early psychedelic research

There is some precedent for taking the lead. In the 1950s and ‘60s, an earlier generation of researchers pioneered the first wave of psychedelic science, including Canadian-based psychiatrists who coined the word psychedelic and made headlines for dramatic breakthroughs using LSD to treat alcoholism.

Vancouver-based therapists also used LSD and psilocybin mushrooms to treat depression and homosexuality. While homosexuality was considered both illegal and a mental disorder until later in the 1970s, psychedelic therapists pushed back against these labels as patients treated for same-sex attraction more often experienced feelings of acceptance — reactions that aligned this particular approach in Vancouver with the gay rights movement.

Despite positive reports of clinical benefits, by the end of the 1960s psychedelics had earned a reputation for recreational use and clinical abuse. And, there was good reason to draw these connections, as psychedelic drugs had moved from pharmaceutical experimentation into mainstream culture, and some researchers had come under scrutiny for unethical practices.

Regulation and criminalization

Most legal psychedelics ground to a halt in the 1970s with a set of regulatory prohibitions and cultural backlash. In public health reports since the 1970s, psychedelics have been described as objects of unethical research, recreational abuse and personal risk including injury and even death.

Underground chemists and consumers tried to combat this image, suggesting that psychedelics provided intellectual and spiritual insights and enhanced creativity.

Most jurisdictions around the world criminalized psychedelics, whether for clinical research or personal experimentation. Indigenous and non-western uses of hallucinogenic plants of course stretch back even further in history, and these too came under legal scrutiny through a combination of colonial pressures to assimilate and a looming war on drugs that did not distinguish between religious practices and drug-seeking behaviours.

The return of psychedelics

At the moment, the next generation of scientific research on psychedelics still lags behind the popular enthusiasm that has catapulted these substances into the mainstream. 

(AP Photo/Peter Dejong)

In the last decade, regulations prohibiting psychedelics have started relaxing. The U.S. Food and Drug Administration has designated breakthrough therapy status to MDMA and psilocybin, based on their performance in clinical trials with post-traumatic stress disorder (PTSD) and treatment-resistant depression, respectively.

Health Canada has provided exemptions for the use of psilocybin for patients with end-of-life anxiety, and has started approving suppliers and therapists interested in working with psychedelic-assisted psychotherapy. Training programs for psychedelic therapists are popping up across Canada, perhaps anticipating a change in regulation and the current lack of trained professionals ready to deliver psychedelic medicine.

At the moment, the next generation of scientific research on psychedelics still lags behind the popular enthusiasm that has catapulted these substances into the mainstream. Celebrity testimonials and compelling patient accounts are competing for our attention.

Meanwhile, the growing burden of mental illness continues to overwhelm our health-care systems. Psychedelics are being held up as a potential solution. But, magic mushrooms are not magic bullets.
Beyond the medical marketplace

Historically hallucinogenic substances have defied simple categorization as medicines, spiritual enhancers, toxins, sacred substances, rave drugs, etc. Whether or not Health Canada, or the province of Alberta, reclassifies psychedelics as a bona fide therapeutic option, these psychoactive substances will continue to attract consumers outside of clinical settings.

Canada has an opportunity to take the lead once more in this so-called psychedelic renaissance. But, it might be our chance to invest in more sustainable solutions to harm reduction and ways of including Indigenous perspectives, rather than racing to push psychedelics into the medical marketplace.

Indigenous approaches to sacred plants are not only about consuming substances, but involve preparation, intention and integration, often structured in ritualistic settings that are as much about spiritual health as physical or mental health.

This cosmology and approach does not easily fit under the Canada Health Act, nor is it obvious who should be responsible for regulating or administering rituals that sit outside of our health-care system. These differences in how we might imagine the value of psychedelics is an opportunity to rethink the place of Indigenous knowledge in health systems.

We are well positioned to take a sober approach to the psychedelic hype, which has been driven in large part by financial interests, and consider what aspects of the psychedelic experience we want to preserve.

Now may be a good time to reinvest in our public institutions to ensure that psychedelics don’t simply become another pharmaceutical option that profits private investors. Instead, we have an opportunity with psychedelics to rethink how a war on drugs has harmed individuals and communities and how we might want to build a better relationship with pharmaceuticals.

This article is republished from The Conversation, an independent nonprofit news site dedicated to sharing ideas from academic experts. It was written by: Erika Dyck, University of Saskatchewan. 

Read more:

The real promise of LSD, MDMA and mushrooms for medical science

Psychedelic experiences disrupt routine thinking — and so has the coronavirus pandemic

Erika Dyck receives funding from Social Sciences and Humanities Research Council. She is a board member of the US not-for-profit Chacruna Institute for Psychedelic Plant Medicines.

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Exploring the nature of anomalous psychedelic experiences

by Ingrid Fadelli , Medical Xpress 

JUNE 4, 2020 FEATURE

Credit: Credit: Emma Miller / Unsplash

Psychedelics are among the most intriguing and mysterious psychoactive substances, as they can radically alter people's perceptions, cognitive processes and emotions. Their unique qualities and their effects on the human brain have made these substances an appealing subject of study for several researchers worldwide.\

While psychedelics have been extensively studied throughout history, many governments effectively banned research involving the use of these substances both outside and inside laboratory settings, which hindered close investigations into their effects on the brain and on human behavior. In recent years, however, there has been a renewed academic interest in these substances and their singular properties.

David Luke, a researcher at the University of Greenwich, recently carried out a study investigating the nature of anomalous experiences induced by psychedelic substances from a humanistic, neuroscientific and parapsychological standpoint. His most recent paper on this subject was published in a special issue of the Journal of Humanistic Psychology called "Anomalous Lifeworlds: Mysticism, Magic and Expanded Consciousness."

The key goal of Luke's study was to closely examine anomalous experiences often reported by people under the influence of psychedelics or after a psychedelic trip. The researcher wished to offer an overview of the prevalence and effects of these substances, summarizing past research findings while also introducing insight about the neurobiology of similar experiences that can occur spontaneously (i.e., without psychedelics), such as near-death experiences.

"I have always been intrigued by the extraordinary experiences people report during their psychedelic journeys, which have festooned the literature since the first 'developed world' discoveries of these substances, such as the original naming of the main ayahuasca alkaloid 'telepathine' in the 1920s, or the demonstration of apparent clairvoyance in the first-ever observed use of psilocybin, or the chemist Albert Hofmann's out-of-body experience on the world's seminal LSD trip," Luke told Medical Xpress. "These anomalous experiences are still commonly reported by people under the influence of psychedelics, but they have been woefully neglected academically in the last 100 years."

Luke has been conducting research exploring anomalous psychedelic experiences for over 20 years now, approaching the subject from an anthropological, psychological and neuroscientific perspective. In his work, he often adopts an interdisciplinary approach, merging ideas from cognitive and behavioural psychology with experimental, lab-based methods, while also conducting surveys, interviews, literature reviews and ethnographical studies with indigenous tribes known to use these substances.

"Much of the available research in this area is extremely nascent, despite these substances having been studied for over 100 years in some cases," Luke said. "Prohibition stalled nearly all human psychedelic research for about 50 years, which unavoidably slowed things down."

Past interviews with people who took psychedelics revealed patterns in anomalous experiences that are far more common in people under the influence of these substances than under that of other psychoactive drugs. Interestingly, some interviewees also said that psychedelic substances had profound and long-lasting positive effects on their life and overall perceptions of the world.

"A recent survey, for instance, found that more than half of all prior atheists reported no longer being atheist after having an entity encounter experience with the potent endogenous chemical DMT," Luke said. "Furthermore, the experiences were rated as among the most meaningful, spiritual, and psychologically insightful lifetime experiences, with persisting positive changes in life satisfaction, purpose and meaning attributed to them."

In his paper, Luke reviews and examines 10 anomalous experiences reported by many people who used psychedelics. These include synaesthesia (e.g., seeing sounds as colourful patterns), extradimensional perceptions, out-of-body experiences, near-death experiences, encounters with seemingly sentient entities, alien abduction experiences, sleep paralysis, interspecies communication, possession, and psychic experiences (e.g., telepathy, precognition, clairvoyance, or psychokinesis).

Luke investigated these experiences in relation with results gathered in past neuroscientific and neurobiological studies, which were carried out on people who were having psychedelic trips and in naturally occurring states of consciousness. In his paper, he concludes that anomalous experiences, such as the ones reported by psychedelic users, appear to be induced by altered states of consciousness rather than by psychedelic chemicals per se, as all the experiences examined in his work were also reported by some individuals who had not taken psychedelics or any other psychoactive drug.

Moreover, the temporary effects of psychedelics on the brain have been found to resemble those observed during naturally occurring altered states of consciousness, for instance, while dreaming, drumming or during a 'creative trance'. According to Luke, while psychedelic-induced and naturally occurring anomalous experiences might be similar in nature and produce analogous patterns in brain activity, each will ultimately have their own 'flavour' depending on how it is induced or how it arises.

"I believe that anomalous experiences with psychedelics have far-reaching implications for the study of consciousness and its applications, including neuroscience, psychiatry, psychology and even philosophy, as regards the mind, and the branches of metaphysics dealing with ontology and epistemology," Luke said.

Overall, Luke's recent study provides a detailed summary and analysis of past research findings associated with 10 of the most common anomalous psychedelic experiences. In the future, his work could inspire new research examining the effects and neurobiological underpinnings of psychedelic use or further investigating the nature of altered states of consciousness reported by individuals under the influence of psychedelics.

"I have several new projects underway, such as mapping some of the psychological correlates of a range of psychedelic and non-drug altered states, to discover commonalities, and exploring the nature of precognitive and shared visionary experiences with DMT under controlled conditions," Luke said.New research confirms lingering mood benefit of psychedelics

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More information: David Luke. Anomalous Psychedelic Experiences: At the Neurochemical Juncture of the Humanistic and Parapsychological, Journal of Humanistic Psychology (2020). DOI: 10.1177/0022167820917767

© 2020 Science X Network

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New study pinpoints the most common long-term challenges after psychedelic use

2023/11/18


A recent study explored the enduring challenges individuals face after using psychedelic substances like psilocybin and LSD, finding that emotional difficulties, such as anxiety and fear, were the most common, along with self-perception and cognitive issues. The study, published in PLOS One, also identified factors that could contribute to these difficulties.

The motivation behind this study lies in the growing interest and use of psychedelic substances like psilocybin and LSD for various purposes, including therapy and personal growth. These substances have shown potential in treating conditions like depression, anxiety, and PTSD, and they are being considered for legal medical use in some countries. However, along with the potential benefits, there have been reports of individuals experiencing enduring difficulties or challenges after using psychedelics.

“We felt that there was a research gap in the field of psychedelic science, specifically looking at whether psychedelic experiences ever led to extended difficulties lasting longer than a day,” said study author Jules Evans, the director of of the Challenging Psychedelic Experiences Project. “If so, what sort of difficulties, and what helps people deal with them. These are important questions – millions of people are now trying psychedelics, encouraged by extremely positive media coverage of the last decade, and they have no awareness that sometimes psychedelics can lead to difficulties lasting beyond the trip.”

The researchers used various channels, such as social media, newsletters, email lists, and newspaper advertisements, to recruit a sample of 608 English-speaking adults who had experienced difficulties lasting more than 24 hours following a psychedelic experience.

Participants were asked to provide detailed information about their psychedelic experiences, including the type of substance used, the dosage, and the setting in which the experience occurred. They were also questioned about the duration and nature of the difficulties they encountered after the experience.

The most commonly reported substances were psilocybin (27%) and LSD (25%), followed by ayahuasca (10%), cannabis (10%), MDMA (7%), DMT (5%), ketamine (4%), mescaline (2%), and salvia divinorum (1%). Some participants also mentioned other substances like iboga, 5-MEO-DMT, PCP, Bufo toad venom, 2C-B, 2C-E, nitrous oxide, and sananga.

The most common setting was “with a friend, partner, or group of friends,” followed by “on my own,” and “in a group ceremony.” These settings were categorized as guided (with a specialist leading the experience) and unguided (without a specialist guide) for later analysis.

One of the most striking findings was the duration of difficulties reported by participants. Many individuals experienced enduring difficulties that lasted for 1–3 years or even longer. Evans said she was surprised to uncover “how long some people’s difficulties last – one sixth say their difficulties last over three years. For some people they lasted decades.”

The enduring difficulties reported by the participants were categorized into eight main themes:

1. Emotional difficulties, such as anxiety, fear, and panic, were the most prevalent, reported by 67% of participants.
2. Existential or ontological difficulties made up 42% of the reports, where existential struggle (17%) and derealization (15%) were predominant. Struggles to integrate experiences into everyday life (10%) and magical/irrational/delusional beliefs (6%) were also reported.
3. Social difficulties were reported by 27% of individuals, with communication difficulties (6%) and social anxiety/fear of ostracism (5%) being the most common issues. A sense of disconnection from others/society (13%) was another significant subtheme.
4. Self-perception difficulties were noted by 23% of individuals, with depersonalization/dissociation (16%) and a diminished or disempowered self (9%) being prominent concerns.
5. Perceptual difficulties were experienced by 21% of individuals. Visual hallucinations/visual disturbances and flashbacks/feeling of experience being repeated both stood at 7%, followed by non-specific sensory disturbance/hallucinations (3%).
6. Cognitive difficulties were reported by 18% of the individuals, with difficulty thinking clearly/confusion (9%) and intrusive/ruminative/obsessive/fixed thoughts (7%) as the leading subthemes.

7. Somatic difficulties account for 19% of the reports, with sleep problems and nightmares (9%), non-specific somatic issue (4%), and fatigue (3%) being the most frequently mentioned.
8. Behavioral difficulties made up 11% of the reports, with difficulty with performing in career/studying (6%) and substance use/abuse (2%) being the most common issues.

In addition, 5% of participants reported experiencing symptoms akin to a psychotic episode. This was classified as a distinct category because it encompassed elements from multiple main themes, rather than aligning exclusively with any single one.

“We know from other studies that psychedelic drugs can lead to functional impairment lasting longer than a day, in about 9% of cases,” Evans told PsyPost. “Our study gives us a better picture of the sorts of difficulties people can get into. Clearly psychedelics can sometimes lead to extended difficulties, most typically of the sort described above. We now need to research what may cause these extended difficulties and what helps people cope with them.”

Participants were also asked about their perceptions of the relationship between their difficulties and prior mental illness or childhood trauma. A significant number (28.5%) had been diagnosed with a mental illness before their psychedelic experience, and nearly half of them believed this diagnosis could be linked to the difficulties they faced afterward. Moreover, 40% of participants suspected that childhood trauma might have played a role in the difficulties arising from their psychedelic experiences.

Nearly 19% of the participants reported being diagnosed with a mental illness after the psychedelic experience, and more than half of those with a post-experience diagnosis believed that their psychedelic experience contributed to this diagnosis.

Despite the enduring difficulties, a majority of participants (54.9%) reported still taking psychedelic drugs, and nearly 90% agreed that the insights and healing gained from psychedelics, when taken in a supportive setting, are worth the risks involved.

The researchers also tested several hypotheses to identify factors that predict the range and duration of difficulties. They found that experiencing a more challenging trip and being in an unguided setting at the time of the psychedelic experience were associated with a greater range of difficulties. The challengingness of the trip was also linked to the duration of difficulties. However, other factors like prior mental illness diagnoses did not significantly predict the duration or variety of enduring difficulties.

While this study provides crucial insights into the challenges some individuals face after psychedelic use, it is not without limitations. The predominantly Western, English-speaking sample may not represent the experiences of individuals from different cultural backgrounds or subcultures where psychedelics are used for religious or therapeutic purposes.

Additionally, the study relied on self-reported data, which may be influenced by memory and personal interpretations. It did not explore the duration, significance, or impact of each difficulty type, which could provide further insights into which difficulties cause the most distress.

“Our study only focused on people who said they’d experienced difficulties lasting longer than a day,” Evans said. “We need to see how common these difficulties are as a percentage of total psychedelic experiences. We also need to learn more about what might make extended difficulties more likely, and what specific treatments or interventions shorten the intensity or duration of people’s suffering.”

The study, “Extended difficulties following the use of psychedelic drugs: A mixed methods study“, was authored by Jules Evans, Oliver C. Robinson, Eirini Ketzitzidou Argyri, Shayam Suseelan, Ashleigh Murphy-Beiner, Rosalind McAlpine, David Luke, Katrina Michelle, and Ed Prideaux.

© PsyPost

HIP CAPITALI$M

More Psychedelic Companies Are Going Public

THE NASCENT PSYCHEDELIC industry is booming as several companies have gone public and more are expected to follow this route in 2021 to attract more capital from institutional and retail investors.

© (Getty Images) Psylocibin mushrooms growing in magic mushroom breads on an isolated plastic environment being collected by expert hands wearing white latex medical gloves. Fungi hallucinogen drugs production concept

Competition among the dozens of biopharmaceutical companies is fierce. Many are seeking more capital to conduct expensive and lengthy drug trials and develop intellectual property to synthesize the molecules to help treat various mental disorders. The companies that can bring their psychedelic drugs to the market first will emerge from the pack and could likely hit a home run.

"Within the next six to 12 months, we will see an arms race in the psychedelic space as companies try to innovate and get their drugs to trials and to the market," says Jason Spatafora, co-founder of marijuanastocks.com and head trader at truetradinggroup.com. "These psychedelic companies can cut into the multibillion-dollar industry that is completely dominated by pharmaceutical companies."

Atai Life Sciences, a Berlin-based biotech company that is researching both psychedelic and nonpsychedelic compounds, is expected to go public in 2021.

"This will be the most anticipated IPO coming (out) of this space, and I wouldn't be surprised if it performed similarly to Compass or Cybin in the hundreds of millions," he says, referencing two other biotech companies.

The company closed its $125 million Series C financing round in November, including $32 million of its 2020 convertible debt that converted in connection with the Series C. The round was co-led by Apeiron Investment Group, the family office of Atai's founder Christian Angermayer, Peter Thiel and Catalio Capital Management and joined by other existing investors including Future Ventures and Galaxy Investment Partners, as well as new investors including Falcon Edge Capital and Pura Vida Pro.

The proceeds will fund preclinical and clinical development of Atai's existing mental health programs, expand its drug candidate pipeline and advance ATAI's technologies. The funding will also help with phase 2 trials focused on arketamine for treatment-resistant depression and ibogaine for opioid use disorder.

In January, the company acquired a majority stake in Recognify Life Sciences, an entity developing a treatment for cognitive impairment associated with schizophrenia. Recognify's lead compound has exhibited an effect on three mechanisms that are central to learning and memory.
Going Public to Raise Capital

A handful of psychedelic biotech companies went public in 2020 to access more capital, allowing them to increase their intellectual property that could be later sold to pharmaceutical companies with millions of dollars of cash on hand to conduct expensive phase 3 clinical trials.

Several biopharmaceutical companies listed their companies in Canada since regulators allowed them to go public. In Canada, psychedelics such as psilocybin, LSD, mescaline and DMT are considered Schedule 3 drugs, unlike in the U.S. The U.S. is also conducting dozens of psychedelic clinical trials.

MindMed (ticker: MMEDF), a New York-based psychedelic medicine biotech company, has raised $183.8 million since May 2019 from Canaccord Genuity, Eight Capital and CIBC Capital Markets to finance its research and development and expand its clinical trial pipeline.

"We are still in the early innings here," said JR Rahn, co-founder and co-CEO of MindMed. "The industry is growing a lot faster and more than anyone anticipated."

MindMed is conducting multiple clinical trials of psychedelic substances. The company began a trial combining MDMA and LSD in January at the University Hospital Basel Liechti Lab in Basel, Switzerland. The combination could increase positive drug effects such as positive mood and empathy and lower the negative emotions and anxiety that are sometimes associated with LSD, the company said.

MindMed began a study evaluating the effects of daytime and evening administration of low doses of LSD on cognitive performance, sleep quality, mood, neuroplasticity markers, emotion and immune system response. The company is also undertaking a commercial phase 2a adult ADHD clinical trial evaluating microdoses of LSD and is in the process of applying to start a phase 2b clinical trial evaluating LSD assisted therapy for anxiety disorders.

The company has high-profile investors, including Bail Capital; Bruce Linton, former CEO of cannabis company Canopy Growth Corp. (CGC); and Kevin O'Leary of "Shark Tank."

Compass Pathways (CMPS), a U.K.-based startup working on a formulation of psilocybin to help people with treatment-resistant depression, went public in 2020. The company is working on a phase 2b clinical trial of COMP360 psilocybin therapy and reported it had cash of $196.5 million as of Sept. 30, which should fund operations into 2023.

Toronto-based Cybin (CYBN), a psychedelic pharmaceutical therapies company, went public in November 2020 and acquired Boston-based pharmaceutical company Adelia Therapeutics in December for $15.75 million in an all-stock transaction. Cybin could acquire additional companies in 2021, says the company's CEO Doug Drysdale.

The company raised nearly 90 million Canadian dollars from its seed, Series A, Series B and other financing rounds that will be used to fund clinical trials and its mergers and acquisitions strategy, Drysdale says, adding that psychedelic companies need to have a strong science team, intellectual property and balance sheet.

The company has a provisional patent application for an oral film delivery mechanism covering all psychedelic molecules – this mechanism is expected to have a similar bio-efficacy to oral capsules but at a reduced dosage and cost. Cybin also has a patent application for a delivery technology covering various chemically synthesized psychedelic molecules. Drysdale says the company has a total of 10 patent filings and continues to expand its discovery pipeline.

Companies to Watch

Mindset Pharma (MSET) is a Canadian Securities Exchange-listed drug discovery company that focuses on psychedelic-inspired compounds aimed at treating neuropsychiatric disorders and has started to gain the investing public's attention since its recent IPO.

The company has synthesized more than 50 compounds with positive preclinical data, leading it to file multiple patents around its novel chemical structures and processes.

"We believe that Mindset is undervalued based on a comparative analysis of other publicly traded drug discovery psychedelic companies and feel that the recent investment by the Ontario Brain Institute is a vote of confidence in the management team and a further validation of the company's recent progress," says Aaron Raub, senior equity analyst at Ambria Capital. "Investors are still at an early stage of discovering Mindset, and we feel it is an opportune time for growth-focused investors to take a deeper dive."

Vancouver-based Numinus Wellness (NUMI) is the first public company in Canada to receive a license to produce and extract psilocybin from mushrooms. It also has a dealer's license from Health Canada to import, export, possess, test and distribute MDMA, psilocybin, psilocin, DMT and mescaline. The company researches and develops proprietary, standardized extraction methods, which involves testing methods and product formulations for research and development partnerships.

Numinus is an undervalued company since management has made key strategic steps that investors should take note of in 2021 as it continues building out its ecosystem of psychedelic-assisted psychotherapies, Raub says.

"Investors responded quite bullishly after the company's recent announcement of a ground-breaking collaboration with the highly respected nonprofit research and educational organization MAPS (Multidisciplinary Association for Psychedelic Studies)," he says.

This clinical trial, if approved, would aim to deliver MDMA-assisted psychotherapy for people with post-traumatic stress disorder.

"Additional treatment options for PTSD are becoming more imperative by the day in a pandemic-stricken society," he says. "Institutional investors are taking note of all the recent progress as evidenced by its $17 million capital raise in December 2020 that provides the company with working capital and ability to look for (growth) acquisitions."

Copyright 2021 U.S. News & World Report

Psychedelic-assisted therapies for patients with PTSD

The resurgence of research into psychedelic-based treatments is poised to benefit many people who face mental health challenges, such as post-traumatic stress disorder, but how do they feel about it?

Peer-Reviewed Publication

MEDICAL UNIVERSITY OF SOUTH CAROLINA

 

IMAGE: MEDICAL UNIVERSITY OF SOUTH CAROLINA PSYCHIATRIST DR. JENNIFER JONES (LEFT) AND MELISSA MICHEL (RIGHT, RECLINING), LEAD THERAPIST FOR MUSC'S CENTERSPACE CLINIC, DEMONSTRATING PSYCHEDELIC-ASSISTED THERAPY. view more 

CREDIT: MEDICAL UNIVERSITY OF SOUTH CAROLINA. PHOTOGRAPH COURTESY OF DR. JENNIFER JONES.

Psychedelic-based therapies are poised to change the treatments that psychiatrists can offer patients.

“I often talk about psychedelic treatments as catalysts for change, for both the individual and the field of psychiatry,” said Medical University of South Carolina psychiatrist Jennifer Jones, M.D., who conducts research on these treatments.

The highly anticipated approval of MDMA, or “ecstasy,” to treat post-traumatic stress disorder would be the first for a psychedelic drug, ushering in changes for patients, mental health providers and society. The Food and Drug Administration is expected to issue a decision on MDMA-assisted therapy for PTSD in early 2024.

How well this revolutionary research will be implemented into practice will depend on patients’ willingness to undergo psychedelic-based treatments and their ability to access those treatments, said Jones. Jones’ latest research, published in Frontiers in Psychiatry, examines these potential barriers in a population that stands to benefit greatly from psychedelic therapies for PTSD: individuals that use substances.

Changing treatments and outcomes

Approval of psychedelic therapies could help patients with mental illnesses, particularly those with multiple or treatment-resistant disorders. PTSD is an often severe mental disorder that can occur after being exposed to a traumatic event. Current treatments, while improving symptoms in some patients, leave many without any benefit at all.

For the many people who have PTSD and habitually use alcohol or other substances, rates of nonresponse to treatment are even higher. Jones thinks this is unacceptable, so she started researching new approaches to treat patients with both PTSD and a substance use disorder.

A promising ‘new’ treatment option for patients with both PTSD and SUD may come from an ‘old’ group of drugs called psychedelics. Psychedelics include both natural (psilocybin, mescaline, DMT) and synthetic (LSD, MDMA) drugs. Natural psychedelics have been used medicinally and spiritually in traditional cultures for centuries. However, they were described scientifically mostly in the 1950s and 1960s.

“It is really interesting – in these early studies looking at psychedelic therapy for one indication, like PTSD, they noticed improvements in symptoms of another mental health disorder, like depression or SUD,” said Jones.

Since 2009, approximately 80 clinical trials involving MDMA have been completed or are ongoing, according to Clinicaltrials.gov. These trials investigate the use of MDMA in a wide range of disorders, including anxiety, depression, obsessive compulsive disorder, SUD and PTSD. These diverse studies highlight the potential effects of MDMA across multiple disorders, something that prior treatments have lacked.

“This is really important,” said Jones. “It is very common to have concurrent mental health disorders, so having a treatment like MDMA that could, for example, improve both PTSD and SUD symptoms is really exciting for the field.”

Currently, drugs used to treat PTSD may be given with or without another form of therapy, broadly referred to as “talk therapy.” For MDMA-assisted therapy, the talk therapy component is a fundamental part of the treatment.

“In the context of MDMA-assisted therapy for PTSD, MDMA is thought to dampen the fear response around the traumatic memory, allowing the participant to engage with the therapy team to process this memory, sometimes for the first time in their lives,” said Jones. “Instead of running from it, they can process the traumatic memory and move past it.”

This processing may also apply to other mental functions, perhaps accounting for MDMA’s ability to improve symptoms for other disorders, like SUD.

“Participants in psychedelic clinical trials have lasting benefits that come from changes in their behaviors, their thought processes and their interactions with others,” said Jones. “Participants often point to these changes as what made the difference in their symptoms.”

The immediate effects of MDMA during therapy are not without concern, however. Jones is often asked whether the MDMA will produce feelings of “ecstasy.” “Ecstasy is a common descriptor for the effects caused by recreational MDMA, used so frequently that it became a nickname for the drug. However, because this therapy is a difficult process of self-healing, MDMA in this context does not usually produce ecstasy, Jones said. This common concern points to some of the possible barriers that Jones wanted to assess in her recent publication.

Changing minds

For some, reluctance to receive MDMA-assisted therapy is tied to negative views of psychedelics and their recreational uses. In the 1970s, all psychedelics were classified as Schedule I substances, drugs with high-abuse potential without clinical benefits, tarnishing political and public perceptions of these drugs. Their recreational use and representations in media have continued to perpetuate this stigma.

Negative views of psychedelics and increasing regulatory control halted early promising research on psychedelics in Western medicine in the 1970s, reported the Multidisciplinary Association for Psychedelic Studies. It wasn’t until the 1990s that officially sanctioned psychedelic research resumed on a small scale, only accelerating in the 2010s. New government policies allowed psychedelic clinical research to resume, but public perceptions of psychedelics will determine the success of these drugs as treatments.

In Jones’ study, approximately 70% of survey respondents indicated their support for MDMA-based research and belief that MDMA could be useful for treating mental health disorders. A smaller group, 59%, would be willing to receive an MDMA-based treatment if it were recommended by a mental health provider. The survey results suggest that most people who use substances are open to MDMA research and would be willing to try an MDMA-based therapy.

Jones also examined the role of race and ethnicity on opinions about MDMA-assisted therapy. Despite their underrepresentation in psychedelic clinical trials, racial and ethnic groups had similar levels of support for MDMA research. However, there were small, but potentially important, differences in willingness to try an MDMA-based therapy. “While largely a hypothesis,” said Jones, “differences in willingness to participate in clinical trials are probably related to prior use or cultural beliefs.”

While this research brings up additional questions for Jones and colleagues, she believes these results can help researchers and mental health providers to understand how to develop and implement treatments more equitably for different patient and ethnic populations.

By discussing these issues prior to the FDA decision, Jones hopes steps can be taken to address patient concerns.

“It is my heartfelt goal that everyone who might benefit from MDMA-assisted therapy is able to receive treatment once it is available, and that they will not be held back by worries or stigma about the treatment,” said Jones. “For that to be a reality, we have to seek input directly from those most likely to benefit from the treatments that we are developing.”

 

# # #

About MUSC

Founded in 1824 in Charleston, MUSC is the state’s only comprehensive academic health system, with a unique mission to preserve and optimize human life in South Carolina through education, research and patient care. Each year, MUSC educates more than 3,200 students in six colleges – Dental Medicine, Graduate Studies, Health Professions, Medicine, Nursing and Pharmacy – and trains more than 900 residents and fellows in its health system. MUSC brought in more than $298 million in research funds in fiscal year 2022, leading the state overall in research funding. MUSC also leads the state in federal and National Institutes of Health funding, with more than $220 million. For information on academic programs, visit musc.edu.

As the health care system of the Medical University of South Carolina, MUSC Health is dedicated to delivering the highest-quality and safest patient care while educating and training generations of outstanding health care providers and leaders to serve the people of South Carolina and beyond. Patient care is provided at 16 hospitals (includes owned and equity stake), with approximately 2,700 beds and four additional hospital locations in development; more than 350 telehealth sites and connectivity to patients’ homes; and nearly 750 care locations situated in all regions of South Carolina. In 2022, for the eighth consecutive year, U.S. News & World Report named MUSC Health University Medical Center in Charleston the No. 1 hospital in South Carolina. To learn more about clinical patient services, visit muschealth.org.

MUSC has a total enterprise annual operating budget of $5.1 billion. The nearly 26,000 MUSC family members include world-class faculty, physicians, specialty providers, scientists, students, affiliates and care team members who deliver groundbreaking education, research, and patient

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JOURNAL

Frontiers in Psychiatry

DOI

10.3389/fpsyt.2023.1096298 

METHOD OF RESEARCH

Survey

SUBJECT OF RESEARCH

People

ARTICLE TITLE

Perspectives on the therapeutic potential of MDMA: A nation-wide exploratory survey among substance users.

How do mushrooms become magic?

Research examines why some fungi evolve psychedelic properties

Grant and Award Announcement

UNIVERSITY OF PLYMOUTH

 

VIDEO: A TIMELAPSE VIDEO OF PSYCHEDELIC AND NON-PSYCHEDELIC FUNGI GROWING IN THE LAB view more 

CREDIT: UNIVERSITY OF PLYMOUTH

Psychedelic compounds found in ‘magic mushrooms’ are increasingly being recognised for their potential to treat health conditions such as depression, anxiety, compulsive disorders and addiction.

However, very little is known about how such compounds have evolved and what role they play in the natural world.

To address that, scientists from the University of Plymouth are conducting a first-of-its-kind study using advanced genetic methods and behavioural experiments to address previously untested hypotheses into the origin of psychedelic compounds in fungi.

This includes exploring whether such traits have evolved as a form of defence against fungus-feeding invertebrates, or whether the fungi produce compounds that manipulate insect behaviour for their own advantage.

The project will particularly focus on psilocybin, commonly found in so-called ‘magic mushrooms’. In chemical terms, it is very similar to serotonin, which is involved in the sending of information between nerve cells in animals.

The researchers are sampling psychedelic and non-psychedelic fungi, and using next-generation DNA sequencing to test whether or not there is a diverse animal community feeding on psychedelic fungi.

They are also using laboratory tests to investigate fungal-insect interactions, and whether the fungi undergo genetic changes during attack and development. They will also investigate the effect of psilocybin on the growth of soil bacteria.

The research will also involve using cutting-edge gene editing technology to try and create mutant fungi that cannot synthesize psilocybin. It is hoped this will help researchers better understand the role of a wide range of fungal compounds in future.

The study is being led by a team of experienced researchers in molecular ecology, animal-plant interactions and fungal biology in the University’s School of Biological and Marine Sciences. Driving the study are Post-Doctoral Research Fellow Dr Kirsty Matthews Nicholass and Research Assistant Ms Ilona Flis.

Dr Jon Ellis, Lecturer in Conservation Genetics, is supervising the study. He said: “In recent years, there has been a resurgence of interest in psychedelic compounds from a human health perspective. However, almost nothing is known about the evolution of these compounds in nature and why fungi should contain neurotransmitter-like compounds is unresolved.

“The hypotheses that have been suggested for their evolution have never been formally tested, and that is what makes our project so ambitious and novel. It could also in future lead to exciting future discoveries, as the development of novel compounds that could be used as fungicides, pesticides, pharmaceuticals and antibiotics is likely to arise from ‘blue-sky’ research investigating fungal defence.”

Dr Kirsty Matthews Nicholass said: “Within Psilocybe alone, there are close to 150 hallucinogenic species distributed across all continents except Antarctica. Yet, the fungal species in which these ‘magic’ compounds occur are not always closely related. This raises interesting questions regarding the ecological pressures that may be acting to maintain the biosynthesis pathway for psilocybin.”

The research is being funded by the Leverhulme Trust and builds on the University’s long-running expertise in novel elements of conservation genetics.

Researchers involved in this project have previously explored the genetic diversity among UK pollinators, the feeding preferences of slugs and snails, and developed an early warning system for plant disease.

 

Scientists are looking to address untested hypotheses into the

 origin of psychedelic compounds in fungi

The researchers have sampled psychedelic and non-psychedelic fungi

from the wild to explore a range of currently untested hypotheses

CREDIT

University of Plymouth

Dr Jon Ellis talks about the history of research into psychedelic compounds in nature

“Fungi generally receive less attention overall than animals and plants, partly because they are less apparent, people interact with them less and they can be hard to study. Historically, there have also been legal barriers which meant certain research has not previously been possible. Saying that, there were some very interesting studies in the 1940s and 50s into the use of LSD as a psychotherapeutic treatment for alcoholism and obsessive-compulsive disorder. Around that time, people also became interested in fungi from an anthropological perspective.

"One couple, the Wassons, went to Mexico and witnessed the ritual use of fungi for the first time in religious ceremonies. Articles they published brought public attention to psychoactive mushrooms. Around this time, there were also other charismatic individuals, such as Timothy Leary, who advocated the use of LSD more widely by the general public. In the 1960s, psychedelic compounds really came to widespread public attention and that ultimately led to governments introducing new laws to restrict their use.

"For some time, that also restricted the fundamental research that could be carried out. More recently, people have returned to that initial research and found that compounds such as psilocybin can have psychotherapeutic benefits. However, that has not addressed their evolution in nature, which is what makes the research we are doing so exciting.

"I hope our project can change the public perception of magic mushrooms. But beyond that, asking questions about the biological world is a fundamental part of our human nature and this project fits into a long narrative of research asking questions about biodiversity and its evolution.”

Magic mushrooms could replace antidepressants within five years, says new psychedelic research centre

Exclusive: ‘People on antidepressants long-term say they feel blunted, with psychedelic therapy it’s the opposite, they talk about an emotional release, a reconnection’

Alex Matthews-King Health Correspondent

Hallucination-inducing drugs like magic mushrooms could be about to break big pharma’s stranglehold on the hugely lucrative market for antidepressants, according to the head of the world’s first centre for psychedelic research.

Antidepressant prescriptions have doubled in England in a decade with around seven million adults taking the drugs, and the global market is predicted to be worth $15.9bn (£12.5bn) by 2023.

At Imperial College London, Dr Robin Carhart-Harris is leading one of the first trials to test how therapy using psilocybin mushrooms, which are currently banned in the UK, compares to leading antidepressants.

While he won’t prejudge the results of the study, he says participants describe a cathartic emotional “release” with psilocybin therapy – the polar opposite of antidepressants, which patients complain leave their emotions, whether positive or negative, “blunted”.
It is the first of many studies planned under the banner of the new Centre for Psychedelic Research at London’s Imperial College.

Read more

The medicinal wonders of psychedelics are finally being recognised

A large empty floor of the university’s Hammersmith campus will house a bank of treatment rooms that make it the UK’s first psychedelic therapy research clinic, and a “prototype and inspiration” for licensed psychedelic medicine clinics of the future.

Trials of psilocybin in treating eating disorders, and a study of the effects of powerful hallucinogenic DMT on the brain, are already planned following Imperial’s commitment to the centre.



The future home of the Psychedelic Research Centre treatment rooms which could become the model for future clinics (The Independent)

But it is the work on depression where research is most advanced, and most promising.

On the current trial, around 60 participants with moderate to severe depression will receive psilocybin treatment accompanied by a therapy session with a clinical psychologist.

The participants will also be randomly allocated to receive either a placebo or the drug escitalopram, with neither researchers or patients knowing who is in each group.


Magic mushrooms could be bought in the UK until 2005 (Getty)

Escitalopram is a type of selective serotonin reuptake inhibitors (SSRIs), the drugs which account for the largest chunk of the antidepressant market.

“If you ask people who are taking SSRIs chronically, they often say ‘I feel blunted’,” Dr Carhart-Harris told The Independent, meaning both negative and positive emotions are suppressed.

“With psilocybin therapy they say the opposite, they talk about an emotional release, a reconnection, and this key emotional centre being more responsive.”




Patients will have MRI scans to test changes in their brains after
psilocybin therapy (Centre for Psychedelic Research)

The team use MRI scans to study psychedelics’ effects on the brain and the drug appears to reduce activity in the coordinating regions, releasing their grip and allowing the more primitive emotional centres to the fore.

Other early indications are that the list of side-effects is “twice as long” for escitalopram as it is for psilocybin therapy, and it is much faster acting than antidepressants – which can take months to work.



Treatment rooms are a soothing environment where participants are 
supported through their psychedelic experience (Centre for Psychedelic Research)

However, the treatment may not be suitable for everyone.

During the therapy sessions, patients are encouraged to follow the stream of the psychedelic experience which can be extremely vivid and may require them to confront past traumas or experiences.

“We don’t call it a ‘bad trip’,” Dr Carhart-Harris says. “We call it a ‘challenging psychological experience’ and we’re honest with people that it can be hellish.

“It can be nightmarish, but we’re prepared for this and this treatment model requires you literally face your demons.”

Psychedelic therapy is unlikely to be suitable for people with psychosis and regulators will need evidence of its effectiveness and safety from clinical trials.

But there is little evidence that they pose a risk of overdose or addiction and that could speed their route to approval.

Fresh magic mushrooms could be picked or bought in shops legally in the UK until 2005, when a change in law closed the loop hole and made them Class A drugs alongside crack cocaine.

“I would imagine if you had some bookmakers doing the odds, there would be strong odds on that [psychedelic therapy] will be licensed sometime in the next five to 10 years – maybe sooner,” Dr Carhart-Harris says.

That could put it on a collision course with powerful interests of the pharmaceutical industry, particularly if trials show psilocybin therapy to be superior to SSRIs




Psilocybin therapy may allow depressed people’s brains to rewire in 
a positive way, rather than suppressing good and bad emotion (Centre for Psychedelic Research)

“The implications of that are actually frightening to me, thinking of the power and influence of big pharma,” Carhart-Harris says. “What are they going to do with that if there’s this big public demand for the ‘mushroom therapy’, and not the Prozac?”

While there is a growing trend for “microdosing” psilocybin or LSD, the evidence to date suggests it is the combination of therapy and psychedelic experience that offers the best option of a lasting alternative to chronic antidepressants.




Psychedelics research has had to rely on philanthropic funding for years, 
but latest wave of trials show the field is set on not repeating the mistakes 
of the past (The Independent)

“If you strip the drug away from therapy you start seeing the adverse events that were being reported in the 1960s, when psychedelics left the clinic and became popularised,” Dr Carhart-Harris adds.

“None of us want those mistakes to be made again.”

Dr James Rucker is another of those researching the potential benefits of psychedelics, over at the Institute of Psychiatry, Psychology and Neuroscience at King’s College London.

The King’s team are launching two trials, one looking at whether psilocybin therapy can help people whose depression is resistant to treatment with conventional antidepressants.

He says it was “possible” the drug could be licensed in five years. “But only if everything goes to plan, and you know what they say about best-laid plans.”

In Dr Rucker’s mind the process is similar to the approval of ketamine, where the first trials in depression took place in the 1990s and the first ketamine-based medicines are only now being licensed.

Psilocybin has much lower potential for abuse and overdose, but watchdogs will still need stage three trials which haven’t even begun.

“Like all treatments, they will suit some people but not others,” he told The Independent. “The trick, as ever, is trying to work that out before administration. But that trick has proven to be remarkably difficult to pull off, particularly in psychiatry.

Psychedelics research has had to rely on philanthropic funding for years, but latest wave of trials show the field is set on not repeating the mistakes of the past (The Independent)

“If you strip the drug away from therapy you start seeing the adverse events that were being reported in the 1960s, when psychedelics left the clinic and became popularised,” Dr Carhart-Harris adds.

“None of us want those mistakes to be made again.”

Dr James Rucker is another of those researching the potential benefits of psychedelics, over at the Institute of Psychiatry, Psychology and Neuroscience at King’s College London.

The King’s team are launching two trials, one looking at whether psilocybin therapy can help people whose depression is resistant to treatment with conventional antidepressants.

He says it was “possible” the drug could be licensed in five years. “But only if everything goes to plan, and you know what they say about best-laid plans.”

In Dr Rucker’s mind the process is similar to the approval of ketamine, where the first trials in depression took place in the 1990s and the first ketamine-based medicines are only now being licensed.

Psilocybin has much lower potential for abuse and overdose, but watchdogs will still need stage three trials which haven’t even begun.

“Like all treatments, they will suit some people but not others,” he told The Independent. “The trick, as ever, is trying to work that out before administration. But that trick has proven to be remarkably difficult to pull off, particularly in psychiatry.”

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