Showing posts sorted by relevance for query PSYCHEDELIC. Sort by date Show all posts
Showing posts sorted by relevance for query PSYCHEDELIC. Sort by date Show all posts

Wednesday, December 28, 2022

Psychedelic chaplains: In clinical trials, a new form of spiritual guide emerges

Spiritual care practitioners are being trained to support patients undergoing psychedelic therapy in clinical trials and decriminalized settings.

Photo by Raimond Klavins/Unsplash/Creative Commons

(RNS) — Moana Meadow was 22 when her grandmother died in a hospital room, sitting up, eyes open, gripping the hands of her family members.

“Her spirit left her body like that. In an instant,” she said. “I wasn’t religious, but her spirit felt like it was hovering in the room for 15 minutes. There was this energy, pulsating. I’ve never experienced anything like that before.”

The event, though painful, left an imprint on Meadow and convinced her to pursue the life of an interfaith chaplain so she could accompany others who were dying.

Now, the hospice chaplain is interested in helping people through other transitions — the perceptual changes brought on by psychedelic drugs. “Being with people in altered states of consciousness” can be similar to pivotal moments like marriage, childbirth or death, Meadow said, and she is on a mission to bridge chaplaincy and the work of accompanying people who are under the influence of psychedelics.

“Psychedelic experiences, particularly at higher dosages, can feel like dying,” said Sam Shonkoff, assistant professor of Jewish studies at Graduate Theological Union in Berkeley, California. “One can feel as if they’re being born. One can feel a sense of existential rupture. To have a chaplain there, who maybe has a lot of experience with sitting with people who are facing death, that can be really applicable to accompanying people who are having these experiences with psychedelics.”

Since the mid-aughts, a tidal wave of scientific research on psychedelics has flooded academic journals with evidence that these substances may be able to provide relief for everything from smoking addiction to anxiety and depression. These benefits arise at least in part, some psychedelic researchers argue, from the mystical or spiritual encounters the drugs can induce.

Moana Meadow. Photo by Julia Maryanska

Moana Meadow. Photo by Julia Maryanska

“As the scientific research on spiritual experience with psychedelics has started to come out so strongly,” said Meadow, “I think people are beginning to understand or admit the importance of religious training and knowledgeability in psychedelic work.” 

As a result, academic institutions across the U.S. are launching training programs in which spiritual practitioners can become qualified psychedelic facilitators, paving the way for a new field of psychedelic chaplaincy.

Current opportunities for these roles are limited in the U.S., as the use of the drugs themselves is considered experimental. Ketamine, a powerful but relatively safe anesthetic, is legal for medical use, and some health care chaplains act as facilitators for ketamine-assisted therapy, which has shown promise for relieving depression. As researchers have begun conducting clinical trials for psychedelic treatments, too, they are recruiting chaplains.

The Rev. Caroline Peacock, an ordained Episcopal priest and a chaplain for Emory Healthcare in Atlanta, will be serving as a spiritual health clinician in a clinical trial assessing whether psilocybin might help treat anxiety, depression and chronic pain experienced by cancer survivors.

In these settings, psychedelic chaplains are asked to provide spiritual care for clients before, during and after a psychedelic dose, aiding them as they work to elicit meaning from the experience. 

“Some of the questions psychedelic chaplaincy is bringing to the table are some of the oldest questions of all,” said Shonkoff, who pointed out that Indigenous shamans, medicine women and elders have been doing this work for centuries. But the presence of a psychedelic chaplain on these scientific teams is something new.

Jamie Beachy, left, with Rick Doblin, the founder of MAPS, at the MAPS MDMA training center in Red Feather Lakes, Colorado, in May 2019. Courtesy photo

Jamie Beachy, left, with Rick Doblin, the founder of MAPS, at the MAPS MDMA training center in Red Feather Lakes, Colorado, in May 2019. Courtesy photo

Jamie Beachy, a chaplain by training and the director of education for the Center for Psychedelic Studies at Naropa University in Boulder, Colorado, joined a study looking at MDMA, also known as the recreational drug ecstasy, as an aid for treatment-resistant post-traumatic stress disorder. The research, led by the Multidisciplinary Association for Psychedelic Studies, shows that 67% of participants taking MDMA no longer meet the criteria for PTSD, compared with 32% of participants in the placebo group.

“I have been compelled to see how people are able to move through traumas in a way that I wasn’t seeing in the hospital or the trauma settings I was working in,” said Beachy, a former health care chaplain.

Beachy said chaplains, who are often “present to traumas unfolding in real time,” can help clients navigate events that could disrupt their existing belief systems, something psychedelic therapy patients may face. “In one of the Johns Hopkins studies of DMT — another powerful psychedelic — people that went into the study reporting that they were atheists apparently came out of the study feeling less connected with atheism,” Beachy told RNS.

Beachy is developing a degree concentration in psychedelic care for the Master of Divinity program at Naropa, which already offers a psychedelic-assisted therapies certificate for professionals. 

Meadow, meanwhile, is program director of a new psychedelic facilitator certification program at the UC Berkeley Center for the Science of Psychedelics, aimed at people who are already professionals in spiritual care and health care. Graduates may be eligible to apply for a Psilocybin Facilitator License in Oregon or Colorado, which recently decriminalized psilocybin. Religious professionals would be able to act as psychedelic chaplains in health care or research settings where regulations permit.

“At the program that I’m running at UC Berkeley, there’s a clear value on the spiritual aspects of psychedelic work,” said Meadow. “So we’re attracting chaplains to our training program and promoting their expertise in this field as well.”

Sam Shonkoff. Courtesy photo

Sam Shonkoff. Courtesy photo

At both UC Berkeley and Naropa, the programs emphasize the Indigenous roots of many psychedelic practices, which Shonkoff celebrates. “There has been a tendency in this burgeoning field of psychedelic study to try to talk about the so-called mystical aspects of psychedelics without reference to particular cultural and spiritual traditions that have used these substances,” he said.

As states decriminalize psychedelics, said Ron Cole-Turner, professor emeritus at Pittsburgh Theological Seminary who often writes on theology and psychedelics, recreational, ceremonial and religious uses for psychedelics will likely expand. 

“Give us a decade, and I can’t imagine we won’t have well-established opportunities in multiple parts of the United States, definitely Oregon, very likely Colorado and other places … where there will be open, out, legal and reasonably well-supervised and therefore safe pathways for people who just simply want to see if this enriches their spiritual lives,” he told Religion News Service.

Chaplains will be necessary for these grassroots uses as well, said Celina De Leon, founder and director of the Circle of Sacred Nature 501(c)3 Church, based in California’s Bay Area, for which taking ayahuasca is a “sacramental practice” that is a “fundamental expression of our religious beliefs,” De Leon told RNS.



While De Leon views these substances as having “beautiful potential,” she readily acknowledges that not all psychedelic experiences are positive. “Sometimes psychedelic experiences can be very challenging, and people can really benefit from having support in their meaning making process,” she said. “I think chaplains can be very well suited for that on a community level, outside of clinical contexts.”

Some people, De Leon adds, have destabilizing encounters — the colloquial “bad trip” — and because of a person’s vulnerability during psychedelic therapy, there can also be safety risks.

Currently, there’s no standard pathway for becoming a psychedelic chaplain. Beachy would like to see nondegree programs like Naropa’s be complemented by a national advanced certification for psychedelic chaplains, similar to those that certify chaplains in palliative care or ethics consultation.

The first wave of psychedelic chaplains is already here, however, reconnecting the link between psychedelics and religion, as science reconnects the link between the drugs and health.

“Psychedelics have traditionally been medicines that were used for spiritual growth, healing and prayer,” said Meadow. “If we’re not thinking about them that way, we are missing something very important.”


Monday, January 16, 2023

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.

SEE




Tuesday, June 09, 2020





Exploring the nature of anomalous psychedelic experiences
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  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- 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  than under that of other psychoactive drugs. Interestingly, some interviewees also said that  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

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

Thursday, November 23, 2023

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

Tuesday, February 02, 2021

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

Friday, July 14, 2023

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

Demonstration of psychedelic-assisted therapy 

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.”

 

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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