Category Archives: Psychedelics

TORONTO, June 24, 2022 /PRNewswire/ - Braxia Scientific Corp. ("Braxia", or the "Company"), (CSE: BRAX) (OTC: BRAXF) (FWB: 4960), a medical research company with clinics providing innovative ketamine treatments for persons with depression and related disorders, is pleased to announce its participation at the H.C. Wainwright Global Investment Conference from June 27 28, 2022 in New York.

Braxia Scientific CEO Dr. Roger McIntyre will deliver two live presentations at the conference beginning with a Keynote address - Introduction to the State of Mental Healthcare to kick off the conference on Monday, June 27 at 8:15 a.m. ET

Dr. McIntyre, will also deliver a second presentation on Monday, June 27 at 4:00 p.m. ET providing an overview of the Braxia's business, including its progress on increasing access to novel ketamine and psychedelic treatments for patients with depression, while also expanding the clinical research infrastructurerequired to execute on the Company's growing pipeline of registered clinical trials alongside third-party sponsors.

Braxia's trials include Canada's first multi-dose psilocybin-assisted therapy trial which commenced in November 2021 and recently reported positive preliminary results.

Dr. McIntyre will also be available to host one-on-one meetings with institutional investors registered with H.C. Wainwright and Co.

About Braxia Scientific Corp.

Braxia Scientific is a medical research company with clinics that provide innovative ketamine treatments for persons with depression and related disorders. Through its medical solutions, Braxia aims to reduce the illness burden of brain-based disorders, such as major depressive disorder among others. Braxia is primarily focused on (i) owning and operating multidisciplinary clinics, providing treatment for mental health disorders, and (ii) research activities related to discovering and commercializing novel drugs and delivery methods. Braxia seeks to develop ketamine and derivatives and other psychedelic products from its IP development platform. Through its wholly owned subsidiary, the Canadian Rapid Treatment Center of Excellence Inc., Braxia currently operates multidisciplinary community-based clinics offering rapid-acting treatments for depression located in Mississauga, Toronto, Ottawa, and Montreal.

ON BEHALF OF THE BOARD"Dr. Roger S. McIntyre"

Dr. Roger S. McIntyreChairman & CEO

The CSE has not reviewed and does not accept responsibility for the accuracy or adequacy of this release.

Forward-looking Information Cautionary Statement

This news release contains forward-looking statements within the meaning of applicable securities laws. All statements that are not historical facts, future estimates, plans, programs, forecasts, projections, objectives, assumptions, expectations, or beliefs of future performance are "forward-looking statements."

Forward-looking statements include statements about the intended promise of ketamine-based treatments for depression and the potential for ketamine to treat other emerging psychiatric disorders, such as Bipolar Depression. Such forward- looking statements involve known and unknown risks, uncertainties and other factors that may cause actual results, events, or developments to be materially different from any future results, events or developments expressed or implied by such forward-looking statements. Such risks and uncertainties include, among others, the failure of ketamine, psilocybin and other psychedelics to provide the expected health benefits and unanticipated side effects, dependence on obtaining and maintaining regulatory approvals, including acquiring and renewing federal, provincial, municipal, local or other licenses and engaging in activities that could be later determined to be illegal under domestic or international laws. Ketamine and psilocybin are currently Schedule I and Schedule III controlled substances, respectively, under the Controlled Drugs and Substances Act, S.C. 1996, c. 19 (the "CDSA") and it is a criminal offence to possess such substances under the CDSA without a prescription or a legal exemption. Health Canada has not approved psilocybin as a drug for any indication, however ketamine is a legally permissible medication for the treatment of certain psychological conditions. It is illegal to possess such substances in Canada without a prescription.

These factors should be considered carefully, and readers are cautioned not to place undue reliance on such forward-looking statements. Although the Company has attempted to identify important risk factors that could cause actual actions, events or results to differ materially from those described in forward-looking statements, there may be other risk factors that cause actions, events or results to differ from those anticipated, estimated or intended. Additional information identifying risks and uncertainties that could affect financial results is contained in the Company's filings with Canadian securities regulators, including the Amended and Restated Listing Statement dated April 15, 2021, which are available at http://www.sedar.com. There can be no assurance that forward-looking statements will prove to be accurate, as actual results and future events could differ materially from those anticipated in forward-looking statements.

SOURCE Braxia Scientific Corp.

Read the original here:

Braxia Scientific CEO to Deliver Keynote Address at HC Wainwright & Co. 1st Annual Mental Health Conference: Neuropsychiatry, Psychedelics, and...

Of Hawaii's residents, around 8.8% and 8% report a lifetime prevalence of depression or anxiety, respectively [1].A Hawaii personality and health survey showed that 83.1% of participants reported at least one traumatic event occurring in their lifetime [2], higher than the national average of 70.4% [3].Yet around 20% of Hawaii's residents, exceeding the national average of 8.3%, were not able to receive care due to access to care barriers [1].

On April 4, 2019, United States Senator Brian Schatz (D-HI) wrote a letter to the Food and Drug Administration (FDA) and the National Institute of Health (NIH) inquiring about the governments plans to investigate the medicinal value of psychedelics [4].On June 13, 2019, the FDA and NIH responded in a co-authoredmessage acknowledging the therapeutic potential of psychedelics from the results of recent clinical trials and the need for more research [5].On June 28, 2021, the Multidisciplinary Association for Psychedelic Studies (MAPS) responded to the FDA and NIH with clarification regarding clinical trials evidence supporting the safety and efficacy of psychedelics in the treatment of mental health disorders [5].

On January 22, 2021, Hawaii Senator Stanley Chang (District 9) introduced Senate Bill No. 738, which will potentially remove psychedelic mushrooms (psilocybin) from the list of Schedule I controlled substances and establish psychedelic treatment centers as well [6].Promising clinical trials of psychedelics used as medications to treat mental health disorders, such as major depressive disorder, are driving the State of Hawaii to consider the potential medical benefits of psychedelics for Hawaii's residents [4].

Ketamine, a substance producing psychedelic experiences and hallucinations, has been used to treat depression for many years. In 2019, esketamine-a non-psychedelic enantiomer of ketamine-became approved by the FDA as a psychiatric treatment for major depressive disorder [7].Currently, MDMA is estimated to be the next psychedelic to be FDA-approved potentially. Psilocybin, ketamine, and MDMA all have an extensive history of use in recreational settings. However, in controlled clinical settings, each has been adapted for therapeutic purposes as an adjunct in treatment [8].

When paired with therapy, MDMA is the only psychedelic drug proven efficacious for treatment-resistant post-traumatic stress disorder (PTSD). Methylenedioxymethamphetamine-assisted therapy (MDMA-AT)to treat other conditions such as eating disorders and alcohol use disorder continues to be researched. To date, MDMA-AT is found to be potentially beneficial for various problems related to psychological trauma, such as anxiety from a life-threatening illness and social anxiety in autistic adults.

In 1912, pharmaceutical company Merck filed two patent applications that described the chemical synthesis of MDMA and its unique psychoactive properties. Further drug development research halted until 1959 when Wolfgang Fruhstorfer synthesized MDMA for pharmacological testing while researching stimulants [9].In the 1960s, chemist Alexander Shulgin documented his experiments with synthesizing MDMA and numerous other related compounds in Phenethylamines I have known andloved (PIHKAL): A Chemical Love Story [9]. Leo Zeff would later use MDMA as an adjunct to psychotherapy, introducing it to approximately 150 other psychotherapists, ultimately responsible for an estimated 500,000 doses of MDMA administered in therapeutic settings [10]. By the 1980s, many psychotherapists adapted MDMA as part of their practice due to its ability to accelerate the therapeutic process. Although there were no clinical trials nor government approval, MDMA-AT was legally used for couplescounseling, relationship problems, depression, anxiety, substance use disorders, premenstrual syndrome, and autism, among several other psychiatric disorders [10].

As the war on drugs raged on with racially disproportionate mass incarceration amid crack cocaine-dominated headlines, MDMA raised the attention of the Drug Enforcement Agency (DEA). During a debate on the Phil Donahue show on banning MDMA, researchers shared pre-published reports stating that the drug caused brain damage in rats and soit could do the same in humans. However, the information was misleading since it did not note the significantly large and frequent intravenous doses given to the rats [11].A study [12] published in Science showing MDMA was neurotoxic in primateswas later redacted due to the lab being found to have been injecting methamphetamine instead of MDMA [13]. Other news sources furthered the claim that MDMA caused brain damage, but they confused it with the synthetic heroin designer drug 1-methyl-4-phenyl-1,2,3,6-tetrahydropyridine (MPTP), which caused acute onset Parkinsonism. Methylenedioxymethamphetamine entered a burgeoning recreational drug counterculture before being banned as a Schedule I substance in 1985 as another salvo in the War on Drugs [10].

The DEAsdrug denominations range from Schedule I to V, with Schedule I drugs having the highest risk of abuseand Schedule V drugs having the lowest potential for abuse [14]. The DEA designated MDMA as Schedule I, declaring that it had no currently acceptable medical use [14] despite the Schedule III recommendation from the DEA judge overseeing the proceedings [15]. Due to the extensive hurdles involved with DEA approval and public funding, clinical research was stunted. Medical researchers still believe in MDMA's therapeutic potential, particularly among people with PTSD, depression, and other psychiatric issues. In 1986, the nonprofit Multidisciplinary Association for Psychedelic Studies (MAPS) was founded to secure private funding for clinical trials despite these barriers [10].Since then, MAPS has raised over $130 million for scientific research of psychedelics and cannabis for therapeutic purposes. In 2004, the DEA and the FDA approved MAPS to research MDMA's efficacy as an adjunct to psychotherapy. The first clinical trial of MDMA-AT was conducted in Spain but ended early due to political pressure[16]. The first completed study was conducted in the United States and was published in 2011 [17].

The FDA granted breakthrough therapy status to MDMA-AT in 2017 based on evidence from the phase-II clinical trials [18]. Multidisciplinary Association for Psychedelic Studies reported a series of six phase-II clinical trials looking at MDMA-AT for PTSD. Participants met the Diagnostic and Statistical Manual of Mental Disorders, 4th Edition, Text Revision (DSM-4-TR) criteria for a diagnosis of PTSD and were treatment-resistant to at least three months of antidepressant treatment and six months of psychotherapy. Participants were provided several preparatory pre-MDMA sessions, two or three eight-hour MDMA-assisted psychotherapy sessions each one month apart, and several follow-up non-drug psychotherapy sessions described as integration sessions. After two MDMA-AT sessions, 54% of participants in the MDMA group did not meet the criteria for PTSD compared to 23% of the placebo group [19]. After three MDMA-AT sessions, 67% of participants no longer met the criteria for PTSD [20]. These effects were durable at the one-year follow-up, with 67% not meeting PTSD criteria [21]. At nearly four years, 74% no longer met PTSD criteria. Participants who reported suicidal ideation decreased from approximately 60% to 24% [21].

In 2021, MAPS and the FDA agreed on the design for phase-III trials. The phase -III trials were the first multi-site randomized, double-blinded, placebo-controlled trial, testing 90 participants with severe PTSD [20]. Participants received three sessions with 80 mg to 120 mg of MDMA and either an additional half-dose after 1.5-2 hours or, a placebo combined with three preparatory and three integrative therapy sessions after each medication session. Drug safety included assessing the participant's heart rate, blood pressure, and body temperature while being cognizant of any signs of adverse events and thoughts such as suicide. Common side effects included decreased appetite, muscle tightness, and hyperhidrosis, but they were transient and mild to moderate in severity [20].

Phase-III data indicates that MDMA-AT is highly effective, safe, and well-tolerated in individuals who have a treatment-resistant PTSD diagnosis, and even in those with comorbidities.Post-traumatic stress disorder treatments are desperately needed, and MDMA-AT represents a potential breakthrough treatment that merits expedited clinical development [20].

A second phase-III clinical trial at MDMA-AT-approved clinics is currently enrolling participants and is expected to be published in 2022. If the FDA approves MDMA-AT, policies will be required for determining physician qualifications to prescribe and administer MDMA, MDMA-AT site qualifications, and how it will be produced and stored.

Methylenedioxymethamphetamine is a psychoactive drug that increases the endogenous release of the neurotransmitters serotonin, norepinephrine, and dopamine. It also leads to the release of neurohormones such as oxytocin, which is thought to be a primary mediator of its effects. Subjective effects include stimulating social connectedness, empathy, euphoria, and feelings of communion. Oxytocin has emerged as an essential component in elucidating the reopening of critical periods for social reward learning and mediating interpersonal bonding [22]. The use of MDMA alongside psychotherapy allows participants to revisit past distressful memories in a state of emotional security and empathic self-reflection.

Individuals with PTSD have an amplified and uncontrolled response from the amygdala to trauma-specific cues. Increasing serotonin helps regulate mood, while oxytocin increases trust and emotional awareness by reducing the amygdalas response [23]. The effects are decreased hypervigilance and anxiety and improved states of consciousness [24]. Moreover, MDMA activates serotonin (5-HT2A) receptors, which increases sedation and relaxation that may be conducive to addressing trauma-induced hypervigilance and promoting memory consolidation [25].

Oxytocin, commonly referred to as the love hormone, has sparked the interest of scientists for its potential to regulate anxiety and promote social bonding. However, translational pharmaceutical research has proven difficult, as oxytocin does not readily cross the blood-brain barrier. Methylenedioxymethamphetamine is an indirect inducer of oxytocin release and thus may explain MDMA's effects on PTSD. Because of this unique property, Nardou et al. [22]decided to use MDMA to investigate oxytocin's role in critical periods. Critical periods are developmental periods during which the nervous system is expressly sensitive to specific environmental stimuli required for proper organization and learning [22]. Closure of critical periods limits the ability of the brain to adapteven when optimal conditions are restored. This could explain the high treatment non-response rates seen in PTSD. A single dose of MDMA was enough for adult mice to reopen the critical period for social reward learning via oxytocin-mediated plasticity in the nucleus accumbens. In contrast, isolated adult mice administered MDMA did not exhibit the reopening of their critical period. These data suggest that it is the combination of the MDMA-mediated effects of oxytocin along with a therapeutic environment that is the key to the therapeutic efficacy of MDMA-AT [22].

The treatment approach of MDMA-AT is ultimately an interaction between the drug's effects, the therapeutic setting, and the mindset of the participant and therapists. Methylenedioxymethamphetamine catalyzes therapeutic processing, promoting participants emotional engagement with decreased anxiety or other painful emotions at the time of revisiting traumatic experiences.Frequently, participants can experience and express fear, anger, grief, empathy, love, and gratitude as part of the therapeutic process in a manner with less judgment and greater acceptance. Also, MDMA can facilitate a heightened state of empathic therapeutic rapport that promotes the therapeutic process and develops a corrective experience of secure attachment [8].

The primary focus of MDMA-AT is to diminish symptoms related to unresolved trauma and improve the overall wellbeing and quality of life of the participant. Processing traumatic experiences is an essential part of MDMA-AT, though sessions may explore other psychological, interpersonal, and spiritual aspects of life. Empathy and self-exploration facilitate the healing of participants since it allows each participant's experience to unfold spontaneously. However, if a patient encounters emotional or somatic blocks that stymie this process, the therapist can provide more active guidance to help them work through past events and arrive at a new emotional resolution. Therapists help explore and validate new perspectives about other life experiences and authentically join participants in embracing joyful moments [26].

The MDMA-AT consists of a preparatory stage with screening and introductory sessions, followed by one to three experimental sessions interspersed with integrative sessions and follow-up evaluations. The screening and preparatory stage is when the therapist gathers the participants history and builds therapeutic rapport [27]. During the experimental stage, an 80 mg to 120 mg capsule of MDMA is orally administered. The participant is monitored through medical devices, listens to a predetermined setlist of emotionally provocative music, engages in mindful use of touch as appropriate, and engages in conversation with the therapist. Peak effects typically occur 70 to 90 minutes after drug administration and persist for one to three hours [28]. After two hours, a supplemental half dose of 40 mg to 60 mg is optionally provided. Therapists work with the participant for six to eight hours or until the drug's psychedelic effects have worn off. As the MDMA subsides, therapists may talk with the participant more extensively about what they experienced during the session [27].

During the MDMA experience, participants acquire heightened clarity about the traumatic event and can view it as something of the past. Participants have disclosed that through MDMA-AT, processing painful emotions successfully changed their relationship with their emotions and trauma narrative. Methylenedioxymethamphetamine grants access to meaningful spiritual experiences and other transpersonal experiences. Although unexplainable, many participants feel a sense of healing on a non-verbal level, which is deemed essential to the therapeutic process [29].

The terms 'ecstasy' and 'MDMA' are commonly confused. Substances classified as ecstasy may contain MDMA, but frequently contain other unknown and/or dangerous components. In controlled doses, pure MDMA has been proven safe for human consumption. Furthermore, critics highlight studies that illustrate the dangers of MDMA as a recreational drug, which is misleading since there are sufficient differences between ecstasy and MDMA that would confound a generalized comparison between the two [30].

While it is well established in rat studies that injected doses of MDMA are neurotoxic, these doses are well above those provided for therapy. Likewise, human trial participants have failed to show evidence of neurotoxic effects of any minuscule amount. Additionally, while some studies have shown an inconsistent pattern of mild memory deficits, these have been blended by substantial polysubstance use among MDMA users [11]. In a study of 87 deaths where MDMA was present, only six involved the drug alone, and the two most common causes of death were heatstroke and anti-diuretic hormone (ADH)-mediated hyponatremia, both likely exacerbated by recreational settings with increased physical exertion [31]. Of the approximately 200 participants in recent clinical trials of MDMA-AT for PTSD, none have suffered serious adverse events related to hyponatremia or hypothermia, which are the most common causes of morbidity and mortality in recreational settings [20].

Yet, MDMA is to some degree unpredictable, producing diverse responses in people. Methylenedioxymethamphetamine causes neurotransmitter activation across the main neural pathways, including serotonin and dopamine, and norepinephrine, resulting in substantial fluctuations in mood and emotions depending on the memories that emerge for the participant. When the effects of MDMA taper, there is a neurochemical depletion stage due to serotonin exhaustion. Neurochemical depletion can invoke temporary anhedonia, lethargy, anger, depression, irritability, anxiety, increase in daily stress, altered pain thresholds, changes in sleep, and nightmares, especially in female participants [32]. However, these pitfalls are duly addressed in MDMA-AT by having the participant stay overnight at the site of administration with a trained same-sex overnight attendant, and the first integration session is scheduled for the morning after with the second integration session often within a week after the MDMA session to allow for closer monitoring and follow-up care.

Methylenedioxymethamphetamine has a risk of dependence and harm compared to other recreational substances [33,34] and is often described as a "self-limiting" drug due to its usage patterns often being relatively infrequent [35]. Because MDMA is a self-limiting drug, dependency rates may be as low as 1% of users [24].

More here:

Methylenedioxymethamphetamine (MDMA)-Assisted Therapy in Hawaii: A Brief Review - Cureus

Riley Cotes journey to enlightenment began in earnest when a hulking man punched him in the face. Cote, now 40 and retired from professional hockey, remembers the moment with a dark laugh. Hed gotten into this particular bust-up one night during the 2009 season with one of the NHLs most vicious fighters, and took the worst of it, waking the next day with his left eye blackened shut.

What, he asked himself, am I doing?

He drove to the Philadelphia Flyers training facility and got into the shower. Feeling congested, he reached for a tissue. He didnt realize hed suffered a cracked sinus, so what happened next was physics. When he blew his nose, the air rather than coming out of his nostrils inflated his face. The pressure surged instantly behind his good eye and closed it tight.

Team trainer Derek Settlemyre heard Cote scream. His whole face had swollen up, Settlemyre recalls. We tell them, if they think they have a fracture, Dont blow your nose and he did.

After eight years in pro hockey (four in the NHL, four hopping around its minor-league teams), Cote felt his retirement bearing down. As an NHL enforcer a player whose main role is to get into fights hed taken countless hits on the ice. Off it, he self-medicated with booze and drugs. Hed brutalized his body inside and out by the tender age of 28. I damaged my brain, Cote says. Punching it and dehydrating it and partying my ass off.

Today, Cote is a new man, with a mane of long brown hair, a yoga-trimmed physique, and an aura of ease in his own skin. It is a transformation he credits largely to psychedelic drugs. Since retiring, Cote has emerged as one of the sports worlds most vocal advocates for what he calls plant medicines from cannabis, itself a light psychedelic, to weightier hallucinogens including DMT and magic mushrooms to treat post-concussion symptoms (think headaches, insomnia, depression, and possibly, the degenerative brain condition known as chronic traumatic encephalopathy, or CTE). In 2017, Cote co-founded Athletes for Care, a group that promotes research into the physical and emotional health issues athletes face and novel paths for treatment. He regularly speaks at conferences on the benefits of psychedelics. And, perhaps most important, he reaches out to players who are known to be struggling post-career, even arranging magic-mushroom ceremonies where they can safely experiment with the drug.

Cote understands the hesitation surrounding these substances. While psychedelics fill him with love, gratitude, and a connection to a higher energy source, they are technically illegal throughout most of the U.S. Beyond that, the experience, whether good or bad, can be intense. Certain users experience not just so-called bad trips, but also psychotic breaks from reality. Cote says talking to a first-timer about using psychedelics is basically like asking them: Do you want to see God? Are you sure? The ask is so big, the answer is often no.

Cote was worried when he walked into the lunch area at the Good Hope House Retreat Center in Jamaica one day in April, got a green smoothie, and waited for one of the biggest weekends of his life to unfold.An ESPN crew was coming to film a magic-mushroom ceremony hed helped organize for a group of retired athletes, including former players from the NHL and NFL. All had pledged to eat breakthrough doses enough, that is, to induce a mystical state of mushrooms containing psilocybin, which is legal in Jamaica.

The opportunity to showcase mushrooms as medicine to a mainstream television audience was a precious thing, but as Cote sat with some early arrivals, he couldnt enjoy it. He kept mulling a more practical concern: Would everyone actually show up?Two people in particular Steve Downie, an ex-Flyers teammate, and Justin Renfrow, a former NFL lineman were due any minute. Or not.In the past 11 years, Cote has invited a lot of people to venture down the magic-mushroom path, and most who say yes subsequently run into excuses not to follow through. In fact, second-thought declinations are so common in Cotes experience that he doesnt judge anyone for them.

Its scary, right? Cote says. Theres a fear associated with it. Theres a lot of unknowns, like, Where am I going? What am I getting myself into? It all sounds grand when youre sitting on your couch, you know, and talking about it via text or phone. But when youve actually got to be committed to something and actually do it, its another story.

There is some irony here. Since Cote began proselytizing, scientific research bolstering the case for psychedelics has accumulated.Johns Hopkins University in Baltimore established a center for psychedelic and consciousness research in 2019, and has published 50 peer-reviewed papers that indicate psychedelics help treat depression, promote psychological insight, alleviate anxiety in cancer patients, break smoking addiction, and improve overall life satisfaction.In 2018, the Food and Drug Administration, which had for decades held the line against psychedelics, granted breakthrough therapy status to psilocybin use for severe depression, an act designed to accelerate the drug development and review process. MDMA, better known as the club drug Ecstasy, also won breakthrough status, and could receive full approval to treat post-traumatic stress disorder next year.

At the same time, the discovery of CTE has created a crisis across all contact sports, linked to myriad symptoms, including memory loss, confusion, impaired judgment, impulse-control problems, aggression, depression, anxiety, suicidality, and progressive dementia. The condition can only be confirmed after death, but the list of the dead with CTE is long, including four soccer players, more than 300 NFL players, and at least a dozen high-profile hockey players: Stan Mikita, Bob Probert, Derek Boogaard, Jeff Parker, Wade Belak, Larry Zeidel, Reggie Fleming, Rick Martin, Steve Montador, Zarley Zalapski, Todd Ewen, and Dan Maloney.

Dr. Julie Holland, a practicing New York psychiatrist and psychedelics expert, says the application of psychedelics to sports medicine is new, but makes sense based on the current scientific literature.We know that many psychedelics have really potent anti-inflammatory effects, says Holland, who is also a longtime medical adviser for the Multidisciplinary Association for Psychedelic Studies, or MAPS. The other thing is, theyre being explored for treating neurodegenerative disorders, including chronic traumatic encephalopathy. These athletes that get multiple blows to the head [represent] a case where you really need not only anti-inflammatory effects, but this purported neuroplasticity that comes with psychedelics.

Cote during his playing days with the Flyers, in December 2008.

Jeff Vinnick/Getty Images

Studies largely involving rodents suggest that psychedelics reduce neuroinflammation, a key component of both Alzheimers disease and CTE; produce healing from brain injury; and possibly even prompt neurogenesis, or the birth of new neurons. They have also been shown to increase the density of dendritic spines small protrusions found on nerve cells in turn spurring the growth of neuronal connections that can be lost in cases of chronic stress or depression. Some human experiments suggest that psychedelics reduce activity in the default mode network (DMN), a web of connected brain regions responsible for self-awareness, social thinking, and thoughts about the past and future. The mystic feelings that users like Cote report such as the loss of a sense of self, and the ability to set aside the past or think afresh about the future are thought to arise from this reset of the DMN.

Cote started Athletes for Care with such edgier therapies in mind initially just cannabis, and then psychedelics as the encouraging science grew. And while he might not be the groups most famous retiree (members include former NFL star running backs Tiki Barber and Chris Johnson, and former UFC champ Bas Rutten), he looms as perhaps its most pivotal figure.He is a partner in a hemp-derived CBD recovery product line called BodyChek Wellness and an adviser to Wake, a multipronged company that is collaborating with Baltimores Lieber Institute for Brain Medicine to use genetics research for the development of psilocybin-based treatments tailored to individual patients a potentially dramatic step toward eliminating bad or ineffective trips. At AFCs most recent board meeting, in March, Cote led a deep discussion around psychedelics, presenting the current body of research and urging the group to strengthen its commitment to incorporate psychedelics into its work.

Riley has been a leader in this space for a long, long time, says Marvin Washington, a former NFL defensive lineman, who won a Super Bowl with the Denver Broncos in the late Nineties and became a pro-cannabis activist in retirement. He was the first athlete I ever heard talking about psychedelics.

The pair were at a cannabis-related conference several years ago when Cote waxed on about the mental-health benefits associated with taking both small and reality-shifting doses of psilocybin. Washington was surprised and started checking out Cotes claims. He was right, he says. He deserves a lot of credit for being in early on all plant medicines.

In his early days playing hockey, as a teenager, Cote discovered that a bong hit in the morning helped him maintain his focus through a long workout. Later, after his skill set proved unequal to becoming a scorer, he remodeled himself as an enforcer, or goon, a hockey player whose main job is to punish opponents for any penalties the referee missed. Undersized for the role at six feet one and a playing weight of 220 pounds, Cote brawled his way into the league, racking up more than 200 professional hockey fights. He increased his cannabis use then, smoking weed on a regular basis and finding that it helped him sleep, recover, and manage the anxiety and trauma of bare-knuckle fighting. Magic mushrooms, when he took them, were more of a party drug, a way to enhance the lights and music at a concert.

Cotes delivery while retelling his own journey is understated. But his presence speaks loudly. His face is rugged, with a nose that moves this way and that, like a switchback trail, to suggest his past. His hands are gnarled. By the time he retired, he had accumulated a litany of injuries: torn ligaments in both knees, a dislocated finger, broken ankle, separated shoulder, three broken noses, and at least four diagnosed concussions. Cote knew back then that he needed to heal up, and intuitively wanted to build on his past experiences with cannabis and psychedelics. So he began reading deeply, discovering that cannabis and psychedelics bore rich histories as natural medicines.

Cote also did as he learned, securing five grams of mushrooms, or whats known as a heroic dose, for his first ceremonial trip. He set an intention to treat the experience as important, even sacred, and arranged his house for the occasion, putting on some ambient music, turning off the electric lights, and setting out a couple of candles. Still, nothing hed read or done truly prepared him.

Acknowledging the experience was ineffable, indescribable, Cote reaches for language, doing his best. It was bliss, he says, and delivered an incredible sense of knowing. Eventually, he lands on something particularly hard to explain to potential initiates: I felt my ego dissolve.

This specific result suggests an additional, perhaps unexpected use for psychedelics that might be uniquely valuable to athletes: For a lot of athletes, and these could be amateurs or professionals, says Cote, everything you do from a very young age is geared toward achieving success in that sport. It becomes your identity.

In Cotes case, the identity hed spent so long forging for himself with blood and terror, jacking up his emotions to punch people he didnt hate and often admired, lifted off his shoulders during that first trip like he was shedding his skin with no more importance or difficulty than he would remove a coat. I felt free, he says.

What Cote experienced was actually a typical effect reported by users, and left him feeling like he could set hockey aside to do whatever I wanted. He spent the next several years banging away at his new cause, eventually finding a high-profile supporter in Lindy Snider, former vice president for sales with the Flyers and daughter of the teams beloved late owner, Ed Snider. Cote called her and asked for a meeting, Snider says, and came in quoting the science as it stood at the time. She was impressed.

Hes by far one of the leading voices in sports around these issues, Snider says. And the athletes hes brought into Athletes for Care are all very similar. Theyve run the gauntlet in the physical realm like nobody else. And, you know, theres associated deeper meaning with looking at all of these alternative ways to ameliorate your health, your mental wellness, your state of being, and Riley is always looking at a higher state of being. Whatever those tools look like that help us get there is what his mission is.

Snider was open to cannabis. She ran a skin-care company that made products for cancer patients and knew of the drugs potential as medicine. She also helped get her father some cannabis for relief as he lay dying in 2016. But the evolution of Cotes story has educated her, helping her see that psychedelics, too, bear importance not just in the treatment of brain injury and CTE, but also to help former athletes lead productive, enjoyable post-career lives.

Within the Flyers family, Snider says, she had too often witnessed players suffer a failure to launch after retirement. She sadly recalls one player she declines to name who felt so lost after hockey he succumbed to alcoholism and died of liver failure. I felt we failed him, Snider says. And it was this notion that there were things that could have helped him, and he didnt have access to this stuff.

It is easy to imagine that athletes would prove particularly challenging to invite on this kind of a trip, the hippie-dippy side of the experience too off-putting for people so deeply task-oriented and rooted in their physical bodies. But Cote says they are no more resistant on that front than anyone else. The spiritual side of this is always more difficult to address, in general, he explains. Thats the world were living in. Still, he routinely pitches the physical benefits as his way in, and finds retired sports stars uniquely receptive. Elite athletes are always looking for the next best thing and how to optimize their performance, he says. The average Joe in the Western world doesnt give a shit about optimization. They dont even know what that word means. They dont understand theres higher levels of performance. So they just think that wherever theyre at, thats just the hand that God dealt them.

Washington, the retired NFL player and cannabis activist, tried psilocybin after listening to Cote talk about it. He now describes it as the next moonshot beyond cannabis legalization. He also credits the drug with helping him find a sense of himself far greater than football.

From left: Justin Renfrow; Daniel Carcillo.

Brett Carlsen/Getty Images; Dale MacMillan/Getty Images

One of Cotes biggest success stories might be retired NHL star and two-time Stanley Cup champion Daniel Carcillo. Nine years of pro hockey had left Carcillo suffering from light sensitivity, headaches, insomnia, anxiety, depression, slurred speech, suicidal ideation, and more. He was public about it, speaking out toward the end of his career, in 2015, about his concussion history, hockeys disregard for players health, and his own failed attempts to find some solution in modern medicine.

After Carcillo retired, Cote says he reached out to him for more than a year about trying cannabis and psilocybin. No luck. It was only when Carcillo reached his darkest point, and started thinking about how he might get a rope around the big wood beams in his ceiling, that desperation, as he describes it, drove him to meet with Cote and learn more.

Cote made arrangements for Carcillo to attend a mushroom ceremony in Colorado, a decriminalized state. That first experience, says Carcillo, included the spiritual sensations that psilocybin is known to induce and something more. A few days later, Carcillo realized that he could start crossing off symptoms: light sensitivity, slurred speech, his suicidal feelings giving way to hope.

Carcillo came home from Colorado and started taking microdoses of psilocybin and occasional breakthrough amounts. He began to enjoy that sense of rebirth that Cote, Washington, and so many others describe. Soon, he was in the news, crediting Cote with saving my life.

In May 2020, Carcillo founded Wesana, a startup trying to develop its own psilocybin treatment and earn FDA approval. He is, perhaps out of necessity, more buttoned up than Cote. In the space that Rileys in, Carcillo says, you can talk more freely about what this does for the spirit. For me, when you go down the FDA path, they dont care about that. Like, they dont want to hear that. In fact, Carcillo says, he no longer uses words like psychedelic at all in his work. I say its a compound found in nature. Most all of our medicines are a single extract from a plant found in nature, or fungi. Thats the reality.

The effects of that compound on his psyche have been profound: This medicine, the biggest stuff that it does there is always that feeling that you are enough. And one of the things that Im really interested in is showing people not only can we recover and be a beacon of hope, but you can break out of what you think you need to stay in and do new things.

In science, a story like Carcillos might be dismissed as only an anecdote. But his recovery is seemingly validated through brain scans. The images Carcillo received from neurologists before he tried psilocybin showed a brain suffering from decreased connectivity. Big pockets of red signified areas of the brain that werent communicating. His slurred speech was a byproduct the signals from one part of his brain having to travel around these red areas, a slowdown that affected his enunciation. According to Mark Wingertzahn, Wesanas chief scientific officer, those initial scans qualified Carcillo for a diagnosis of moderate traumatic brain injury.

After hed come home, however, and continued his own ad hoc psilocybin therapy for about six months, Carcillo got another set of scans. What [doctors] were able to see is, those areas of red may have gone down to blue, or in some cases white, which is consistent with that normal brain pattern, says Wingertzahn, meaning Carcillos brain was suddenly showing greater connectivity and function. What interested Wingertzahn most, though, was what happened to Carcillos symptoms, which the former hockey player says have been reduced, on a scale from one to 10, to a number not even on the menu: Zero.

The reduction of symptoms is what the FDA does care about, says Wingertzahn, who spent 25 years at pharma companies, including Pfizer, getting new drugs to market. He thinks psilocybin-based medicines will be approved in three to five years.

Human trials have shown significant success in the areas of depression, death anxiety, smoking cessation, positive personality changes, and more. Not only that, a pair of studies have suggested that psilocybin treats depression at rates at least equal to, and by some measures much better than, todays available meds along with a whole different class of side effects.

Listed side effects for drugs like Lexapro include nausea, sleepiness, weakness, dizziness, anxiety, trouble sleeping, delayed ejaculation, painful erections, difficulty with orgasms, sweating, shaking, reduced appetite, and dry mouth. Noted side effects of psychedelics, aside from that small number who experience a psychotic break, and the occasional bout of nausea or insomnia, include joy, calm, increased awareness, self-confidence, and a sometimes obnoxious desire to tell everybody you meet about your awesome fucking experience.

Carcillo, during a Zoom call, smiles and asks: Are you interested in something like that? Its the same question, essentially, that Cote has been asking for years the seemingly obvious answer left hanging in the air.

In the days before Cote left for Jamaica, a few of the people scheduled to come canceled, including the former offensive lineman Justin Renfrow.

I was trying to make a lot of excuses, says Renfrow, who has a lot in common with Cote, having made it to the pros as an undrafted free agent and carved out a difficult career bouncing between NFL squads and the Canadian Football League. I played football injured since my sophomore year of high school, he says, explaining that the grind slowly took its toll.

The journeyman tackle told Cote he wasnt going to make it to the retreat, then secretly asked the universe for a sign. The night before the scheduled trip, he got one: a text message from Wake, the psilocybin research company, delivered at 11:11, a time his family had always invested with mystical meaning. He felt it was his deceased grandmother encouraging him to go.

Cotes old teammate Downie, meanwhile, said yes to Jamaica, and then complained that he did not have a valid passport, so he would not be able to travel. Cote talked him through that episode. Still, he couldnt be sure either man would actually get on the plane.

Cote, left, with his former teammate Steve Downie at a magic-mushroom retreat in Jamaica.

Courtesy of Riley Cote

Khara Cartagena, vice president of business development with the Spore Group, one of many startups across the country prepping for the Wild West of psychedelic legalization, was sitting with Cote as he waited to see if Downie and Renfrow would arrive.

I could see he was distracted, says Cartagena. He was clear that it meant a lot to him to help these people.

But eventually, after an anxious several minutes, Cote lit up at the appearance of Renfrow. And again when he saw a figure he thought he could recognize at a distance the height just about right, the shape in silhouette familiar, until finally the man got close enough that Cote could see the trademark missing tooth in his smile: Steve Downie, Cotes old teammate.

It was all just really beautiful, says Cote. I shouldnt be surprised. Plant medicine delivers, you know. But it was really maybe even better than I expected.

Both men were moved by their magic-mushroom experiences. Downie teared up after his first dose, and spoke during a subsequent integration session held to help people process the intense experience about how his father had died in a car accident while taking him to hockey practice. The ceremony had given Downie an incredible sense of relief.

Perhaps the most powerful moment, though, came when Cote looked at Renfrow deep into the ceremony. Renfrow had spoken to Cote beforehand about his personal uncertainty: Should he continue playing in the CFL, or pursue his passion for the YouTube food show hes created, Whats Cooking, and try to grow it? A hulking man at six feet five and 320 pounds, Renfrow was wearing a T-shirt with his initials on it in a circle. Then, methodically, he took it off. Cote felt he was watching a peace settle over the big man as it had once settled over him: a shedding of the skin and the birth of someone new.

Renfrow, in a tearful interview after the trip, confirms Cotes observation: It felt like my grandma was taking that weight, the pain and stress of playing through all those injuries, he says. I didnt need to keep going through that. He emerged knowing that he could leave football behind.

Cote, for his part, says that bringing people like Renfrow this kind of existential healing is his calling now, and he marvels at the dichotomy between the old Riley and the new. In Flyers-related photos, his eyes are often filled with terror, bestial anger, and sadness. Now, he says, here I am talking about a flower.

He laughs.

Its been an incredible journey, he says, and really, I just want to take as many people with me as possible.

Read this article:

How an NHL Enforcer Broke His Body and Turned to Psychedelics to Heal His Brain - Rolling Stone

Psychedelic drugs have the potential to become an effective treatment for crippling mental health conditions such as depression. Here are five of the top drug developers leading their particular niches in the emerging field of psychedelic medicines.

For decades, research into the therapeutic properties of psychedelic drugs was almost snuffed out as recreational use of the substances was banned in the U.S. and Europe. In recent years, however, an emerging industry is now coalescing around the potential of hallucinogenic compounds such as lysergic acid diethylamide (LSD), psilocybin and 3,4-methylenedioxymethamphetamine (MDMA) to treat mental health conditions such as depression and post-traumatic stress disorder (PTSD). The global market is expected to grow from around $5 billion in 2020 to more than $10 billion by 2027.

While there are already a number of approved approaches to treating depression, many only last a short time, cause side effects, and cant help all patients. Psychedelic drugs are increasingly seen as a potential long-lasting alternative for patients that are left behind by existing approaches.

One of the first psychedelic drugs to be approved in the U.S. for treating a mental health indication was a nasal spray form of the drug ketamine in 2019. Branded as Spravato and marketed by Janssen, the drug was greenlit for treatment-resistant depression. However, the drug also carries risks of adverse effects including high blood pressure, sedation and the potential of drug abuse.

The hunt is now on for psychedelic compounds that are capable of treating mental health disorders long-term with fewer side effects than current treatments. With the help of experts in the field, weve drawn up a list of five of the top psychedelics developers pushing the boundaries of this exciting field.

Founded: 2018

Headquarters: Berlin, Germany

Market cap: $522 million

Atai Life Sciences was set up in response to what the founders saw as a lack of innovation in the mental health treatment landscape, along with growing opportunities surrounding the development of psychedelic medicines and digital health technology.

The firm operates with many smaller companies under its umbrella. For example, Atai fully owns the psychedelics developers EmpathBio, Revixia and Viridia. The German firm also has stakes in other players including Compass Pathways, Recognify Life Sciences and Perception Neuroscience. By working as a wide decentralized network of companies, Atai aims to streamline internal processes like HR and accounting to allow the founders to spend more time on advancing their research.

The most advanced program in Atais pipeline is a form of ketamine that may cause fewer adverse side effects than approved forms of ketamine, and is less prone to abuse by patients. Developed by the firm Perception Neuroscience, the drug is currently in a phase 2a trial to treat treatment-resistant depression.

To finance its drug development and business operations, Atai Life Sciences raised around $362 million in venture capital funding between 2020 and 2021. In June 2021, the firm took the plunge with an IPO on the Nasdaq stock market and bagged an impressive $259 million in proceeds.

Founded: 2016

Headquarters: London, U.K.

Market cap: $422 million

Compass Pathways is developing a synthetic form of psilocybin, the main psychedelic compound in magic mushrooms. Its been suggested that this hallucinogenic drug can rewire the brain to treat depression long-term after just one or two doses. In Compass Pathways lead program, the drug is given during supervised therapy sessions, where patients are provided a pill containing psilocybin, an eye mask to help them focus and a specially designed music playlist.

According to a recent phase 2b trial, Compass Pathways lead psilocybin treatment significantly reduced depressive symptoms by three weeks after a single dose. Patients given the highest dose also had benefits lasting for up to 12 weeks.

Compass Pathways is following up the trial results in a phase 3 trial planned to launch this year. The company is also testing the drug in other mental health conditions including PTSD, and supporting investigator-initiated studies in conditions including bipolar disorder, anorexia and major depressive disorder.

To fund its drug development activities, Compass Pathways raised $80 million in a Series B round in 2020, and followed up just months later with a $146.6 million IPO on the Nasdaq stock market.

Founded: 2018

Headquarters: Dublin, Ireland

Market cap: $549 million

GH Research is researching the antidepressant potential of the drug 5-methoxy-N,N-dimethyltryptamine, or 5-MeO-DMT. This molecule occurs naturally in several species of plants and even a species of toad.

In GH Researchs lead program, 5-MeO-DMT is being tested as an inhaled treatment for treatment-resistant depression. According to results from a phase 1/2 clinical trial, seven out of eight patients given the treatment went into remission seven days after receiving the treatment. The company is now planning a phase 2b trial of the drug, and later this year GH Research expects to submit applications to several European countries to run the trial.

Additionally, the company is planning a phase 2a trial for the same drug in patients with bipolar II disorder and a current depressive episode. In preclinical programs, GH Research is also developing ways to deliver 5-MeO-DMT via an injectable and intranasal approach, which could benefit certain subpopulations of patients.

GH Research jumped on the psychedelics funding trend in April 2021 when it raised a Series B round of $125 million. In June 2021, the firm went public on the Nasdaq, bagging $160 million in an IPO to fund its clinical development activities.

Founded: 1986

Headquarters: California, U.S.

The Multidisciplinary Association for Psychedelic Studies (MAPS) is a non-profit organization that has the most advanced clinical program for any psychedelic compound. MAPS is running a phase 3 program testing the benefits of the drug MDMA, also known as ecstasy, in people suffering from PTSD.

Though MDMA often makes headlines as a recreational drug, the molecule combined with intensive therapy also has the potential to regulate emotional responses that can overwhelm patients with PTSD, allowing them to cope with traumatic memories. MDMA treatment combined with therapy outperformed the placebo at treating severe PTSD in a phase 3 trial run by MAPS last year. Results from a second phase 3 trial are expected by October 2022.

MAPS is also testing the benefits of MDMA therapy in several other mental health indications including eating disorders and social anxiety in autistic adults.

An honorable mention also goes to the Canadian firm Awakn Life Sciences. With an MDMA therapy in phase 2a testing for the treatment of alcohol addiction, Awakn has one of the most advanced MDMA programs amongst the for-profit players.

Founded: 2019

Headquarters: New York, U.S. and Toronto, Canada

Market cap: $300 million

MindMed was co-founded by the entrepreneur J.R. Rahn, who suffered from mental health problems and was interested in the Silicon Valley trend of improving focus by microdosing on psychedelic drugs.

The firm is testing the benefits of the hallucinogenic drug LSD with professional supervision to treat a range of mental health conditions including generalized anxiety disorder and attention deficit hyperactivity disorder (ADHD). Like psilocybin and DMT, LSD is believed to rewire the brain and provide long-lasting mental health benefits to patients.

According to recent phase 2 results, LSD met the goal of significantly improving anxiety symptoms. MindMed is soon launching a phase 2b trial of its lead candidate in generalized anxiety disorder, and is also running a phase 2a trial of the same drug in patients with ADHD.

MindMed was one of the first psychedelics developers to go public, listing on the Canadian stock exchange NEO in 2020. MindMed then went public on the Nasdaq in April 2021. In the last three years, MindMed has raised roughly $190 million to fund its business and drug development activities.

Cover image via Anastasiia Slynko.

Thanks to feedback from MAPS, MindMed, Atai Life Sciences and Tryp Pharma

22 June 2022: Updated to correct upcoming milestones for MAPS and the pipeline of Compass Pathways.

See the rest here:

The top psychedelic drug developers leading the market - Labiotech.eu

Filing would offer added protection to IP already submitted to USPTO

VANCOUVER, BC, June 22, 2022 /PRNewswire/ - Numinus Wellness Inc. ("Numinus" or the "Company") (TSX: NUMI) (OTCQX: NUMIF), a mental health care company advancing innovative treatments and safe, evidence-based psychedelic-assisted therapies, today announced that its subsidiary Numinus Bioscience Inc. ("Numinus Bioscience") has filed a patent application to the World Intellectual Property Organization (WIPO), an agency of the United Nations, for a rapid production process for Psilocybe and other fungi species containing psilocybin and other compounds.

A provisional patent application for the process was submitted to the United States Patent & Trademark Office (USPTO) on June 24, 2021. With this additional filing, international patent protection would extend to all WIPO member states that have signed the Patent Cooperation Treaty (PCT), including Australia, Germany, Netherlands and the United Kingdom, where psychedelic research is currently active.

"The WIPO is an important global forum that provides reassurance to the patent offices of member states. Numinus is confident that the robust evidence supporting the production process will further inform regulators as they consider policy changes to make psychedelic-assisted therapies and products more accessible," said Sharan Sidhu, VP, Scientific Research, Innovation & Laboratory Operations, Numinus. "We look forward to advancing current research and paving the way for eventual commercialization and mainstream access."

The purpose of the process is to significantly increase production of therapeutics for use in psychedelic-assisted therapy, while reducing product variability, increasing production efficiency and ultimately reducing commercialization costs. Since the initial filing, data-sets validating the process for additional fungi specifies have been completed, broadening its potential application and scope from psilocybin to other active compounds.

Story continues

"This application is part of Numinus' long-term IP strategic focus on scalable and sustainable production that advances research, development and delivery of innovative psychedelic-derived formulations in North America and beyond," said Payton Nyquvest, Founder and CEO, Numinus.

About Numinus

Numinus Wellness helps people to heal and be well through the development and delivery of innovative mental health care and access to safe, evidence-based psychedelic-assisted therapies. The Numinus model including psychedelic production, research and clinic care is at the forefront of a transformation aimed at healing rather than managing symptoms for depression, anxiety, trauma, pain and substance use. At Numinus, we are leading the integration of psychedelic-assisted therapies into mainstream clinical practice and building the foundation for a healthier society.

Learn more at numinus.comand follow us onLinkedIn,Facebook,Twitter, andInstagram.

Disclaimer

Neither Numinus Wellness Inc., nor any of its subsidiaries is a professional corporation licensed to practice health services. In jurisdictions where health services may only be provided by a corporation if that corporation holds a valid permit to do so, Numinus and its subsidiaries operate in a management services function to affiliated professional corporations, who provide health services to patients. Numinus and its subsidiaries do provide health services directly to patients in those jurisdictions where authorized to do so.

Forward-Looking Statements

Statements and other information contained in this press release about anticipated future events constitute forward-looking statements. Forward-looking statements are often, but not always, identified by the use of words such as "seek", "anticipate", "believe", "plan", "estimate", "expect" and "intend" and statements that an event "may", "will", "should", "could" or "might" occur or other similar expressions. Forward-looking statements are subject to risks and uncertainties and other factors that could cause actual results to differ materially from those contained in the forward-looking statements. Forward-looking statements are based on estimates and opinions of management at the date the statements are made. The Company does not undertake any obligation to update forward-looking statements even if circumstances or management's estimates or opinions should change except as required by applicable laws. Investors should not place undue reliance on forward-looking statements.

Cision

View original content:https://www.prnewswire.com/news-releases/numinus-applies-for-international-patent-filing-of-psychedelics-production-process-301572540.html

SOURCE Numinus Wellness Inc.

More here:

Numinus Applies for International Patent Filing of Psychedelics Production Process - Yahoo Finance

DENVER Two ballot initiatives dealing with the decriminalization and regulation of psychedelics in Colorado might appear on this years November ballot.

Initiative 61 and Initiative 58 are still in the signature gathering phase and petitioners have until Aug. 8 to turn in 124,632 valid signatures to make the ballot.

Nicole Forester, a co-proponent of Decriminalize Colorados Initiative 61 officially known as Legal Possession and Use of Entheogenic Plants and Fungi says the measure would decriminalize the personal use of certain entheogenic plants and fungi (including psilocybin, psilocin, ibogaine, mescaline (not including peyote), and dimethyltryptamine) for adults age 21 and older.

So, the initiative that we're proposing would make the facilitation, possession, (and) use no longer a crime, Forester told Denver7. People are using these medicines; we have data that it's safe, that there's not a public health and safety risk in those cities that have decriminalized (them) so far. We know that safe use is happening outside of regulated frameworks.

Melanie Rose Rodgers, the other co-proponent of Initiative 61, told Denver7 the measure does not allow for the sale of these entheogens, only for their cultivation and sharing for personal use.

But despite these assurances, not everyone is on board.

Jeff Hunt, the director of the Centennial Institute a policy institute out of Colorado Christian University said hes concerned about how far these decriminalization efforts will go.

Denver has already decriminalized psilocybin and no one would be saying that we're doing very well in the City of Denver with our drug issues, Hunt said. And so, I'm concerned that this will take a problem that we're having in the City of Denver with the decriminalization of drugs to the entire state. I think the people of Colorado need to look at this and ask ourselves, is this really going to make our state a better place?

Initiative 61 isnt the only one advocates are looking to get on the November ballot.

Initiative 58 officially known as the Natural Medicine Health Act of 2022 would create a state-regulated access model to make it legal for people to receive natural medicine services at licensed healing centers and approved health care locations, like palliative care. It would also remove criminal penalties for the use of these natural medicines, according to co-proponent of Initiative 58, Kevin Matthews.

For those whove tried psilocybin as an alternative to prescribed medications, however, legalization creates skepticism of what pharmaceutical giants will do once these entheogens are part of the health care conversation.

I think everyone has to thread very carefully with legalization, said Alan Floyd, a cancer patient who uses psilocybin under Right-to-Try a federal law passed under the Trump administration that allows patients with life-threatening diseases or conditions to access unapproved treatments if all other approved treatments have been tried. The last thing I would want to see on Earth is for the pharmaceutical companies to have a stranglehold on this medicine; I feel that that is wrong.

It's the potential cost related to these treatments that Veronica Lightening Horse Perez hopes Initiative 58 will address in order to make natural medicine more accessible to lower-income Coloradans and those seeking other forms of care outside a traditional health care setting.

Three-thousand dollars is a lot of money for most people, Perez, a co-proponent of Intiative 58, said of the hypothetical cost of going to a healing center, where these natural medicines would be administered. So, we did look at that (the potential high costs) and write into the measure that we need to be really careful with this (costs). We want to have access programs; we want to make sure that these prices aren't getting so out of hand.

Read more from the original source:

Two psychedelic-related initiatives may be on the 2022 Colorado ballot - Denver 7 Colorado News

TORONTO--(BUSINESS WIRE)--Cybin Inc. (NEO:CYBN) (NYSE American:CYBN) (Cybin or the Company), a biopharmaceutical company focused on progressing Psychedelics to TherapeuticsTM, today reported audited financial results for its fiscal year ended March 31, 2022 and recent business highlights. The Company also reiterated its anticipated pipeline and strategic milestones for the remainder of 2022.

Cybin made important progress across the board in recent months, accelerating both our pipeline of proprietary investigational psychedelic-based treatments and strategic partnership programs. Our successful preclinical work has set the foundation for a seamless transition to in-human trials, said Doug Drysdale, Chief Executive Officer of Cybin. Over a very short time horizon, we have evolved into a multi-program clinical-stage company, which marks the dedication of the Cybin team to developing improved treatment options for mental health conditions.

Recent Business and Pipeline Highlights:

Upcoming Pipeline and Strategic Milestones:

The Company expects to achieve the following milestones across its pipeline and partnership programs:

CYB003: Deuterated psilocybin analog for the potential treatment of MDD and AUD

CYB004: Deuterated DMT for the potential treatment of anxiety disorders

CYB005: Phenethylamine derivative for the potential treatment of neuroinflammation

Kernel Flow

We gain confidence every day in our ability to create a true paradigm shift in the way mental health conditions are understood and treated. By working to develop treatment options that can potentially offer improved efficacy, greater remission rates, and longer duration of effects, we have the potential to provide patients and providers with a new standard of care. We look forward to continued momentum and sharing meaningful data readouts later this year, Drysdale continued.

Fiscal Year 2022 Financial Highlights:

Our financial position remains strong. Despite the overall softness in the markets, we are pleased with our industry leadership position and remain confident that we are on the right path forward to progress psychedelics into therapeutics, concluded Drysdale.

Additional non-cash consideration in the amount of C$4,655.29 is being issued to the previous shareholders of Adelia Therapeutics Inc. in respect of the achievement of a previously announced milestone on April 1, 2022.

About Cybin

Cybin is a leading ethical biopharmaceutical company, working with a network of world-class partners and internationally recognized scientists, on a mission to create safe and effective therapeutics for patients to address a multitude of mental health issues. Headquartered in Canada and founded in 2019, Cybin is operational in Canada, the United States, the United Kingdom and Ireland. The Company is focused on progressing Psychedelics to Therapeutics by engineering proprietary drug discovery platforms, innovative drug delivery systems, novel formulation approaches and treatment regimens for mental health disorders.

Cautionary Notes and Forward-Looking Statements

Certain statements in this news release related to the Company are forward-looking statements and are prospective in nature. Forward-looking statements are not based on historical facts, but rather on current expectations and projections about future events and are therefore subject to risks and uncertainties which could cause actual results to differ materially from the future results expressed or implied by the forward-looking statements. These statements generally can be identified by the use of forward-looking words such as may, should, could, intend, estimate, plan, anticipate, expect, believe or continue, or the negative thereof or similar variations. Forward-looking statements in this news release include statements regarding sharing additional data later this year, the Companys CYB003 Phase 1/2a trial in mid-2022 and anticipated results, the potential closing of the Entheon acquisition, statements regarding the Companys Phase 1 DMT clinical study for CYB004 and anticipated results, the Companys plan to report interim safety and PK data from the Phase 1/2a study in Q4 CY2022, the Companys statements regarding its preclinical data for CYB005 and partnering opportunities, statements regarding the Phase 1 Flow feasibility study and expected results, statements regarding the EMBARK psychotherapy model and anticipated results and the Companys plans to engineer proprietary drug discovery platforms, innovative drug delivery systems, novel formulation approaches and treatment regimens for mental health conditions.

These forward-looking statements are based on reasonable assumptions and estimates of management of the Company at the time such statements were made. Actual future results may differ materially as forward-looking statements involve known and unknown risks, uncertainties, and other factors which may cause the actual results, performance, or achievements of the Company to materially differ from any future results, performance, or achievements expressed or implied by such forward-looking statements. Such factors, among other things, include: implications of the COVID-19 pandemic on the Company's operations; fluctuations in general macroeconomic conditions; fluctuations in securities markets; expectations regarding the size of the psychedelics market; the ability of the Company to successfully achieve its business objectives; plans for growth; political, social and environmental uncertainties; employee relations; the presence of laws and regulations that may impose restrictions in the markets where the Company operates; and the risk factors set out in the Company's management's discussion and analysis for the year ended March 31, 2022, and the Companys annual information form for the year ended March 31, 2022, which are available under the Company's profile on http://www.sedar.com and with the U.S. Securities and Exchange Commission on EDGAR at http://www.sec.gov. Although the forward- looking statements contained in this news release are based upon what management of the Company believes, or believed at the time, to be reasonable assumptions, the Company cannot assure shareholders that actual results will be consistent with such forward-looking statements, as there may be other factors that cause results not to be as anticipated, estimated or intended. Readers should not place undue reliance on the forward-looking statements and information contained in this news release. The Company assumes no obligation to update the forward- looking statements of beliefs, opinions, projections, or other factors, should they change, except as required by law.

Cybin makes no medical, treatment or health benefit claims about Cybins proposed products. The U.S. Food and Drug Administration, Health Canada or other similar regulatory authorities have not evaluated claims regarding psilocybin, psychedelic tryptamine, tryptamine derivatives or other psychedelic compounds. The efficacy of such products has not been confirmed by approved research. There is no assurance that the use of psilocybin, psychedelic tryptamine, tryptamine derivatives or other psychedelic compounds can diagnose, treat, cure or prevent any disease or condition. Rigorous scientific research and clinical trials are needed. Cybin has not conducted clinical trials for the use of its proposed products. Any references to quality, consistency, efficacy and safety of potential products do not imply that Cybin verified such in clinical trials or that Cybin will complete such trials. If Cybin cannot obtain the approvals or research necessary to commercialize its business, it may have a material adverse effect on Cybins performance and operations.

Neither the Neo Exchange Inc. nor the NYSE American LLC stock exchange have approved or disapproved the contents of this news release and are not responsible for the adequacy and accuracy of the contents herein.

Read more:

Cybin Inc. Reports Fiscal Year 2022 Financial Results and Recent Business Highlights - Business Wire

Dr. Zinia Thomas at Radiance Wellness, St. Louis MO Dr. Zinia Thomas is a psychiatrist whose interest in utilizing the power of psychedelics to promote mental wellness and recovery in her patients with treatment-resistant depression and substance use disorder was peaked long before she began to utilize IV Ketamine as a therapeutic in her own clinic. Dr. Thomas shares her holistic approach and examples of whats gotten amazing results for her patients.

Bob Parsons is an American entrepreneur and a Marine Corps veteran who suffered all his life from PTSD incurred while serving in Viet Nam. It wasnt until he read HOW TO CHANGE YOUR MIND by Michael Pollan, that he became inspired by the potential in psychedelics, in conjunction with more mainstream counseling practices, to alleviate suffering from trauma commonly associated with military service. The message continues to be plain and simple, and heard now from voices with no reason to embellish on their beliefs: psychedelics help heal trauma and can save lives.

In May of 2022, NUMINUS WELLNESS sponsored the first in a series of immersive healing sound events entitled MUSIC AS MEDICINE. Olive Kimoto, East Forest, Superposition and Jon Hopkins each shared the stage to engage an audience, present with the intention to heal, with waves of lushly composed ambient and electronic sounds, delivered through high end audio and augmented by evocative visual projections. Numinus CEO Payton Nyquvest and Justin Boreta of Superposition spoke with us about the event, which gloriously exceeded expectations.

#Psychedelics #Numinus #psychiatry

source

More here:

SPOTLIGHT IN FOCUS - The Rise of Psychedelic Therapy - Psychedelic Spotlight

Although I stopped training, I never stopped being a martial artist. In 2018 Travis Barker connected me with my sensei in Los Angeles who is a world-champion kickboxer named Majid Raees. He is a marvel. Hes almost like a life coach and a martial arts sensei. More recently, I connected with my sensei in Chicago who Ive been training with consistently for the past two years.

Through training with my sensei in Chicago, Chandler, I got locked back into the principles of martial arts. Violence is something we train to be able to unleash, but the foundation is mental discipline. As Ive been growing its become one of my most important pursuits.

Sobriety

Stopping drinking has been one of the most pivotal pieces of my present reality. I stopped drinking, stopped smoking cigarettes and taking drugs. Ive been implementing discipline in my life in a much more intentional and critical way than ever before. I feel like Im living an entirely different experience. Ive cut out so many things, including in my sex life everything.

I still have a lot of ground to cover in my actual diet. I did Ramadan. That was my first experience with fasting. That shit was hard as fuck. I was far from perfect but I did gain insight into the power of self. I felt like every time I was on the brink and wanted to stop at Popeyes but pushed through, I feel like I gained power. Right now Im trying to put on weight so Im eating a lot. The balance Im trying to figure out is how to do that while eating healthily.

Psychedelics

I dont use psychedelics right now but microdosing has been incredibly beneficial and valuable for me. Mushrooms in general are something that has been in my life for a decade now. They have been integral in different creative periods. In more recent times I really dove into microdosing.

When I was in Ghana this past December and January I was newly sober I went sober August last year, and Id also recently started microdosing. I was packing my things and I decided not to take my antidepressants with me. Since I was 15 Ive tried maybe 10-15 different antidepressants. Ive had only one of those medicines work and even that was very short-lived.

Most recently, during the process of changing my dosage there was a point in time where I didnt take it for a few days. I found myself driving through the south side of Chicago and I realised Oh shit, Im suicidal. I talked to my psychiatrist and realised that I wasnt suicidal when I started taking the medication! It was having an adverse effect, creating a chemical reliance. So I decided to go cold turkey even though youre not supposed to, then I really leaned into the microdosing and I think we know what happened next, haha.

Meditation

At this point, more so than microdosing or anything like that, meditation is my primary form of self-care and wellness. If I dont meditate for a day or two, by the end of those couple of days I find myself being aggy, anxious and getting depressed. Meditation is intertwined with martial arts training. Many of the meditations I study come from the same part of the world as martial arts. Ive been meditating since I was 16 but more recently I started studying more techniques like Transcendental Meditation, and I went on a silent meditation retreat.

Original post:

Rapper Vic Mensa has a more badass fitness routine than you thanks to martial arts, psychedelics and meditation - British GQ

This article was originally published on Psychedelic Spotlight and appears here with permission.

Mystics and psychonauts describe ego death as a form of transcendence for stimulating insights and personal growth, but how does it work, and is it actually good for you?

Imagine you wake up in your body but you have no idea who you are. Everything around you feels new. You cant remember your name or any biographical information, and you are seeing the world without any bias or historical context. In the dimness of your mind you can remember that you are human, and you are standing on a planet spinning in space, but beyond that you are clueless. You have just entered ego death.

Ego death,or ego dissolution, is a term used in psychedelic and mystical communities to describe a temporary state ofautobiographical amnesia, a psychological condition where you are fully awake and functional, yet cannot remember any information about yourself, even your name or your gender. Ego death is often described as feeling very light and pleasant, as if the weight of the biographical self had been lifted from the body. Alternately, depending on context, ego death can be extremely disorienting and terrifying.

Imagine walking into a room and instantly forgetting what you walked in for, and you stand blankly waiting for some piece of information to pop into your mind and solve the puzzle. But then that moment stretches on for minutes, and you still have no clue how you got there, or what you were doing. If you find yourself in a state of temporary amnesia, you may have also forgotten how you came to be there, or how long it might last. Without knowing answers to any of these questions, the experience can become very frightening.

Some people experiencing ego death on psychedelics for the first time may believe that the state will last forever, and they will never return to their old life. This realization is often met with horror and panic, and is one of the primary causes of bad trips and freak outs. Some people may come to the conclusion that they have died and entered an entirely new world, hence the term ego death. But drug induced ego death is always temporary, and when you come out of it and begin to put the pieces of yourself back together, it can be a long and painful process. Thats why the practice ofpsychedelic integrationis so important following ego death, and why the archetype of death and rebirth is central to psychedelic spirituality and healing.

In recent years, ego dissolution has become a hot topic of study in psychedelic therapy. Cases of autobiographical amnesia are usually related to unusual activity in thehippocampus, the area of the brain responsible for storing and retrieving memories, located in themedial temporal lobe. In the case of ego death, It is reasonable to assume that higher doses of psychedelics disrupt the information flow from the hippocampus to theexecutive areasin the forebrain responsible forworking memory, causing autobiographical memory to become temporarily offline.

To quote a 2015scanning studyfrom Imperial College, ego dissolution under the effects of psilocybin was found to be associated with decreased functional connectivity between the medial temporal lobe and high-level cortical regions. Also, individuals with lower diversity of executive network nodes were more likely to experience ego-dissolution under psilocybin. Both of these findings suggest that the communication of biographical information from the hippocampus to the executive areas of the forebrain is severely diminished during ego death.

The state of ego death can last as long as a few minutes to a few hours, depending on the dose and type of psychedelic. Ego death is most commonly reported on longer lasting psychedelic drugs like psilocybin and LSD. Short-duration drugs like vaporized DMT may produce an intense state of ego death lasting only a minute or two, dropping the user into a disoriented state with unsettling questions like, Who am I? and What just happened?

When the state of ego death begins to wane, autobiographical memories may begin pouring back into consciousness, giving the user the experience that their life is flashing before their eyes, a trait commonly reported in near death experiences. This experience of metaphorically dying and being reborn is widely considered to be one of the most profound aspects of the psychedelic experience.

Although ego death shares similarities with other well known mystical states, in many ways it is wholly unique to the psychedelic experience. The termego, which broadly means ones sense of self, wasnt popularized until the turn of the 19th century, whenSigmund Freudmade it a central part of his theory of psychoanalysis. The termego deathorego dissolutionwasnt popularized until 1964, when Timothy Leary used it to describe the mystical effects of LSD. Even though psychedelic advocates naturally compared the psychedelic state to other mystical states like enlightenment,samadhi, orsatori, those terms all have common definitions intrinsically tied to ancient mystical traditions. In clinical terms, ego death is more like a fugue state, reverie, amnesia, senility, or dementia an episode that may be phenomenally similar to a mystical state but is otherwise lacking in spiritual context.

In the proper set and setting it can certainly feel like a mystical experience. If you find yourself in a natural setting exploring the wonders of the world with fresh eyes, you will experience everything as new and beautiful with no boundaries between yourself and the rest of creation. If you are in a shamanic setting, you may experience a sense of timelessness or infinity that feels like it can last an eternity. These states are often described with feelings of openness and connection or oneness with all things, and a sense of awe at the unfathomable size and mystery of the universe.

In a 2018 study ofayahuasca drinkers, researchers measured the levels of ego dissolution experienced by each subject using an ego dissolution questionnaire, and then measured short term and long term changes in their mood and behavior. The study found that ratings of depression and stress significantly decreased convergent thinking improved and, Changes in affect, satisfaction with life, and mindfulness were significantly correlated to the level of ego dissolution experienced during the ayahuasca ceremony. These results suggest that ego dissolution may be an essential component of psychedelic therapy, though this is still a subject of some debate.

In recent years, on some corners of the internet, the concept of ego death has been popularized as a kind of achievement to be unlocked for leveling up in mystical or psychonautical practice. The general sentiment seems to be that if you experience ego death, you will become a more humbled, thoughtful, and wiser person with fewer emotional attachments. However, there is no evidence this is true. In fact, some people in the psychedelic community feel the term ego death may be a misnomer because even though the ego temporarily dies, when it comes back, it comes back stronger.

Recent researchhas shown some paradoxical and counterintuitive effects of spiritual practice on the sense of self. One potential unintended consequence of a hyperfocus on self-improvement through spiritual training is elevated levels of narcissism and spiritual superiority. Instead of ego death leading to a state of openness and compassion, it may lead to heightened levels of superiority and ego inflation. So even though the mystical effects of ego death are undeniable, theres no guarantee that it is a shortcut to becoming a more thoughtful person. Because of this, It would be a mistake to frame the experience of ego death as an achievement that leads to a more rounded sense of self. After all, an obsession with ego death is still an obsession with the ego.

Link:

What is Ego Death And How Does it Work? - Benzinga - Benzinga