Category Archives: Psychedelics

A Newfoundland woman whosays psilocybin a hallucinogenic compound found in some mushrooms helped get her life backis sharing her story in the hopes it will change the perception of psychedelic drugs.

The 55-year-old wife and mother CBC has agreed to withhold her name to protect her privacy was diagnosed with severe post-traumatic stress disorder in her late 40s, brought on by childhood trauma. Traditional therapies and medications helped, she said, but over time she became resistant to treatment.

"It was making my anxiety worse. Itwas making my sleep worse. I was panicking all the time," she said. "It would come in waves all day long, to the point where I would have to go to bed by about oneor two o'clock in the afternoon because I was just exhausted from sort of fighting the demons."

That all changed last winter, she said, after a weeklong retreat at a psilocybin psychotherapy clinic in Jamaica in February 2020. The drug is legal in that country, but not in Canada.

Health-care professionals were there at all times, she said, monitoring patients during their use of psilocybin, and each psychedelic trip was followed by intense group therapy. While she did have a euphoric trip with calm waves and magical colours, she said, it wasn't all fun.

"It was intense work to get through the barriers that had been holding me back through my PTSD. That was really, really tough work and it wasn't a joyful trip in any way shape or form."

She now microdoses with capsules, taken when she needs them, once or twice a week. She says she gets the calming effects without the high, even though she knows she's breaking the law.

She's one of dozens of members of the Psychedelic Society of Newfoundland and Labrador. Founder Brandon Batstone created the society in April as a safe space for people to be open about their experiences.

"It's really hard for people to talk about these things. They are illegal," he said."Here in Newfoundland, there is no safe place for people to come together, talk about it, and to really share in a community of like-minded people who are advocates for the responsible use of these medicines."

He says became a believer in the use of psychedelics after they helped him kick a drug addiction, when nothing else did. Batstone says he isn't trying to convince anyone to use these drugs; for him, he said, it's about education, awareness and changing people'sperspectives.

"There's no way to remove the stigma until people like me and others come out and tell their stories. We should have access to it. I think that people should be aware of the consequences as well, because it's not all rainbows and butterflies."

There is a growing body of scientific evidence on the therapeutic use of psychedelics.

The world's largest centre for these studies isJohn Hopkins Center for Psychedelic and Consciousness Research, where they use drugs including ketamine, MDMA, and psilocybinin experimental treatments fordepression, PTSD, and Alzheimer's. A psychedelics studies program at theUniversity of Torontois awaiting Health Canada approval to usepsilocybin in its research on microdosing.

But a world-renowned addictions expert says we're a long way from it being a part of mainstream health care.

"At this point it's a small, minuscule part of our approach to mental health problems because it's illegal," Dr. Gabor Mat told CBC. "And governments have made it really difficult to even do studies. And the difficulty is the prejudiceand the unscientific approach that regulation authorities have taken."

Mat anexpert in trauma, addiction, stress and childhood development says he has seen positive results over his 12 years of working with psychedelics.

"If you ask me, 'How safe is brain surgery?' well, if you did it on the highway in the middle of a busy intersection out on the street, it wouldn't be safe at all. But in the proper hospital setting with trained professionals, there are some risks, but it's highly safe. Same for psychedelics and I would say at least as safe and a lot safer than the psychiatric drugs that we regularly give to people these days."

Dr. Pierre Blier, a professor in the University of Ottawa's psychiatry department, is more cautious. He is studying the useofketamine for treatment-resistant patients with depression, work he says is done under highly controlled conditions.

But he notesit's still experimental and people should be careful when seeking their own treatments.

"When you buy something from a non-regulated source, you don't know what you are buying."

While Batstone believes in the use of psychedelics and is willing to bea face for the movement, the woman in her 50s is reluctant evento tell her family doctor. But she hopes one day the scientific proof will be on her side, so others can gethappiness back in their lives, something she never thought was possible for her.

"I had to be at that point where I could talk about my trauma. And then the psilocybin took me the rest of the way," she said.

"I really do see it more as when you're at that point where your treatment-resistant, there's just nothing that's working. I think that's what I want to make sure people understand, is that this was a process, this wasn't something I just jumped into."

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A trip to recovery: N.L. patients using psychedelics therapeutically, hoping for legal vindication - CBC.ca

Global Trac Solutions, Inc. (OTCPink: PSYC), a digital media company focused on the psychedelics sector, published traffic results for its Psychedelic Spotlight news platform.

The company reported record page views of almost 125,000 views for May alone, surpassing the previous record of 105,000 views for April.

Global Trac viewed the data as an indication of the notable growth of interest in psychedelics medicine.

From my perspective, with the psychedelics industry still very much in its infancy, I cant help but to see the advantageous and opportunistic position that, in my opinion, we are creating for PSYC through the success of Psychedelic Spotlight, Global Trac's CEO David Flores said.

Benzingas Take: Benzingas own page views around the keyword psychedelics show a different trend. May was the lowest performing month of the year for the category, which peaked in January 2021.

From a broader perspective, however, the last six months (from December 2020 to May 2021) showed an increase in traffic of almost 300% for the psychedelics category when compared to the six months raging from June 2020 to November 2020.

Photo by Myriam Jessier on Unsplash

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Global Trac Solutions Reports Record Pageviews Of Psychedelics Industry Indicate An Expanding Interest In The Sector - Yahoo Finance

In 2014, during my first pregnancy, I felt happy and healthy almost all the time. I rode my bike to work at the Department of Energy & Environment in Washington, D.C., until I was six or seven months pregnant and took kickboxing classes until about four weeks before my daughter was born.

So it was a bit of a shock when my second pregnancy was so different. Around the four-month mark, I developed sciatica, which is intense nerve pain that runs from your pelvis down your leg. By the end of each day, I could barely walk. I had to crawl up the stairs to the bedroom. Because of the pain, I wasnt able to be as active as I wanted. Then other parts of my health started to decline I stopped eating healthy food and doing other things I needed to do to take care of myself physically and mentally.

Courtesy of Subject

I developed whats called antepartum depression, or depression during pregnancy. I had never heard of it, but it's not uncommon about 7% of pregnant women experience it, according to the Mayo Clinic, and many more cases may go unreported. My doctor prescribed an antidepressant, which I know is lifesaving for many people, but for personal reasons I decided not to take it.

I tried to manage my pain with over-the-counter pain relievers, heating pads, warm baths and acupuncture, which did provide some short-term relief. I also tried meditating, but I would just sit there hurting, my mind swirling. In the summer of 2017, I delivered my son, Ramsey. He had a head full of curls and for a couple of weeks, all was well. Then he developed GI issues and we had some other challenges. Plus, going from one kid (my daughter Lola was three) to two doesnt just double the work it quadruples it. I felt so overwhelmed. Other moms I knew seemed like they had it all together. I thought, why am I the only one who's struggling? Id just put on my happy face and pretend like everything was okay. But it wasnt.

By late 2017, I developed severe postpartum depression. It wasnt just profound sadness, it was dread. I had a constant chatter of negative self-talk going on, a voice in my head reminding me what a terrible wife and mother I was. I had a therapist, but the depression made me feel so unmotivated, I'd find any excuse not to go.

That fall, my husband Daniel and I drove down to Alabama with the kids to see his parents for Thanksgiving. A friend of mine suggested that we listen to a podcast that he thought might help me, so we turned it on in the car. The guest on the show was Paul Stamets, a mycologist, or mushroom scientist, who was talking about psilocybin, the psychedelic component of some mushrooms, as a treatment for depression. I've never taken any kind of psychedelic drug, but at that point, I was open to considering just about anything.

Courtesy of Subject

After a ton of research, I began to realize that psychedelics arent the hippie drug they used to be considered. In fact, research centers at Johns Hopkins University, New York University and the University of California, Berkeley, have begun to study the potential of psilocybin and other psychedelics to help a range of ills, including depression, anxiety, addition and eating disorders. The treatments are administered in research settings, with therapists in the room to keep watch over a person who has taken a precise dose of psychedelics. The treatment is also often combined with psychotherapy.

I couldn't get psychedelic therapy at Johns Hopkins, the closest hospital to me that offered it. They required treatment resistant depression, and since I didn't try antidepressants, I didn't qualify.

Instead, in January 2018, my husband began the process of growing psilocybin mushrooms himself. After a lot of research into legitimate sellers, we ordered mushrooms spores online its legal because the spores themselves dont contain psylocibin and started growing them in our bedroom. I don't recommend anyone do this and we didnt say a word to anyone about it. Daniel and I were local government employees, and I was taking the biggest risk of my life. Once the spores grew into mushrooms, which do contain psilocybin, we were breaking the law. I was terrified of getting caught and losing everything. But by that point, my mental health was hanging by a thread.

My lowest point was on Valentines Day, when I told my husband I was hearing voices.

My lowest point was on Valentines Day 2018 when Daniel and I went to lunch and I told him I was hearing voices. The look on his face said it all. His way of getting me in front of a professional was to suggest we go to couples therapy. And it was true that our marriage was struggling. We were not communicating with each other. We were sleeping on the very edges of the bed. We were constantly fighting. And truthfully it was easier to focus on our marriage than on myself.

Couples therapy provided some relief in our marriage, but it was not addressing the core of my deep depression. Our therapist recommended that I find a one-on-one therapist (I'd stopped going to one I had previously seen), but the time and financial commitment were too much and the depression had stripped me of nearly all my motivation to try to help myself. Finally, by March, I got to the point where I no longer wanted to live. I would fantasize about going to the roof of my building at work and what it would be like to jump. Every time I walked across the street, I envisioned a car turning the corner quickly and hitting me. I had panic attacks about once a week where I would punch my body.

I convinced myself that my kids would be better off with a different woman as their mother. My parents, who are immigrants from Iran, knew what was going on, but depression isn't really discussed in Iranian culture. My husband told me later that he called my mom several times to try to figure out how to help me, but neither of them really knew what to do. But he picked up all the household duties and childcare and encouraged me to get out of the house. He helped me work through panic attacks and allowed me as much alone time as I needed.

The first batch of mushrooms matured by April. I wasnt interested in tripping, so after reading deeply about other people's experiences and dosing approaches, I decided that whats called microdosing was right for me. I bought a small digital scale and measured out the tiniest amount, less than half a gram of a mushroom. I'd eat it with my breakfast and go to work. Again, I don't recommend this it's illegal and I didn't have a doctor monitoring me. But desperation is a powerful motivator.

I took my first microdose in April, and I started to notice a big difference three days later. Depression had made me feel very detached from my body and a bit disassociated from what was going on around me, like I was just going through the motions. Microdosing mushrooms made me feel very present in my body. There were no hallucinations or other symptoms you might associate with a psychedelic experience. I compare the feeling to getting eight hours of sleep, having a good workout and drinking the perfect amount of coffee. I just felt sharp and ready for my day.

Some of the numbness from depression started to lift. I could smell and taste things like normal again. My husband said I was walking taller, speaking differently and engaging with my children again. As the fog started to lift, I began to get even more invested in my own recovery, and I was motivated to return to one-on-one therapy.

After my first microdose, there were no hallucinations. It felt like getting eight hours of sleep and drinking the perfect amount of coffee.

I was microdosing mushrooms about three times a week and starting to feel a lot better, more like myself. But when my supply of mushrooms ran out and after a couple attempts of growing more mushrooms failed, my depression symptoms started to creep back. A friend suggested I try ayahuasca, a hallucinogenic tea made from the leaves of a South American shrub. The practice of drinking it for mental and spiritual healing originated thousands of years ago; the ceremonies are often lead by shamans.

I nervously participated in a few ceremonies. The experience can be difficult to describe, but ayahuasca opened my mind and allowed me to face and process my trauma. It didn't cure my depression, but after the ceremonies, I began to understand that the solution to my issues is not found in anything or anyone except myself. Knowing that I had all the tools within me already was a powerful feeling.

I hated that I had to sneak around and feel ashamed about ingesting two substances, mushrooms and ayahuasca, that literally grow out of the ground. I wanted more people to be aware of the potential benefits of psychedelics, so I started to explore what a campaign in D.C. to legalize entheogens, which are naturally occurring plants or fungi like psilocybin mushrooms, ayahuasca and others that can initiate altered states of consciousness that inspires mental or spiritual growth and healing, would look like. At that time, two U.S. cities, Denver and Oakland, had legalized them, and I reached out to the person who had led the campaign in Denver for advice.

Pretty early on, I realized that if I wanted the referendum, Initiative 81, to be successful, I needed to be the face of the campaign. It's very disarming when a message about psychedelics comes from a someone who might sit beside you at a PTA meeting. So, I became the Chairwoman of the Campaign to Decriminalize Nature DC and we launched the campaign and website with my story at the center and very credible research about the mental benefits of psychedelics from Johns Hopkins and NYU right alongside it.

Courtesy of Subject

I was fully prepared for blowback, to be called a bad mother and wife, but I didnt get much of that. When we held public meetings, a few people said, these substances could harm children and thats an unnecessary risk to take. But my response was that we have all sorts of things in our homes that can harm children scissors, knives, alcohol, medication. We protect our kids from these things, and we can protect our kids from entheogens, too.

We actually knew well before voting day that we were going to win. But when I heard the results 76% of voters approved the referendum I was shocked. Initiative 81 doesnt legalize entheogens or reduce penalties for having them. Rather, it decriminalizes them by making planting, buying or using them among the police departments lowest law enforcement priorities.

Mental health, especially for women and moms, isnt talked about nearly enough. Everyone feels like theyre the only ones having issues, but the truth is, one in nine new mothers experience postpartum depression. As my name and face came to be associated with the campaign, I found out that a lot of my friends were dealing with similar issues. Some of them hated to be medicated and were so happy to have another potential option. Not to mention that the pandemic has made nearly everyone so stressed and persistently anxious. Were all just trying to make it through. When this is over, were going to have a lot of mental health ramifications to deal with. And I think psychedelics can help play a role in the healing.

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Magic Mushrooms Helped Me Cope With My Severe Postpartum Depression - GoodHousekeeping.com

PALM BEACH, Fla., June 8, 2021 /PRNewswire/ -- The illegal drugs of the 1960's are becoming highly valued drugs for various new therapeutic uses across a growing list of maladies. The door of previously prohibited drugs has been opening and it appears that there will be more treatments, more surprises and more revenues as the door continues to open. Psychedelic drugs involve various types of chemical substances including LSD and chemical extracted from plants. Psychedelic drugs have the ability to change or enhance the sensory perceptions, thought processes, energy levels and have also been reported to facilitate spiritual experiences. Psychedelic drugs can be categorized into empathogens and dissociative drugs (such as PCP) and serotonergic (classic hallucinogens) such as LSD. The rising prevalence of mental depression and anxiety and availability of off-label drugs are the major drivers which has propelled the demand of the psychedelic drugs market in the next several years. A reportfrom Data Bridge Market Research projected that the psychedelic drugs market is expected to gain market growth in the forecast period of 2021 to 2028. Data Bridge Market Research analyses that the market is growing with a CAGR of 11.5% in the forecast period of 2021 to 2028 and is expected to reach USD 6,433.94 Million by 2028. Active companies in the markets this week include: COMPASS Pathways plc (NASDAQ: CMPS), Silo Pharma, Inc. (OTCQB: SILO),MindMed Inc.(NASDAQ: MNMD), Numinus Wellness Inc. (OTCPK: LKYSF)(TSXV: NUMI), Cybin Inc.(OTCQB:CLXPF) (NEO:CYBN).

But another reportfrom ResearchAndMarkets shows even more optimism in the market prediction that The Psychedelic Drugs Market size is projected to reach USD 10.75 Billion by 2027, from USD 4.75 Bn in 2020 growing at a CAGR of 12.36% during 2021-2027. The awareness campaigns have encouraged people to select appropriate treatment for mental disorders procedures and professionals which is increasing the demand of psychedelic drugs and the rising awareness towards mental health is acting as a driver for the psychedelic drugs market Increasing research and development expenditure in the psychedelic drugs is creating new opportunities in the psychedelic drugs market, thus increasing R&D activities in psychedelic drugs is acting as an opportunity for the growth of the psychedelic drugs market."

Silo Pharma, Inc. (OTCQB: SILO) BREAKING NEWS: Silo Pharma Announces Collaboration with University California San Francisco to study Psilocybin as an Anti-Inflammatory agent in Parkinson's and Bipolar Patients - Silo Pharma, Inc., a development-stage biopharmaceutical company focused on the use of psychedelics as a therapeutic, is pleased to announce that it hasentered into a Scientific Research Agreement (SRA) with the University of California San Francisco (UCSF). This SRA will leverage four other clinical trials being planned by the university, to determine the effects of psilocybin on inflammatory markers of patients who have exhibited Parkinson's, Bipolar disorder, and chronic back pain.

Eric Weisblum, CEO of Silo Pharma commented "Inflammation is a common mechanism across numerous physical diseases. Inflammation has specifically been implicated in the pathophysiology of Parkinson's Disease,chronic pain, and bipolar disorder. Psilocybin and related compounds have shown strong anti-inflammatory effects in non-human animals, raising the possibility that reducing inflammation is a possible mechanism underlying psilocybin's positive treatment effects in multiple disorders. A better understanding of the anti-inflammatory effects of psilocybin has potential to allow for optimization and personalization of psilocybin treatment."

The study will take place at The Translational Psychedelic Research (TrPR) Program at UCSF. The TrPR brings together scientists and care providers across disciplines to understand how psilocybin, LSD, ketamine, MDMA, and related compounds impact the brain and other organ systems. The goal at TrPR is to accelerate progress towards impactful and accessible psychedelic treatments. Formoreinformation,visit http://www.silopharma.com

For more information about SILO please click herehttp://bit.ly/silo-news-6-8

Other recent developments in the markets include:

COMPASS Pathways plc (NASDAQ: CMPS), a mental health care company dedicated to accelerating patient access to evidence-based innovation in mental health, has recently reported further results from a phase I study showing that its COMP360 psilocybin had no clinically-relevant negative effect on cognitive function, when administered to healthy adult volunteers with support from specially trained therapists.

The data from the randomized, double-blind, placebo-controlled, phase I trial conducted at King's College London, will be presented today at the American Society of Clinical Psychopharmacology (ASCP) Annual Meeting, by Dr James Rucker, Consultant Psychiatrist and Senior Clinical Lecturer in Psychopharmacology at King's College London's Institute of Psychiatry, Psychology and Neuroscience (IoPPN). Initial results from the study were published in December 2019. The results published today present a more in-depth analysis of cognitive data and showed some trends of positive effects, but these were minor and call for further exploration in clinical populations.

MindMed(NASDAQ: MNMD), a leading psychedelic medicine biotech company, recently announced the publication of the first pharmacogenetic data on LSD to help personalize dosing. The study results from a pooled secondary analysis of four Phase 1 studies that each used a randomized, double-blind, placebo-controlled, crossover design and were conducted at the University Hospital Basel Liechti Lab, inBasel, Switzerland.

The results of this study indicate that pharmacogenetic testing prior to LSD-assisted treatment may inform LSD dose selection at the individual patient level. Dr.Matthias Liechtisaid, "This is the first data on the pharmacogenetics of LSD. The results indicate that a test of the metabolic function of a patient by CYP2D6 phenotyping and genotyping can be used to adjust the dose of LSD. Such information is important for the further development of LSD into a medication and could ultimately help to personalize patient treatment."

Cybin Inc.(OTCQB:CLXPF) (NEO:CYBN), a biotechnology company focused on progressing psychedelic therapeutics, recently announced the sponsorship of Kernel's feasibility study of its Kernel Flow technology to measure Ketamine's psychedelic effect on cerebral cortex hemodynamics.

On January 11, 2021 Cybin announced that it would be partnering with Kernel to leverage Kernel's proprietary Kernel Flow device for psychedelic-based studies and clinical trials. The Kernel Flow device is the first-of-its-kind that uses quantitative neuroimaging technology that can measure brain activity in real time using a wearable helmet during psychedelic treatments.

Numinus Wellness Inc. (OTCPK: LKYSF)(TSXV: NUMI), a mental health care company advancing innovative treatments and safe, evidence-based psychedelic-assisted therapies, andOptimi Health Corp.(CSE: OPTI) (OTC: OPTHF) (FRA: 8BN), developers of a vertically integrated functional mushroom brand focused on the health and wellness sector, have met another early milestone in the development of an initial all natural psilocybin extract.

Optimi and Numinus, through Impact Clinical Trials Accelerator at theUniversity of Calgary("Impact"), have submitted a pre-clinical trial application to Health Canada for review and comment. Meanwhile, cultivation, research, formulation and continuous validation studies to produce the investigational psilocybin extract for trial continue at the Health Canada-licensed Numinus lab inBritish Columbia, Canada.

DISCLAIMER: FN Media Group LLC (FNM), which owns and operates FinancialNewsMedia.com and MarketNewsUpdates.com, is a third party publisher and news dissemination service provider, which disseminates electronic information through multiple online media channels. FNM is NOT affiliated in any manner with any company mentioned herein. FNM and its affiliated companies are a news dissemination solutions provider and are NOT a registered broker/dealer/analyst/adviser, holds no investment licenses and may NOT sell, offer to sell or offer to buy any security. FNM's market updates, news alerts and corporate profiles are NOT a solicitation or recommendation to buy, sell or hold securities. The material in this release is intended to be strictly informational and is NEVER to be construed or interpreted as research material. All readers are strongly urged to perform research and due diligence on their own and consult a licensed financial professional before considering any level of investing in stocks. All material included herein is republished content and details which were previously disseminated by the companies mentioned in this release. FNM is not liable for any investment decisions by its readers or subscribers. Investors are cautioned that they may lose all or a portion of their investment when investing in stocks. For current services performed FNM has been compensated twenty six hundred dollars for news coverage of the current press releases issued by Silo Pharma, Inc. by a non-affiliated third party. FNM HOLDS NO SHARES OF ANY COMPANY NAMED IN THIS RELEASE.

This release contains "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E the Securities Exchange Act of 1934, as amended and such forward-looking statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. "Forward-looking statements" describe future expectations, plans, results, or strategies and are generally preceded by words such as "may", "future", "plan" or "planned", "will" or "should", "expected," "anticipates", "draft", "eventually" or "projected". You are cautioned that such statements are subject to a multitude of risks and uncertainties that could cause future circumstances, events, or results to differ materially from those projected in the forward-looking statements, including the risks that actual results may differ materially from those projected in the forward-looking statements as a result of various factors, and other risks identified in a company's annual report on Form 10-K or 10-KSB and other filings made by such company with the Securities and Exchange Commission. You should consider these factors in evaluating the forward-looking statements included herein, and not place undue reliance on such statements. The forward-looking statements in this release are made as of the date hereof and FNM undertakes no obligation to update such statements.

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Why the North America Psychedelic Drugs Market is Expected to Grow With the Fastest CAGR for Next Several Years - PRNewswire

NEW YORK, June 11, 2021 (GLOBE NEWSWIRE) -- Wall Street Reporter, the trusted name in financial news since 1843, is highlighting the latest CEO comments and news from companies recently presenting at its highly acclaimed NEXT SUPER STOCK livestream investor conferences, and investor LiveChats on social media streams. Over 170,000 investors have participated in Wall Street Reporters livestream events in the past 30 days.

Red Light Holland (OTC: TRUFF) (CSE: TRIP) CEO Todd Shapiro: Psychedelics is Next Billion Dollar Market Opportunity

In a recent presentation on Wall Street Reporters NEXT SUPER STOCK livestream, Red Light Holland (OTC: TRUFF) (CSE: TRIP), CEO Todd Shapiro updated investors on the TRUFFs latest market expansion and success in the psychedelics sector, and major new growth opportunities in coming months. TRUFF produces and sells recreational grade psychedelic Magic Truffles to the current legal adult use market in the Netherlands, and is planning global expansion as legislation is rapidly changing globally.

TRUFF: The Tesla of Psychedelics

Todd was joined by cannabis industry pioneer and TRUFF advisory board chairman, Bruce Linton who shared his perspective on TRUFFs growth opportunities. Also joining the livestream was TRUFF CTO Sarah Hashkes who shared the companys unique technology-driven marketing and branding strategy for psychedelics, which has been likened by some investors as the Tesla of Psychedelics

Watch (OTC: TRUFF) Next Super Stock livestream Video: https://bit.ly/3u4aGR4

June 10 - TRUFF closes acquisition of 80% stake in Happy Caps Mushroom Farm based in in Nova Scotia, Canada. Happy Caps is a unique gourmet mushroom farm, cleverly positioned in the mushroom plug spawn business, selling fresh mushrooms for the wholesale market and specializing in 'grow your own mushroom kits' with sales in Canada and the United States. The transaction is immediately revenue accretive, and the Company will aggressively pursue additional revenue growth opportunities, including potentially introducing Happy Caps' products to Europe via SR Wholesale, RLH Netherlands B.V.'s wholly-owned wholesale company which has established a distribution network of over 400 companies that sell products across Europe.

June 8 - TRUFF closes acquisition of Radix Motion Inc., a technology and innovation company focused on empowering the psychedelic ecosystem with embodied technology, including augmented reality, virtual reality, and interactive holograms. "Psychedelics increase the plasticity in our brain and I believe the future of psychedelics will be using technology like ours to create support structures and customizable settings that will allow for tight feedback loops to help people achieve personal growth," said Sarah Hashkes, the CEO of Radix Motion and CTIO of Red Light Holland. "The broader vision we have for Radix Motion is utilizing my neuroscience research in movement data and psychedelics with Co-Founder Matthew Hoe's expertise in immersive technology and AR/VR to create healthy bridges between our body and technology. With Red Light Holland's support, we can further our vision and build technology that increases the bandwidth of human connection by linking us to our body and to each other in alignment with the magic of psychedelics."

Watch (OTC: TRUFF) Next Super Stock livestream Video: https://bit.ly/3u4aGR4

Tetra Bio-Pharma (OTC: TBPMF) (TSX: TBP) CEO, Dr. Guy Chamberland: Expecting to Launch 3 New Cannabinoid-Derived Drugs in 2022 - Addressing $200 Billion Market Opportunities

In a recent presentation at Wall Street Reporters NEXT SUPER STOCK livestream, Tetra Bio-Pharma (OTC: TBPMF) CEO, Dr. Guy Chamberland shared TBPMFs advanced pipeline of cannabinoid derived drugs targeting $200 billion addressable market opportunities including pain, inflammation, oncology, and sepsis.

TBPMF boasts one of the most advanced pipelines of Cannabinoid-derived medicines, supported by the urgent need for non-opioid alternatives to treat pain and inflammation. Significantly, TBPMFs portfolio of IP and patents is spearheaded by a team experienced at bringing new drugs to market.

TBPMF now has 3 drugs in the advanced clinical stages, which it expects to bring to market in 2022: Quixleef targeting pain management, a $58 billion market opportunity, ARDS-003 immunomodulator which is a $132 billion market opportunity, and PPP-003 for ophthalmic inflammation indication - a $31 billion market.

Compelling for investors, TBMPF has multiple near-term catalysts in place, and with a current valuation of about $50 million, TBPMF is trading at a just a small fraction of its peer group in the biotech space, with similar pipelines.

Watch Tetra Bio-Pharma (OTC: TBPMF) Next Super Stock video: https://bit.ly/2QzBElc

June 2 - TBPMF announces Health Canada has accepted its New Drug Submission (NDS) for REDUVO and has formally entered the final review phase in the drug review process. If successful, REDUVO will be issued a Notice of Compliance (NOC) as well as a Drug Identification Number (DIN) which permits Tetra to market the drug in Canada and indicates the drug's official approval in Canada. REDUVO is a soft gel capsule used to treat chemotherapy-induced nausea and vomiting (CINV). It is also used to treat weight loss and severe nausea in people living with HIV infection. The active pharmaceutical ingredient in REDUVO is dronabinol, also known as THC, a synthetic form of the active natural substance in cannabis.

May 11 - TBPMF announces acceleration of a revolutionary Phase 2 clinical trial, PLENITUDE, to evaluate the safety and efficacy of the investigational cannabis medicine, QIXLEEF, for use in managing uncontrolled pain in patients with advanced cancer.

May 6 - TBPMF announces start of REBORN1 clinical trial. This trial is designed to evaluate the effect of the Company's inhaled proprietary drug formulation, QIXLEEF, against immediate release oral morphine sulfate on onset of pain relief in people living with cancer. QIXLEEF is a botanical drug product with a "fixed ratio" of THC and CBD and is inhaled through a Class 2 medical device vaporizer. REBORN1 is being conducted in the United States in collaboration with the Hassman Research Institute, a clinical research organization, who will enroll twenty adults living with breakthrough cancer pain (BTcP) and currently taking stable opioid treatment for breakthrough pain. This innovative Phase 2 pilot, proof-of-concept open-label crossover comparison study will assess whether inhaled QIXLEEF will control BTcP faster than immediate-release morphine sulfate tablets.

Watch Tetra Bio-Pharma (OTC: TBPMF) Next Super Stock video: https://bit.ly/2QzBElc

FansUnite (OTC: FUNFF) (CSE: FANS) Positioned for Exponential Revenue Growth in iGaming, E-Sports, Online Sports Betting

In their latest presentation at Wall Street Reporters NEXT SUPER STOCK livestream, FansUnite (OTC: FUNFF) (CSE: FANS) CEO Scott Burton, and President Darius Eghdami explained how FUNFFs latest distribution deal with an online casino games aggregator, sets the stage for exponential revenue growth opportunities. In the next 12 months, FUNFF plans to expand its current line from three games to twelve - while adding multiple aggregators for each game - reaching millions of new online casino customers worldwide. With each game generating as much as $500,000 in revenue per month for FUNFF - per online casino - and the potential to be in hundreds of online casinos - these numbers can quickly add up.

Watch FansUnite (OTC: FUNFF) NEXT SUPER STOCK Video: http://bit.ly/3sGSvAs

May 12 - FUNFF has entered a brand partnership with Cash Live Inc. to launch FansUnite branded live games on the Cash Live mobile app. FansUnite has a minority interest in Cash Live, a tech start-up that offers a new popular poker and social casino game show platform. Cash Live is a free-to-play gaming app that is designed for mobile devices and features daily live-streamed poker game shows paying out real cash to its winners.The first branded FansUnite game will be available on Wednesday, May 12th at 6:00 pm PT and will play down to a winner in under 20 minutes. The Cash Live mobile app can be downloaded in the App Store: https://cashlivepoker.page.link/FansUnite

April 14 - FUNNF reports record $28.3M in betting volume and a 136% increase in revenue for its McBookie subsidiary in Q1 2021, compared to same period last year.

Watch FansUnite (OTC: FUNFF) NEXT SUPER STOCK Video: http://bit.ly/3sGSvAs

Skylight Health Group (NASDAQ: SLHG) (TSX.V: SHG) CEO, Prad Sekar: Now At Inflection Point - Positioned for 10X Upside Revenue Growth Potential

Skylight Health Group (NASDAQ: SLHG) (TSX.V: SHG) was recently a featured presenter at Wall Street Reporters NEXT SUPER STOCK livestream investor conference. CEO Prad Sekar, outlined his vision for building Skylight into a multi-billion dollar business focused on the highly fragmented US healthcare market. Skylight already operates 30 clinics, in 14 states, with virtual telehealth overlay, serving over 120,000 patients - and is one of the fastest growing multi-disciplinary health systems in the United States.

Watch Skylight (NASDAQ: SLHG) Next Super Stock video: http://bit.ly/3qAZAAr

Skyllight is now at an inflection point. SLHG revenues are expected to be $56 million and $5.5 million EBITDA run rates, with a recently announced acquisition. SLHG boasts a profitable base of operations, no long-term debt and cash balance of $10 million. In his presentation, Skylight CEO Prad Sekar, explains how the company can increase revenues organically by about 10X, as it optimizes clinics for profitability by expansion of services to the existing patient base, with its proven business model, stating: "$200 Million Revenues Run Rate in 2021 Is Goal".

Watch Skylight (NASDAQ: SLHG) Next Super Stock video: http://bit.ly/3qAZAAr

June 7 - SLHG up-lists to NASDAQ from OTC BB to improve market access and liquidity access for retail and institutional investors globally.

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Next Super Stocks on the Move: Tetra Bio-Pharma, Red Light - GlobeNewswire

During his reign as heavyweight champion of the world, no one was more feared than Mike Tyson, who obliterated opponents with ruthless efficiency.

But all the while, the troubled superstar was at war with himself, battling an abusive voice in his battered head that led "Iron Mike" to the brink of suicide.

He said that all changed when he began taking psilocybin mushrooms, more commonly known as "magic mushrooms," and other similar consciousness-altering substances.

Now the boxing prodigy from Brooklyn is experiencing a career renaissance that he said is the result of psilocybin-powered mental and spiritual exploration.

"Everyone thought I was crazy, I bit this guy's ear off," an upbeat Tyson told Reuters, referring to his infamous 1997 fight against Evander Holyfield.

"I did all this stuff, and once I got introduced to the shrooms ... my whole life changed."

To be sure, many people have had negative experiences with psilocybin, which can cause disturbing hallucinations, anxiety and panic. Medical professionals studying them warn against self-medicating or using them outside of an approved medical framework.

But Tyson, who turns 55 next month, and impressed in his November exhibition bout against Roy Jones Jr, said he has never felt better.

"It's scary to even say that," said Tyson, who is also a cannabis entrepreneur and podcast host.

"To think where I was - almost suicidal - to this now. Isn't life a trip, man? It's amazing medicine, and people don't look at it from that perspective."

"I AM CURED"

Humans have been ingesting psychedelics since the earliest days and as stigmas slowly dissolve, it is beginning to be taken seriously as a psychiatric medicine.

There is still much to learn.

Enter former NHL enforcer Daniel Carcillo, who was nicknamed "Car Bomb" for his violent approach to the sport.

After 164 fights, thousands of hits and at least seven concussions, the two-time Stanley Cup champion was forced to retire in 2015 due to repeated head trauma.

Like Tyson, he was at war with himself and struggling to connect with his wife and young children after his retirement at age 30.

He said psilocybin helped him bridge that gap and the experience led him to found Wesana Health, a first-of-its-kind company dedicated to studying its ability to treat traumatic brain injury (TBI) in athletes, veterans and others.

Wesana recently entered into a clinical research project with the World Boxing Council (WBC) to examine the potential of psilocybin to help boost the brain health of boxers, and Carcillo says he is proof that it works.

"I am cured, for sure, of TBI and any related symptoms. 100%," Carcillo said.

"I do not suffer from slurred speech, headaches, head pressure, insomnia, impulse control issues, anxiety, depression or suicidal ideation," he said.

"I do not suffer from any of that (anymore)."

Carcillo and his team are hopeful psilocybin will become an FDA-approved drug to treat TBI.

OPEN TO THE WORLD

Tyson said he wants to spread word of the benefits of psilocybin as widely as possible, which is why he has partnered with Wesana.

"I believe this is good for the world," said Tyson, who said he thinks its use could also help create a more empathetic and just society.

"If you put 10 people in a room that don't like each other and give them some psychedelics, they'll be taking pictures with each other," he said.

"Put 10 people in a room who don't like each other and give them some liquor, and they'll be shooting everybody. That's real talk.

"(Wesana) was on the same level of thinking that I was. They wanted to share this with the world. This is very limited, us doing this in these small ceremonies.

"It needs to be open to the world."

Our Standards: The Thomson Reuters Trust Principles.

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Mike Tyson says psychedelics saved his life, now he hopes they can change the world - Reuters

During a WednesdaySenate budget hearing,Francis Collins, director of the National Institutes of Health (NIH) expressedpositive remarks about the therapeutic potential of psychedelics such as psilocybin and MDMA.

I think as weve learned more about how the brain works we began to realize that these are potential tools for research purposes and might be clinically beneficial, Collins said.

The NIH is the countrys main health agency responsible for public health research. As its director, Collins stands as the highest ranking health officer in the federal government.

Psychedelics: Collins said there has been a resurgence of interest in psychedelic drugs, which for a while were sort of considered not an area that researchers legitimately ought to go after.

He went on to explain that psilocybin has been tested in three randomized, controlled trials for depression, showing signsof potential interest.

That could be quite exciting, because we all are looking for new approaches to that.

Collins added that MDMA and LSD are also under research and acknowledged that psilocybin is the psychedelic molecule that hasgarnered the most attention of late.

He told the committee hearingthat he hasbeen inconversations with the National Institute of Drug Abuse and the National Institute of Mental Health about whether its a good moment to consider having perhaps a workshop to say, OK, what have we learned so far and what more might we want to do as far as designing the next generation of clinical trials to see where these provide benefits going beyond depression to such things as PTSD?

These agencies, he estimates,will want to have a hard look at these treatments over the course of the next year.

Medical Cannabis: The NIH directoralso referred to progress being made in access to medical marijuana for federal research.

Were making some progress. You may know that in the past, researchers who wanted to do clinical studies on marijuana had all kinds of limitations," Collins said, adding that for the past five decades there had been onlyone source of marijuana for federal research purposes.

That of course is an issue because its a limited opportunity for access.

Collins said that the DEA hadrecently grantedpermission to expand the number of research marijuana providers.

However, Collins said,the best solution is to remove cannabis from its classification as a Schedule I drug.

What we really need is to moderate the schedule 1 limitation, Collins said, proposing the creation of a Schedule 1R category that would create a different pathway for researchers.

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NIH Director Praises Psychedelics' Potential As Therapeutic Treatment, Touts Progress In Access To Cannabis For Research - Benzinga

Psychedelics may be one step closer to decriminalization. All after the Director of the National Institutes of Health (NIH), Francis Collins touted the benefits of psilocybin and MDMA, as noted by Marijuana Moment . There has been a resurgence of interest in psychedelic drugs, which for a while were sort of considered not an area that researchers legitimately ought to go after,” Collins said. And I think as we’ve learned more about how the brain works, we’ve begun to realize that these are potential tools for research purposes and might be clinically beneficial.” That support could be beneficial for companies, such as NeonMind Biosciences ( CSE:NEON) (OTC:NMDBF), Cybin Inc. (NEO:CYBN)(OTC:CLXPF), Mind Medicine Inc. (NEO:MMED) (NASDAQ:MNMD), HAVN Life Sciences Inc. (CSE:HAVN)(OTC:HAVLF), and Mydecine Innovations Group (CSE:MYCO)(OTC:MYCOF).

Studies have already shown that some psychedelics could be useful for treating anxiety, PTSD, opioid addictions, obsessive-compulsive disorder (OCD), and alcoholism. We may also soon learn psilocybin could potentially assist in treating eating disorders and obesity from a NeonMind Biosciences study. That's because psilocybin activates serotonin receptors, or "nature's own appetite suppressant," as noted by Psychology Today. "This powerful brain chemical curbs cravings and shuts off appetite. It makes you feel satisfied even if your stomach is not full. The result is eating less and losing weight."

NeonMind Biosciences (CSE:NEON)(OTC:NMDBF) to Commence Trading on OTCQB

NeonMind Biosciences announced that its shares will commence trading on the OTCQB® Venture Market on May 28, 2021, under the symbol NMDBF”. NeonMind will continue to trade on the Canadian Securities Exchange under its existing symbol NEON”.

The OTCQB, operated by OTC Markets Group Inc., is designed for early-stage and developing U.S. and international companies. Companies must be current in their financial reporting and undergo an annual verification and management certification process, including meeting a minimum bid price and other financial conditions. With more compliance and quality standards, the OTCQB provides investors improved visibility to enhance trading decisions. The OTCQB is recognized by the United States Securities and Exchange Commission as an established public market providing public information for analysis and value of securities.

With this OTCQB listing, NeonMind has achieved a significant milestone in its mission to advance its psilocybin drug development programs,” said Robert Tessarolo, President & CEO of NeonMind. We expect this listing to increase our financial capabilities and expand our exposure to the U.S. investment community. This capital markets support will be extremely valuable as we continue to execute on our long-term strategy to advance the use of therapeutic psychedelic compounds for weight management conditions including obesity, which is a growing global health crisis.”

Other related developments from around the markets include:

Cybin Inc., a biotechnology company focused on progressing psychedelic therapeutics, announced that it has filed an international patent application that brings the potential to obtain patent coverage in 153 countries. The application, governed by the Patent Cooperation Treaty, grants the Company the right to file future national applications into treaty member jurisdictions, including important potential markets for the Company. The PCT claims a library of psychedelic derivative drug development candidates.

Mind Medicine Inc., a leading psychedelic medicine biotech company, announced the publication of the first pharmacogenetic data on LSD to help personalize dosing . The study results from a pooled secondary analysis of four Phase 1 studies that each used a randomized, double-blind, placebo-controlled, crossover design and were conducted at the University Hospital Basel Liechti Lab, in Basel, Switzerland. The results of this study indicate that pharmacogenetic testing prior to LSD-assisted treatment may inform LSD dose selection at the individual patient level.

HAVN Life Sciences Inc., biotechnology company pursuing standardized extraction of psychoactive compounds and the development of natural health products, is pleased to announce a production and supply agreement with Lobe Sciences Ltd. , an innovative biotech company committed to investigating and developing treatments using psychedelic and non-traditional medicines for better brain health. Pursuant to the Agreement, HAVN Life will produce and supply an offering of Natural Health Products, which will include plant-based compounds and non-psychoactive mushrooms. The Agreement with Lobe Sciences will create an additional revenue stream for HAVN Life, and the team will look to generate additional agreements in the coming months.

Mydecine Innovations Group said that it has received approval from Health Canada to significantly expand” its cultivation capabilities at its current good manufacturing practice (cGMP) facility, at the Applied Pharmaceutical Innovation in Canada. The Denver, Colorado-based biopharma company focused on the research and development of alternative nature-sourced medicine, said that it would use the new guidance from Health Canada to expand its cultivation facilities and rapidly scale up the supply of pharmaceutical-grade psilocybin for both its internal clinical research and for its industry partners. The increased cultivation will also allow the company to more efficiently and quickly study the medical utility of naturally occurring psilocybin and psilocybin-like compounds,” said the company.

Legal Disclaimer / Except for the historical information presented herein, matters discussed in this article contains forward-looking statements that are subject to certain risks and uncertainties that could cause actual results to differ materially from any future results, performance or achievements expressed or implied by such statements. Winning Media is not registered with any financial or securities regulatory authority and does not provide nor claims to provide investment advice or recommendations to readers of this release. For making specific investment decisions, readers should seek their own advice. NeonMind Biosciences Inc. has paid three thousand five hundred dollars for advertising and marketing services to be distributed by Winning Media. Winning Media is only compensated for its services in the form of cash-based compensation. Winning Media owns ZERO shares of NeonMind Biosciences Inc. Please click here for full disclaimer.

Contact Information: 2818047972 ty@LifeWaterMedia.com

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NIH Director Touted Benefits of Psychedelics Including Psilocybin and MDMA - Stockhouse

TORONTO, May 27, 2021 (GLOBE NEWSWIRE) -- PharmaTher Holdings Ltd. (the Company or PharmaTher) (OTCQB: PHRRF) (CSE: PHRM), a clinical-stage psychedelics biotech company, is pleased to announce that it has entered into a collaboration agreement with MediSynergics, LLC. (MediSynergics), a drug discovery company, to develop MediSynergics patented ketamine derivatives for pain and other CNS disorders and to investigate drug discovery and development of next-generation psychedelic derivatives, such as psilocybin, N,N-Dimethyltryptamine (DMT), 3,4-Methylenedioxymethamphetamine (MDMA) and lysergic acid diethylamide (LSD), mescaline, and ibogaine.

PharmaTher and MediSynergics will initially collaborate to advance the research of MediSynergics patented ketamine derivatives as an alternative to opioid medications for pain disorders using predictive preclinical animal models. Efficacy of the patented ketamine derivatives were demonstrated to be comparable or better than ketamine when tested in a murine capsaicin inflammatory pain model. The patented ketamine compounds are derivatives discovered by MediSynergics of which the majority were determined in preclinical in vitro binding affinity studies to not bind to the NMDA receptor, suggesting they may have fewer side effects that have limited ketamines use as a pain treatment. In parallel, MediSynergics, out of its research and controlled-substance licensed laboratory, is planning to evaluate novel formulations of psychedelics for clinical development to advance through the FDA regulatory pathway.

MediSynergics was founded over eleven years ago by two former Pfizer drug discovery researchers, Mr. Dennis Godek, M.A., CEO and Mr. Harry R. Howard, M.S., CSO, having extensive experience in CNS and infectious disease therapeutic areas. Since then, MediSynergics has secured 12 patents, two provisional patents in the U.S., and has discovered ketamine derivatives that potentially have changed the pharmacology of ketamine. Mr. Howard, Chief Scientific Officer of MediSynergics, co-discovered the $1 billion atypical antipsychotic drug ziprasidone (Geodon, Zeldox) which is used to treat schizophrenia and mania. Mr. Howard also developed expertise in the design of novel compounds to treat CNS disorders including depression and ADHD and is listed as an inventor of 58 U.S. patents issued to Pfizer Inc. and named on 71 U.S. and Worldwide patents.

Fabio Chianelli, Chief Executive Officer of PharmaTher, said, We are excited to work with MediSynergics in the discovery and development of novel psychedelic derivatives and formulations for pain and CNS disorders. This drug discovery and development collaboration complement our current strategy of finding novel uses and delivery forms of psychedelics by diversifying our product pipeline and building our product lifecycle plans with robust intellectual property and know-how, as well as strengthening our drug discovery and development capabilities with experienced chemists that have FDA drug approvals on their resume. We continue to focus on our core competencies in quickly advancing our ketamine programs to clinical studies and developing our novel microneedle patch for the intradermal delivery of psychedelics. The addition of our drug discovery division focused on novel psychedelic formulations uniquely position us as an up-and-coming player in prescription-based psychedelics for unmet medical needs and partnering opportunities.

Dennis Godek, Chief Executive of MediSynergics, said, We are extremely pleased to be working with PharmaTher to help advance the development of ketamine derivatives and the future potential of novel psychedelic derivatives and formulations for treating CNS disorders of unmet medical need. The benefits of ketamine for treatment resistant depression are already being realized by patients with FDA approval in 2019. It is hoped that the discovery and development of novel psychedelics and formulations will greatly benefit patients suffering from debilitating neurological illnesses.

Under the collaboration agreement, PharmaTher and MediSynergics will share the results of the ketamine program and will work toward exclusive licensing of any of the inventions that show potential entering into clinical studies.

About PharmaTher Holdings Ltd.

PharmaTher Holdings Ltd. (OTCQB: PHRRF) (CSE: PHRM) is a clinical-stage psychedelics biotech company focused on the research, development and commercialization of novel uses, formulations and delivery methods of psychedelics to treat mental illness, neurological and pain disorders. PharmaTher is currently conducting an FDA approved phase 2 clinical study with ketamine to treat Parkinsons disease and is developing a novel microneedle patch for the intradermal delivery of psychedelics.

Learn more at: PharmaTher.com and follow us on Twitter and LinkedIn.

For more information about PharmaTher, please contact:

Fabio ChianelliChief Executive OfficerPharmaTher Holdings Ltd.Tel: 1-888-846-3171Email: info@pharmather.comWebsite: http://www.pharmather.com

Neither the Canadian Securities Exchange nor its Regulation Services Provider have reviewed or accept responsibility for the adequacy or accuracy of this release.

Cautionary Statement

This press release contains 'forward-looking information' within the meaning of applicable Canadian securities legislation. These statements relate to future events or future performance. The use of any of the words "could", "intend", "expect", "believe", "will", "projected", "estimated", "potential", "aim" and similar expressions and statements relating to matters that are not historical facts are intended to identify forward-looking information and are based on PharmaTher Holdings Ltd. (the "Company") current belief or assumptions as to the outcome and timing of such future events. Forward-looking information is based on reasonable assumptions that have been made by the Company at the date of the information and is subject to known and unknown risks, uncertainties, and other factors that may cause actual results or events to differ materially from those anticipated in the forward-looking information. Given these risks, uncertainties and assumptions, you should not unduly rely on these forward-looking statements. The forward-looking information contained in this press release is made as of the date hereof, and Company is not obligated to update or revise any forward-looking information, whether as a result of new information, future events or otherwise, except as required by applicable securities laws. The foregoing statements expressly qualify any forward-looking information contained herein. Factors that could cause actual results to differ materially from those anticipated in these forward-looking statements are described under the caption "Risk Factors" in Company's management's discussion and analysis for the period of February 28, 2021 ("MD&A"), dated April 28, 2021, which is available on the Company's profile at http://www.sedar.com.

This news release does not constitute an offer to sell or the solicitation of an offer to buy, and shall not constitute an offer, solicitation or sale in any state, province, territory or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state, province, territory or jurisdiction.

Originally posted here:

PharmaTher Collaborates with MediSynergics to Develop Patented Ketamine Formulation for Pain Disorders and to Discover Novel Psychedelic Formulations...

Psychedelic drugs such as psilocybin, used in combination with talking therapy, are opening new avenues of possibility within mental health care by offering a very different mechanism of treatment from existing psychiatric medications. By inducing a unique state of consciousness, these drugs temporarily alter peoples perception of themselves and their experiences.

This altered state of consciousness creates a window of opportunity by allowing thought processes and perceptions to occur in novel ways, which can enable people to approach their problems from a new perspective. Creating the right conditions for people to confront their distress, so they can generate new solutions for resolving their problems, is what separates psychedelic drugs from the way in which we use other medications, which may only provide short-term relief. Expecting psychedelic drugs to do all the work on their own, however, is not helpful for the advancement of mental healthcare; it is the talking therapy which targets psychological reorganisation that must be focused on.

Mental health difficulties are not caused by biochemical imbalances in the brain. Our mental health is multifaceted and influenced by numerous factors, such as chronic stress, historic trauma, levels of social support, and the meaning we make of it all. Working with mental health issues, therefore, is not just about creating changes to receptors in the brain; it is about having a multifaceted approach to dealing with the very idiosyncratic issues that lead to people becoming distressed.

A drug-centred, dose-response approach in psychedelic research may, misleadingly, communicate that mental health issues are simply the result of some deficit that needs to be rectified and the drug alone is the vehicle of change.

Losing focus on the role of therapy risks overplaying the importance of neurological mechanisms that contribute to mental health, whilst underplaying social, cognitive, emotional, and behavioural processes underlying mental distress.

It might be dangerous to regard psychedelic drugs as silver bullets that can directly solve mental health problems. This is a reductionistic understanding of the problems that affect peoples mental health and one that could give false hope to those who seek help. Early-stage clinical research indicates that psychedelics could be an important component of what must be a multifaceted approach, where emphasis on psychological processes is, at least, as important as what is happening biologically.

Psychedelic drugs may help people experience their problems in ways that they havent been able to before, leading to novel insights which potentially allows new solutions to be generated. In this respect, the drug is more of a catalyst that can enable people to develop awareness of the root causes of their difficulties. To quote the director of the Multidisciplinary Association for Psychedelic Studies (MAPS), Rick Doblin in the New York Times, Its not the drug its the therapy enhanced by the drug.

Psychological support provided during psychedelic-assisted therapies, whether it is non-specific support or shaped by a therapeutic model, is designed in three phases: preparation, dosing, and integration. In preparation, the therapist builds a therapeutic alliance with the participant and prepares them for what to expect. The drug is administered in the dosing session in which the therapist(s) supports the participant for the duration of the drugs effects. The integration phase focuses on making sense of the experiences the participant had during dosing and on helping them incorporate the insights and lessons learned into their daily lives.

It is widely posited that the integration phase plays an important part in generating insights from psychedelic experiences and facilitating the chance of meaningful long-term change. Yet, clinical research into what the specific mechanisms of change are and the most efficacious methods for facilitating such change is limited. A clear, empirically sound framework of understanding is needed, which provides a coherent understanding of individuals mental distress and informs a clear set of principles on which interventions can be based.

People who seek treatment from mental health services often experience multiple and varied issues, yet current practice usually involves providing a problem specific intervention based on a diagnosis. For example, there are hundreds of problem-specific talking therapies, which can be confusing for service users and unduly expensive when training mental health service providers in hundreds of approaches. We therefore need approaches that place the individual at the centre and can deal with the varied problems they face from their perspective.

Our upcoming trial, a collaboration between the University of Manchester and Clerkenwell Health, aims to investigate the impact of talking therapy alongside two different doses of psilocybin. The therapy is informed by Perceptual Control Theory (PCT), which understands mental health issues as the result of a person having reduced or loss of control over the things they value in life, usually because there are two or more competing goals that are mutually incompatible.

PCT provides an empirical framework of understanding that helps to integrate findings from across the mental health literature and informs clinical practice by identifying and capitalising on key principles common to many effective psychotherapeutic interventions. This framework advocates helping people develop their own solutions to problems by mobilising their attention to different aspects of their experiences in order to evaluate them from different perspectives.

There is an emphasis on helping people develop awareness of important values and goals so that they can work out new ways to balancing competing needs. In this respect, psilocybin may serve a useful role in helping an individual redirect their awareness to what is most salient for them, as opposed to other more directive therapeutic approaches.

A number of other therapeutic approaches are emerging for psychedelics, including the Psychedelic Harm Reduction and Integration framework used by MAPS, which has yielded promising results in early research trials. Research in this field is still in its infancy, yet what is becoming increasingly clear, is that service users must be at the centre of psychedelic-assisted therapy and the therapists role should be to guide rather than instruct.

In the Clerkenwell Health trial, psilocybin is understood as temporarily reducing our use of strategies to control experiences, including those that may be counterproductive like worry and rumination. This enables us to be exposed to emotions and wider experiences that we might not have been able to identify or focus on before.

In conclusion, we cannot expect the drug to do all the work on its own. We need more focus on the therapy, which creates the conditions required for people to get themselves better. If we want to improve clinical practice for those who seek help, a principles-based, theoretically driven approach, which builds on what is known to be useful across different psychotherapies is essential. This needs more clinical research. Developing best practices through clinical research, and more importantly, sharing these practices, is crucial for psychedelic-assisted therapy to be incorporated into mainstream clinical practice.

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Are psychedelics the whole answer? | MHT - Mental Health Today