Category Archives: Psychedelics

Lets get three truths out of the way. 1. Drugs are a sensitive topic. 2. In a lot of the world, many drugs that can be used recreationally including psychedelics are illegal. 3. A lot of people are willing to break the law to use psychedelic substances, whether recreationally, as part of spiritual practice or as a tool to explore and work on mental health issues.

Given the legal status of these substances, people are hesitant to call 911 if they are experiencing a crisis, many dont have access to peer groups that can offer support and theres not a lot of other support available either. Fireside Project is a notable exception the organization runs a hotline you can call when you need a bit of support when the walls are melting and it feels like your ego is sitting on a mushroom next to your body, arguing with the nearest lamp post.

In the process of launching the hotline, Fireside is placing itself in a really interesting position. Mental health is getting a lot of attention right now, and a lot of things are shifting in the world of drug decriminalization.The FDA approved ketamine as a treatment for medicine-resistant depression back in 2019, and startups like Mindbloom have popped up to fill that gap in the market. MDMA (ecstasy) is hella illegal, (its a Schedule 1 drug in the U.S., which means drugs with no currently accepted medical use and a high potential for abuse. This includes heroin and LSD, but also curiously cannabis, which today is legal for medical use in 37 states, and recreationally in 18 states in the U.S.), but research shows that MDMA can have incredible results for people with severe PTSD. Magic mushrooms are decriminalized in my hometown of Oakland, California, and a bunch of other cities and states are considering legalizing various psychedelics, including LSD, mushrooms, peyote, ayahuasca and many others.

Something interesting happens when a powerful psychedelic becomes legal somewhere; a bill is working its way through the California legislature now that might make psychoactive substances such as psilocybin mushrooms, LSD, ketamine, MDMA and ibogaine legal for people 21 and older. Should that happen, the roughly 23 million or so 21-and-over adults in California will legally be able to embrace their inner hippie. It bears pointing out that a tab of acid is a different experience than having a beer or two, and it stands to reason that people might need a bit of support from time to time. In a nutshell, thats what Fireside is tooling up to help support instead of dialing 911 because you feel like the trees are breathing along with you and its a little scary to face your deepest demons head-on, talking to a trained volunteer might be a better option.

To me, my psychedelic work is really a continuation of the healing work and the growth work that youre doing in other parts of your life. For my own personal experience, my own relationship to anxiety has been a lifelong struggle. The psychedelic work is not separate from that work. Its not separate from doing the deep dive into your own psyche and understanding your inner landscape and understanding the different parts of your being and your spirit. I think for me, psychedelics help to accelerate that process, explains Joshua White, founder and executive director of Fireside. But psychedelic work doesnt exist outside of this work of getting to know yourself, discovering and falling in love with the different parts of yourself. That work has innumerable parts; it could be psychotherapy, it could be walking in the forest and journaling, it could be conversations with friends theyre all interrelated. The psychedelic work is part of and it can be foundational to ones inner work and other parts of ones life.

Since its launch in April 2021, Fireside Project has fielded nearly 2,000 calls, and trained around 100 volunteers in the ability to field calls from the public. The org also developed an app to help keep people tethered to planet earth, and to help people who need some assistance with a trip they are currently on, or integrating a recent journey.

The two founders have an interesting background and context for how they ended up dedicating their lives to psychedelic medicine.

I spent the first chapter in my professional life as a practicing lawyer working for the San Francisco city attorneys office, mostly doing public interest impact litigation cases. It really got me thinking about the relationship between resources and impact, says White. How can we have the biggest possible impact using the smallest amount of resources? I started having my own psychedelic experiences many years ago, the first one was in 2002 I think. But psychedelics became a bigger part of my life around 2010. And for me, they were incredibly healing, helping me change my relationship to my anxiety, and really just develop a more loving relationship with each part of myself. I think it was due to my own experiences that I was deciding whether I wanted to leave my career as a lawyer to become a therapist with the hope of eventually working as a psychedelic therapist with MAPS. To explore that career transition, I figured I should try to get a couple of volunteer opportunities to see if I actually liked providing emotional support to other people. I volunteered at the Zendo Project at a few festivals. I fell in love with support lines, and really thought that support lines are a radically underappreciated, but foundational part of a community mental health ecosystem. Fast-forward many years to the start of the pandemic, I was sitting around in my apartment in San Francisco, as so many of us were forlorn about the direction the world was going. Everything from the pandemic, to the epidemic of disconnection and loneliness, to really the country, waking up to the ways that systemic oppression and injustice have been really afflicting our society from the very beginning. And so I thought, well, what can I do in this moment to try to help change the direction of the way things were going. I really believed as I still do that psychedelics have amazing healing potential for the world.

White found his co-founder for the Fireside Project in Hanifa Nayo Washington.

I am a cultural activist, musician and artist. I am also someone whos had 20 years of working in the nonprofit sector leading nonprofits and community organizing. What I bring to the world is around really wanting to create spaces of healing and wellness and connection. Ive been centered around that practice. I want to live in a world where everybody is living to their full potential, you know, where everybody is inspired and supported, and has all of their basic needs met, a world where everybody can show up at the table, bringing their full gifts, says Hanifa Nayo Washington, co-founder and chief of strategy at Fireside Project. What is in the way of us doing that right now? That was, for me, a question that I brought into some of my earliest psychedelic experiences for my particular type of healing path and journey. To me, life is a healing journey. Some of the earliest downloads or visions that I received, particularly after my first ayahuasca experiences, was about starting with you first. And when you do that all else will fall into place. And so that has really stuck with me. I live in New Haven, Connecticut, and am very into meditation and yoga and mindfulness practices and healing community. All the studios and places that are available yoga studios, meditation halls there were very few people of color, very few women of color. Very few people in the LGBTQ+ communities. I wanted that, and I figured that if I want that, it means that theres probably other people who do, too.

Psychoactive drugs tend to skew more educated and more white, with people of color being underrepresented in research studies, and generally offers fewer opportunities to the people who need it the most.

Healing communities are important, and within this are affinity groups. To me, affinity is like likeness it can be racial affinity, gender affinity or a connection to whatever career you might have. We are using it as sameness or likeness and identity, explains Washington. We are starting with some particular identities, including BIPOC communities, military veterans and transgender folks. We will bring on 40 volunteers who share these identities and train them. These volunteers will be on call three shifts per week, and theyll be able to offer support to people who call in and they want to integrate with someone sharing that part of their identity. We know that representation matters, and it builds trust. It opens the possibility for more vulnerability and safety. The communities that were focusing on are communities that have been made to be marginalized, and that are underserved within the current psychedelic space.

In addition to training volunteers to offer more inclusive support to marginalized groups, Fireside recently launched a $200K fund that is available to its volunteers who fall into these categories. After theyve completed a year of volunteering with Fireside, they will be able to apply for up to $10,000 for initiatives that make psychedelic medicine more available to a broader group of people.

With the equity initiative we have launched our equity fund that any of our affinity volunteers will have access to after they complete a year of service on the line. They can apply for up to $10,000, and the fund also has educational and internship collaborators and partners. The volunteers will have the option to apply to become students of these institutions. So for example, were working with Naropa University, as well as MAPS, Fluence and others. Many of those groups are offering reduced or free tuition, explains Washington. We are also able to offer paid internships working with renowned researchers and clinicians. We want to offer them more pathways, support and connections if they want to continue developing their careers within the psychedelic fields.

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Fireside Project manifests a $200K fund to improve access to careers in psychedelic health - TechCrunch

'Magic Mushroom' psychedelic may ease anxiety, depression

The psychedelic drug in "magic mushrooms" has been found to help treat anxiety and depression in cancer patients. The substance, psilocybin, also called shrooms, is illegal in the United States.

USA TODAY

Bipartisan support is mountingfor legislation that would add an unusual new tool to combat the state's mental health crisis byseeking to legalize research of psychedelic substances.

The bill, authored by Rep. Daniel Pae, R-Lawton, would allow for the state's universities and research institutions to begin studyingpsilocybin and psilocin, the chemicals in "magic mushrooms"that produce a psychedelic state.

It is an attempt to build on and become involved in ongoingresearch that has shown positive results in psychedelics helping with mental health issues rangingfrom addiction to post-traumatic stress disorder (PTSD).

The immediate goal of the bill is to help speed up thatresearch in hopes to lower suicide rates, especially among veterans, and provide health care professionals an additional treatment for a spectrum ofproblems, sponsors say.

"I thought about, as we move beyond this pandemic, how we can address the mental health crisis our state faces.With so many folks who are struggling right now, I think we need to think outside the box, we need to think creatively," Pae said.

If passed, the bill would allow clinical trials on psychedelics in relation to depression, anxiety, opioid use disorder and dementia, among others.

"These trials are going to be very much in controlled environments with folks who are overseeing it.We are going to be micro-dosing," Pae said.

While psychedelics are still a Schedule 1drug and federally illegal, the federal government has allowed states to conduct research on psychedelics, largely staying out of the way.

Federal overreach:Oklahoma legislature fights the feds as questions come from both sides of the aisle

During a House Public Health committee meeting, questions came up onthe intent of the bill and why the state needs to jump in when research is already happening elsewhere.

Rep. Logan Phillips, R-Mounds, who worked closely with Pae on the bill and made the presentation to the committee, responded that time is of the essence in trying to prevent suicide.

In the most recent available data from the National Center for Health Statistics, Oklahoma had 816 suicide deaths in 2019.Meaningforevery 100,000 peoplethere were just over 20 suicide deaths,eighth mostin the nation.

"By jumping into the field we can immediately start helping our people, and our veterans. And get these changes into our community at a much higher rate of speed," said Phillips, an Army veteran.

Viewpoint: Addressing mental health issues in the Black community requires attitude shift

"Most of the people I served with killed themselves after they came back, he said. This treatment could have helped my soldiers, my friends, my colleagues.So its a passion to me to make sure that we get this to where we are moving the needle quickly to actually help these people.

At the same time House Bill 3414gives room for researchers to work, it also lessens the penalty for those caught with psychedelics under 1.5 grams to a $400 fine. ButPae and Phillips said the bill is not meant to promote or allow growth and consumption outside of medical purposes.

"Early researchis already showing that this is a light switch, this is automatic treatment for PTSD (and)lowers suicidal thoughts," Phillips said.

The Morning Brew: Magic mushrooms lift severe depression in clinical trial

Much of the research being cited comes from the Johns Hopkins Center on Psychedelic and Consciousness Research, one of the only institutions of its kind in the world.

Over various studies conducted by the Johns Hopkins center, psychedelics have been shown to alleviate depression and reduce the urge to smoketobacco. One study found80% of participants lessened their smokingfrequency after the psychedelic trials.

A secondstudy reported that 80% of participants had fewer suicidal and depressive thoughts, andsomereportedovercoming a fear of death.

In 2020, Dr.Roland Griffiths, the Center's founding director and professor at John Hopkins,told Scientific American that psychedelics have helped researchers,peer into the basic neuroscience of how these drugs affect brain activity and worldview in a way that is ultimately very healthy.

In Oklahoma's Legislature, the idea of improving brain activity through psychedelics has robust support with 14co-sponsors standing with Pae's bill, including Democrats, Republicans and leadership in both chambers.

Report: Oklahoma's cannabis program 'most accessible' nationwide but enforcement lagging

Additionally, theOklahoma LegislativeMental Health Caucus is interested in thebill that would provide help to mental health institutions outside of typical infrastructureand program spending.

"We have to be creative in the ways that we approach this issue, and the ways that we approach care, and I'm willing, whether it's Johns Hopkins or any other research university, to support those endeavors, even though, you know, we might have a certain reaction,"said Rep. Merleyn Bell, D-Norman, co-chair of the Caucus.

That reaction, stemming from a 1960s' counterculture understanding of psychedelic drugs, may leave some asking questions.

ButBell thinksthe idea of working with psychedelics is not uncommon compared to recent decisionsmade by Oklahomans.

"It reminds me very much of the conversation that we had around medical marijuana not too many years ago, and we've seen the benefits of that not just economically but for the health of our citizens,"she said.

Busted: Officers conduct massive raid of black market marijuana, issue arrest warrants

For Pae, the intention is not to create an entirely new industry or allowmushroom farms to sprout up across the Sooner State.

"Honestly, I haven't really thought that farbecause I want to get this outof the session. I want to see where the research takes us in the bill," he said.

Pae expects the legislation willbe heard on the floor as early as this week or next week and, if passed, SenateAssistant Majority Floor LeaderLonniePaxton, R-Tuttle,is slated to take up the bill asprincipal author in the upper chamber.

Read more: Nonprofit's top priorities for Oklahoma's mental health focus on wellness in children

If passed, the research conducted under the bill's purview would result in a report given to the Legislature by 2025.

"Withthe results, we want to see how it can be done in a medically safe way for folks who really have these types of mental health challenges," Pae said.

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Oklahoma bill to study mental health effects of 'shrooms' advances - Oklahoman.com

NEW YORK, March 8, 2022 /PRNewswire/ -- Terran Biosciences, Inc. ("Terran") has entered into an agreement with the University of Maryland, Baltimore ("UMB") for a worldwide exclusive license to develop and commercialize a portfolio of UMB's patents and data to support a novel approach to the treatment of neurological and psychiatric illnesses with psychedelic therapeutics.

With this transaction, Terran further expands their broad pipeline of promising clinical stage CNS therapeutics and technologies. This intellectual property and data will also complement Terran's current portfolio of over 150 patents covering new compounds and applications in the psychedelic therapeutic space.

"We couldn't be more excited about these discoveries at UMB, which are some of the most innovative we've seen in psychedelic medicine," Dr. Sam Clark, Terran's CEO, commented, "These data represent a major breakthrough in the understanding of how psychedelics act on the brain. We look forward to advancing these assets to help patients suffering from devastating neuropsychiatric illnesses."

About Terran Biosciences, Inc.

Terran is a biotech platform company developing a portfolio of therapeutics and technologies for patients with neurological and psychiatric diseases. Backed by a number of life-science and tech investors, Terran has built a CNS-focused, tech-enabled drug development platform, and is rapidly advancing of number of late-stage assets, which include novel psychedelic-based therapeutics.

Terran Contact:

Dustin Tetzl, MDChief Business OfficerTerran Biosciences, Inc.[emailprotected]

SOURCE Terran Biosciences, Inc.

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Terran Biosciences and University of Maryland, Baltimore announce exclusive licensing deal for a portfolio of patents and data supporting novel...

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Dr. Deepak Chopra recently stated that there was anurgent need for more effective treatmentsin the mental health space, a statement with which Doug Drysdale, CEO of Cybin Inc. (NYSE:CYBN) (NEO: CYBN), agrees. Drysdale stated that he believed that the largest barrier in the advancement of the flourishing psychedelics industry was the stigmatization and misinformation concerning psychedelic compounds.

He explained that many individuals who werent involved in the psychedelics sector knew so little about these compounds and

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NOTE TO INVESTORS:The latest news and updates relating to Cybin Inc. (NEO: CYBN) (NYSE:CYBN) are available in the companys newsroom athttps://ibn.fm/CYBN

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PsychedelicNewsWire (PNW) is a specialized content distribution company that (1) aggregates and distributes news and information on the latest developments in all aspects and advances of psychedelics and their use, (2) createsPsychedelicNewsBreaksdesigned to quickly update investors on important industry news, (3) leverages a team of expert editors to enhance press releases for maximum impact, (4) assists companies with the management and optimization of social media across a range of platforms, and (5) delivers unparalleled corporate communication solutions. PNW stays abreast of the latest information and has established a reputation as the go to source for coverage of psychedelics, therapeutics and emerging market opportunities. Our team of seasoned journalists has a proven track record of helping both public and private companies gain traction with a wide audience of investors, consumers, media outlets and the general public by leveraging our expansive dissemination network of more than 5,000 key syndication outlets. PNW is committed to delivering improved visibility and brand recognition to companies operating in the emerging markets of psychedelics.

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Cybin Teams With Chopra Foundation To Foster Psychedelics Awareness - Benzinga - Benzinga

Five years ago, I called the hotline for adult psychological services at a major university hospitals psychiatry department. After completing a half-hour intake, during which I had disclosed problematic alcohol consumption, I was informed I could not receive treatment for my crippling depression because I must first graduate from addiction treatment. They quickly me routed into group services for alcohol use disorder.

I received a dual diagnosis, but the solution to both of them was apparently to stop drinking. By the departments reasoning, I couldnt worry about being depressed if I was dead from alcohol use. This was a strange logic; I had been suicidally depressed since I was 11, and at times alcohol was the only tether tying me to this Eartha force of vitality, joy and desire amidst my anhedonia.

The treatment plan, the development of which I was not involved in, had a secondary focus on SSRIs and cognitive behavioral therapy. The priority was getting me sober. Still, I attended the recommended groups and classes. Over the course of the next few months, I reduced my alcohol consumption as well as improving my mental health.

But while I felt I was making progress, the treatment providers disagreed. They became increasingly frustrated that my goal was to manage my alcohol use rather than abstaining; that I continued to use marijuana with no goal of modifying that behavior at all; and that I had additionally begun to pursue self-healing with psychedelics.

Marijuana had never caused me harm or brought any consequences to my health. No one in my life was concerned about it. Why would I stop? Conventional medications hadnt brought me relief from my depression or alcohol cravings, and psychedelics seemed to promise that. Why wouldnt I try something new?

Ultimately, I was discharged for non-compliance with the treatment plan.

The clinician I was working with suggested I enroll in a psychedelics research study, but everything I could find excluded participants with comorbidities like depression or substance use. It was the same reasoning the department itself gave me when I first accessed services: that a condition can only be evaluated and treated when its isolated as a single variable.

Since I couldnt access psychedelics in a therapeutic setting, I pursued them on my own. Ultimately, I was discharged for non-compliance with the treatment plan.

In what other area of medicine would a patient be denied all medical services due to their partial non-compliance with a prescribed treatment, or use of an alternative treatment? Diabetes care isnt withheld because a patient ate dessert. Antibiotics wouldnt be denied to someone whos also trying homeopathics or a salt lamp at home. And yet substance use is considered a valid reason to deny medical treatment, including treatment for substance use disorders.

Disclosing substance use instead of lying about it disqualified me from treatment of what was, in my case, the root cause. The stereotype is that people who use drugs are manipulative liars, but frequently the health care system leaves us no other choice.

Once alcohol use disorder was stamped onto my medical records, along with non-problematic consumption of two of the least-stigmatized controlled substances, medical appointments rarely focused on anything else. It didnt matter if the visit was for an ear infection. Id greet the provider as a person, and then my medical record would transform me into an addict.

I remember the look in one psychiatrists eye when I told him Id relapsed. Ive never seen more glee.

Ive worked with wonderful providers, but they have not been my predominant experience. Most required a confessional, unwilling to move on from the alcohol use disorder part of my medical history until Id satisfied them with a salacious story.

I came to learn which anecdotes and word choices got the biggest reactions for the least emotional labor. Over the years I developed a tight routine, as though I was a traveling road comic who tells dark jokes at which no one laughs. It feels fair to say that the persistence with which clinicians pursued and felt entitled to these preconceived narratives kept me mired in my addiction.

Patients should not be forced to relive (or invent) addiction-related traumas during every clinical encounter before they can be offered care. I remember the look in one particular addiction psychiatrists eye when I told him Id relapsed over the weekend. Ive never seen more glee. He furiously scribbled a script for Antabuse. Thisll teach ya! Im gonna make you so sick from alcohol, youll never want it again!

Another spent the majority of our interactions asking about every conceivable instance in which cannabis might have caused me harm, searching for symptoms to justify a diagnosis that didnt exist. Eventually, he gave up and declared that I was lying or in denial.

Mandatory treatment is known to be harmful, not helpful. It demands adherence to a prohibitionist code under which drugs are associated with pleasure, making all abstinence virtuous and all use harmful without allowing for nuance or individual experience.

The treatment plan that would later work for me ended up being psychedelic use, and therapy from a queer-focused practice. Which makes sense, because these were the things that I had chosen and pursued according to my needs.

Photograph by jarmoluk via Pixabay

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How My Drinking Was Used to Deny Me Treatment for Depression - Filter

Even if not on most peoples sexiest shroom stock list, Seelos Therapeuticshas been a solid presence in the psychedelic medicine space for some time.

For those who might not know, Seelos is a biopharmaceutical company focused on the development of novel therapeutics to treat central nervous system (CNS) disorders and other rare conditions.

The company has a portfolio of non-psychedelic compounds but its their SLS-002, an intranasal ketamine, thats made them an often overlooked but serious psychedelic player.

In 2019, the FDA granted Fast Track designation for Seelos SLS-002 molecule (ketamine) and Seelos has begun dosing patients as part of a study for Major Depressive Disorder giving the company a leg-up in the approval process of psychedelics.

With $20 million in capital raised in November, Seelos now has $78.7mm in cash on hand, a very healthy number that can help them withstand the current market pullback.

Theyre also in advanced clinical trials for other compounds like SLS-005, which is moving forward to Phase IIb/III after approval of its IND application by the FDA.

A pretty solid pipeline. See below for the companys 2021 year-end results and business highlights.

NEWS PROVIDED BY

Seelos Therapeutics, Inc.

Mar 07, 2022, 08:00 ET

NEW YORK, March 7, 2022 /PRNewswire/ Seelos Therapeutics, Inc. (Nasdaq: SEEL), a clinical-stage biopharmaceutical company focused on the development of therapies for central nervous system disorders and rare diseases, today announced its year-end 2021 business and clinical update.

In the second half of 2021, we continued to accomplish several significant milestones and continued to execute in the face of one of the most difficult environments for publicly-traded biotech companies that Ive seen in my career, said Raj Mehra Ph.D., Chairman and CEO of Seelos. We began the placebo-controlled Part 2 of the registration directed study of SLS-002 and plan to enroll in over 30 sites. The SLS-005 IV trehalose programs registrational study in ALS, which was accepted into the HEALEY ALS Platform Trial at Harvard, commenced dosing participants in February 2022 and our IND was accepted to study SLS-005 in spinocerebellar ataxia and its Phase IIb/III pivotal study should begin dosing in Q2 2022. We have begun additional in vivo studies with our Parkinsons disease focused gene therapy program SLS-004 after demonstrating its capability of reducing alpha-synuclein expression. We look forward to continuing to provide meaningful updates on the current state of progress on all of our programs as well as additional initiatives.

Seelos Clinical Update

SLS-002 (intranasal racemic ketamine)

SLS-005 (IV Trehalose)

SLS-004 and SLS-007 (Parkinsons disease gene therapy programs)

Seelos Business Update

Contact Information:

Anthony Marciano

Head of Corporate Communications

Seelos Therapeutics, Inc. (Nasdaq: SEEL)

300 Park Avenue, 2ndFloor

New York, NY 10022

(646) 293-2136

anthony.marciano@seelostx.com

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https://www.linkedin.com/company/seelos

Mike Moyer

Managing Director

LifeSci Advisors, LLC

250 West 55th St., Suite 3401

New York, NY 10019

(617) 308-4306

mmoyer@lifesciadvisors.com

SOURCE Seelos Therapeutics, Inc.

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Seelos Therapeutics: Year-End Results and Business Highlights Microdose - Microdose Psychedelic Insights

Incannex and Monash University will collaborate on ground-breaking research to advance treatment for severe forms of anxiety disorders using virtual reality combined with psychedelics.

Medicinal cannabis and psychedelic clinical development companyIncannex Healthcare (ASX:IHL)has joined with Monash University to develop a novel treatment that combines Virtual Reality (VR) and psychedelics.

Incannex has executed an exclusive, global license in perpetuity over an immersive therapeutic VR environment developed by BrainPark, a state-of-the-art clinical research platform at Monash Universitys Turner Institute for Brain and Mental Health.

The license allows Incannex to investigate use of Monashs VR therapy tool in combination with a psychedelic drug to develop a new treatment for severe forms of one or more anxiety disorders.

The established VR treatment uses an exposure-based approach, providing triggering stimuli in a graded and controlled manner, known as Exposure and Response Prevention or ERP.

By adding specialised clinical support and the administration of a psychedelic drug, the combined approach may allow for the development of a totally new therapy for severe forms of anxiety mental illness.

The research will be led by Monashs The Clinical Psychedelic Research Lab, Turner Institute and Department of Psychiatry Head Dr Paul Liknaitzky and BrainPark, Turner Institute Director Professor Murat Ycel.

Monashs Department of Psychiatry Head Professor Suresh Sundram and BrainPark Deputy Director Dr Rebecca Segrave will collaborate on the project.

The parties are working towards a research agreement for the first of these trials, which will assess optimal dose, safety, and tolerability of the combination treatment method.

Incannex CEO and Managing Director Joel Latham said the company was delighted to start the project with Monash and further use of combined psychedelics and VR therapy.

The combination of psychedelic compounds with an evidence-based VR therapy is a leading edge in the field of mental health treatments, Latham said.

We look forward to providing more detail about the project in due course when clinical trial planning has been finalised.

This is Incannexs second psychedelic therapy clinical program. Incannexs initial psychedelic clinical trial is using psilocybin to treat severe generalised anxiety disorder and has already achieved FDA comments and HREC approval to commence patient recruitment.

The research deal follows Incannexs much anticipated Nasdaq listing with the company hoping to attract keen medical cannabis investors as it pursues North American growth.

Incannex commenced trading on the Nasdaq under ticker Code IXHL on February 25.

American Depositary Shares (ADS) representing Incannex ordinary shares started trading following a declaration of effectiveness by the US Securities and Exchange Commission (SEC) of its registration statement on Form 20-F and formal approval from Nasdaq upon meeting listing requirements.

Each IXHL ADS represents 25 ordinary shares of Incannex with the company simultaneously retaining its listing of ordinary shares on the Australian bourse.

The Nasdaq listing is part of the companys goal to be more accessible to a wider audience of investors with sophisticated understandings of medicinal cannabinoids, psychedelic therapies, and pharmaceutical development.

This article was developed in collaboration with Incannex, a Stockhead advertiser at the time of publishing.

This article does not constitute financial product advice. You should consider obtaining independent advice before making any financial decisions.

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No worries: Severe anxiety disorders to get the Incannex, Monash Uni treatment via psychedelics within vir ... - Stockhead

Women working in psychedelics are shattering the status quo and shaping an industry that's set to become worth more than$100 billionat its peak, according to analysts.

From business executives to scientists, Insider has identified 16 of the most influential women in psychedelics. The list, comprising a mix of academia, investment firms, businesses, and advocates, is a microcosm of the wider industry, which has various forces collaborating to form its future.

Insider published a callout asking for nominations for the most influential women in psychedelics and received 158 names. We asked that nominees identify as women, be deeply involved in the psychedelics space, and stand out from their peers.

After careful review, Insider chose a list of 23 people and interviewed each to come up with the 16 names below. We considered past achievements and current work to determine how they might shape the space to come. Insider editors and reporters made the final decisions.

Perhaps unsurprisingly, many of the women on our list were affiliated with or have worked with the Multidisciplinary Association for Psychedelic Studies (MAPS) which is the closest of any organization to bringing a psychedelic compound to market.

Many of the nominees personally knew of or had collaborated with one another in their research, business ventures, and funding efforts, and many others were making active efforts in their work to highlight more women in the space.

Below, meet the most influential women in psychedelics in 2022, listed in alphabetical order by first name.

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Meet the 16 Most Influential Women Shaping the Future of Psychedelics - Business Insider

Psychedelics, long stigmatized as risky recreational drugs, are finally finding a place in polite society. More and more research from prominent institutions like Johns Hopkins suggests that such drugs, in the right formulations and with supervision, can bring about therapeutic breakthroughs in patients, notably in those who have proven to be resistant to other types of treatment.

Venture capital firms have taken noticepouring money into startups developing psychedelic treatments for everything from PTSD to smoking cessation. A January analysis by Business Insideridentified 11 venture capital firms (most of them founded in the past three years) that have collectively invested roughly $140 million in the psychedelics category. Funding accelerated after psychedelic startup Compass Pathways raised $146 million in its September 2020 initial public offeringand an additional $144 million in a secondary offering in April 2021.

And on Thursday a group of mid-tier VCs (and a group of angels) announced an investment of $11.5 million in a small biotech company called Mindstate Design Labs, which is creating therapy drugs based on psychedelics. The funding round in Mindstate, which exited stealth mode Thursday after a stint in the Y Combinator startup accelerator, was led by Initialized Capital and included money from Metaplanet Holdings, Day One Ventures, Negev Capital, K50 Ventures, Page One Ventures, and a group of angels.

Mindstate founder and CEO Dillan DiNardo tells Fast Company that his first product is based on the design of MDMA, or ecstasy, and is meant for people suffering from treatment-resistant post-traumatic stress disorder (PTSD). MDMA-based drugs aim to remove the mental barriers that prevent patients from talking openly about the root causes of their PTSD.

Its creating this state of mindthe technical name is the entactogenic statethats characterized by a reduction in fear, this feeling that all is well with the world, says DiNardo, who cofounded the company with evolutionary biologist Tom Rayin 2021 after working as an investor in biotech companies at UPMC Enterprises in Pittsburgh. It creates an overwhelming feeling of empathy and the ability to safely contemplate mental pain.

In May the journal Nature published the startling results of aPhase-III clinical trials study of MDMA-assisted therapy. After three MDMA-assisted sessions, more than two-thirds of patients with severe PTSD saw their symptoms reduced to the point where their condition no longer met PTSD diagnostic criteria.

Unfortunately, psychedelic drugs can come with some considerable side effects, including fatigue, irritability, depression, and anxiety, which can become more pronounced with repeated use. DiNardo believes Mindstates MDMA-based drug will minimize the negative side effects, making more treatment sessionsand faster relief for the patientpossible. It could also open the door toward the use of MDMA-based drugs for treating other types of mental disorders. The drug will enter clinical trials next year.

Mindstate is starting with its MDMA-based drug, but intends to create designs based on other drugs in the psychedelics family. Psilocybin (the hallucinogenic agent in magic mushrooms) is currently the focus of much of the research on psychedelics because of its ability to induce an ego loss state.

Dillan DiNardo [Photo: courtesy of Mindstate]Its an oceanic boundlessness state where the patient loses this I am a separate entity from the rest of the world,' DiNardo says. Its a profound state that can have enduring consequences that are very positive across the board when you look at treatment outcomes in addiction, depression, and anxiety.

What were doing is designing . . . psychedelic states, other forms of consciousness that are very different from normal waking consciousness that can be applied in specific therapeutic settings, DiNardo adds, stressing that his company uses many types of data, including biochemical and anecdotal experience information, to carefully design the desired mental state. It then uses AI to find the combinations of molecules that interact with brain receptors in a way that safely induces the desired state.

The federal Controlled Substances Act of 1970 outlawed psychedelic drugs such as LSD and magic mushrooms, and put barriers in place to prevent research into the potential clinical uses of the compounds. Despite that, psychiatrists have been using small doses of psychedelic drugs to enhance cognitive therapy since the 1970s, and perhaps before. With the development of new safe drugs that are more carefully tailored for in-office use, the practice could become more common.

The World Health Organization says almost a billion people worldwide suffer from mental health problems.

State legislatures have begun altering the law to allow psychedelics for clinical use. Oregon passed a law that legalizes the production, sale, and use of psilocybin (magic mushrooms) at licensed facilities starting next year. Washington is considering a similar bill that would legalize the administration of psilocybin within clinical settings.

Theres rising demand for new approaches for treating depression and anxiety. Rates of depression and anxiety around the world have soared during the pandemic. The World Health Organization says almost a billion people worldwide suffer from mental health problems.

Mental health is by far the biggest market in the life sciences, far bigger than cancer or cardiovascular disease, DiNardo says. Currently theres a 3-to-1 ratio between disease burden (how much it costs societies) and the level of healthcare spending on the problem, he says, a ration that should be 1-to-1.What that tells us, he says, is if we actually do develop medicines that are curative, that market could very quickly expand.

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Psychedelics startups are taking on mental health - Fast Company

This article was originally published on Cannabis.net and appears here with permission.

Yes, Psilocybin Is In Every Headline Now And Thats Exciting!

Psilocybin, better known asmagic mushrooms, are clearlyall the rageright now.

From consuming the raw real deal to accurately-dosed capsules, people are reaping the benefits of magic mushrooms left and right. They arent wrong: this compound in mushrooms is nothing short of miraculous when it comes to treating a variety of ailments affecting us, both mentally and physically. But since its still fairly new and less studied compared to conventional medications, theres always going to be some kind of backlash.

Having said that, here are some of the biggest recent news on psilocybin:

On January 11, the International Therapeutic Psilocybin Rescheduling Initiative (ITPRI) began their campaign for medical mushroom reform globally. They state that the notoriously old1971 UN Convention on Psychotropic Substances Actneeds some serious updating as it was originally established to keep people away from harmful drugs. They are working in collaboration with theBeckley Foundation,Mind Medicine Australia,MAPS,Osmond Foundation,Open Foundation, andNierika AC.

However, we now have more data that psilocybin is therapeutic, and thus requires a change in its category.

In most countries, legal control of psilocybin results from its Schedule I status under the 1971 Convention on Psychotropic Substances, they said in a press release. Meant for dangerous drugs which create an especially serious risk to public health and whose therapeutic value is little to none, Schedule I drugs are subject to strict limits on their scientific and medical use. Schedule I licensing, safe-custody, security, manufacturing, quantity, and import/export restrictions result in a level of regulatory control and oversight that is drastically more onerous than for the Conventions other three schedules. As a result, researchers wishing to study psilocybin face numerous regulatory hurdles which add significantly to the cost, complexity, and duration of research and can negatively impact ethical approvals, funding and collaboration.

Given todays scientific understanding of psilocybins high potential therapeutic value and low risk of dependence, a change of its status as a Schedule I drug is long overdue.

Researchers from theDell Medical School at the University of Texas at Austinhave just launched the Center for Psychedelic Research and Therapy. Its the first of its kind in the state, with a focus on clinical research aimed at determining the potential for psilocybin as well as other psychedelics including ibogaine, ayahuasca, and MDMA for the treatment of PTSD, anxiety, and severe depression when used in conjunction with treatment from a trained professional.This research will bring further scientific rigor and expertise to study psychedelic therapy, explains Charles B. Nemeroff, the center co-lead, as well as chair and professor of the Dell Meds Department of Psychiatry and Behavioral Sciences. Recent studies have demonstrated considerable promise for these drugs when incorporated with clinical support, and this work has the potential to transform how we treat conditions like depression and PTSD, and to identify synergies between these and other well-established therapies to achieve long-term benefits for those seeking treatment.

They will begin with a focus on military veterans suffering from PTSD, adults living with depression or prolonged grief, and those who struggle with childhood trauma.

In early January 2022, researchers releasedresults of a studyrevealing that there was no detrimental long or short term effects when 10 or 25mg doses of psilocybin were given to groups of healthy individuals. The researchers, from the Institute of Psychiatry, Psychology, and Neuroscience at Kings College London, was the first step they were taking to prove the safety of the compound in treating a range of conditions including treatment-resistant PTSD. They add that psilocybin should be taken in controlled settings together with talk therapy.

This rigorous study is an important first demonstration that the simultaneous administration of psilocybin can be explore further, explains lead author James Rucker, PhD. If we think about how psilocybin therapy (if approved) may be delivered in the future, its important to demonstrate the feasibility and safety of giving it to more than 1 person at the same time, so we can think about how we scale up the treatment.

Throughout it all, they found that the participants displayed no results of any long or short term effects as a result of psilocybin intake.

Israeli pharmaceutical startupPsyRxbelieves that psychedelics obtained from natural sources may be key in treating mental health conditions, and they are now working on it.

The world urgently needs a new way to treat mental health issues, and at PsyRx we believe psychedelics are a big part of the solution, explains co-founder and CEO Itay Hecht. The company uses an agro-medical bioreactor that they developed at the Hebrew University Faculty of Agriculture to come up with psychedelic botanic extracts psilocybin, from mushrooms, and ibogaine, from the iboga shrub root bark.

These natural ingredients have been promising in treating addiction, depression, PTSD, and anxiety among more, especially when compared to dangerous and addictive SSRI medications which have been the norm for decades now. SSRIs have some very bad side effects on libido and appetite, and patients often stop using them. We believe adding a microdose of ibogaine will counter those effects and make a better drug, Hecht explains, adding that microdosing psychedelic drugs wont cause hallucinations.

We are starting small animal trials soon to check safety and efficacy. Hopefully in a years time we can start human trials, he toldISRAEEL21C.

Originally posted here:

Psychedelics Are Trending: If You Are Seeing Psilocybin In The Headlines Everywhere, You Are Right! - Ben - Benzinga