Daily Archives: June 29, 2022

On 10 January, just as the sun was setting behind the Rocky Mountains, uniformed narcotics officers raided an industrial storage facility in Denvers north end, in a commercial strip between a coffee wholesaler and a plumbing supply store. There, they found scales, petri dishes, grow tents and multiple white miniature freezer units, jam-packed with several pounds of magic mushrooms.

The facility was linked to Benjamin Gorelick, a rabbi who leads the Sacred Tribe, a multi-faith membership-based non-profit, which Gorelick calls a synagogue. The Sacred Tribe counts about 270 members and Jewishness is not a precondition of membership. (According to its website, they even welcome rascally atheists.) The Sacred Tribe celebrates the Jewish high holidays, hosts breath-work seminars, and routinely congregates for a sacred sacrament, in which the mushrooms feature.

Gorelick, 43, was raised Jewish, in New Mexico. He left the south-west (and religion) behind in his late teens, decamping to Alaska to teach mountaineering. In the mountains, he reconnected with his spirituality. He sought a deeper connection to his community and to God. In 2018, he began rabbinical training. He was ordained in 2019. In photos, Gorelick sports a spiky blue mohawk hairdo, bisecting his skull like a punk rock dorsal fin. His fingernails are painted sparkly silver and black. Definitely and, one gets the sense, rather deliberately not your bubbies rabbi.

While training, Gorelick also had his first psychedelic experience. That was the first time when I felt, in my body, God and oneness, he tells the Guardian, speaking from his home in Broomfield, Colorado, about 15 miles north of Denver. The Sacred Tribe is his way of facilitating such experiences with others. The group is donations-based, and he maintains that 90% of its members have never given him so much as a thin penny for anything, including access to psychedelic drugs.

Gorelick (who asks to be called Rabbi Ben) has been charged with felony possession of a Schedule I controlled substance with intent to distribute. The Denver district attorney sees him as a narcotics manufacturer. Rabbi Ben insists that his sacraments are (or ought to be) protected by the first amendments religious protections. At an upcoming court hearing this Monday, he faces a minimum of eight and maximum of 32 years in state prison. We didnt commit a crime, Gorelick insists. This is part of 2,300 years of Judaism.

In the US, religious groups have secured the right to use psychedelic drugs, under the first amendments protection of religious freedom. A unanimous 2006 supreme court ruled that a New Mexican Christian church, the Unio do Vegetal (UDV), could legally host ceremonies featuring DMT-containing ayahuasca. In How To Change Your Mind, his bestselling 2018 chronicle of the current psychedelic renaissance, Michael Pollan called the ruling a watershed event. It made crystal clear that the government was in no position to impinge on sincere exercise of religion.

Hes practicing in the lane of what seems like sincere religious belief to me, says Danny Peterson, a DC-based attorney advising on Gorelicks case. The question is not whether Bens actions constitute violations of controlled substance laws. They do. The question is: is the government committing a new crime by enforcing these laws against him? And they are.

Gorelicks fellow travelers seem similarly sincere. Yehuda, 24, flew to Denver to partake in the Sacred Tribes psychedelic sacraments. (Yehuda is a pseudonym.) He was raised Jewish and had nurtured an interest in Jewish mysticism, including the Kabbalah. He had never taken a psychedelic before congregating with Gorelick and other members of the Sacred Tribe. The reason that I was motivated to do it, he says, was because it was being done as a Jewish religious ceremony.

Some of the Tribes members are more Kabbalah-curious. Sofia (also a pseudonym), 33, identifies as culturally Lutheran and theologically Unitarian, and works at a multi-faith community center. She, too, was attracted to Gorelicks exploration of the Kabbalah by psychedelic means. She sees Gorelicks psychedelic exploration as falling squarely within the first amendments religious protections. She drank wine when she was 10, at her first communion a Christian sacrament that contravenes drinking age laws. I see that as very analogous, she says.

Some outside of Gorelicks direct orbit wince at the idea that psychedelic drugs are part of some age-old Jewish practice. Its just not the case, says Rick Strassman, research pharmacologist and author of DMT and the Soul of Prophecy. The only intoxicants mentioned specifically in the Hebrew Bible are strong wine and liquor. Thats it.

Still, the entwined histories of psychedelia and Judaism run wild with speculation. Strassmans own research compares biblical mysticism to psychedelic states. He theorizes that certain prophetic visions like Ezekiels description of a many-faced cherub, its wings bedecked with whirligig wheels are attributable to endogenous DMT, produced naturally in the human body. Others theorize that the burning bush, which commanded Moses to liberate the Israelites from Egypt, was made of acacia, a DMT-containing shrub. Still others wonder how Moses could have inhaled enough vaporized acacia to trip out, without dying of asphyxiation.

On a Facebook page for the Jewish Entheogenic Society, a discussion group organized by the Bay Area rabbi Zac Kamenetz, some question Gorelicks interpretation of Jewish texts and their validity. Even in a religion as decentralized and diverse as Judaism, Gorelicks approach seems non-doctrinaire. There are many, many paths, Kamenetz says. But for the past 2,000 years, weve liked to show our sources.

The American community of Jewish psychedelic enthusiasts is pretty tight-knit. And Gorelick had, until recently, a minimal presence in that community. Natalie Ginsberg, a policy lead at the Multidisciplinary Association of Psychedelic Studies (Maps) and co-founder of the Jewish Psychedelics Summit, had never heard of Rabbi Benjamin Gorelick until his arrest. I was a bit surprised, she says, That I had never come into contact, or heard from him, or worked with him.

Gorelicks arrest has thrust him into the spotlight. He has retained Grasslands, a Denver-based cannabis marketing agency, to manage his communications. Hes set up online petitions and crowdfunding campaigns. Hes being positioned as the Mushroom Rabbi: a victim of religious persecution and a spokesperson for Jewish psychedelia. A GoFundMe to Help R Ben Defend Religious Use of Psychedelics says that the Sacred Tribes regular operations have been put on hold, a claim which is highly suspect. Yehuda, for one, took part in a psychedelic sacrament in March, after the grow-up raid. Gorelick clarifies that ceremonies have not stopped. But membership, and active participation, has declined.

Gorelicks legal team does not seem bothered by his image as a newcomer, or even a bit of a pariah, in the Jewish psychedelic community. His version of certain rituals isnt really relevant to the legal question, Peterson maintains. It doesnt matter if people dont like the way he talks about it. Or his haircut.

But nobody is grousing about Gorelicks hairdo. His credentials bear more serious scrutiny. Gorelick trained at the Jewish Spiritual Leaders Institute, a one-year, online cyber-synagogue, whose graduates are not recognized by many major organizations, such as Central Conference of American Rabbis (CCAR). In an email statement, a spokesperson for the CCAR says, The depth and breadth of a rigorous rabbinic education is not possible in just a year.

Sidestepping more traditional, Torah-based teachings, Gorelicks interests are almost purely mystical, and Kabbalistic. Called a mysterious and sacred science by the 19th-century French-Jewish philosopher Adolphe Franck, Kabbalah was long regarded as an advanced course of study, undertaken only by those with an exhaustive knowledge of the Torah. Kabbalah was revived in America in the 1960s, alongside the first wave of psychedelia, and the reignited western interest in Buddhism, Hinduism, occultism and emerging New Age practices.

In 1968, theologian Arthur Green pseudonymously published Notes From The Jewish Underground: Psychedelics and Kabbalah, which analyzed the awesome implications of drug use for religious thinking. More recently, clinicians at Johns Hopkins and NYU have put Greens heady thesis to the test. In 2017, they dosed two dozen clergy (including rabbis) with psilocybin. They were studying the relationship between psychedelics and mystical experiences, which, according to veteran Hopkins researcher Bill Richards, seem to be at the origin of most religions. Still, in such studies psychedelics are seen as a chemical precursor to experiences that were traditionally spurred by periods of intense meditation, fasting and prayer a spiritual catalyst, or performance-enhancing drug.

Given the alleged links between psychedelic use and Jewish mysticism, its a bit of a mystery why a challenge like this has not arisen before. Gorelick is candid on this point. He may not be the first rabbi to use psychedelics. But he was the first to get caught. We always knew someone would come knocking at our door.

Certainly, such first amendment defenses tend to emerge, well, defensively. The supreme court decision on ayahuasca came after 30 gallons of the psychoactive brew were seized by US customs agents. Historic as such rulings are, some activists regard them as a bit old hat, especially in light of broader decriminalization efforts. It can be harmful if people are not working in coordination with the bigger movement, says Maps Ginsberg. Implying that certain use should be protected over other use? Thats where I see problems.

But Gorelick can seem like a casualty of that existing decriminalization patchwork. In 2019, Denver became the first US city to effectively decriminalize psilocybin. The law itself is a bit peculiar: while the drug remains illegal under federal law, local police were prohibited from allocating resources to prosecute use or possession. Still, selling shrooms remains a felony. Such piecemeal approaches produce legislative inanities: how are people supposed to procure the psychedelic mushrooms, which are permissible to carry and consume?

In November, Coloradans will vote on a ballot measure legalizing psilocybin, while also providing a framework for licensed psychedelic healing centres. (A similar measure was successfully passed in Oregon in 2020.) We are including retroactivity in our measure, says Kevin Matthews, an activist leading the charge. Any individual who would not have been in violation of whats included in the measure, can actually actively petition to have the record sealed.

So, in a few months, Gorelicks case could be old news. Yet hes still pursuing his explicitly religious crusade. Theyre trying to create a secular, medicinal, therapeutic structure with the ballot initiative thats coming out this fall, Gorelick says, But its not the place where were looking to have protection.

Gorelicks team thinks his case and cut-and-dried enough to be reduced to a misdemeanor, or be thrown out of court altogether. He is, as Peterson, Gorelicks co-counsel, terms it, a church of one, even if his credentials or approaches may raise a few eyebrows. Of course, a religious exemption can be opportunistic, even if its totally sincere. Decriminalization, legalization all these other paths are important, says Peterson. But right now, none of those keep Rabbi Benjamin out of prison.

Those who are working to expand legal psychedelic use for everyone, regardless of faith or affiliation, do not want to see Gorelick imprisoned, even if they take issue with his tactics. As someone who cares deeply about Jewish psychedelia, I dont want to see anyone in jail, Ginsberg says. I do believe we actually have a history of use.

In early June, I meet up with Gorelick in New York, a few weeks before his court date. Seated on a luxe leather sofa in the lobby of a midtown hotel, his once-defiant mohawk has grown shaggier, tufting out from under a kippah, as if wilting under the pressure of his current legal woes.

Hes in Manhattan, he says, to attend a Shavout dinner with a group of Hasidic Jews. Shavout is a traditional holiday celebrating the harvest, which, in some orthodox circles, also marks the occasion of the Torahs revelation to Moses. These particular orthodox Hasids followers of Rabbi Nachman of Breslov, a 19th-century Kabbalah revivalist had been conducting their own experiments with psychedelics to explore the faiths more mystical, further-out dimensions. Gorelick was not there to grace them with audience with the Mushroom Rabbi. He came to learn from them, and their traditions. I kind of invited myself, he admits.

Even as others pressure Gorelick to show his work to point out where in Torah, or in Kabbalah, or anywhere in rabbinic teachings, mind-expanding drugs are justified, or even explicitly mentioned hes confident in his legal standing and in the future of Jewish psychedelia. By showing people what is possible in the psychedelic space, he explains, it makes it more conceivable to achieve these insights in daily life.

The rest is here:

Magic mushrooms are all the rage. But are they Jewish? - The Guardian

Its no secret that millions of people have been dealing with huge amounts of stress recently. From global crises, to the more mundane strains of work and family life, millions are burning out, leading to deteriorating mental and physical health. Its with this in mind that people have begun seeking natural and effective ways to counteract their bodys stress responses, including turning to wearable technology.

Many wearable devices have been shown to help with stress. These are pieces of wearable technology that use sensors to monitor biometrics like heart rate, and even can make interventions to promote better health. One similar tool that has been proven to work in scientific studies is the Apollo wearable. However, rather than passively tracking your biometrics, it actively improves your health and wellbeing.

A finalist in the World Changing Ideas Awards of 2021, the Apollo wearable is a watch-sized stress relief device that delivers soothing vibrations to your nervous system, harnessing the power of touch therapy. Developed by neuroscientists and physicians, Apollo helps you recover from stress more quickly, so you can sleep better, relax, and focus.

Because of its ability to reduce stress and promote feelings of safety, the Apollo wearable has also been a helpful addition for patients undergoing psychedelic-assisted therapy. In fact, Apollo Neuro is the only wearable technology with an issued patent to reduce unpleasant and undesired experiences associated with medicine assisted psychotherapy including psychedelics and traditional medicine. One could easily imagine how such a technology could be used to help induce a good trip, and avoid bad ones.

This is no surprise, as the founder of Apollo, Dr. Dave Rabin, is a trained psychedelic therapist who organized studies for MAPS, the largest group studying psychedelic research for mass mental health. In fact, Apollo Neuro is running a clinical trial in conjunction with MAPS to understand the long-term effectiveness of the Apollo wearable in PTSD patients who have undergone MDMA psychotherapy.

But even without combining its use with psychedelics, some have compared the positive effects of the Apollo wearable to microdosing. For example, Paul Austin, founder of Third Wave, said that I find Apollo can be like a microdose on your wrist, a wearable psychedelic. You do not go on a journey or see visions, of course, but you drop into your body and the present moment. The vibrations remind me to be here, now.

The Apollo Wearable Advantage

To explain how the Apollo wearable works, we first must understand the science behind it.

Stress is an evolutionary necessity that our ancestors relied on. When a person feels stress, the brain releases chemicals such as cortisol, which makes our breathing shallow and fast, and sends our hearts racing. In short, it activates what is commonly known as the fight-or-flight response. Obviously, this was very useful when stress was caused by a pack of hungry hyenas. It is somewhat less useful when the cause is an unopened email from your boss, or a toddler who wont stop shrieking MOM! in the supermarket.

When you are chronically stressed, its physiologically harder to focus, relax, sleep, exercise, or even get through the day. Modern life keeps sending signals to your body that youre under threat, but the hungry carnivore is nowhere to be found.

The Apollo wearable was designed to counteract the bodys fight-or-flight stress response by simulating the feeling of a comforting touch. Evolutionarily speaking, touch is the most important way that mammals communicate safety to one another. Think about your own life. When youre stressed, what helps more: a loved one saying everything will be alright, or them silently holding you? Of course, it is the latter. Perhaps you can feel the rhythmic beating of their heart, telling you that youre safe.

Moving to frequencies and vibrations, the first thing to understand is that your bodys systems already operate in certain frequencies. Your heart rate, pulse, and breathing frequencies will vary depending on your mood. For example, when youre about to fall asleep, these frequencies are slow moving and gentle. When you are competing in a sport, theyre rapid and strong.

By understanding our bodys internal frequencies, the Apollo wearable can, through vibrations, help induce a particular state. When your body is exposed to a vibrational frequency, it will naturally sync with it. Therefore, the premise behind the Apollo wearable is that it vibrates at the frequency of a desired state, be that a relaxed one or a hyper-focused one. Then, your body will naturally sync to that frequency, causing you to feel the intended effects whenever you need it.

The Apollo Wearable

There are seven different frequencies, or Modes, that the Apollo wearable offers. Clear and Focused mode can deepen your focus on any task at hand whether thats clearing your inbox, tackling a workout, or deep work. Social and Open mode can elevate mood and relieve stress in social situations. Rebuild and Recover mode can help ground yourself during psychedelic experiences. There are also frequencies that will put your body in a meditative flow state, a relaxed state, and one to help you unwind into deep sleep. The more you use it, the more naturally your body will learn to sync with whichever frequency you are using.

Importantly, the effectiveness of the Apollo wearable is backed up by extensive scientific study. For example, the University of Pittsburgh found that the Apollo wearable increases the ability to focus and remain calm during periods of stress and that these specific vibration patterns improve the bodys ability to recover and be resilient to stress. Similar studies have shown it improves athletic recovery, and supports access to meditative states. Impressively, in the meditation study, naive meditators EEG signatures looked like those of experienced meditators within twelve minutes of using the Apollo wearable. Likewise, other studies have shown it increases time spent in deep sleep by 19% on average, and increases focus and concentration by up to 25%.

Stunningly, a study of nurses using the Apollo wearable over the course of only two weeks, found that their stress and anxiety levels fell by an average of 40%! On top of this, their sleep, energy, mood, and focus all also improved.

Already, therapists are using the Apollo wearable. For example, neurofeedback therapist Heather Hargraves of Divergence Neuro swears by the device, saying I love my Apollo, I use it all day every day, and my clients like it too.

To learn more about the Apollo wearable, visit their website.

Read the original post:

Treating Stress with Wearable Technology - Psychedelic Spotlight

Filing would offer added protection to IP already submitted to USPTO

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

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

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

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

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

About Numinus

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

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

Disclaimer

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

Forward-Looking Statements

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

SOURCE Numinus Wellness Inc.

View post:

Numinus Applies for International Patent Filing of Psychedelics Production Process - PR Newswire

Compass Pathways (Mostly) Wins their Comp 360 Patent Battle

The biggest story in psychedelic stock news this week, is that Compass Pathways (Nasdaq: CMPS) appears to have won the patent battles surrounding their Comp 360 molecule. Earlier, the company had been granted two patents covering the synthetic psilocybin, but they were being challenged in the Patent Trial and Appeal Board.

The crux of the issue was whether Comp 360 is a novel compound that hasnt been created before, or whether it had previously existed in the public domain. The Board ruled in Compass favor, saying that Comp 360 was in fact novel. This means the patents hold, and can not be challenged in court. The decision was final, and can not be appealed.

To learn more about this decision, and its implications on competition in the psychedelic medicines industry, read Compass Pathways Psilocybin Patent Upheld.

Next up in psychedelic stock news, MindMed (NEO: MMED, Nasdaq: MNMD) has been granted a patent for the practice commonly referred to as Candy Flipping by the United States Patent and Trademark Office. As reported by Graham Pechenik, Editor-at-Large for Psychedelic Alpha, MindMeds patent gives them claims to a composition comprising an empathogen/entactogen and a psychedelic in the same single oral dosage form.

Essentially, this means MindMed has the sole right to combine empathogens (such as MDMA) and psychedelics (such as LSD) into the same single oral dosage form. As Pechenik writes, the patent also covers how such a combination will be used, including in the treatment of psychiatric disorders such as depression, anxiety, anxiety related to life-threatening disease, OCD, personality disorder, and addiction.

This patent will likely be controversial, as the act of combining LSD and MDMA has been done recreationally for decades. MindMed says the difference lies in the fact that their invention is that both drugs reside within the same single oral dosage form, whereas Recreational users use MDMA & LSD in separate dosage forms.

The patent will also cover the combinations of other empathogens (ex: MDA; MDEA; MDAI; and 3-MMC) with other psychedelics (ex: mescaline; and DMT).

To learn more, read Graham Pecheniks Twitter thread.

Numinus Wellness (TSE:NUMI, OTCMKTS: NUMIF) has filed a patent application to the World Intellectual Property Organization (WIPO) for a rapid production process for Psilocybe and other fungi species containing psilocybin and other compounds.

The company had already filed a patent for the same process in the USA, but if this new application is granted, patent protection would extend to all WIPO member states that have signed the Patent Cooperation Treaty (PCT), including Australia, Germany, Netherlands and the United Kingdom.

According to Numinus, the production process they are attempting to patent will significantly increase production of therapeutics for use in psychedelic-assisted therapy, while reducing product variability, increasing production efficiency and ultimately reducing commercialization costs.

Numinus thesis is that naturally produced psilocybin will be more cost-effective than synthetic psilocybin, and thus are trying to perfect the production process for psilocybe fungi.

Continuing with psychedelic stock news, Cybin (NEO: CYBN, NYSE American: CYBN) released financial data for the quarter and fiscal year that ended on March 31st, 2022.

As of March 31st, Cybin had C$53.6 million in cash and cash equivalents.

The net loss for the quarter was C$18.1 million, though C$5.1 million of that was non-cash expenses. Extrapolating into the future, if Cybin were to hold its cash expenditures steady at C$13.0 million per quarter, the company will have enough money for 1 year of operations. Though the company states that C$3.8 million were one-time, non-recurring costs, there are always various one-time costs, so I did not remove these from the calculation.

For the year, Cybin had a net loss of C$67.6 million, of which C$21.8 million were non-cash expenses.

Given these numbers, it seems likely that within a year Cybin will have to raise capital.

Mindset Pharma (CSE: MSET, FSE: 9DF, OTCQB: MSSTF) this week announced that they have entered into an innovative research collaboration with the Centre for Addiction and Mental Health. The Toronto-based hospital and Mindset will run a preclinical study on Mindsets patented next-generation psilocybin molecule, MSP-1014.

The study will investigate how macro and micro doses of both MSP-1014 and classical psilocybin modulate expression levels of molecular biomarkers of brain plasticity in rats. The goal is to understand how changes in biomarkers can cause behavioral changes associated with a single psychedelic experience and develop molecular insights into the magnitude of effects of its lead compound, MSP-1014, compared to psilocybin.

Mindset Pharma says that MSP-1014 has the potential to be a stronger, safer, more cost-effective alternative to psilocybin. This will be tested in future human clinical trials.

This week, Red Light Holland (CSE: TRIP, FSE: 4YX, OTC Pink: TRUFF) announced that they have closed their previously announced acquisition of 100 acres of farmland located in the township of Cavan-Monaghan in Peterborough, Ontario. The company paid C$1.85 million for the land.

Red Light plans to develop the Farm into approximately 65,000 sq. feet of two Mushroom production facilities, with the help of Acadian Exotic Mushrooms, a company that is majority-owned by Red Light. Construction is slated to begin this summer.

Speaking on the acquisition, and Red Lights cash position, Todd Shapiro, CEO and Director of Red Light, said We are extremely confident at Red Light because of how prudent we have been at running our psychedelic business, preserving cash at a time when most of our peers are straining to attract new capital. Red Light Holland, on the other hand, has a significant cash position as we are clearly focused on increasing revenues while having a strategic and aligned plan to grow, in order to weather difficult markets and harder economic times.

Optimi Health Requests Approval To Manufacture MDMA, Other Synthetic Psychedelics

This week, Optimi Health Corp. (CSE: OPTI, OTCQX: OPTHF, FRA: 8BN) submitted a request with Health Canada for an amendment to its Controlled Substances Dealers Licence.

The company, which already can manufacture and sell naturally derived psilocybin, is requesting its license be expanded to include the synthetic production of compounds such as MDMA, DMT, LSD, mescaline, and ketamine.

The company says that this move aligns with Optimis planned year of commercialization, allowing the Company to maximize revenue-generating opportunities through standardized psychedelic drug testing, R&D, and product development through approved clinical trials and exemption-based applications.

This week, Tryp Therapeutics (CSE: TRYP, OTCQB: TRYPF) announced that Sid Taubenfeld, a seasoned executive with healthcare and biotech expertise, has become their new Chief Operating Officer.

Before joining Tryp, Taubenfeld served as the CEO of Tikun Olam Pharma, an Israeli medical cannabis company.

According to Tryp, Sids primary responsibilities will include developing the organizations long-term vision and strategy alongside the CEO and Board; ensuring that the company operates effectively and efficiently in all areas; and helping ensure a high-performing portfolio and psychedelic medicine advancements at Tryp.

BetterLife Pharma (CSE: BETR, OTCQB: BETRF, FRA: NPAU) will present preclinical data for the drug 2-bromo-LSD (BETR-001) at the upcoming Federation of European Neuroscience Societies Forum, held on July 9-13 in Paris, France.

BetterLifes lead compound, 2-bromo-LSD/BETR-001, is a non-hallucinogenic derivative of LSD. At the conference, BetterLife will present preclinical data demonstrating the anti-depressant and neural plasticity-promoting properties of BETR-001 from both in vitro and in vivo studies.

BetterLife believes BETR-001 has the potential to be as effective as LSD in various neuropsychiatric and neurological disorders without the burden of being hallucinogenic. If this can be proved in human clinical trials, it would revolutionize the psychedelics industry, as BETR-001 would not have to be administered in specialized clinics under special treatment protocols. This would drastically cut the costs of psychedelic medicines.

However, we would need to see human clinical data showing non-hallucinogenic versions of psychedelics being effective in treating health conditions before we get too excited about this prospect. This is a topic that Psychedelic Spotlight Editor, James Kent, explored this week in the article, Is the Mystical Experience Necessary for Psychedelic Therapy?

To wrap up this weeks psychedelic stock news, Mydecine Innovations Groups (NEO: MYCO, OTC: MYCOF, FSE: 0NFA) version of psilocybin MYCO-001 has been cleared by the FDA to begin an in-human Investigator Initiated trial.

The trial, being headed by Jons Hopkins psychedelic researcher, Dr. Matthew Johnson, will aim to determine if psilocybin increases smoking abstinence compared to a placebo, when paired with therapy.

Interestingly, the trial is being funded with close to $4 million from the National Institutes of Health, making this the first time in 50 years the U.S. government has funded a study evaluating a psychedelic compound for therapeutic use.

Mydecine is also preparing to launch a phase 2b trial, again testing the ability of MYCO-001 to treat nicotine addiction.

____________________________________________________________________________

Do you want to start investing but need help researching stocks? Check out Wealth Research Groups FREE stock report: Ultimate Forever Stocks: Hold and Add More for the Remainder of Your Life!

This FREE stock report dives into EIGHT stocks that our partners Wealth Research Group believe will transform your portfolio.

Completely FREE, Wealth Research Group wont spam you and will NEVER ask for your credit card. So what do you have to lose? Plus, by downloading the report, you support Psychedelic Spotlight, so it is a win-win!

Read the original post:

This Week in Psychedelic Stocks: Compass Pathways Wins Patent Battle, MindMed Patents Candy Flipping, and More! - Psychedelic Spotlight

RIYADH: Psychedelic researcher Stanislov Grof once wrote that psychedelics, used responsibly and with proper caution, would be for psychiatry what the microscope is for biology and medicine or the telescope is for astronomy.

To many, this may sound like an outlandish claim, but now more than ever, it is proving to be true and may very well become a frontier in practicing medicine.

Saudi Arabia was enduring a mental health epidemic and the psychological strains of the pandemic exacerbated that. People are finding themselves desperate for ways to cope. One of the most recent psychotherapy methods in the region, albeit stigmatized, is psychedelic-assisted psychotherapy. A recent study published by Neuropsychopharmacology showed that the substances were proven to achieve positive long-term mental health effects and their efficiency, safety and tolerability in treating major depression, post-traumatic stress disorder, obsessive-compulsive disorder and certain addictions.

I get more people contacting me asking me how they can receive this treatment, and its really heartbreaking to tell them, Im sorry, but youre gonna have to wait. Its not available yet.

Haya Al-Hejailan, Saudi well-being practitioner and psychedelic integration specialist

It is also associated with enhancing creativity and problem-solving, according to an article published by the Journal of Psychoactive Drugs in 2019.

While the stigma around mind-altering substances, both in the region and globally, is unavoidable, researchers and scientists argue that if these drugs are regulated and used purely for medicinal reasons, what is the harm?

The term psychedelics, a class of hallucinogens, comes from the Greek words psyche, meaning the mind, and delia, meaning manifesting. The psychoactive substances are meant to alter the mind and create an alternative cognitive perception.

Psychedelics are classified into classical, which includes lysergic acid diethylamide (LSD), psilocybin (commonly known as magic mushrooms), mescaline and others, and non-classical, such as methylenedioxymethamphetamine (MDMA or ecstasy) and ketamine.

(Theyre) really great tools for us being able to understand the brain and the study of consciousness better, Saudi well-being practitioner and psychedelic integration specialist Haya Al-Hejailan told Arab News. Her work centers on psychedelic research and the treatment of borderline personality disorder.

This point may seem counterintuitive: How can addiction be treated with a substance that may cause another addiction? But psychedelics are, in fact, anti-addictive in nature.

They have anti-addictive properties, meaning they dont constitute physiological addiction, but one can become psychologically addicted to anything, said Al-Hejailan, refererring to non-substance addictions such as coffee or mobile devices.

However, the use of psychedelics can pose certain dangers, making it crucial to undergo treatment strictly under professional medical supervision, which can only be accessible through clinics. Psychedelic therapists are trained to create a controlled environment for patients undergoing psychedelic therapy, with sessions prior to administering the treatment dose to identify any red flags or possible risks that would otherwise create a larger margin of error. Patients who self-dose could potentially be subject to health risks, retraumatization, depersonalization and dissociation.

I get more people contacting me asking me how they can receive this treatment, and its really heartbreaking to tell them, I'm sorry, but youre gonna have to wait. Its not available yet, Al-Hejailan said. But Im optimistic with highlighting the word yet.

An article published by The Lancet showed that most antidepressants are ineffective and can be harmful to adolescents and children.

In an attempt to fulfill that medical need, several research efforts and trials have been unertaken to evaluate alternative routes, such as psychedelic-assisted therapy.

A study published by the National Library of Medicine found that small IV doses of ketamine can have positive, long-lasting antidepressant effects in patients. Although the scientific research regarding psychotherapeutic psychedelic use in the region is insufficient, Saudi Arabia has been easing its way into their use use for other purposes. Last year, the Saudi Journal of Emergency Medicine published a paper describing a successful case of refractory status epilepsy, a life-threatening condition, in a child treated with a single dose of ketamine.

Despite its growing popularity in mainstream media, psychedelic science is one of the cutting-edge neurosciences, yielding insufficient research compared to other sciences. The 1950s saw the first English-language report published on LSD, and research continued into Richard Nixons US presidential term, ending in the 70s. However, research efforts were quickly banned under the justification of the war on drugs as a public enemy declared by the US president. However, it was supported by other factors, such as the lack of funding for psychedelic research and failed medical trials, according to an article published by the Cambridge University Press.

That area of medicine was considered niche until recently. In 2017, MDMA was given breakthrough therapy designation by the Food and Drug Administration, meaning it was granted an expedited review process. In 2018, the FDA granted a group of psychiatrists researching psilocybin-assisted therapy for treatment-resistant depression the same status.

In the same year, Michael Pollans book How to Change Your Mind created a public space for people to think differently about psychedelics and the consciousness expansion of the mind. Ketamine was granted the same status a year later. Arguably, that is when psychedelics hit the mainstream, although its resurgence into clinical research and trials resumed in the 1990s.

(Before that) I was met with a lot of skepticism. People literally thought I was talking about something thats crazy, Al-Hejailan said in reference to discussing psychedelic-assisted psychotherapy before 2018.

Theres a lot of interest, enthusiasm and curiosity that Im met with now when I talk about my work.

With a masters in applied positive psychology and coaching psychology from the University of East London, Al-Hejailans work also includes positive psychology integration and psychedelic education, providing training in psychedelic therapy and ketamine-assisted psychotherapy. She also co-directed and co-produced a documentary titled Psychedelic Renaissance, centered on the reemergence of the psychedelic movement globally and its cultural significance.

Al-Hejailan said that raising awareness about psychedelic studies was the first step in creating a regional environment that allows for alternative psychotherapy methods.

I think we need to, in general, focus more of our energy and attention on psychoeducation, educating the public about mental health and well-being. The more we do that, the more people are likely to continue becoming accepting and interested, she said.

Future steps to normalize the use of psychoactive drugs include active training for clinicians and therapists on their uses and benefits and eventually establishing specialized clinics and research centers.

My goal is to have presentations specifically on psychotherapy and to meet with therapists, psychologists, psychiatrists and other physicians, and policymakers at some point. To show them whats happening abroad, what the science shows and to discuss how we can replicate this here in a safe way that respects our culture and that respects our specific or unique needs, Al-Hejailan said.

I really want to open a clinic and research center here. Me and my colleagues would very much love to see Saudi pioneer in psychedelic research in the region, and maybe globally.

Excerpt from:

Is there a future for psychedelic treatment in Saudi Arabia? - Arab News

VANCOUVER, British Columbia, June 28, 2022 (GLOBE NEWSWIRE) -- Optimi Health Corp. (CSE: OPTI) (OTCQX: OPTHF) (FRA: 8BN) (Optimi or the Company), a homegrown, Canadian company producing natural, scalable, and accessible psychedelic and functional mushrooms, as well as synthetic formulations for transformational human experiences, is pleased to announce that it has entered into a supply agreement with SABI Mind, a Calgary-based clinic group providing psychedelic-assisted therapies.

The Company has signed an agreement which will provide SABI Minds trained clinical staff with supplies of GMP psilocybin and 3,4-Methylenedioxymethamphetamine (MDMA), pending the anticipated approval of its previously announced licensing amendment, for use by practitioners in psychedelic-assisted therapeutic protocols with approved patients via Health Canadas Special Access Program, clinical trials, and academic studies.

This agreement is an important step forward for both parties, said Optimi Health CEO Bill Ciprick. SABI Minds initiation of this agreement demonstrates a commitment to safe supply for the development and implementation of therapeutic modalities using psilocybin and MDMA.

Clinical distribution is a major milestone in the growth of Canadas psychedelics sector from the standpoints both of business operations, and as a medical option for those in need.

Theres growing evidence that MDMA and psilocybin assisted therapies can help treat PTSD, depression and other chronic mental health conditions, said Philippe Lucas PhD, SABI Mind President. Were very pleased to be working with Optimi to ensure a safe, consistent supply of psilocybin and MDMA to SABI patients qualifying under Health Canadas Special Access Program.

As we continue to establish the logistical channels of our new industry, Optimi is extremely gratified to receive requests such as this, added Ciprick. The knowledge that the substances we produce, natural or synthetic, will be used by patients in a safe environment to further psychedelic science is a vindication of the principles on which this company was established.

Optimi Health recently requested an amendment to its Controlled Substance Dealers Licence from Health Canada which would enable it to utilize its state-of-the-art analytical laboratory for the production of synthetic MDMA, among other substances.

SABI Mind currently operates a best-in-class clinic in the Sunalta area of Calgary, with expansions planned into Edmonton, Alberta and Victoria, British Columbia.

Authorized parties interested in purchasing Optimi psilocybin and functional mushroom products, MDMA, or other synthetic psychedelics are invited to contact sales@optimihealth.ca where a member of the sales team will respond within 24 hours.

ABOUT OPTIMI (CSE: OPTI) (OTCQX: OPTHF) (FRA: 8BN)

Optimi Health Corp. is a homegrown, Canadian success story producing and supplying natural, EU-GMP grade psilocybin and functional mushrooms that focus on the health and wellness markets. Built with the purpose of producing scalable, natural mushroom formulations for transformational human experiences, the Companys goal is to be the number one trusted, compassionate supplier of safe, natural EU-GMP psilocybin throughout the world. With a vertically integrated approach, Optimi is engaged in the cultivation, extracting, processing and distribution of high quality functional and psychedelic mushroom products at its two facilities comprising a total of 20,000 square feet in Princeton, British Columbia.

About SABI Mind

Located in Calgary, SABI Mind supports the careful and necessary mending of mental health and chronic pain through psychedelic-assisted therapies. Founded by a group of Calgary-based entrepreneurs brought face-to-face with the challenges of those suffering from mental health conditions, SABI Mind empowers those discouraged by the conventional medical methods with a patient-centered treatment model supported by experienced psychiatrists, anesthesiologists, therapists, client experience specialists, and other clinic staff specially trained in ketamine-assisted psychotherapy and other psychedelic therapies.

FOR INTERVIEW REQUESTS OR FURTHER INFORMATION PLEASE CONTACT:

Investor Relations Michael Kydd Email: investors@optimihealth.ca Phone: +1 (902) 880 6121 Web: https://optimihealth.ca

FORWARDLOOKING STATEMENTS

This news release contains forwardlooking statements and forwardlooking information within the meaning of Canadian securities legislation (collectively, forwardlooking statements) that relate to Optimis current expectations and views of future events. Any statements that express, or involve discussions as to, expectations, beliefs, plans, objectives, assumptions or future events or performance (often, but not always, through the use of words or phrases such as will likely result, are expected to, expects, will continue, is anticipated, anticipates, believes, estimated, intends, plans, forecast, projection, strategy, objective, and outlook) are not historical facts and may be forwardlooking statements and may involve estimates, assumptions and uncertainties which could cause actual results or outcomes to differ materially from those expressed in such forwardlooking statements. No assurance can be given that these expectations will prove to be correct and such forwardlooking statements included in this news release should not be unduly relied upon. These statements speak only as of the date of this news release. In particular and without limitation, this news release contains forward looking statements pertaining to activities proposed to be conducted under the Companys dealers license and associated business related to Psilocybin and Psilocin and Optimis plans, focus and objectives.

Forwardlooking statements are based on a number of assumptions and are subject to a number of risks and uncertainties, many of which are beyond Optimis control, which could cause actual results and events to differ materially from those that are disclosed in or implied by such forwardlooking statements. Such risks and uncertainties include, but are not limited to, the impact and progression of the COVID19 pandemic and other factors set forth under ForwardLooking Statements and Risk Factors in the Companys Annual information Form dated January 12, 2022, and other continuous disclosure filings available under Optimis profile at http://www.sedar.com. Optimi undertakes no obligation to update or revise any forwardlooking statements, whether as a result of new information, future events or otherwise, except as may be required by law. New factors emerge from time to time, and it is not possible for Optimi to predict all of them or assess the impact of each such factor or the extent to which any factor, or combination of factors, may cause results to differ materially from those contained in any forwardlooking statement.

Any forwardlooking statements contained in this news release are expressly qualified in their entirety by this cautionary statement.

A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/67fd5330-02d3-40bb-af5b-938cb2c94f6d

A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/49bf2da6-a0b2-481e-9cf3-eed6879d5af7

Optimi Health Cultivation and Analytical Facilities

Optimi Health Cultivation and Analytical Facilities

Optimi Health Fruiting Room

Optimi Health fruiting room being prepared for second grow.

2022 GlobeNewswire, Inc., source Press Releases

Continue reading here:

Optimi Health Initiates Agreement With SABI Mind For Therapeutic Supplies Of Psilocybin, MDMA - Marketscreener.com

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

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

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

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

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

About Braxia Scientific Corp.

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

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

Dr. Roger S. McIntyreChairman & CEO

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

Forward-looking Information Cautionary Statement

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

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

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

SOURCE Braxia Scientific Corp.

Read the original here:

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

More here:

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