Snortable Shrooms: The New Magic Mushroom Nasal Spray

Magic mushrooms are taking center stage as research points in the direction of the fungus’s many mental-health boosting qualities. Though tea’s, and eating raw mushrooms have been the norm, new technology will let you snort your shrooms with a new biopharma-made magic mushroom nasal spray.

A decade ago, the idea of a magic mushroom nasal spray would have been laughed at and rejected. Now it’s something that will likely be on store shelves whenever possible. We specialize in reporting on the expanding cannabis and psychedelics fields. Follow along by signing up to The Cannadelics Weekly Newsletter, and make sure you’re in first place for all new product promotions, as they begin to come out. We’ve also got standout offers on cannabinoids, like HHC-O, Delta 8Delta 9 THCDelta-10 THCTHCOTHCVTHCP HHC, which won’t kill your bank account. Head over to our “Best-of” lists to get these deals, and remember to enjoy responsibly!


What’s the news?

A couple weeks ago, reports surfaced of Israel biopharma company Madrigal Mental Care’s new magic mushroom nasal spray. The new device was recently unleashed at the Biomed Israel Life Science and HealthTech conference in Tel Aviv, which is an international conference that took place earlier in May. The device is geared toward treating those with PTSD, and provides exact dosing via a nasal inhaler that goes inside the nostril.

The nasal spray is a nano-technology based delivery system, which can deliver nanoparticles of psychedelic medicines like psilocybin, more directly to the brain, without going through the digestive tract. The medicinal molecules are encapsulated in nanoparticles, which themselves are biodegradable, and break down in the body to release the medicine. The nasal inhaler can be used for more than just magic mushrooms, and is spoken about for use with ketamine, mescaline, and MDMA as well.

Stated cofounder and chairman of Madrigal, David Gabay, this system makes for “a significant advantage over common practices in terms of stability and accuracy.” He continued about current trials: “We are currently beginning preclinical trials with rodents with the aim of achieving efficacy and safety approvals in order to begin first-in-human clinical trials next year.”

The device was designed by Prof. Amnon Sintov of Ben-Gurion University of the Negev’s biomedical engineering department. He said, “An increasing number of studies point to the advantages of using psychedelic drugs for the treatment of psychiatric disorders such as PTSD, depression, anxiety, obsessive compulsive disorder, and even addiction, with low doses.”

He went on, “Due to their powerful effect on the human brain, it is imperative to be able to deliver these drugs in a safe manner and in precise doses.” The current non-human trials are being carried out with psilocybin, led by Prof. Shimon Ben-Shabat from Ben Gurion’s department of biochemistry and pharmacology.

The technology which was developed at Ben Gurion University, was licensed to Madrigal by Ben Gurion University’s tech transfer company, called BGN Technologies.

Is this the first of its kind?

Actually no. This is not the first magic mushroom nasal spray announced. The first one came out several years ago in 2019. At that time, Silo Wellness out of Oregon created its own magic mushroom nasal spray for use with PTSD and depression. The device was developed in Jamaica, where magic mushrooms are legal and openly sold, and provides for metered dosing of the active component psilocybin.

At the time, according to board advisor Becky Rotterman, “Many psilocybin patients, particularly women, complain of upset stomach or vomiting when taking high-doses of mushrooms… We want to bring this wonderful natural medicine first to Oregon and then the flyover states – to those who would be afraid to eat a handful of fungi and who feel more comfortable seeing their medicine in a familiar delivery modality, such as a metered-dose nasal spray.”

While this certainly doesn’t say much for what a person expects treatment to look like, or the implication that people are actually happier with what looks like a pharmaceutical, over what looks like nature, this nasal inhaler marked the first of its kind concerning the delivery of psilocybin nasally.

psilocybin mushrooms

Mike Arnold, the founder of Silo Wellness, said he created the device after his first experience with psilocybin, in an effort to make it easier for people who don’t have the luxury of benefiting from a medical setting, for their experience.

“I couldn’t help to think how fortunate I was to have an actual physician take me on my first trip rather than ‘some guy’ I know, but I realized that most first-time users don’t have that luxury,” he said. “I reached out to my long-time colleague from the marijuana space, brilliant inventor Michael Hartman, and we agreed that we need to be able to give patients predictable dosing so they can self-titrate into the desired levels of sub-psychedelic or psychedelic treatment.”

He concluded, “We solved the age-old problem with plant- and fungus-based medicine: How do you know how much is a dose? How do you avoid taking too much, like the cannabis edibles dilemma? We also managed to solve one of the common complaints of some mushroom users: taste and upset stomach.”

Much like with Madrigal, this first news story was more a press release for the product’s existence, than a new product offering. Since that time, Silo has established a patent for its product in June of 2020. The company is patiently waiting for regulation on the new magic mushroom industry to be released in Oregon, so it can begin dispensing its product. While it waits, it promotes its Marley One non-psychedelic mushroom product line.

Other applications

Now we know that magic mushroom nasal spray is a thing, but how else can magic mushrooms be taken? We know that smoking them isn’t terribly effective because psilocybin breaks down in heat. Though some say they may have felt something (not the most convincing of statements), others complained of feeling sick, or just simply being disappointed.

This also makes it necessary to make teas out of mushroom powder in order to retain the effects, considering the thermal lability of psilocybin in heat. Drinking it as tea is similar to eating a mushroom, in that it still goes through the digestive tract.

magic mushroom tea

Skin applications are also growing in popularity. Though mushroom products on the market now don’t have psilocybin, due to regulation, there are a bunch of interesting products taking advantage of other medical benefits of non-psychedelic mushrooms. I expect when legalizations do come through, these companies will be quick to incorporate compounds currently illegal for use, into their products. Unlike eating raw mushrooms or drinking tea, skin products bypass the digestive tract.

So far, injecting these compounds isn’t really a thing, though it has been mentioned in some studies. Many compounds are more easily absorbed when taken via IV or IM administration, but this doesn’t mean everything works this way. It is quite possible that as research continues, we may start hearing about mushroom injections in the future. For now, best to focus on forms of administration that are already cleared as safe for use.

Skin patches

The other application getting a lot of attention right now are magic mushroom skin patches. There are different models under testing and they come in different forms. Skin patches are a basic mode of medication delivery that are used for a range of things from pain management, to birth control administration, to help removing warts. The basic idea is that there’s some kind of adhesive, with medicine within or around it, that gets absorbed into the skin over time, making for an even dose over many hours.

A couple companies are already creating magic mushroom skin patches in this way. Nova Mentis (NOVA) and Mycrodose teamed up to produce skin patches particularly for the genetic condition fragile X syndrome. Ei.Ventures and Tioga research also partnered up and are getting in on the action, with their psilocybin skin patches meant for transdermal delivery of psilocybin, as well as other psychedelic compounds.

However, even this standard model is under construction. The Terasaki Institute for Biomedical Innovation (TIBI) recently partnered with Pharma Ther, Inc. (PHRM) to create microneedle patches. These patches differ in that they contain tons of microneedles on the surface layer that penetrate the skin to leave the medicine within. These patches are made of a gelatinous substance, and are currently under investigation for use with MDMA, LSD, DMT, psilocybin, and ketamine delivery.

Conclusion

It’s always cool to see something new and technologically advanced come out. And it’s always useful to have better treatment options. In the next few years, we should see tons of applications involving magic mushroom usage in products like nasal spray, skin patches, skin creams, and possibly more. We’ll just have to wait to see how far this goes.

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Is the Future of Psychedelic Medicine Synthetic?

The urge to improve the world around us is very much a human trait, it’s the entire basis of forming civilizations. It’s the reason we created cities, developed medications, manufactured housing, vehicles, and computers, and it’s why we continue trying to make progressive changes with every incoming generation. This concept of constant improvement is being applied to drugs as well. There are some relatively standard objectives as far as modifying hallucinogenic compounds. These include trying to get rid of unpleasant side effects, altering the length and severity of the trip, and sometimes, even removing the hallucinogenic effects entirely (psychedelics that are not psychedelic?).  

And this all brings us back to the age-old debate: natural vs synthetic, traditional vs modern, Eastern vs Western, and so forth. It’s what separates the purists from the futurists. In the last few years, we have definitely seen an increase in the recreational use of psychedelics, especially natural ones. But when we look at availability, what compounds are being researched and what’s gaining FDA approval – it’s synthetics.  

The psychedelics industry is on fire, but it might be taking on a different form. In the future, will the psychedelic industry be oversaturated with a bunch of different, synthetic compounds we have never heard of? Will the classics be all but phased out of the legal or medical markets? It’s hard to say for sure, but if you want to stay on top of all the latest, cannabis and psychedelics-related news, make sure to subscribe to The Cannadelics Weekly Newsletter, your top source for all things relating to these blossoming industries.


Natural vs synthetic  

Hallucinogenic compounds can be either natural or synthetic. The natural ones are mainly found in plants, such psilocybin from mushrooms, mescaline from peyote, and ibogaine from iboga; while a few select others are produced by animals, like 5-MeO-DMT from the Sonoran Desert Toad. Natural psychedelics have a much richer history than synthetics, having been used ceremoniously by numerous different cultures for centuries.  

In modern, western culture, psychedelic use has been severely limited, but over the last few years we’ve been seeing a greater understanding of these compounds. However, it seems most people are more inclined to favor natural psychedelics, rather than synthetics. This actually doesn’t apply to only hallucinogens, but everything really. Overall, there is this perception that “natural” is healthier, safer, and inherently superior to “unnatural”; and generally, we have found this to be true.  

However, when it comes to getting patents for medications, and getting them approved by the FDA, it’s many times easier and more likely to happen if the drug is made with synthetic compounds. Just look at cannabinoid-based medications. Most consumers like to think they’re using all natural products, but when it comes to pharmaceuticals, there are quite a few synthetic cannabinoid medications in use, such as Marinol and Cesamet, whereas only one prescription drug using natural, plant-extracted CBD has received FDA-approval, and that’s Epidiolex, a drug that has been approved for the treatment of a couple different rare forms of epilepsy.  

The same concept can be applied to psychedelics. People are generally more comfortable with natural compounds, but so far, synthetics are dominating the research and development sectors. Although we’re starting to see more talk about psilocybin, the majority of psychedelic studies and available treatments thus far have been limited ketamine and MDMA. Esketamine, which is one of Ketamine’s two enantiomers, received FDA approval three years ago and is prescribed under the brand names Spravato and Ketanest, among others.  

Even LSD has a rather extensive history of therapeutic use. Back in 1943, Swiss chemist Albert Hofmann first synthesized lysergic acid diethylamide, and over the next 15 years, over 1000 studies were published on its uses and benefits. During the 1950s and well into the 1960s, LSD was used quite successfully to treat alcoholism, depression, and a handful of other mental health disorders by abridging what could possibly be years of therapy into one or two intensive and self-reflective sessions.  

That’s not to say that natural entheogens aren’t gaining popularity as effective therapeutic tools. They most certainly are. But currently, it’s more common for substances like psilocybin, DMT, mescaline, and so one, to be in done more in wellness-type, retreat-like settings.  

Synthetic hallucinogens are derived from phenethylamine, while natural hallucinogens are typically of the tryptamine class, although there is some overlap. For example, mescaline is substituted phenethylamine. Despite many differences, the molecular structures of all phenethylamines have a couple things in common – contain a phenyl ring, joined to an amino group via an ethyl side chain (phenyl-ethyl-amine). 

Synthetic versions of natural compounds, and improving one existing synthetics 

When it comes to replicating natural compounds, the goal is usually to improve them in some way. Think psilocybin without the nausea, or DMT without increased heart rate. Many such ideas are circulating at the moment, and some are already in development. A Canadian-based company called Mindset Pharma is working on psilocybin analogues that are five to ten times more potent than existing psilocybin, producing a high that only lasts a couple of hours. They’re also working on another group of compounds that would produce the opposite effects, a trip with little to no hallucinogenic effects.  

But researchers aren’t just making synthetic versions of natural compounds, they’re also making new and improved versions of existing synthetics. Like the company, who is Tactogen is in the process of developing a “gentler” MDMA-like compound with less stimulant properties, less risk of increased heart rate and blood pressure, and no tolerance build-up; making it much safer for people with cardiovascular conditions. It would still induce the neuroplasticity that MDMD is known for, but without any of the dangerous side effects that street ecstasy is commonly associated with. 

Others are looking in a completely different direction, attempting to change the mechanisms by which some drugs work in our bodies. For example, Ron Aung-Din, the clinical medical advisor of Pyscheceutical, discussed a different delivery approach for psychedelics that “avoided the bloodstream all together, through application from a cream or a patch at the back of the neck of the hairline where there are free nerve endings in the skin under the surface, which go right to the brain.” 

Non-psychedelic, psychedelics? 

One of the more interesting ideas that researchers have been focusing on, is trying to completely remove the psychoactive effects of some of these drugs. For the psychonauts among us, that may seem, for lack of a better word, completely pointless. Afterall, it is believed that the trip is what leads to all the therapeutic breakthroughs. And on a certain level, this is true, but psychedelics also promote neuroplasticity in the prefrontal cortex of the brain, whether one experiences hallucinations or not.  

These non-hallucinogenic compounds are being referred to as “psychoplastogens”. Chemical neuroscientist at the University of California and chief innovation officer at Delix Therapeutics, Davis, David Olden, along with his colleagues, have developed a library of nearly 1,000 psychoplastogen compounds, some of which will begin to undergo testing early next year.  

There are numerous different uses and indications for non-psychedelic, psychedelic compounds that can be used clinically for a myriad of different health conditions, without inducing a hallucinogenic state. People with psychotic disorders, for instance, are currently prohibited from using psychedelic therapies, for fear the hallucinations could lead to a worsened state of psychosis. But a compound that does not cause hallucinations could be a safer way to treat their conditions. Additionally, this could possibly be used for people who suffer from chronic pain, cluster headaches, and other ailments, in which the patient wants to reap the benefits of psychedelics without necessarily experiencing a “trip”.  

Another company, Mindstate Design Labs, is looking at this same concept but from the opposite angle, by creating compounds that produce consistently good trips, or as the put it, “reliably produce the state of oceanic boundlessness or ego loss”.  

“[Current psychedelic] compounds are just what happened to be available,” said Dillan DiNardo, Mindstate’s CEO. “And the experiences associated with those compounds are just what happened to be available. By no means is it the full scope of the altered states of consciousness that are possible.” New compounds, theoretically, could produce experiences that people have never had before. That’s a challenge in terms of describing them, and even determining if you’ve discovered something new. “We will have to develop the validated rating scales to be able to capture the nature of the experience, and the intensity,” DiNardo said. 

“A bogus pipedream” 

Although certainly ambitious, drug discovery and development is difficult work. Not only are there many challenging aspects when it comes to simply creating the drugs, but once developed, there is no guarantee that just because its molecular structure is similar to another, that its effects in the human body will be similar or predictable. For example, a drug called Ondansetron that is used to treat nausea, interacts with serotonin receptors 5-HT3, but it is in no way a psychedelic drug.  

Plus, if it was so easy to tweak and alter drugs, and eliminate unwanted side effects, why is this not being applied to more pharmaceutical compounds? Many critics don’t think the idea of such highly personalized psychedelics is plausible either, like Rick Doblin, founder of the Multidisciplinary Association for Psychedelic Studies (MAPS), who believes that non-psychedelic psychedelics are a “bogus pipedream”.  

Another major facet that seems to be getting overlooked is the patient/user experience. This intense focus on individual drugs and the discovery of new ones can distract from something very important: what should clinicians do with these people when they’re on psychedelics? What are the best methods for treating these patients? And how do different patients, taking different compounds, react to different protocols in a therapeutic setting? This will involve much more in-depth research on specific interactions over an extended period of time.  

And not to mention, we still don’t even have an extensive amount of data on exisiting psychedelic compounds, like comparing LSD versus psilocybin in a clinical setting. Does it really make sense to work on creating hundreds of new psychedelic compounds when we’re still almost completely unfamiliar with the full potential of existing ones? 

Regardless, the researchers working on these discoveries say their work is vital to the development of the psychedelics industry. “There are components of the current psychedelic compounds that are very important,” Olson said, and shouldn’t be ignored. “But psychedelic science will never realize its true promise if that’s where we stop, if we don’t innovate beyond that,” he said.

“Hundreds, if not thousands of experiments are happening in companies and in research institutions,” said Suran Goonatilake, a co-founder of April 19 Discovery Inc. and a visiting professor at University College London’s Center for Artificial Intelligence. “It’s almost like we now have this permission to innovate around whole classes of receptors that we ignored.” 

Patents and FDA approvals  

Aside from what seems like complete customization, another benefit to creating new compounds is access and scalability, meaning it is much easier to get patents. It makes sense, since patents are granted for “new” inventions, how can anyone patent nature? The only way to own a compound like this is by creating it, and then getting a patent. Companies like Atai Life Sciences are already claiming that they will “focus on the generation of intellectual property”.

And patented compounds are also more likely to get FDA approval. When we consider what has already been legalized for pharmaceutical use – like Marinol which is a synthetic version of THC, or even Esketamine, which is not replacing any natural compound, but is basically a very slightly altered version of ketamine that has received FDA approval – we start to see a pattern.  

They want us using their drugs exclusively. And why wouldn’t they? The pharmaceutical industry is one of the most profitable in the United States, and they’re showering congress members with cash in the form of political lobbying and various campaign distributions. Every year, the federal government receives millions of dollars from pharmaceutical companies, and for obvious reasons, they want this relationship to continue. 

Patents can also help secure funding to research and develop even more drugs. So, this brings up some interesting questions and ideas, like whether the benefits of these drugs will be overstated in marketing campaigns now that money is on the line. Will this lead to the development of compounds with little to no improvements simply because this new compound can be owned and turned for profit?

Matt Baggott, a neuroscientist and the co-founder and CEO of Tactogen, says that, from scientific and economical standpoints, it’s unlikely and doesn’t make sense for an infinite amount of new compounds to be created. “I do think that we’re going to hit a point where it’s not going to make financial sense for companies to continue to develop products,” he said. “A lot of the patent applications you hear about or read about, I think, are really designed to secure the company’s kind of ability to operate.”  

Final thoughts  

Are “precision psychedelics” the way of the future? A few years from now, will we be faced with a psychedelics market that’s almost entirely synthetic, full of recently developed compounds we know little to nothing about? While the idea of a personalized drug experience certainly sounds interesting, it does seem a bit obtuse to focus so wholeheartedly on the creation of new compounds rather than gaining more knowledge about the ones we already have. But if the whole point is to make money off patentable products, then it’s possible that the psychedelics industry will one day see the level of variety that we’re currently experiencing in the cannabis industry, with the recent introduction of dozens of new cannabinoids, many of which are synthetic.

So, how many psychedelic-like drugs will exist in the future? That part remains unclear. It will depend on where consumer demand sits for these products, which ones have the highest profit margin, and hopefully also of considering, which of these drugs actually work.

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Preemptive Bill? Colorado House Committee Passed 1344 to Legalize MDMA

Looks like a pretty cool title, right? And it’s true, but with a caveat. A Colorado House committee did pass a bill to legalize MDMA, but it still must clear the state’s Congress, and will only take effect when MDMA is legalized by the federal government. Even so, perhaps Colorado’s move is predictive of a trend we can expect to see among US states.

A Colorado House committee just voted through a bill to legalize MDMA, assuming the US government also does so. This is the first state to make a preemptive move like this. We’re an independent publication specializing in cannabis and psychedelics news reporting. Keep up with us by signing up for The Cannadelics Weekly Newsletter, and get yourself first in line for new product promotions and deals, as they become available.


What’s the news?

On Tuesday April 5th, a House committee in Colorado approved HB 1344 that will legalize MDMA prescriptions, but only upon the federal government legalizing the compound. Essentially, the Colorado bill says it will legalize MDMA immediately upon federal government approval. This bipartisan bill is supported by both sides, and is sponsored by two US army veterans, Representatives Patrick Neville and David Ortiz.

At the April 15th vote, the bill passed unanimously, 11-0, which shows an intense amount of support for it, but this doesn’t mean that the bill is actually law. In order to become official, it still must pass the entire House, the Senate, and then get a governor signature on it. However, if the most recent House vote tells us anything, its that this has a pretty good chance of passing through.

The vote came after legislators listened to testimony given by several people, including military veterans. Testimony was also included from Will Van Derveer, a psychiatrist who saw the firsthand effects of MDMA on trauma victims a decade ago. He eventually joined a Boulder research team, where he worked specifically with patients who suffered from treatment resistant PTSD. The positive results of this research led him to add his testimony for Bill 1344.

What would the bill do?

HB 1344 is most definitely an MDMA legalization bill, but it wouldn’t lead to the immediate legalization of the compound, nor would it be an all-encompassing legalization. It would be a medical legalization, and it would depend entirely on the US federal government legalizing the compound first. In fact, bill 1344 is essentially useless without the US federal government legalizing the compound independently. The bill says:

“if the United States food and drug administration approves a prescription medicine that contains 3,4-methylenedioxymethamphetamine (MDMA), and if that medicine has been placed on a schedule of the federal “Controlled Substances Act”, other than schedule I, or has been exempted from one or more provisions of such act, then thereafter prescribing, dispensing, transporting, possessing, and using that prescription drug is legal in Colorado.”

In the end, Colorado is trying to pass a bill for something that can’t go through all the way right now, but which will put the state in a ready-to-go position should the right factors be in place. I don’t know if such a preemptive bill has been passed before, or if Colorado is the first to attempt this with House Bill 1344.

How soon could such an approval be? And how likely?

Even though MDMA is a Schedule I drug in the US, it was given ‘breakthrough therapy’ status via the US’s FDA in 2017 through the organization MAPS. MAPS is currently in phase III of trials, which are trials meant for use with treatment-resistant PTSD. Not only have trials thus far been promising in showing the ability of MDMA to help with treatment resistant PTSD, but the current trials were planned directly with the FDA by way of a Special Protocol Assessment agreement, to ensure that outcomes meet regulatory guidelines. This is a huge indication of a desire to legalize the medication by the federal government.

A ‘breakthrough therapy’ designation is given to a “…drug that treats a serious or life-threatening condition”, where “preliminary clinical evidence indicates that the drug may demonstrate substantial improvement on a clinically significant endpoint(s) over available therapies.”

This designation was given to MAPS back in 2017, so this initiative is not a new one, and the buildup for MDMA has been going on for several years on a federal level. The FDA has also given this designation to two companies studying another Schedule I substance: psilocybin. In 2018 and 2019 COMPASS Pathways and Usona Institute respectively also gained this FDA ‘backing’ for their research, signaling a major change in how psychedelics are viewed.

medical MDMA

Phase III trials are the last phase of trials. They involve large numbers of participants, and are designed to establish general safety and efficacy levels for a drug. They come after Phase I and Phase II trials which investigate basic pharmacology, dosing, and general patient response. Assuming current trials also show a positive result, a ‘new drug application’ can be filled out and submit to the FDA, followed by an approval or denial. Considering the FDA is already putting in effort to ensure MAPS’ trial results meet regulation, it seems a legalization is not far off, and could happen within 1-2 years.

What is MDMA?

What is this MDMA compound? MDMA – 3,4 methylenedioxymethamphetamine, is a synthetically made psychoactive drug, which fits under the definition of hallucinogens, and therefore, psychedelics. It goes by the names ‘molly’, and ‘ecstasy’ as well, though these often refer to non-pure forms, while the term MDMA generally denotes a pure form. Much like other psychedelics, its serotonergic, meaning it forces the brain to release large amounts of this neurotransmitter, while also blocking its re-uptake. It’s usually found as a crystal, powder, or pressed into pills, often with the insignia of whatever organization is putting them out.

Much like other psychedelics, MDMA is known for causing hallucinations, and it seems to greatly impact the sense of general feeling. People on MDMA sure love to touch and feel things for this reason. It’s also known for making people feel good. It promotes feelings of connectedness between people and with their environment, it brings on spiritual and mystical experiences, promotes feelings of euphoria and well-being, and reduces fear and anxiety.

MDMA was created by Merck Pharmaceutical all the way back in 1912, but it wasn’t well understood until decades later. In the 1970’s, chemist Alexander Shulgin found a new way to synthesize the compound, and much like Albert Hofmann who created LSD, and therapists like Humphrey Osmond who first used it, Shulgin experimented on himself first as a test subject, along with his psychotherapist friends.

It was illegalized by the federal government in 1985 by way of the Comprehensive Crime Control Act, which was signed into law the previous year, and which allowed for the immediate banning of a drug by the federal government. Incidentally, this was despite a judge ruling that MDMA should be Schedule III, and open for medical use.

Medical MDMA

How useful has MDMA been in testing for dealing with issues like PTSD? Phase III of MAPS trials are underway, and include 15 different sites in three countries (US, Canada, Israel). Trials involve patients receiving three therapy sessions with MDMA or a placebo over 12 weeks of time. This also includes three preparatory sessions, and three integration sessions, as per standard psychedelic-assisted protocol.

MDMA

Phase II findings indicated that MDMA can reduce fear and defensive feelings, increase introspection and communication abilities, and help with patient empathy and compassion. In the previous trials, MDMA improved the therapeutic experience of PTSD sufferers. Phase II consisted of 107 participants, and two months after treatment, 61% of the subjects no longer identified as PTSD sufferers. One full year later, and 68% no longer officially qualified as having PTSD.

All of these participants were considered treatment-resistant, with an average amount of time of 18 years with the disorder, between participants. The term ‘treatment-resistant’ generally means that patients already tried at least two standard FDA approved medications, and received no positive response from them. Especially considering this, the results so far are very, very encouraging.

Conclusion

If Colorado fully passes HB 1344 to legalize MDMA upon a federal government legalization, it will be the first state to do so. Not only is this interesting since MDMA is currently Schedule I, but its also interesting because it means passing a bill which relies 100% on another legal change at a higher level. However this goes, it will be interesting to watch it pan out.

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COMPASS Pathways Magic Mushroom Drug Shows Very Positive Results in IIb Trials

As the psychedelics industry grows, more companies that once would never have had the option, are now going public. Such is the case with COMPASS pathways, which is getting closer to a legalization with the positive results of its magic mushroom trials. Not only are trials going well, but the company has been publicly traded since 2020.

COMPASS Pathways is looking good with its magic mushrooms trials, and is getting that much closer to an FDA approval. It’s new drug COMP360 is a psilocybin treatment that the FDA is already helping promote with its ‘breakthrough therapy’ designation. We’re here to cover everything going on in this new and emerging medical field, and you can keep up by signing up for The Cannadelics Weekly Newsletter. Get all the latest news in the industry, and be the first to gain access to new deals and offers on psychedelic products, as they start to enter the market.


What is COMPASS Pathways?

COMPASS pathways is a UK-based mental health agency that works to accelerate access to innovative treatments for patients. Established by George Goldsmith and Ekaterina Malievskaia, the company came out of the pain and depression of their personal lives, and the realization that current mental health treatment models are not adequate in providing real world answers to these problems.

With that idea, the two partnered with Lars Christian Wilde to form COMPASS Pathways in order to find and promote better mental health treatment methods. As per the company, “Every one of us is committed to discovering and developing new therapies that will help patients and their families, and ease the burden on our overstretched healthcare systems. For too many people, mental health care today isn’t good enough. We are determined to change that.”

The first major initiative of the company is the COMP360 psilocybin therapy, which is undergoing trials. How effective have these trials been? Not only have recent trials turned out positively, spurring COMPASS into going public, but positive results were shown so early, that COMPASS received ‘breakthrough therapy’ designation from the FDA in 2018 for the treatment. And this even though psilocybin is a Schedule I – and therefore completely illegal – drug. This psilocybin treatment is aimed at helping those with major depression.

COMPASS magic mushroom trials

What are these trials which propelled COMPASS pathways to an IPO in 2020? COMPASS Pathways has been working on psilocybin trials for several years, with results of its IIb trials showing reduced symptoms of depression. The trials were randomized, controlled, and double-blind, meaning the researchers and trial participants were all unaware of who was getting what treatment; and the people chosen for different groups were chosen randomly.

COMP360 is the specific psilocybin drug used in the trials. This was given to 233 patients who were also given psychological therapy at the same time. All participants stopped other antidepressant medication prior to trials beginning, and were given only one dose, of either 25mg or 10mg, which was compared to a 1mg dose as well.

According to COMPASS, there was a “statistically significant and clinically relevant reduction in depressive symptom severity after three weeks.” These phase II trials are specifically about finding correct dosing. The designated dose will go on to be used in phase III trials, which are last before a drug can be approved. According to trial information, 179 participants did report an adverse effect, but generally nothing more than headaches, nausea, fatigue or insomnia. 12 reported more serious effects like suicidal behavior, intentional self-injury, and suicidal ideation. Overall, over 90% of treatment-emergent adverse events were considered only mild.

Says George Goldsmith, COMPASS’s CEO, “We set out to explore the safety and efficacy of COMP360 psilocybin therapy in treatment-resistant depression, through a rigorous and large-scale trial, and to find an appropriate dose to take to the next stage… With these compelling data, we will urgently progress our clinical development program and move closer to making this therapy accessible to patients in need, if approved.”

More specifics of the COMPASS magic mushroom trials

Here’s some more of what was specifically found in the trials. When comparing the 25mg group and the 1mg group, the 25mg group had a -6.6 difference on the MADRS (Montgomery-Asberg Depression Rating Scale) at week 3 (p<0.001). This higher mg group showed statistical significance on the MADRS the very next day after the COMP360 treatment was administered (p=0.002).

In terms of the 10mg group compared to the 1mg group, there was no statistically significant difference after three weeks. The MADRS answers were assessed by an independent rating group which was separate from the trials, and unaware of the study design or details of patients.

magic mushroom therapy

At least 2X the participants in the 25mg group showed a positive response and lessening of depressive symptoms at the 3rd week and 12th week, in comparison to the 1mg group. At the 12th week, 20.3% of the 25mg group vs 10.1% of the 1mg group, showed the protocol-defined sustained response. When using a consistent definition of ‘sustained response’, in line with other TRD (treatment resistant depression) studies, the difference becomes 24.1% of the 25mg group vs 10.1% of the 1mg group.

Of the 233 participants in the study, 94% had no previous exposure to psilocybin. Participants came from 10 different countries from North America and Europe. All cases were considered treatment-resistant depression, which means they had already undergone two or more anti-depressive treatments, which did not help.

Much like MAPS, which is working on an MDMA medication, and which structured its phase III trials with help directly from the FDA, this is the case with COMPASS pathways as it looks to phase III of its own magic mushroom trials. According to the company’s Chief Medical Officer, “We are now looking forward to meeting with the FDA early in the new year in light of these new data to finalize our plans for the phase III program, which we expect to begin in Q3 2022.”

COMPASS Pathways is publicly traded

COMPASS is not some little dingy company rooting around in the dirt. It is, in fact, a high profile company, and a publicly traded one, despite the fact it works with a Schedule I substance. COMPASS completed its IPO in late October 2020, even ringing the Nasdaq Stock Exchange opening bell to celebrate on October 26th, 2020. For the IPO the company raised $146.6 million.

At the time of the bell ringing, Goldsmith said, “I am honored to be ringing the Nasdaq opening bell on behalf of everyone at COMPASS Pathways. We are on a mission to transform mental health care and I know that every member of our 60-person team shares our strong sense of purpose and our determination to reduce the personal and economic burden of mental health suffering.”

Not only is COMPASS publicly traded, but it’s also got an FDA stamp of approval…to a degree. No, nothing has been officially approved, of course, as COMP360 is still undergoing trials. But it got as close as it can for now. On October 23rd 2018, it was announced that the US’s FDA gave COMP360 a ‘breakthrough therapy’ designation. COMPASS is NOT the only company to receive this for magic mushroom research, though. In 2019, Usona Institute also got a breakthrough therapy designation from the FDA for its magic mushroom drug.

breakthrough therapy

This designation is given when “preliminary clinical evidence shows that it may demonstrate substantial improvement over available therapy. Breakthrough Therapies are supported by the FDA throughout the clinical development program to ensure as efficient a process as possible.” In other words, it’s meant to get a product to market faster.

COMPASS pathways is one of several growing companies that support the medical use of psychedelics. It is a major point of interest for those who want to invest in the emerging psychedelics market, and will likely be the first company to have a psilocybin medication officially approved.

Conclusion

As COMPASS Pathways gets into Phase III of its trials, it gets that much closer to an endpoint where its drug COMP360 can go up to the FDA for approval. If it gets there before MAPS gets its MDMA drug there, (and before Usona gets its own magic mushroom drug there) it will be the second company to have a psychedelic drug approved for mental health purposes. Johnson & Johnson was first with its ketamine-sister-drug esketamine, under the name of Spravato, which was approved in 2019.

Should this happen – and it looks like we’re going in that direction, this would mean a much more high-profile legalization than what Spravato got, and a new reckoning for how the US federally regulates psychedelic drugs. It could even push forth an entire federal medical psychedelics legalization. Stay tuned to life to find out what happens.

Hello readers! Welcome to CBDtesters.co, the most comprehensive web spot for all-around independent coverage of cannabis and psychedelics-related news. Read-thru the site regularly to keep up-to-date on the exciting and fast-paced universe of cannabis and psychedelics, and check out The Psychedelics Weekly Newsletterfor your daily dose of industry news.

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Psychedelic Healthcare – Brought to You By Dr. Bronner’s And Enthea

As psychedelics grow in popularity, particularly ketamine due to a legal medical loophole, new questions have popped up. Like, if this treatment is so good, why can’t it be offered to employees of a company? Well, that’s exactly what specialty soap maker Dr. Bronner’s, and the Enthea Psychedelic Healthcare platform are doing, offering workers psychedelic healthcare. Read on to find out more.

Though most psychedelics are still Schedule I, interest in their healing abilities has gotten to such a fever pitch, that psychedelic healthcare options are now being offered for employees. Dr. Bronner’s might be the first, but companies interested in their employees’ well-being, will be quick to look into methods that help keep employees happy and working well. We report on everything related to the emerging field of medical psychedelics, and offer the best stories going on today. Sign up for The Cannadelics Weekly Newsletter to stay on top of everything newsworthy in the industry. Plus, as products and deals become available, be first to get access!


Who are Dr. Bronner’s and Enthea?

Before getting into what they’re doing together, let’s first get into what they are. Dr. Bronner’s is a family run business that specializes in natural soaps, with the business dedicated to producing socially and environmentally responsible products. It’s product catalogue consists of shampoo, body soap, toothpaste, lotion, balm, laundry cleaner, coconut oil, shaving cream, sanitizer, and apparently, some delicious looking fair trade chocolate bars.

The company produces organic and fair trade products, many of which are vegan, and which hold the same certification as organic foods. According to the company, it uses no synthetic preservatives or foaming agents in its products. The company takes part in regenerative organic farming projects, and soil enrichment and tree-planting programs, as well as using 100% post-consumer recycled packaging, and aggressive waste and water-use reduction techniques.

While Dr Bronner’s is certainly not the most highly advertised brand, it has continued to do well, with a sales increase from $4 million in 1998 to $122.5 million in 2018. Dr. Bronner’s is big on activism, and has paid out over $8 million of its sales income to different charitable causes during that time, including $5 million to MAPS (Multidisciplinary Association of Psychedelic Studies), which is the company currently spearheading trials for MDMA, which were designed in conjunction with the US’s FDA.

Enthea Psychedelic Healthcare is a company that provides safe and affordable access to psychedelic treatments, and which is on its own personal mission to get psychedelic assisted therapy into general healthcare coverage for companies. The non-profit benefit plan administrator “provides health plan benefit riders and single case agreement services for psychedelic healthcare.”

The company works with a list of provider networks, which include practitioners for ketamine-assisted therapy and psychedelic-assisted therapy, all of whom have the proper certifications and credentials. The company aims to help create healthcare plans that are affordable for companies, and which provide workers with all necessary healthcare options, including psychedelic therapy. The company deals with medical policy development, manages provider networks, and administers benefit plans.

What’s the news on psychedelic healthcare?

On February 28th, 2022, Dr. Bronner’s released a press statement regarding a partnership between the family-owned company and Enthea Healthcare. This makes Dr. Bronner’s the very first company to offer its employees access to psychedelic therapy as part of its mental healthcare benefits. This is currently in the form of ketamine therapy only, as ketamine/esketamine are the sole drugs which are legal for this treatment right now.

According to the press statement, the partnership came out of a shared appreciation for psychedelic assisted therapy, with the belief that these practices should be a standard part of healthcare offered to employees. Says Dr. Bronner’s President, Michael Bronner, “The health and well-being of our employees is the primary driver in how we think about benefits and compensation. Offering coverage for ketamine assisted therapy is in the interest of providing tools to our workforce to have the best quality of life and best options for mental healthcare.”

Continued Bronner, “Our family and company are no strangers to depression and anxiety. We are deeply concerned about the mental health crisis society is facing, especially in the context of the Covid-19 pandemic. Considering all our advocacy on this issue, this employee benefit is the next logical step.”

Dr Bronner’s offers all of its employees quality health coverage, making no differentiation between high-ranked and low-ranked employees on this matter. Healthcare is offered as a no-deductible PPO health insurance plan for worker’s families as well. The company pays the entire health premium costs as well as all deductibles, so employees don’t need to make out-of-pocket payments. The company very obviously cares about quality of life for its employees, and sees ketamine as a way to further overall worker health and satisfaction.

health care

What does psychedelic healthcare mean for employees?

Starting on January 1st, 2022, Dr. Bronner’s employees have received this new coverage, which offers, as an initial health benefit, integrated ketamine sessions with specialized counseling, for the improvement of mental health issues. Enthea plans to expand its offered treatments to include psychedelics legalized in the future, including MDMA and psilocybin, which both have FDA breakthrough therapy status, and which are currently undergoing trials.

Lia Mix, Enthea’s CEO, makes a great point when she states: “We anticipate both human and financial return on these organizations’ investment in covering psychedelic healthcare”, an interesting way to look at it considering how much time and money is lost by companies because of employee mental health issues. How much? According to nsc.org, “employers that support mental health see a return of $4 for every dollar invested in mental health treatment”, as per research released by the University of Chicago’s National Safety Council and NORC.

The same analysis went on to say that employers “spend over $15,000 on average annually on each employee experiencing mental health issues.” The analysis also gives some other interesting statistics, like that mentally distressed employees on average use about $3,000 more yearly for healthcare services than their non distressed peers, and that the cost for days lost is averaged at approximately $4,783 every year per employee. This leads to an average turnover cost of $5,733 each year per employee.

Given these numbers, and that 85% of employees report they feel distressed at work simply from the workplace alone (without factoring in all the distressing outside-of-work issues that one faces in life), it certainly makes sense for companies to provide the best possible mental healthcare benefits to their employees.

Ketamine for mental health

Ketamine and esketamine are two sister drugs that share the same chemical formula of C13H16ClNO. Ketamine was found first, in 1962, by Parke-Davis pharmaceutical company. By 1970 it was cleared by the FDA for use as an anesthetic. When this happened, despite an already existent understanding that ketamine could be used for pain relief, and that it did have an effect on affect, it was not approved for anything more, and has not been since that time.

On the other hand, esketamine was discovered in 1997 in Germany, while researchers were once again looking for an anesthetic. It was discovered during testing that esketamine was good for depression, though this was at least partially understood before this time in regards to standard ketamine. Esketamine is technically called ‘S-enantiomer’ ketamine, whereas the ketamine used in clinics is called ‘racemic’ ketamine.

ketamine

A racemic mixture refers to a compound that contains “equal quantities of two enantiomers, or substances that have dissymmetric molecular structures that are mirror images of one another.” In this case, R- and S-ketamine. Enantiomers refers to a “pair of objects related to each other as the right hand is to the left—that is, as mirror images that cannot be reoriented so as to appear identical.” Esketamine is therefore S-ketamine only (get the name?), while racemic ketamine includes both enantiomers.

While some studies say esketamine is “reported to be less prone to psychomimetic side effects, such as derealisation and hallucinations”, like this study from 2009, entitled Comparison of racemic ketamine and S-ketamine in treatment-resistant major depression: report of two cases, the general consensus seems to be that they both do the trick, with only minor differences between them.

Apart from major depression, for which the US government approved esketamine in 2019 – along with suicidal ideation, which was approved in 2020, ketamine has shown useful for a number of other psychological issues. Not only has testing uncovered benefits for those suffering from anxiety and PTSD, but with women experiencing postpartum depression, and people with eating disorders. To take it a step further, it’s been known since the 1964 prisoner studies that ketamine offers a safe way to treat pain. Yet this has yet to be an approved feature of the drug, despite the safety of ketamine, and the growing opioid epidemic that claims in the neighborhood of 70,000 deaths per year.

Conclusion

With this new deal between Dr. Bronner’s and Enthea, psychedelic healthcare is now underway. Given how quickly the industry moves, perhaps we’ll see this as a standard part of healthcare options for employees within the next decade. Certainly, if a company wants a good return on investment into its employees, it’ll be quick to look into whatever methods help keep employee populations happy and unstressed.

Hello readers! Welcome to CBDtesters.co, the premiere web spot for current and thought-provoking independent cannabis and psychedelics-related news reporting. Stop by every day to keep yourself informed on the quickly-moving world of cannabis and psychedelics, and subscribe to The Psychedelics Weekly Newsletterfor daily coverage of industry news.

DisclaimerHi, I’m a researcher and writer. I’m not a doctor, lawyer, or businessperson. All information in my articles is sourced and referenced, and all opinions stated are mine. I am not giving anyone advice, and though I am more than happy to discuss topics, should someone have a further question or concern, they should seek guidance from a relevant professional.

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Look How Badly the Government Wants You to Use ITS Ketamine Only

The government sure loves running smear campaigns when it wants its people to believe a certain way, which sometimes seems to be to promote the sale of one product or service over another. These campaigns run rampant in the cannabis and psychedelics industries where Big Pharma is scrambling to gain control from black or gray markets. In just another showing of this, the government released yet another fear tactic smear campaign because it only wants patients to use its ketamine. Take a look.

The government approved one kind of ketamine, called esketamine, and it only wants you to use that one! Problem is, there’s a big wide gray market for ketamine that seems way more inviting, and comes with less restrictions. Why does the government care so much then, when both seem perfectly safe? We cover everything important in the emerging psychedelics industry, and work hard to bring you the best stories out there. Subscribe to The Psychedelics Weekly Newsletter to keep up with everything going on. And make sure you’re up-to-snuff on all the important psychedelics talking points of today.


What is ketamine?

Ketamine has been very much in the spotlight recently, with a strange push-and-pull now going on between the legal market and the gray market. Ketamine (C13H16ClNO) is a dissociative psychedelic that sits in Schedule III of the Controlled Substances list because of its approval as an anesthetic. This makes it different then nearly every other psychedelic compound, which are Schedule I, meaning the federal government decided they are dangerous and with no medical value.

Ketamine was formulated by scientists at Parke-Davis pharmaceutical company in 1962, for use as a strong anesthetic. It is said to have cataleptic, analgesic, and sedative properties, but not hypnotic properties. It is considered dissociative because it can make users feel that different parts of their brains are disassociating from each other. It was written as “electrophysiological and functional dissociation between thalamocortical and limbic systems.”

It was approved for use as an anesthetic in 1970. But it was never approved for anything else, and this despite prisoner studies from the 1960’s showing that not only did ketamine have effects on psychological issues (which were not completely flushed out at the time, but which were later more elucidated), but that it was also a good treatment for pain issues. It became a staple recreational drug in the 1980’s club scene.

Since ketamine is Schedule III, and therefore legal, it can be prescribed by any doctor for off-label use. This refers to using it for something that’s not what it’s approved for, but which can be legally done if the doctor feels that the drug can still be useful for a patient. This is cleared by the FDA, so there’s nothing illegal about the practice, and the practice has led to a large and quickly growing ketamine gray market, where the drug is offered in clinics to help with psychological issues, and pain.

Though ketamine must be prescribed by a doctor, it has no regulation attached for its uses for pain and psychological disorders outside of major depression, meaning there is no added tax structure by the federal or local governments. This is because if a drug isn’t approved for what its being used for, it can’t have a tax regulation structure set for it. To give an idea how the government must feel about that, consider how many taxes are levied on the legal cannabis industry, often to the point of raising prices so far above black market prices, that legal markets, though they can bring in money, realistically have not shown the ability to fully compete.

And then came esketamine

Usually when a new drug is up for approval, especially when that drug comes from a controversial class of drugs like psychedelics or cannabis, it generally is the subject of intense debate. All conversations related to different states legalizing either of these drug classes, are riddled with debaters trying to prove points on both sides.

So it’s a little shocking that in 2019, the US federal government legalized a psychedelic medication, without any conversation, or public knowledge of it at all. Under cover of night decisions and legislation are usually a tactic to get something through expressly without the public knowing, for fear of negative opinions causing issues.

Esketamine shares the same chemical formula, but was discovered much more recently in 1997. It was discovered by German scientists, who were in the search for a better anesthesia, and this was its initial purpose as well. While it was being used in this way, it was noticed that it provides strong anti-depressant effects. It was released in the US on March 5th, 2019 as the Johnson & Johnson drug Spravato. Whereas regular ketamine is generally given by IV, Spravato has only been cleared as a nasal spray.

But the government didn’t approve the ketamine being used in the gray market, it legalized a nearly identical, but mildly different version, called ‘S-enantiomer’ ketamine. The kind being used in the gray market, is ‘racemic’ ketamine. In general, “Ketamine is a racemic mixture containing 2 mirror image molecules, R- and S-ketamine.”

ketamine for pain

A racemic mixture is a compound that has “equal quantities of two enantiomers, or substances that have dissymmetric molecular structures that are mirror images of one another.” Enantiomers are a “pair of objects related to each other as the right hand is to the left—that is, as mirror images that cannot be reoriented so as to appear identical.”

This means that ‘racemic ketamine’ is ketamine with both enantiomers, and ‘S-enantiomer ketamine’ (approved as esketamine) is only the S-enantiomer of ketamine. How much difference is there? Well, in one study from 2009 called Comparison of racemic ketamine and S-ketamine in treatment-resistant major depression: report of two cases, it was found that S-ketamine use was “reported to be less prone to psychomimetic side effects, such as derealisation and hallucinations.” The conclusion was that “S-ketamine might exert similar antidepressant effects as ketamine in drug-resistant depression but may be better tolerated by the patients.” It should be remembered that psychedelic therapy tends to rely on some of the effects mentioned. No one complains that psilocybin causes hallucinations in therapy.

Another one from 2021, Compounded intranasal racemic ketamine for major depressive disorder: A case report, which is a case study of one patient, found that racemic ketamine treatment of a patient with major depression was successful after three doses. As per study investigators “Intranasal ketamine was not associated with significant adverse drug effects and facilitated a relatively short hospital admission. The case report provides support for the use of intranasal racemic ketamine as adjunctive treatment for MDD.”

Why the debate?

The ketamine loophole has allowed for a very large gray market to grow in the US, and which is spreading around the world. Back in 2015 there were about 60 operational clinics giving ketamine therapy in the US. By 2018, that number was up to about 300. With the boom in psychedelics felt all around, that number has surely increased greatly, and this can be seen by simply pulling up an app like Google Maps, going to a location, and looking for ketamine clinics. You might be surprised by how many there are. Most are independent locations, while some like Delic and Field Trip Health run chains with multiple locations across the US and beyond.

Obviously, the US government doesn’t want an industry it can’t control, and as Big Pharma pumps tons of money into the government, it suffices to say that the government will do its bidding. Except that it seems to have messed up with esketamine. Or maybe it wasn’t a mess-up at all. Esketamine prescriptions require use of a standard anti-depressant, which is a major detraction for those who do not want them. And more importantly, despite being well-researched for its ability to help with pain without causing an addiction, it was never cleared for this. Even though the opioid death rate increases every year.

Since esketamine has not seemed to make much chink in the ketamine market, the government has resorted to what it does best: smear campaigns. And this time, its geared toward compounded ketamine nasal sprays, which are in competition with the government-cleared esketamine nasal spray. A compounded drug is a drug formulation made specially for an individual patient, so in this case, it would be a ketamine formulation that involves something else as well, but which is based on racemic ketamine.

esketamine

In a February 17th, 2022 fear article called FDA: Safety Concerns With Compounded Ketamine Nasal Spray, its states that “In animal studies, the use of racemic ketamine has been shown to cause brain lesions in rodents, whereas this association was not observed with esketamine.” Except this doesn’t get mentioned much, not even in this 2016 review called Ketamine enantiomers in the rapid and sustained antidepressant effects, which sources from tons of research out on ketamine. In fact, of R-ketamine, it concludes, “R ketamine appears to be a potent and safe antidepressant relative to S ketamine.”

The FDA points out that: “In recent years, the FDA has received a number of reports of pharmacies compounding nasal spray formulations of ketamine either alone or in combination other ingredients.” If a patient is given ketamine, its by a doctor’s prescription and guidelines. Most ketamine therapy does take place in clinics, but this doesn’t mean a pharmacy can’t fill a valid doctor’s prescription. If this was illegal, the FDA wouldn’t complain about it, it would shut pharmacies down. Since it can’t, it’s trying to make them sound dangerous. Compounded medications may not be FDA-approved, but neither is ketamine for pain, and that doesn’t mean using it that way is illegal, because its not. And it also doesn’t seem to be dangerous.

And then the article continued with this fear tactic: “A search of the FDA Adverse Event Reporting System (FAERS) database and the medical literature revealed 5 cases that were associated with psychiatric events, as well as abuse and misuse between 2016 and 2021.” Five whole cases? Which didn’t end in death, and realistically might have been cleared up within a short period of time? And over five whole years? Kind of makes it sound pretty safe. In fact, with all those clinics in operation, and no stories of issues whatsoever besides this one, it kind of seems like this is the government trying to scare users into only using the legally approved and government taxed version of ketamine.

How this mirrors Quaaludes

Weirdly, the ketamine industry of today mirrors the Quaaludes industry of the 60’s and 70’s. Use of Quaaludes (or methaqualone) was so widespread, that in 1981 the DEA claimed that Quaaludes were second only to cannabis in popularity, and that 90% of production was exclusively for the black market. In 1980, the government announced there were more than 20 million Quaaludes on the street and that that number would likely double in a year. It was even being prescribed in ‘stress clinics’ whereby patients didn’t need to go to a primary care physician, much like the ketamine clinics of today.

So what happened? A bunch of smear campaigns about the danger of the drug that comically included complaints of about 117 deaths in a year (1980) from legally prescribed Quaaludes, which when compared to 70,000+ deaths a year from opioid overdoses, really puts the safety of Quaaludes in perspective. A statistic from Dade Country Florida backs this up (there are very few death statistics out there for Quaaludes), where it was reported there were 246 methaqualone deaths in an 11-year period from start of 1971 to the close of 1981. Considering that same county had 300 overdose deaths in 2019 alone, it speaks volumes to the actual safety of Quaaludes.

So the drug worked well, and for a sedative, had a pretty low death rate (so long as you don’t buy the government hype). But it was also nearly only existent on the black market, meaning no profit for government or Big Pharma. So the US went around the world and shut down almost all production of it, which essentially eradicated it entirely. It still exists in black markets in India (where it was made), and Africa (where it was first used as an anti-malaria medication), but is absent from the streets of America. Methaqualone was replaced by benzodiazepines which boast a higher kill rate, but which don’t exist so widely in a black or gray market. So, maybe it makes sense that the government is trying so hard to dissuade people from the ketamine gray market, which way overshadows the legal one. It would be harder these days to shut down production of ketamine all around the world.

ketamine prescription

Conclusion

It’s not my job to tell you if you should be hesitant to use a compounded ketamine nasal spray, racemic ketamine, or the government sanctioned version. But one thing is for sure, if you don’t want to take an antidepressant with your ketamine treatments, or want them for pain, you only have the choice of the gray market anyway. With no statistics showing a real concern – let alone a grave enough one for warnings from the FDA, it seems this is just another tactic of the US government to get you to take their drug, over the one you can also legally get in a ketamine clinic, but which the government doesn’t make extra money from.

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DisclaimerHi, I’m a researcher and writer. I’m not a doctor, lawyer, or businessperson. All information in my articles is sourced and referenced, and all opinions stated are mine. I am not giving anyone advice, and though I am more than happy to discuss topics, should someone have a further question or concern, they should seek guidance from a relevant professional.

The post Look How Badly the Government Wants You to Use ITS Ketamine Only appeared first on CBD Testers.

Psychedelics as New Answer for Neurodegenerative Diseases

Psychedelics have been in the spotlight of late, with study after study into different compounds showing that there are different, more efficient, and physically healthier ways to treat issues like depression, other psychological issues, and pain. So is it that surprising that psychedelics have also shown promise as a treatment for neurodegenerative diseases?

As psychedelics gain prominence for help with psychological issues, they are also being looked at as an answer for neurodegenerative diseases. As there is currently no real answer to these problems, compounds like LSD, and psilocybin provide answers not currently seen in Western medicine. We’re here to cover everything interesting in this new and emerging medical field, and you can follow along by signing up for The Psychedelics Weekly Newsletter. Get the latest on what’s going on, and when new deals on psychedelic products and paraphernalia become active, be the first to have access.


What are neurodegenerative diseases?

Think of that grandparent, or great uncle, who seemed to forget your name over the years. The one (or maybe several) that started to lose their keys, started mixing new events with old memories, or started telling stories like they were living 50 years ago. These are some of the most noticeable symptoms of neurodegenerative diseases like dementia, which we often see as Alzheimer’s disease.

Neurodegenerative diseases are the accumulation of neurodegeneration, a process in which “nerve cells in the brain or peripheral nervous system lose function over time and ultimately die.” Though symptoms of these problems can be treated, “there is currently no way to slow disease progression and no known cures.” The instance of these diseases rises greatly in the elderly, with a 2021 report by the Alzheimer’s Disease Association estimating that approximately 6.2 million Americans have the affliction, while another 1.2 million will have Parkinson’s by 2030.

Alzheimer’s and Parkinson’s are the two most prevalent neurodegenerative disorders, but the class of diseases also includes several other well-known entries, as well as some lesser-known issues. Huntington’s Disease is on the list, which is generally inherited by way of a mutation in the huntingtin gene, and which results in the gradual worsening of physical abilities and coordinated movement, including the ability to speak. Multiple sclerosis, a demyelinating disease where the covers of nerve cells in the brain and spinal cord are damaged, results in physical, mental, and psychiatric issues.

Multiple system atrophy, a product of degeneration of neurons in different parts of the brain, results in slower movement, tremors, rigid muscles, autonomic dysfunction, ataxia, and a general feeling of unsteadiness. Amyotrophic lateral sclerosis (aka Lou Gehrig’s disease), causes the loss of voluntary muscle control due to the loss of motor neurons. And brain issues caused by prions are included too, which involve misfolded proteins that act like cancer in the brain, spreading their dysfunction. Prion diseases are not well understood, and stand out as a variance to the general understanding of viruses, bacteria, fungi, and parasites.

It is expected that somewhere in the neighborhood of 50 million people in the world currently live with some neurodegenerative disease. This number is estimated to rise to about 152 million by 2050. This makes sense as life expectancy rises, leading to more and more people in the general age range to get dementia, with those in poorer countries where there are fewer medical and nutritional options, showing the highest numbers. Global costs of these diseases run about US$1 trillion per year. As these diseases can’t be cured, and while there are things that can decrease likelihood of getting one, (like drinking less alcohol, or not having diabetes), there is nothing in the currently accepted repertoire of Western medicine to keep them from happening.

Psychedelics and neurodegenerative diseases

Psychedelics are drugs that fit under the heading of hallucinogens, which are themselves part of the grouping of psychoactive substances. They are primarily known for their ability to induce hallucinations, which are sensory experiences that though experienced, don’t actually exist. Beyond this, they are known for causing users to feel euphoric, spiritual, connected to others and the universe, mystical, and to promote life-changing experiences. Recently, they have repeatedly shown to help with psychological disorders and pain issues.

The idea that they can help change a person’s affect, makes it unsurprising that psychedelics have also been eyed for their ability to help with neurodegenerative diseases. And one such study pointing this way comes out of Yale, called Psilocybin induces rapid and persistent growth of dendritic spines in frontal cortex in vivo, which was published in July 2021, in Neuron. In this study, the scientists used imaging of mice brains to show that psilocybin allowed for increases in spinal size and density, changes which were still in effect a month after administration. The study also showed that psilocybin helped improve behaviors related to stress, and helped deal with increased neurotransmissions due to excitation. Overall, the study showed how psilocybin can help to rewire the cortex of the brain with long-term results.

This is backed up by a September 2021 clinical review entitled: From psychiatry to neurology: Psychedelics as prospective therapeutics for neurodegenerative disorders, which investigated research into how “psychedelics may act therapeutically on cells within the central nervous system (CNS) during brain injuries and neurodegenerative diseases.” The final assessment of the review? That “Psychedelics stimulate neuro- and gliogenesis, reduce inflammation, and ameliorate oxidative stress. Therefore, they are promising candidates for future therapeutics for psychiatric, neurodegenerative, and movement disorders.”

The review seeks to “discuss the current state of the art of how psychedelics influence neural tissue homeostasis and activity.” The study authors further clarify, that this is not just about dealing with symptoms either, but that psychedelics may be “disease-modifying therapeutics, and not simply just providing symptomatic relief”, with clinical trials that have “demonstrated both safety and efficacy for their therapeutic use in controlled clinical settings.” They sum it up with, “Therefore, the use of psychedelics as therapeutics is very promising and should be further developed, paying special attention in the future to prospect applications in neurodegenerative diseases.”

neurodegenerative

Another review from 2020 came to similar conclusions, but stated the need for much more research. Psychedelics as a Treatment for Alzheimer’s Disease Dementia points out that “Animal models testing the neurobiological effects of psychedelic compounds have demonstrated hippocampal neurogenesis at lower doses and suppression at higher doses and potent neuroprotective properties.” It further states that neuroplasticity changes suggest “a potential role for both sub-perceptual “micro”- and psychedelic-doses as a strategy for neuroprotection and cognitive enhancement in prodromal AD (Alzheimer’s disease).”

Going back to 2019, and there’s further reason to look at psychedelics for the treatment of neurodegenetative diseases like Alzheimer’s. That year, New York-based biotech company Eleusis Therapeutics finished phase I of trials into how LSD can be used for the disorder, completing the phase with 48 healthy volunteers, with an average age of 63. “The trial compared three ‘microdoses’ of LSD – 5, 10 and 20 micrograms – to placebo and found no significant differences between the groups on cardiovascular measures like ECG reading and blood pressure as well as other clinical measures, other than a slight increase in headache.”

These amounts were not enough to induce a psychedelic response in participants. As of June 2021, the company was working on Phase II, with the examination of microdosing LSD on Alzheimer’s patients.

According to Eleusis CEO and founder Shlomi Raz in an interview with Forbes magazine in 2020, “LSD in particular seemed like an attractive candidate for such a therapeutic approach, as it is capable of potent and prolonged activation of the serotonin and dopamine neurotransmission receptors implicated in Alzheimer’s disease, and specifically the serotonin 2A receptor.”

Psychedelics legality

It’s important to remember that psychedelics were illegalized in the late 60’s and early 70’s, because this means that research into their capabilities was greatly stymied. Why exactly they were illegalized is a highly debatable subject, though the idea of danger which was so tightly tied to them during these times, seems to have been greatly proved wrong. Especially in consideration of the much more dangerous drug options, like opioids, which have been made widely available, despite psychedelic drugs providing the same benefits, with no real death count attached.

One of the biggest hits to the government line happened in 1994, when former Assistant to the President for Domestic Affairs, John Ehrlichman, who worked under President Nixon, made this statement about anti-drug measures taken during that administration:

psychedelics

“The Nixon campaign in 1968, and the Nixon White House after that, had two enemies: the antiwar left and black people. You understand what I’m saying? We knew we couldn’t make it illegal to be either against the war or black, but by getting the public to associate the hippies with marijuana and blacks with heroin, and then criminalizing both heavily, we could disrupt those communities. We could arrest their leaders, raid their homes, break up their meetings, and vilify them night after night on the evening news. Did we know we were lying about the drugs? Of course we did.”

Psychedelics were very much tied to the anti-war movement, and their criminalization started in 1968 with the Staggers-Dodd Bill which made LSD and psilocybin illegal. This was followed by the 1970 Comprehensive Drug Abuse Prevention and Control Act, which enforced stricter measures on pharmaceutical companies and their reporting. Though this doesn’t sound like a bad thing, it worked to rule many drugs out. This was followed up in the US by the 1984 Comprehensive Crime Control Act under President Reagan, which served to allow the emergency banning of a drug by the government, which in turn was used the following year to outlaw MDMA.

On a wider scale, the UN enacted the Convention on Psychotropic Substances treaty in 1971, which placed psychedelic compounds in Schedule I, thereby making a statement that they are dangerous compounds, with no medical value.

In the recent past, however, things have changed, as more comes out about the beneficial properties of psychedelics. This subject was initially investigated in the mid-1900’s before being outlawed; with new researching popping up to supplement it now. Along with this research, a safety profile has developed for psychedelics which includes no real death count. Many locations in the US have subsequently decriminalized psychedelic use, or legalized them for medical use (Oregon), with three states currently working for statewide recreational legalizations: Washington, California, and Michigan.

Conclusion

No one wants to die, and this is probably why this particular topic gets so much attention. End of life diseases come with only one end, and the efforts to find cures for things like dementia attest to how much we don’t want to give up our lives. There are certainly realities related to many of these disorders that undermine the idea of trying to fix them, however, in cases where fixing a problem is applicable, possible, and within reason for someone to live their life, psychedelics could certainly provide a key measure.

Regardless of whether it’s for a child with a genetic condition, or an old person with Alzheimer’s, the growing body of research into psychedelics for neurodegenerative diseases, proposes an option not seen before in Western medicine.

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DisclaimerHi, I’m a researcher and writer. I’m not a doctor, lawyer, or businessperson. All information in my articles is sourced and referenced, and all opinions stated are mine. I am not giving anyone advice, and though I am more than happy to discuss topics, should someone have a further question or concern, they should seek guidance from a relevant professional.

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Phase I DMT Trials Show Consistent And Positive Results

Lots of psychedelic compounds are currently under testing to assess their benefits for treating different psychological issues. Though magic mushrooms, LSD, and ketamine get the most attention, there are many more to consider. Recently, Phase I ended for Small Pharma’s DMT trials into depression, and the results so far are very promising.

Phase I DMT trials look promising which means yet another psychedelic getting closer to legalization. We’re on top of everything important in this growing industry, so sign up for The Psychedelics Weekly Newsletter to stay informed on everything happening now. You’ll also get access to exclusive & premium deals on flowers, vapes, edibles, and more! And don’t worry, our prices on cannabinoids like HHC-O, Delta 8Delta 9 THCDelta-10 THCTHCOTHCVTHCP HHC , won’t break the bank. Head over to our “Best-of” list to find your favorite products, and enjoy responsibly!


What is DMT?

N,N-Dimethyltryptamine, AKA DMT, is a psychedelic compound, meaning it fits under the category of hallucinogenic compounds, which itself is under the heading of psychoactive compounds. DMT is naturally occurring, and can be found in plants such as Psychotria viridis (one half of ayahuasca), in the bark of Virola theiodora, and in the skin of bufo toads, among other places. DMT is processed into a white powder that can be brewed into a tea, snorted, vaped or smoked, or injected.

DMT was synthesized first by Canadian chemist Richard Manske in 1931. It wasn’t found in a plant till years later in 1946 by microbiologist Oswaldo Gonçalves de Lima. It wasn’t until 10 years after that, that the hallucinogenic aspect was discovered, and this when Stephen Szara, a Hungarian chemist and psychiatrist, took DMT he extracted from the Mimosa hostilis plant.

Unlike some psychedelics like LSD and mushrooms, which provide hours long highs, DMT is a relatively short high, lasting 30-45 minutes. When it’s used in ayahuasca, in conjunction with the Banisteriopsis caapi vine, the MAO inhibitors of the Banisteriopsis caapi vine keep the DMT from breaking down as fast, which extends the high by many hours.

DMT is a serotonergic compound, meaning it acts on serotonin receptors, particularly the 5-ht2a receptor. At most/all receptors it acts as a non-selective agonist. Serotonin is a hormone that’s associated with mood stabilization, feeling happy, promoting well-being, but also with anxiety, and depression. Having too little serotonin is associated with depressive issues, while too much is associated with increased activity in nerve cells.

DMT has been used in history going back to around 1,000 years in the Sora River valley in southwestern Bolivia (though this is simply the earliest an artifact of this nature has been found, which doesn’t preclude its use before this time). This is known because of the finding of a pouch which contained both DMT and harmine, which together imply that ayahuasca was being made.

Many scientists believe the human body can create DMT on its own with the pineal gland in the brain. This is thought to happen when a person knows they will die, to minimize the anxiety of dying. However most research into this has been done exclusively on animals. DMT sits in Schedule I of the DEA’s Controlled Substances list, and is a Class A drug in the UK.

Phase I DMT trials

Last year I reported how the very first medical trials ever had started into DMT (called SPL026 for the study). These dose-escalating, placebo-controlled trials were conducted by Small Pharma (a neuropharmaceutical company) in conjunction with Imperial College London, and are being done to investigate DMT for the treatment of depression. Since DMT is a Class A drug in the UK, meaning completely illegal, in order to do the study, the UK Medicines and Healthcare Products Regulatory Agency had to approve the use of DMT in trials. It was announced this was approved in December 2020.

In these Phase I trials, DMT was given to a small grouping of healthy participants in order to judge safety and efficacy. In an upcoming second phase, the drug will be given to patients with depression to test its effects on depression as a part of psychedelic-assisted therapy.

According to Carol Routledge, the chief scientific and medical officer at Small Pharma, “Taking the drug before therapy is akin to shaking up a snow globe and letting the flakes settle… The psychedelic drug breaks up all of the ruminative thought processes in your brain – it literally undoes what has been done by either the stress you’ve been through or the depressive thoughts you have – and hugely increases the making of new connections.” She continues:

DMT frog

“Then the [psychotherapy] session afterwards is the letting-things-settle piece of things – it helps you to make sense of those thoughts and puts you back on the right track. We think this could be a treatment for a number of depressive disorders besides major depression, including PTSD, treatment-resistant depression, obsessive-compulsive disorder, and possibly some types of substance abuse.”

How did Phase I DMT trials turn out?

In September 2021, it was announced that Phase I of the DMT trials had come to an end, leading the way for Phase IIa trials. As explained, this second trial will use patients to start looking at the therapeutic value of the drug.

Small Pharma CEO Peter Rands had this to say about the completion of Phase I: “We are delighted to have made such swift and excellent progress in the seven months since starting Phase I.  The successful completion of Phase I means we can now truly assess SPL026 as a new potential treatment option for patients with MDD. There has been little innovation for patients suffering from MDD in the last few decades and SPL026 has the potential to change the mental health treatment landscape and provide a much-needed alternative therapy for patients.”

Dr. Routledge, explained further, “We have achieved a significant milestone in the development of SPL026. With a strong safety and tolerability profile, now demonstrated, we can move ahead with the first regulated clinical trial of DMT-assisted therapy in patients. These results lay the foundation for Small Pharma’s DMT-assisted therapy as a potential new paradigm in the treatment of MDD.”

What were the general results of Phase I? The main findings thus far, are that:

  • Individuals with no previous psychedelics experience tolerated the DMT well.
  • No statistically significant adverse events were reported, even after a three-month follow-up.
  • Though 20 adverse events were reported, they were all mild (85%) to moderate (15%), and they all resolved themselves quickly.
  • The data points to a strong correlation between the quality of the psychedelic experience and what dose was taken, with a range starting at 9mg going to 21.5mg.
  • A large data set was created that can now be used to effectively find appropriate dosing for the following phase.
  • The DMT cleared so fast from the bloodstream that it was nearly undetectable after 60 minutes, dose unrelated.
  • Psychedelic experiences lasted around 20 minutes.
ayahuasca

Since the end of Phase I in the fall, the second phase, Phase IIa, has been started with 42 patients with major depressive disorder. The main point of this phase is to judge efficacy of a 1-dose model vs a two-dose model, combined with therapy sessions for these patients. This phase also allows the company to gain further information on safety, and how well tolerated the drug is.

For the study, depression levels are measured by the Montgomery-Asberg Depression Rating scale. This will be used to assess if there is a decrease in depression after treatment. The study locations where clinical trial are being held in the UK are Hammersmith Medicines Research and MAC Clinical Research. Topline results can be expected sometime in the first half of 2022 for this part of the study.

Into the future

Though its impossible to say how a study will turn out, or whether it will produce a marketable drug, my guess is that this study will help lead to a medical legalization for DMT in some places. Though the UK is not quite as far ahead as the US in terms of psychedelics, it could be the first to pass such a legalization for DMT.

Should the US consider these study results – and assuming they are positive throughout, it’s quite likely to get a legalization there. The US is already on its way to such legalizations for other drugs. This can be seen in the FDA giving ‘breakthrough therapy’ designations to both psilocybin (twice) and MDMA, which is not only in Phase III trials by MAPS, but which had those trials planned in conjunction with the FDA to ensure results meet regulation.

On a state level, there are tons of locations now that have decriminalized magic mushrooms and/or entheogenic plants as a whole, like Detroit, Seattle, Denver, and the state of Oregon, which also legalized them for medical use. Three states are also attempting to push through state-wide recreational legalization measure. Though the laws are slightly different by location, California, Michigan, and Washington are working to get initiatives through.

Conclusion

We’ve still got plenty of time until final results come in on this study, but the Phase I DMT trials sure show a lot of promise. With psychedelics becoming more accepted, and getting closer to large scale legalizations, its certainly not out there to think that DMT could be one of the first to get a pass.

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DisclaimerHi, I’m a researcher and writer. I’m not a doctor, lawyer, or businessperson. All information in my articles is sourced and referenced, and all opinions stated are mine. I am not giving anyone advice, and though I am more than happy to discuss topics, should someone have a further question or concern, they should seek guidance from a relevant professional.

The post Phase I DMT Trials Show Consistent And Positive Results appeared first on CBD Testers.

‘Breakthrough Therapy’: How the FDA is Pushing for Legal Psychedelics

The psychedelics boom is underway, that’s for sure, and its moving full steam ahead. Perhaps pushed on by the success of the cannabis industry, which has been lighting the way, psychedelics have much more quickly come into the spotlight and gained acceptance. While they are still mainly federally illegal, recent breakthrough therapy designations given by the FDA indicate that at least one government body is pushing for legal psychedelics.

The FDA might not have explicitly stated it, but its breakthrough therapy designations given to companies studying psilocybin and MDMA make a pretty big statement, and it seems the FDA wants legal psychedelic medications. We cover everything important in the growing field of psychedelics, so subscribe to The Cannadelics Newsletter for more stories like this, and to stay on top of the big news items coming out of the industry.


What is a breakthrough therapy?

The FDA – Food & Drug Administration, is the US federal agency that governs and regulates all medicines that can be marketed and sold in the US. The FDA sits under the Department of Health and Human Services, and is responsible for more than drugs, also regulating the food industry, tobacco products, dietary supplements, over-the-counter medications, biopharmaceuticals, blood transfusions, vaccines, medical devices, electromagnetic radiation emitting products, animal food, veterinary products, and cosmetics.

In order to get a medication approved, a compound must go through different rounds of testing through clinical trials. After it has passed this part, a company must submit a new drug application to the FDA, and then the FDA decides whether the medicine should be approved or not. The FDA is the sole body to do this, so if it does not approve, a medication cannot legally be sold.

When a drug is in the testing phase, the company that created it and is having it go through trials, can submit it to the FDA for a ‘breakthrough therapy’ designation. This goes for whether the drug is specifically illegal according to the Controlled Substances list, or not. The term ‘breakthrough therapy’ is defined this way by the FDA, as a:

“…drug that treats a serious or life-threatening condition and preliminary clinical evidence indicates that the drug may demonstrate substantial improvement on a clinically significant endpoint(s) over available therapies.”

What is this designation meant to do? According to the FDA, the “Breakthrough therapy designation is intended to expedite the development and review of drugs for serious or life-threatening conditions.” Let’s say a new drug is going through testing that could be used in place of chemotherapy, and which shows promise as a better option in preliminary testing for treating cancer. Then the company that made the drug can apply for a ‘breakthrough therapy’ designation to quicken its product to market, with the hope that this could in turn save lives.

So the point of it is essentially to speed things up. If the FDA gives this designation, it wants to get the drug through trials, and get it on pharmacy shelves. This, of course, becomes all the more interesting when the drugs in question are Schedule I drugs, deemed by the federal government to be dangerous, and with no medical value. Having said that, we all know the government can get it wrong, as it also has cannabis in Schedule I.

How does the breakthrough therapy designation apply to psychedelics?

The FDA has now officially given out three breakthrough therapy designations to three different companies studying either psilocybin or MDMA. All of which has occurred within the last few years. Which companies got it? And what are they studying?

One company to get such a designation is Compass Pathways which received the designation in 2018 for research into psilocybin for use with treatment resistant major depression. The following year, the company Usona Institute also applied for, and received, this designation for its research into psilocybin for treatment resistant depression.

It doesn’t stop at psilocybin though. In fact, before Compass or Usona got their designations, a 2017 breakthrough therapy title was given to the organization MAPS (Multidisciplinary Association for Psychedelic Studies) for its research into MDMA for PTSD. And in this case, the FDA went a step further than simply giving it the title to speed things along.

MDMA

When it came time for MAPS’ phase III trials, they were designed with help by the FDA. The two organizations came up with a ‘Special Protocol Assessment’ to ensure that trial outcomes would be in line with regulation. So not only has the FDA basically said it’s cool with these drugs being studied for use as medications, but it actually helped one of the companies to make sure that should the study results be positive, that there will be no issue with them breaking regulation. Maybe it’s just me, but this seems to outwardly imply that the FDA wants the drugs approved.

Are all psychedelics illegal?

The recent moves by the FDA to give breakthrough therapy designations to psilocybin and MDMA, is just another part of a general trajectory when it comes to psychedelics. Back in 2019, the FDA very quietly (as in, under cover of night quietly) legalized a form of ketamine for use with treatment-resistant depression, called esketamine. This is odd when you consider just how much of a debate exists with legalizing cannabis, or when it comes to the legalization of pretty much any drug. Why was this done without discussion, or the public being aware at all?

The US government isn’t big on explaining its moves, but it seems the most probable reason for this change, was related to the quickly expanding gray market ketamine industry which relies on off-label prescribing. As ketamine is Schedule III, this is possible within general regulation, but makes for a market that is untaxed by the federal government, at least beyond standard taxing. Think about how many taxes are applied to the cannabis industry. It would be silly to think a psychedelics industry wouldn’t have the same, so ketamine proposes an issue to the US government.

If this burgeoning market was the reason for the esketamine legalization, the government failed on a couple levels. For one, it requires a regular antidepressant to be taken as well, and that defeats the purpose of using esketamine for treatment, while also making it more likely to have drug interactions. And second, it was only cleared for treatment resistant depression despite the large amount of evidence for it to be used for pain. This is odd considering the current opioid epidemic, and the ability for ketamine to not only deal with pain issues, but also possibly with the addictions that have grown around opioids. In fact, the US government has made no mention of using esketamine in this way at all, while 75,000+ people die a year from opioid overdoses.

Apart from esketamine, there’s another psychedelic that has been legal for quite some time: DXM – dextromethorphan. DXM is a dissociative psychedelic which is in the morphinan class, and not only has it been legal since 1958, but despite its known abuse, it’s been an over-the-counter drug the whole time. And one that can be accessed by anyone of any age. DXM can be found in tons of cold medicine products, and the US government has actually turned down initiatives to make it a prescription medication, though some states like California and Oregon have made their own regulation to stop the sale of DXM to minors.

State’s rights and psychedelics

Everything I just went through relates to federal guidelines, but there’s a caveat here, and it’s the same reason we have legal cannabis in 18 states: whatever isn’t covered explicitly by the constitution, falls under ‘states’ rights’, which are also ‘personal rights’. Because of this, psychedelics are not illegal everywhere.

magic mushrooms

Several locations throughout the US have instituted decriminalization measures, including: Denver, Colorado; Oakland, Santa Cruz, and Arcata in California; Ann Arbor, Washtenaw County, and Detroit, Michigan; Washington, DC; Somerville, Cambridge, Northampton, and Easthampton in Massachusetts; and Seattle, Washington.

Not only that, but as of the 2020 elections, the entire state of Oregon decriminalized psychedelics, while legalizing them for medical use. Three more states are looking to up the ante with full state recreational legalization policies: California, Michigan, and Washington. Though they propose different measures in their respective bills, in all cases legalizations would be made for the recreational use of at least some psychedelics, generally in the form of entheogenic plants (plants with psychedelic compounds).

Conclusion

Right now psychedelics are on the cusp of a major growth spurt, aided in part by breakthrough therapy designations from the FDA, the momentum of the cannabis industry, and the lightening mood of the population toward these two drug classes. I tend to think, when there’s this much of a rally, it can be expected that change is coming. So even if the three current states don’t get their bills through this time, something will pass soon enough. The one thing for sure is, psychedelics are coming.

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DisclaimerHi, I’m a researcher and writer. I’m not a doctor, lawyer, or businessperson. All information in my articles is sourced and referenced, and all opinions stated are mine. I am not giving anyone advice, and though I am more than happy to discuss topics, should someone have a further question or concern, they should seek guidance from a relevant professional.

The post ‘Breakthrough Therapy’: How the FDA is Pushing for Legal Psychedelics appeared first on CBD Testers.

How Psychedelics Can Positively Impact Eating Disorders and Self Image

As eating habits and sedentary lifestyles make us balloon out as a general population, for some, it’s about losing weight, and for some its about gaining it. New research into psychedelics show they can be an effective treatment for eating disorders like anorexia and bulimia, where self-image and control can play a big role in a person’s eating habits, as well as overeating disorders like binge eating.

Considering how many bad eating issues are out there, it’s nice to know that a better treatment method might be on the way. Psychedelics for eating disorders represent just one of the many uses this pretty awesome drug class offers. We’re dedicated to bringing you all the important stories in the growing industry of psychedelics, both on the medical and recreational front! For more articles like this one, sign up for the Psychedelics Weekly Newsletterto keep a mainline to all the psychedelic news going on in the world today.


Eating disorders

First and foremost, eating disorders are not medical conditions, they are psychiatric issues. What this means is that there will never be a test to establish that a person has one of these disorders. Rather, the diagnoses are made by psychiatrists based on their opinions of behaviors. Therefore, it’s good to remember that diagnoses are not rules, and different doctors can offer different diagnoses, meaning that diagnoses are subjective in how a specific doctor interprets behaviors.

An eating disorder is generally described as a disorder “in which the people experience severe disturbances in their eating behaviors and related thoughts and emotions. People with eating disorders typically become preoccupied with food and their body weight.” This definition applies to both sides of the spectrum. Those who eat too much, and those who eat too little.

As per the National Eating Disorders Association (NEDA), about 20 million women and half as many men will develop an eating disorder sometime in life. This number is higher in other publications, like The National Institute of Mental Health, which says that approximately 1/4 of college students fall prey to eating disorders. Though different doctors are able to give different diagnoses, the following categories of behaviors are what are looked for when making eating disorder diagnoses

Types of eating disorders

There are six main categories of eating disorders.

eating disorders

#1 Anorexia-Nervosa is the most well-known, or at least the one most associated with the idea of having an eating disorder. Sufferers of anorexia generally limit their food intake, often to the point of noticeable starvation. Anorexia tends to come with BDD – Body Dysmorphic Disorder, in which the sufferer sees their own body in a distorted way, with a general negative connotation. People who have anorexia are very focused on their weight and image, and though it typically affects women, it can be seen in men as well.

#2 Bulimia-Nervosa is another commonly known eating disorder which is similar in some ways to anorexia. In the case of bulimia, however, the sufferer does eat, but follows a binge-purge cycle in which large amounts are eaten in a short time, and then purged back out. Binge periods are characterized by their lack of control, and purging can be done through vomiting, as well as excessive exercise, enemas, laxatives, and diuretics. This is also more commonly experienced in women.

#3 Binge eating might not be thought of as a disorder by some, but it is considered an eating disorder. Binge eating is characterized by the person consuming excessive amounts of food, but with no attempt made to purge it afterwards. Binge eating might be the most common eating disorder, though many people will simply call it ‘overeating’. This behavior is seen commonly in the overweight and obese population. In both this case and bulimia, the binge eating shows a massive lack of control, and the eating in both cases is often accompanied by feelings of shame, guilt, and embarrassment. This has to be a consistent behavior in order to receive the diagnosis.

#4 Pica, #5 Rumination disorder, and #6 Avoidant/Restrictive Food Intake disorder, are all lesser known eating disorders. Pica is defined by an individual feeling hunger for things that are not food. This can involve nearly anything from dirt to rocks to soap, which can obviously cause problems if a dangerous substance is eaten. This disorder is usually experienced by children, pregnant women, and those with mental disorders.

Rumination disorder is characterized by a person regurgitating their food, before chewing again and re-swallowing it. The reflux happens within a half hour of eating and is voluntary. This is a newly recognized disorder which affects both sexes, and which usually sorts itself out in infants. Avoidant/Restrictive Food Intake disorder is about a disturbance in eating habits, which is related to lack of interest, smell, texture, temperature, or something like that. This disorder has nothing to do with food being available or not, and is way more extreme than simply being picky.

Psychedelics as a treatment for eating disorders

Psychedelics are mind-altering compounds in the category of hallucinogens, which are psychoactive drugs. Beyond creating hallucinations, wherein a user has a sensory experience that doesn’t exist, psychedelics are also known for promoting feelings of euphoria, well-being, connectedness, spirituality, and of causing life-changing experiences. There is even a theory that psychedelics are what allowed our brains to evolve. Though this is obviously just theory, it does come with the reasonable idea that psychedelics can change the way we think.

Since eating disorders are about the way people think, and therefore behave, the idea of altering these thought patterns could mean the ability to change how a person behaves with food. As such, according to the authors of the 2021 article Psychedelics and Eating Disorders, the two ways psychedelics stand to help with symptoms of these disorders are: “1) the potential to alleviate symptoms that relate to serotonergic signaling and cognitive inflexibility, and 2) the induction of desirable brain states that might accelerate therapeutic processes.”

1 – Serotonergic signaling and cognitive inflexibility

Psychedelic drugs like LSD, psilocybin, and DMT are known to disrupt the default mode network – DMN, which is often thought of as where the ego resides in the brain. Explain writers Adele Lafrance, PhD and Reid Robison, MD, “The DMN is a collection of pathways that govern our self-image, our autobiographical memories, and our deeply ingrained beliefs and thought patterns.”

psychedelics

They go on to explain, “While results from brain imaging studies in eating disorders are diverse, findings seem to converge on a common theme of overactivity in the DMN, showing up in our clients as rumination over caloric intake and food rules, compulsive exercise or eating behavior patterns, body checking, etc.”

Why does this matter? Well, “like a ski slope, the mind develops and strengthens pathways as we repeat patterns. Every time the thoughts and actions are engaged, the grooves get deeper and deeper, and before long, no matter where we start, we’re likely to slip into the same ruts and end up following the same path down the mountain. When a psychedelic medicine is ingested, the DMN is downregulated, and it’s like the mind benefits from a fresh coat of powder.”

This creates a new slate, which means a break from known patterns, which in turn allows for new connections to be made in the brain, which can lead to new patterns being formed.

2 – Induction of desirable brain states

The second way in which psychedelics might offer help for eating disorder patients, is by the psychedelic drug helping to promote desirable brain states that might be able to quicken therapeutic recovery. “Specifically, the increased neuroplasticity observed with classic psychedelics and ketamine can also be leveraged in the context of psychotherapy.”

For example, “Brain imaging after being administered MDMA shows decreased amygdala activation, and the reduced fear response that follows allows the client to emotionally engage in therapy without becoming overwhelmed by anxiety or negative affective states.”

The authors point to the oft mentioned (by me) MAPS (Multidisciplinary Association for Psychedelic Studies) study into MDMA for PTSD, which is in Phase 3 of its trials. They pointed to the Phase 2 trials, and how after 12 months, 67% of these treatment resistant cases, no longer qualified for PTSD. That says quite a bit about the ability of a drug to help change brain structure.

As one of the participants in the MAPS study stated: “I’m tempted to say MDMA gave me ‘hope,’ but that word isn’t right—the insight was more substantive than hope. I’d held the sensation in my body; I understood, at a visceral level, what might someday be mine: the sense of peace and joy within my body. For me, the therapeutic process could unfurl from there.”

Data was also analyzed from ayahuasca ceremonies in which people with eating disorders participated. According to one participant: “I still experience periods of feeling anxiety, but I feel like they don’t last as long, whereas before, I would spiral downward and get depressed and then start to restrict and start to purge and binge and all of that. I feel like I can notice when my energy is changing, and then I am more able to be with it and sort of resist it, and then it moves after.”

eating disorder recovery

Research into psychedelics for eating disorders

Though there is not yet a large array of published research on the topic, more is being done of late. This isn’t to say that nothing exists from the past, however. This study was published in 1998, Treatment of compulsive behaviour in eating disorders with intermittent ketamine infusions, which assessed the use of ketamine for compulsive thoughts related to eating disorders. The idea being that “memory is a neocortical neuronal network, excitation of which involves the hippocampus, with recall occurring by re-excitement of the same specific network. Excitement of the hippocampus by glutamate-NMDA receptors, leading to long-term potentiation (LTP), can be blocked by ketamine.” Basically, its saying that memory is like a network. That exciting this network creates specific pathways in the brain, that recall can then re-excite. And that ketamine can possibly block this process.

The study involved 15 treatment resistant eating disorder participants, who were given 20mg infusions of ketamine an hour for 10 hours, along with 20mg twice a day of nalmefene, an opioid antagonist. (Opioid antagonists keep participants from losing consciousness from the ketamine.) Treatments were given at intervals of between five days and three weeks. Nine participants showed significant and prolonged decreases in Compulsion scores after the ketamine therapy. As in, they had fewer compulsive behaviors related to eating.

In six cases there was no significant decrease in these behaviors when at least five treatments were administered. The investigators posit that this could be because the compulsive behaviors were re-established too quickly after the infusion, without allowing new connections to be made; or that the nalmefene might have been dosed too low. Even with these six cases, the idea that 60% of treatment-resistant cases were significantly helped, speaks volumes to the possibilities of what ketamine can do. Considering nothing was done to try different dosing, its even quite possible that the six participants who did not show significant results, might have with a little tweaking to the study. Why it is that this was done in 1998, and there seems to be no follow-up, is the bigger and scarier question. It seems something was found here, and then completely buried.

Conclusion

Whether its too much or too little, the idea of bad eating habits to the point of an eating disorder, is way more commonplace than many people think. Though with a quickly expanding (sideways) population, maybe it shouldn’t be. That psychedelics might be an answer to eating disorders and their associated behaviors, is just another benefit that these drugs are offering, along with tons of other benefits like help with PTSD, treatment resistant depression, addiction, and other psychological, and physical ailments.

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Hi, I’m a researcher and writer. I’m not a doctor, lawyer, or businessperson. All information in my articles is sourced and referenced, and all opinions stated are mine. I am not giving anyone advice, and though I am more than happy to discuss topics, should someone have a further question or concern, they should seek guidance from a relevant professional.

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