Study on MDMA for Traumatic Brain Injury Boosted By $1.5M Donation

In a September 14 press release, Wesana Health Holdings Inc. announced its commitment to fund $1.5 million to assess the efficacy of Multidisciplinary Association for Psychedelic Studies (MAPS) MDMA-assisted therapy to treat traumatic brain injury (TBI).

The funding will allow MAPS Public Benefit Corporation (MAPS PBC) to activate a team to evaluate the scope of the lack of resources needed for TBI treatment.  

“Wesana is a serious, thoughtful and ethical company engaged in the development of psychedelic-assisted therapy. What Daniel and his team are doing is in line with MAPS’ ethics, mission, values and scientific rigor, and we believe together, MAPS and Wesana can bring much needed help to the massively underserved TBI population. Data collected from MAPS-sponsored Phase 3 clinical trials suggests that MDMA-assisted therapy appears promising in the treatment of TBI. Consistent with our mission, we seek to investigate treatments for affected patients who can be helped by MDMA—this is an important step in that direction” said MAPS Executive Director Rick Doblin, Ph.D.

Lately, MAPS research zeroed in on MDMA-assisted therapy for PTSD. The first of two Phase 3 trials demonstrated a “clinically significant reduction” in PTSD symptoms for 88 percent of participants. 

Existing research suggests that MDMA improved cognitive function in mice with minimal TBI.  Like PTSD, TBI can have a profound impact on mental health. Research indicates that there is a disproportionate impact for people of color. 

Over 6.2 million Americans are estimated to have chronic TBI-related disabilities, not to mention the symptoms that are more mild but also impact daily life. Nearly 414,000 Iraq and Afghanistan Veterans had a TBI.

“The work MAPS has done for more than 35 years with regulators and clinical researchers to navigate the rigorous and necessary FDA approval process for MDMA therapeutic use has positioned psychedelic-assisted therapy on the precipice of national—and global—acceptance,” Daniel Carcillo, CEO of Wesana Health said. “The millions of people afflicted with PTSD may soon have access to MDMA therapy, and we believe the millions suffering from TBI may experience similar relief in the future.”

This collaboration between MAPS and Wesana will boost MAPS PBC’s research timelines and provide additional support for further research, advocacy, education and equitable access to MDMA-assisted therapy treatments. 

Wesana outlined five key goals:

  • Gain expertise and information to design psychedelic-assisted therapy programs for TBI and improve the Wesana timeline and path to market for its treatments
  • Explore obtaining an exclusive commercial license to use MDMA for the treatment of TBI
  • Evaluate the viability of revenue share agreements between the organizations
  • Adapt MAPS’ equitable access research projects to develop a meaningful patient access program
  • Fund associated research, administered by MAPS PBC, with additional capital

Beyond MDMA, MAPS Pushes Psychedelic Research Forward

MAPS is pushing forward research on a number of psychedelics with potential in medicine. On August 10, MAPS was awarded a $12,979,050 grant from the state of Michigan to fund a study on post-traumatic stress disorder (PTSD) and cannabis.

According to Dr. Sue Sisley, President of the Scottsdale Research Institute and longtime cannabis researcher, this new study is sorely needed in the community.

The grant comes from Michigan’s 2021 Veteran Marijuana Research Grant Program, and is funded by the state’s recreational cannabis taxes. With a goal of determining the “the efficacy of marijuana in treating the medical conditions of United States armed services veterans and preventing veteran suicide.”

The Michigan grant makes it the second clinical trial to give cannabis medicine or placebos to participating military veterans, and according to the Chief Science Officer of the MAPS Public Benefit Corporation, Berra Yazar-Klosinki, PhD, the first trial was a great success.

Now, with the commitment from Wesana Health, MAPS’ research on MDMA can accelerate as well.

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MAPS Organization Granted $12.9 Million to Study Cannabis and PTSD

MAPS, The Multidisciplinary Association for Psychedelic Substances, was awarded a $12,979,050 million grant from the state of Michigan to fund a study on PTSD and cannabis on August 10.

According to Dr. Sue Sisley, President of the Scottsdale Research Institute and longtime cannabis researcher, this new study is sorely needed in the community. “Suicide among veterans is an urgent public health crisis, but it’s solvable if we invest in researching new treatments for pain, depression, and PTSD,” said Sisley in a press statement. “This grant enables more rigorous study, overseen by the FDA, which may lead to cannabis flower becoming prescribable medicine someday. Veterans are demanding objective cannabis drug development research, and the state of Michigan is fulfilling our collective obligation to our beloved Veteran community.”

The grant comes from Michigan’s 2021 Veteran Marijuana Research Grant Program, and is funded by the state’s recreational cannabis taxes. With a goal of determining the “the efficacy of marijuana in treating the medical conditions of United States armed services veterans and preventing veteran suicide.”

MAPS Makes History

This will be the second clinical trial to give cannabis medicine or placebos to participating military veterans, and according to the Chief Science Officer of the MAPS Public Benefit Corporation, Berra Yazar-Klosinki, PhD, the first trial was a great success. “We overcame significant regulatory obstacles obstructing cannabis research to conduct the first clinical trial of inhaled cannabis for PTSD,” said Yazar-Klosinki. 

“This grant funding provides the resources needed to leverage the results from the first trial, conduct a fully-powered clinical trial, and align the body of scientific evidence with cannabis that more closely mirrors what is available within state-regulated cannabis programs.” This trial will be the second of its kind to be conducted so far, and one that is an FDA- and DEA-regulated double-blind, placebo-controlled study.

The study will enlist 320 eligible veterans who have been diagnosed with either moderate or severe PTSD, and also includes those who suffer from major depressive disorder or substance abuse disorders. Four trial sites will be set up, two of which will be located in Michigan. Once participants pass a three-week enrollment period, they will be given five weeks for “self-administering inhaled, self-titrated doses of high-quality botanical cannabis.” This second trial will also use higher quality cannabis to better determine the effects of those who receive medicine versus a placebo.

The Founder and Director of MAPS, Rick Doblin, PhD, expresses the significance of this amount of money from cannabis taxes being used for research efforts. “Michiganders are granting non-profit researchers the opportunity to establish whether marijuana is helpful for Veterans with PTSD. If so, we will seek to return that generosity by developing a public-benefit cannabis pharmaceutical product that would be eligible for insurance coverage, just like any other pharmaceutical drug.”

The first trial was funded by MAPS Public Benefit Corporation (a MAPS subsidiary) which was also responsible for the only FDA-regulated controlled study for PTSD. The study was funded with $2.2 million from the Colorado Department of Public Health and Environment, and was led by the Scottsdale Research Institute. Results of this study showed evidence of the pros and cons to cannabis as a treatment for PTSD patients. According to the MAPS press release, all participating patients showed improvements in their symptoms after three weeks.

PTSD affects a large number of military veterans. According to data from the Veterans Association (VA), about 11-20 percent of veterans who served in Operations Iraqi Freedom and Enduring Freedom suffer from PTSD. Twelve percent of veterans who participated in the Gulf War are diagnosed with PTSD every year. Finally, 15 percent of veterans who served in the Vietnam war are sufferers of PTSD (but the VA also estimates that 30 percent of all Vietnam veterans will be diagnosed with PTSD in their lifetimes).

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Wesana Health to Acquire PsyTech, Emphasizing New Shift to Psychedelics

If you haven’t been paying attention, medical psychedelics are on the rise, with the new industry gaining an impressive foothold even before legalizations occur. In this new move, Wesana Health will acquire Psytech, Inc., giving the company new strength to dominate this new emerging market.

The world changes quickly. Not only is Wesana Health about to acquire PsyTech, Inc., signaling even more growth in the medical psychedelics industry, but our favorite psychedelic – cannabis – has more options for consumers than ever. Take Delta 10, THCV, THC-O or Delta-8 THC for example. This half-brother of delta-9 THC provides users with a slightly less intense psychoactive high, doesn’t produce anxiety, and leaves users clear-headed and energetic. This is amazing for anyone who wants a different option. Check out our array of delta-8 THC products – along with tons of other compounds offered, and take advantage of new drug technologies and formulations.

Wesana will acquire Psytech, Inc., what will this mean?

Wesana Health Holdings, is a life sciences company that specializes in developing and delivering therapies for neurological health issues. The Chicago-based company looks to help patients overcome the damage of physical brain trauma which results in neurological, psychological, and mental health problems. The company was founded recently, in 2020, and looks to develop therapeutic solutions using psychedelic therapies including drugs like: Ketamine (and esketamine, which is currently legal), mescaline, MDMA, and psilocybin.

Psychedelitech, Inc. (PsyTech, Inc.) is a company specializing in the medical psychedelics industry, which provides clinical tools and education, as well as clinical care. The company promotes psychedelic-assisted therapy, novel methods of care and the tools to go along with them, and integrative ways for mental healthcare delivery. The company focuses a lot on the use of psilocybin therapies. The company has three parts: Tovana Solutions – a SaaS platform, Tovana Clinics – which provides a psychiatric care network, and PsyTech Connect – a community for psychedelic practitioners.

It was announced on June 13th, 2021, that Wesana Health would acquire PsyTech for $21 million, making PsyTech a completely owned subsidiary of Wesana. This will give Wesana access to all three parts of PsyTech. Wesana is looking to expand its efforts into neurological healthcare. According to CEO Daniel Carcillo (who is also a former NHL hockey player and two-time winner of the Stanley Cup), Wesana is working on new treatments and medications to treat traumatic brain injuries. He made this statement about the acquisition:

medical psychedelics

“The acquisition of PsyTech will greatly accelerate our ability to understand, analyze and improve neurological health and performance by providing a data platform on which to build our technical strategy, clinics in which to apply and accelerate our neuroscience research and relationships with many thousands of the practitioners who will leverage our medicines, diagnostics, and technology to heal people.”

The three arms of PsyTech

PsyTech has three components that Wesana will be taking over. Tovana Clinics – soon to be Wesana Clinics is a chain of mental health clinics which specialize in the delivery of psychedelic-based care, which currently involves esketamine therapy (as this is the only currently legalized psychedelic medication), and looks to incorporate new compounds as they become legal. The chain currently involves two locations, with a third set to open later this year, and about 12 more in the works that should be operational by this time next year.

PsyTech’s Tovana Solutions platform provides data collection, tracking in real-time, patient management, and general analysis tools. It also provides healthcare professionals the ability to learn current protocols and track effectiveness. The platform will be renamed Wesana Solutions.

The last arm, PsyTech Connect, is a network of over 8,000 professionals who tune in to find out about best clinical practices and protocols. Besides the network of practitioners, it also provides conferences, and educational material. The idea for Wesana is to integrate with psychiatrists across the US to expand the company and its therapeutic model.

Wesana founder and Executive Chairman, Chad Bronstein, reminds: “There are over 50,000 psychiatrists and 15,000 psychiatric practices in North America alone who will require solutions to adopt the novel and effective psychedelic-assisted therapies that already exist and are currently in development.”

Both the boards of Wesana and PsyTech have approved the acquisition unanimously. In order for it to officially go through, 2/3 of PsyTech’s shareholders must also approve. With 67% of shareholders already signed onto an agreement of support for the measure, there shouldn’t be anything getting in the way of the acquisition happening.

What psychedelic medications are already used?

Esketamine therapy

The medical psychedelic movement is massively picking up speed, even if it hasn’t quite filtered through to mainstream media just yet. There are, by the way, reasons that news of this industry’s growth hasn’t made major headlines in major publications. As of right now, there are a lot of smaller biotech companies like Wesana and PsyTech getting in on it, and that means competition for the major pharmaceutical companies, which so far do have the only legal offering. Until large pharmaceutical companies can fully profit off the industry, I expect it will be kept quiet, despite major growth.

So what is currently legal? Only one medication is out called esketamine. What is this compound? Esketamine, as the name implies, is a close relative of the dissociative and psychedelic party drug, (and animal tranquiller and human anesthetic), ketamine. In 2019 the FDA approved esketamine for treatment for major depression.

In 2020, the FDA updated the approval to cover prescription for suicidal thoughts as well because of how fast-acting the compound is. Esketamine is the first new medication approval for depression which does not fit the standard model of antidepressants, as its not an SSRI, tricyclic antidepressant, or MAO inhibitor. In fact, it entirely goes against the current model for the treatment of mental illness, meaning it does not work with monoamines.

Esketamine is sold under the name Spravato, being marketed by Johnson & Johnson’s Janssen Pharmaceutical Companies. It has been approved as an anesthetic under other trade names like ketanest. Esketamine is a Schedule III substance in the US.

What psychedelic medications are on the way?

Obviously, if one psychedelic drug has been approved, which already breaks with the idea that all psychedelics are illegal (obviously not the case), then why shouldn’t it be expected that more are on the way? In fact, they most certainly are, and to show how clear it is these legalizations are coming, the US government is actually pushing for them through its own Food & Drug Administration. In fact, the two compounds its currently pushing, are specifically Schedule I drugs at the moment, but will not be for much longer. Here’s why:

In 2017, the FDA earmarked the drug MDMA as a ‘breakthrough therapy’ for the treatment of PTSD. What does this term mean? According to the FDA, “A breakthrough therapy designation is for 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.” This designation isn’t blindly made, but generally comes at the request of a drug company, which is currently doing research that shows the compound is more promising than current options.

mdma therapy

This description is meant to quicken research and get products to market faster. What this means, is that the FDA is pushing for a Schedule I substance – defined as a highly dangerous compound with no therapeutic value, to be on pharmacy shelves sooner, rather than later. To make it even more clear, the Multidisciplinary Association for Psychedelic Studies (MAPS) – which is the organization that won the designation for its research, is currently in phase 3 trials for an MDMA drug, which were put together in conjunction with the FDA to ensure the trials and outcomes would be in line with FDA regulation. Is there a better way to say the US government wants this drug out to consumers?

The thing is, MDMA isn’t the only drug being backhandedly pushed by the US government. In 2019, the FDA gave two separate ‘breakthrough therapy’ titles to psilocybin from magic mushrooms, for use with major depressive disorder. The first granting of this designation was given to Compass Pathways, which looks to treat the most severe treatment-resistant depression, and the second time around it went to Usona Institute, which has ongoing trials to test the efficacy of just one dose of psilocybin to treat major depression.

Conclusion

That Wesana Health is about to acquire PsyTech, is just another indication of the growing magnitude of this new industry. The acquisition also highlights not only the growing appeal of psychedelic compounds to treat mental illness, but of the networks now being put together, which will set up the entire framework of how these therapeutic services will run.

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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 advise, 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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Vancouver Study on MDMA Therapy Approved by Health Canada

Vancouver-based company Numinus received federal approval for a study on MDMA. Sponsored by the Multidisciplinary Association for Psychedelic Studies (MAPS), the therapy study will involve twenty people with post-traumatic stress disorder. The goal is to learn more about MDMA-assisted therapy, specifically as a treatment for PTSD and eating disorders. In addition, researchers are hoping to […]

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How to Invest in Multi-Billion Dollar Medical Psychedelics Industry

As the legal cannabis market booms, another class of drugs on the horizon is getting closer to legalization, with its own impending boom coming. And that means a whole new place for investment. So as MDMA, psilocybin, and DMT work their way through medical trials, here’s how to invest in this new medical psychedelics field.

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What are psychedelics?

Psychedelics are a subset of hallucinogenic drugs, which themselves are a subset of psychoactive drugs. Whether made in a lab like LSD, or found in nature like psilocybin or peyote, psychedelics are known for causing ‘trips’. When a person is tripping, they may have altered perceptions of the world around, experience/feel/taste/see/hear things that are not real (hallucinations), feel a heightened sense of connection to those around them, experience euphoria, feel a sense of spirituality and connectedness with the universe, and a greater sense of self-introspection. A large percentage of psychedelics are serotonergic, meaning they effect serotonin receptors in the brain, though they can do this in different ways.

Some drugs like DMT produce short trips of less than an hour in duration. While other drugs like LSD, psilocybin, and mescaline can cause trips that last for many hours, as many as eight or ten. Sometimes people experience bad trips in which negative, or even scary, hallucinations are experienced, and/or a rapid heartbeat, sweating, nausea, disorientation, and fatigue occur. There is indication that the majority of these symptoms can be controlled through proper dosing. In fact, many therapeutic psychedelic users consume the drugs in micro-doses.

All psychedelics are Schedule I in the Convention on Psychotropic Substances, a drug scheduling treaty which defines the legality of different compounds globally. Starting with the Staggers-Dodd bill in 1968 which illegalized LSD and psilocybin, and finishing with the placement in the Convention, making all such substances illegal to buy, sell, or consume, with no purported medical value.

psychedelics

Psychedelics have been used for thousands of years, all throughout the world, though their uses in medicine in the mid-1900’s, and proposed uses today, are generally different than the shamanistic/ritualistic way they were primarily used in history, although this is not to say that there were not traditions that did use psychedelics therapeutically. Technically, if a shaman is consuming ayahuasca to get rid of demons, I suppose that could be thought of as therapeutic anyway.

Medical psychedelics research

Psychedelics, particularly, LSD, were introduced to modern medicine around the 1950’s after Albert Hoffman synthesized the compound in Switzerland in 1938. Several psychotherapists at the time, like Humphry Osmond and Ronald Sandison caught onto the idea, bringing these treatments to England and America. Hoffman conducted, among other research and therapy, the Saskatchewan trials, and ultimately came up with the idea of ‘psychedelic therapy’ in which a single large dose of LSD was given along with therapy sessions.

‘Psycholytic therapy’ is what Ronald Sandison’s version became known as in the UK, with the difference being that Sandison’s treatment style was to do multiple sessions with smaller amounts of the drug that increased through the process. Both doctors found great success particularly with alcohol addiction. How much success? According to the Saskatchewan trials, as many as 40-45% of drinkers were still not drinking a full year after the therapy session.

Unfortunately, when the drugs were made illegal, all ability to continue such treatments ended, and the ability for research into the field was completely stymied, and did not pick up again until much more recently. However, to give an idea of the massive turnaround that has been going on when it comes to psychedelics, consider that the US’s Food & Drug Administration (FDA), singled out both psylocibin in 2019 and MDMA in 2017 as ‘breakthrough therapies’ for depression and PTSD respectively. Such a designation by the FDA is meant to speed up research and development for products deemed necessary for health.

This indicates a desire by a US government agency to not only test these drugs, but to get them to market. And they’re all schedule I right now. One exception to psychedelics all being schedule I, however, is magic mushrooms. Though its psychoactive components like psilocybin are Schedule I, and therefore illegal, the plants themselves are not outlawed, creating a bit of gray area in terms of mushroom use, cultivation, and production. This gray area could prove useful in the future.

What can be expected?

If you’re wondering why this matters, consider how massive – and growing – the legal cannabis markets are. Well, psychedelics offer many of the same medical benefits, especially psychologically, with possibly added abilities in other departments. And they’ve proven to be very safe. As an industry in which much of it is pharmaceutical to begin with, it’s a safe bet that these drugs are going to pick up quickly. Because the pharma world is sure to take a massive interest, it gives even more reason to invest in medical psychedelics now, before everything explodes.

psychedelic-assisted therapy

So how much is it worth? I’m not the kind of writer who generally likes to get into these numbers. Every publication makes its own predictions, off its own information, and very rarely do these predictions seem to consider world changes. Whatever the size of the CBD industry was originally predicted to grow to a few years ago, that number would be invalid by now because it didn’t account for THC-based medicines growing in popularity, or legal markets, or psychedelics.

Imagine how much psychedelics could eat away at cannabis revenue. And not only that, any predictions of the future market size for psychedelics would have to take into account the still expanding cannabis markets (with more countries constantly legalizing in some form or another), and the question mark of what currently unforeseen factors could upend the trend a few years down the line. So, I’m not concerned with too many predictor numbers, but here’s just one, in order to get an idea what we’re dealing with.

PRNewswire, citing an analysis by Data Bridge Market Research, explained the forecast for 2020-2027, in which the field is expected to grow to $6.8 billion by 2027. It was worth just over $2 billion in 2019.

Best ways to invest in growing medical psychedelics field

Now that a certain barrier seems to be broken, more companies are conducting clinical trials, getting patents, and starting to get clearances for products. In fact, if you thought the psychedelics market was off limits, you’d be very much mistaken. Not only is this a growing market with a lot of possibility, but companies are already staking their claim, leaving room for you to start investing. So, if you like the idea of getting in on something before it explodes, consider investigating the following companies, and invest in the medical psychedelics field.

Much like with cannabis, Canada is quickly establishing itself as a leader in medical psychedelics, with the top companies coming out of this country. In the first half of 2020, $150 million USD was raised by six different companies: Mind Medicine, COMPASS Pathways, Field Trip Psychedelics, ATAI Life Sciences, Orthogonol Thinker, and Numinous Wellness. Mindmed and Numinous are already publicly listed companies. This is an early stage entry for investors. In fact, to give an idea of how seriously Canada is taking this, the first exchange traded fund – The Horizons Psychedelic Stock Index ETF, made its debut in January. ETF’s are like regular asset exchanges, except that they include a mix of stocks, commodities, and bonds. This exchange is solely for psychedelics.

The CEO of the fund, Steve Hawkins, said that while larger pharmaceutical companies have been admitted to the fund, the idea is to keep it mainly for smaller psychedelics companies. Companies can be added to the fund if they can tick the following boxes: be a part of a regular US or Canada-based stock exchange, be a biotechnology company focusing on medical psychedelic research, be a producer and/or supplier of psychedelic medicines, and be a company that works within the general supply chain for psychedelic medications.

medical psychedelics

Biggest names so far

When it comes to emerging fields and investing, the majority of people will never get there preemptively, and will instead act by reaction. For anyone who wants to get in on it before the top blows off, the following companies currently provide the best prospect for future growth, expansion, approval, and ability for revenue. These names should be noted, they will likely be bringing you the first approved medical psychedelic products, and for anyone looking to invest in this rapidly growing field of medical psychedelics, they stand out as the best options so far.

Mind Medicine is one of the furthest along when it comes to getting a product out there. It’s a pharmaceutical company that specifically works to develop psychedelic medications. The company is currently in the middle of six different trials on drugs like MDMA, LSD and DMT. In January of 2021, MindMed announced the first ever clinical trials to involve a combination of MDMA and LSD, with company president Dr. Miri Halperin Wernli stating:

“I believe that when LSD and MDMA are taken together they have exceptional potential to open a window into our mind which will awaken it to new levels of awareness by changing the fluidity of the ‌state‌ ‌of‌ ‌consciousness, amplifying‌ ‌changed‌ ‌perceptions,‌ ‌intensifying ‌emotions‌, ‌and‌ stimulating ‌novel‌ ‌thoughts. It is like a gateway to a multidimensional universe.”

When it comes to MDMA trials, MAPS – Multidisciplinary Association for Psychedelic Studies,  is also making its way to approval. MAPS entered phase III of its trials into MDMA for PTSD, and aligned this phase with the FDA according to a Special Protocol Assessment made directly with the FDA. This means that so long as the trials show clinically significant results, the study will already check all FDA regulatory boxes, and make it that much easier for approval.

However, a psychedelic drug has technically already been approved by the FDA. In March of 2019, Johnson & Johnson’s Spravato got approval. The spray treatment is considered for those who have not received a benefit from at least two separate anti-depressants. Spravato is a drug that’s a chemical cousin of the drug ketamine, which is classified as a dissociative drug, but also as a psychedelic. The medication is meant for severe depression.

There are tons of companies popping up. Apart from the companies already listed, prospective investors should check out Champignon Brands, Hollister Biosciences, Better Plant Sciences, Captiva Verde Land, Core One Labs, Cybin, Empower Clinics, Ehave, Jazz pharmaceuticals and EGF Theramed Health. All of these companies are associated in some way or other with the production of psychedelic medications. And while I have yet to see it mentioned in an article, it seems to me that what might upend everything I just said, is the ability to cultivate magic mushrooms.

LSD

Something to consider

Much like cannabis, mushrooms come with the ability for easy self-cultivation, as well as large scale cultivation. People who invest in today’s cannabis cultivation already know the value of having growing fields. Imagine the same thing, but with mushrooms. I personally believe that the biggest way in the future to invest in medical psychedelics, will be through the growing of mushrooms.

As stated, this is my opinion, and has not been discussed much as far as I can tell. This is not shocking though, and really doesn’t mean much, as this topic is also an undesirable one for any biotech or pharmaceutical company that – much like with cannabis – would much prefer you know nothing about how to do this on your own. And much like cannabis, it’s easy enough to learn how for anyone who needs some help getting started. Plus, since cultivation and sale of the mushrooms themselves is actually legal in many places, it’s way more legal to grow a field of mushrooms in much of the world, than to grow a field of cannabis.

How to invest in Medical Psychedelics – Conclusion

That the medical psychedelics field is coming is not as much up for debate as many would believe. It might be growing in the shadow of the cannabis market, and being kept quiet until the ability for large scale monetization is possible, but it’s coming, and it will be big. For those who want to invest in the growing medical psychedelics field, getting in now is probably the best idea, and with all the new companies popping up every day, it’s sure to become a heated race very soon.

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References

Why the Vape Ban Is Happening, and How It Will Impact Delta-8 THC
Florida Bill Aims to Legalize Medical Magic Mushrooms

DIY: How to Make Delta-8 THC at Home
Here is everything wrong with Biden’s “forced rehab” plan for drug reform
What is DELTA 8 THC (FAQ: Great resource to learn about DELTA 8THC)

Can LSD Treat Your Mental Illness?
Welcome to the World’s 1st DMT Trials into Depression
The CBD Flowers Weekly newsletter (your top resource for all things smokable hemp flowers). Delta 8 / 9 / 10 / 11… How Many THCs Are Out There?
The New Rise of Medical Psychedelics

The Delta 8 Weekly Newsletter (All you need to know about Delta 8 thc) and the Best Delta 8 THC Deals. How To Choose Delta-8 THC Flowers?
Ayahuasca In the Fight Against Drug Addiction The Many Faces of Tetrahydrocannabinol – Different Types of THC and Their Benefits Psychedelic-Assisted Therapy, and How It Works
Desert Tripping – A Closer Look at Peyote: Spiritual, Medicinal, & Controversial Nature’s Magic – The Health Benefits of Psilocybin Mushrooms

Disclaimer: Hi, I’m a researcher and writer. I’m not a medical professional, I have no formal legal education, and I’ve never been to business school. All information in my articles is sourced from other places, which are always referenced, and all opinions stated are mine, and are made clear to be mine. I am not giving anyone advise of any kind, in any capacity. I am more than happy to discuss topics, but should someone have a further question or concern, they should seek guidance from a professional in the relevant field for more information.

Yup, there’s a vape ban in the USA, but that doesn’t mean we can’t get you any delta-8 THC products at all. Delta-8 THC is the less psychoactive THC compound that produces less anxiety and panic for users. Check out the great delta-8 THC deals we’ve got, and start experiencing delta-8 in a whole new way.

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MDMA – The New Way to Treat PTSD

For sufferers of PTSD, the world can be a scary place. Modern medicine has attempted many ways to treat the disorder ranging from medications to therapy tactics, but they don’t always work. Building evidence shows that alternative remedies like the psychedelic drug MDMA might be a better long-term answer to treat PTSD.

Are you a THC lover? The best thing about being on team THC is that the variety is opening up. Not only is there the standard delta-9 THC, but now there’s delta-8 THC as well, which has the same general medical benefits, but with less anxiety and less psychoactive effect. We’ve got great Delta-8 THC deals here, so go on and give it a shot.

What is PTSD?

Post traumatic stress disorder is a psychiatric disorder, which means it is diagnosed subjectively. It effects people who have gone through a traumatic experience, whether they were actually a part of it, or just witness to it. This can include things like being physically attacked, witnessing atrocities of war, living through natural disasters, or being the target of bullying or psychological abuse. PTSD is diagnosed separately from other anxiety-based mental illnesses based on the experiencing of a traumatic event.

PTSD was known as ‘shell shock’ during World War I, and was referred to as ‘Battle Fatigue’ after world war II. It is associated with disturbing, and often very intense thoughts concerning past traumas. This can include reliving the event in flashbacks or nightmares, fear, sadness, anger, and feelings of detachment and estrangement from other people. Sufferers of PTSD often display strong negative reactions to situations that others would find non-triggering, and may avoid situations or people entirely that remind them of their past trauma.

Subjective diagnoses make for a difficult time adding up statistics, however, according to psychiatry.org, approximately 3.5% of adults in the US suffer from PTSD per year, and its estimated that about one out of every eleven people will experience PTSD in their lifetime. Women are the predominant sufferers, outnumbering men 2:1, and the three ethnic groups where PTSD symptoms show up the most in the US, are Latinos, African Americans, and Native Americans – all minorities that have experienced a lot of overall violence, intolerance, and general contempt aimed at them throughout history.

medical psychedelics

What is MDMA?

3,4 methylenedioxymethamphetamine, known colloquially as ecstasy, or molly (which is slang for ‘molecular’), is a man made psychoactive drug which is derived from the safrole oil, found primarily in sassafras plants. MDMA has properties of both hallucinogens and stimulants, acting primarily through its interaction with serotonin receptors. It forces the brain to released large amounts of the neurotransmitter, while blocking its reuptake to aid in extra absorption. MDMA comes as either pressed pills, or as a powder that can range from brown to white.

MDMA is known for promoting a feeling of connectedness between people, of reducing fear and anxiety, and increasing feelings of empathy. It was created by Merck Pharmaceutical back in 1912, however its effects were not well understood until the 1970’s when chemist Alexander Shulgin created a new method to synthesize the drug, and tested it out along with a few of his psychotherapist friends. This is around when it started being used in psychotherapy practices, as a treatment method coupled with therapy sessions, known as psychedelic-assisted therapy.

Despite showing usefulness in dealing with mental disorders, MDMA was illegalized in 1985. In 1984, President Ronald Reagan’s administration enacted the Comprehensive Crime Control Act which allowed for emergency banning of drugs by the government. When the subject of MDMA came up in 1985, after other psychedelic drugs had already been illegalized, this act was used to immediately illegalize the compound by placing it in Schedule I of the Convention on Psychotropic Substances treaty, ending therapeutic uses of it.

The illegalization of psychedelics started with smear campaigns during the Vietnam war which culminated in the passage of the Staggers-Dodd bill in 1968 illegalizing LSD and psilocybin specifically. This was followed up with the creation of the Convention on Psychotropic Substances treaty in 1971 which outlawed most of the rest, with the exception of MDMA, which was outlawed later.

While the topic is obviously a controversial one, statements made by John Ehrlichman – former Assistant to the President for Domestic Affairs under President Nixon in 1994, made evident that the war on drugs wasn’t necessarily about drugs at all. Creating further concerns about why drugs like MDMA were illegalized. In his statement he claimed:

“The Nixon campaign in 1968, and the Nixon White House after that, had two enemies: the antiwar left and black people… 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.”

MDMA treat PTSD

MDMA to treat PTSD

So, what do we really know about the ability of MDMA to treat PTSD symptoms? In 2020, a systematic review was released that investigated articles published up until the end of March 2019, that used key terms like ‘treatments for PTSD’ and ‘MDMA pathway’. All articles came through PubMed and ScienceDirect.

It was found in the identification and review of these articles (and their sources) that many small scale investigations had been done that show MDMA aids in reducing psychological trauma. The review authors made a very important point, though. They emphasized that none of the research showed MDMA as a cure for PTSD, as that specifically had not been researched.  What the review was identifying, and what had been studied, was the usefulness of MDMA assisted psychotherapy, and its ability to help people who have been unable to resolve their trauma issues through other avenues.

The big story today with MDMA revolves around currently in-progress trials. As of last summer, the Multidisciplinary Association for Psychedelic Studies (MAPS) had begun Phase 3 of clinical trials into MDMA. MAPS is conducting double-blind, placebo-controlled, randomized trials at multiple sites, testing the safety and efficacy of MDMA-assisted therapy for PTSD. The participants are 200-300 PTSD sufferers who are all 18+ in age, but with varied histories to produce their traumatic experiences.

These trials follow the Phase II trials which had promising outcomes, and are the last hurdle required by the US Food & Drug Administration (FDA) in order to be assessed for legalization in the treatment of PTSD. Should it get the pass, MDMA would be able to be prescribed along with therapy, in outpatient settings with residential stays – to allow users to have their experience in a safe and controlled environment.

How likely is the FDA to approve MDMA to treat PTSD? It is, after all, a psychedelic drug in Schedule I, which defines it as highly dangerous with no therapeutic value. Apparently, back in 2017, the FDA identified MDMA as a ‘breakthrough therapy’ for PTSD.

The FDA defines a ‘breakthrough therapy’ 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.” This definition is meant to help speed up research progress in order to get products to market. In 2019, the same designation was made by the FDA for psilocybin in magic mushrooms.

medical MDMA

More about MAPS Phase 3 trials

Phase 3 trials were designed according to an agreed upon Special Protocol Assessment between MAPS and the FDA to make sure trials and outcomes would be in line with regulation. The trials take place at 15 different sites between three countries: the US, Canada, and Israel. Participants receive three therapy sessions with either MDMA or placebo over a 12-week therapy period, along with three preparatory sessions and three integration sessions, without any drugs. The MDMA/placebo sessions are spaced every 3-5 weeks.

The (CAPS-5) – Clinician-Administered PTSD Scale – is the primary measurement tool for success in the study. This is a loosely structured interview used in most PTSD trials, and requires assessment by raters who are ‘blinded’, or do not know where the study participant falls in terms of actual drug or placebo. The study investigators will use other measurement tools as well including, but not limited to: Beck Depression Inventory and Inventory of Psychosocial Functioning.

‘Phase 3’, of course, implies that this is not the beginning of the study. Phase 2 findings of the study indicate the following about MDMA and its ability to treat PTSD: it can cause a reduction in fear and defensiveness; increase introspection and communication, as well as empathy and compassion; and generally improves the therapeutic experience of those suffering from PTSD. Phase 2 consisted of 107 patients.

Two months following the MDMA-assisted treatment in Phase 2, 61% of patients were no longer identified as having PTSD. One year following treatment, 68% no longer qualified as PTSD. All participants had chronic PTSD that was treatment resistant, and had been suffered from for an average of almost 18 years.

Conclusion

It’s getting heated in the race to see which psychedelic drug gets the first US medical legalization (as the US so often sets the standard for other parts of the world). Psilocybin from magic mushrooms is certainly making waves, but it looks like MDMA might take the win. With the FDA already drooling at the mouth to approve, and the pharmaceutical world getting its ducks in a row, it looks like very shortly MDMA will officially be approved to treat PTSD, with a change in global legalization measures likely to follow.

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Resources

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The CBD Flowers Weekly newsletter (your top resource for all things smokable hemp flowers). How to choose Delta-8 THC flowers?  Delta-8 THC Flowers: Everything You Need To Know.
The Medical Cannabis Weekly newsletter (International medical cannabis business report)
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The Delta 8 Weekly Newsletter (All you need to know about Delta 8 thc) and the Best Delta 8 THC Deals. Best Delta-8 THC Vape Bundles – Winter 2021 Denver Residents Vote to Decriminalize “Magic Mushrooms”
Cannabis and the South: How Things Change Plant Power: Everyday Plants That Activate the Endocannabinoid System Ask A Doctor – General CBD/PTSD Discussion
The New Rise of Medical Psychedelics
New Jersey Wants Home Cultivation for Cannabis   Is Medical Cannabis A Solution For Veteran PTSD Suicide Epidemic? Nature’s Magic – The Health Benefits of Psilocybin Mushrooms

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