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Psilocybin Designated As A “Breakthrough Therapy” For Major Depressive Disorder (MDD)

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In Brief

  • The Facts:

    Numerous studies have proven the efficacy of treatment using psilocybin for various mental health disorders including depression. It has now been labelled as a "breakthrough therapy" by the FDA. More research is underway.

  • Reflect On:

    Early research is promising, but is still in it's infancy. At the end of the day, people still need to do the inner work and not be completely reliant on substances outside of themselves, although they can be a good source of assistance.

The US Food and Drug Administration (FDA) has recently granted psilocybin treatment (the active component of magic mushrooms) a Breakthrough Therapy classification for the second time this year. They are hoping to accelerate trials that will test its efficacy in treating major depressive disorder (MDD).

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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 new designation of psilocybin as a Breakthrough Therapy for MDD recognizes the hugely unmet medical need in the large population of those who suffer as well as the potential for improvements to the current treatments and therapies. This is being coordinated by a non-profit research organization, the Usona Institue.

“The results from previous studies clearly demonstrate the remarkable potential for psilocybin as a treatment in MDD patients, which Usona is now seeking to confirm in its own clinical trials. What is truly groundbreaking is FDA’s rightful acknowledgement that MDD, not just the much smaller treatment-resistant depression population, represents an unmet medical need and that the available data suggest that psilocybin may offer a substantial clinical improvement over existing therapies,” says Charles Raison, MD, Director of Clinical and Translational Research at Usona. “Given that there is so much complexity with psilocybin and that Usona is charting new ground, these interactions will ensure that Usona and the FDA are aligned in approaching the development program with acceptable best practices.”

The Multidisciplinary Association for Psychedelic Studies (MAPS) has done numerous studies over the years involving psilocybin for treating various disorders including addiction, depression and use in palliative care.

The new status given to psilocybin follows the launch of Usona’s Phase 2 clinical trial, which will involve 80 participants and seven study sites across the US. 2 of the 7 sites are recruiting and the rest should be active within the first quarter of 2020.

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The methodology is comparable to other therapeutic studies involving psilocybin — preparatory psychotherapy sessions before the active psychedelic dose is administered, followed by a number of integrative psychotherapy sessions after.

The trial will investigate the effects of a single dose of psilocybin and its efficacy in treating general depressive episodes.

The current Phase 2 trial should be completed by the beginning of 2021 and with the assistance of the Breakthrough Therapy classification from the FDA, it should be able to move into much larger Phase 3 trials, if the results from Phase 2 are positive.

“Given that there is so much complexity with psilocybin and that Usona is charting new ground, these interactions will ensure that Usona and the FDA are aligned in approaching the development program with acceptable best practices,” says Raison.

Previous Research

In an attempt to treat depression, researchers from Imperial College, London gave 12 patients psilocybin. The 12 patients who were chosen had been clinically depressed for an average of about 18 years and the results were actually quite remarkable. The results from the psilocybin treatment actually succeeded the typical pharmaceuticals that are prescribed to treat depression like selective serotonin reuptake inhibitors (SSRIs) and electroconclusive therapy. Just 1 week after taking the magic mushrooms, all 12 patients from the study reported feeling better, and checking in 3 months later, 5 of them were in complete remission. Quite impressive from only one dose.

“That is pretty remarkable in the context of currently available treatments,” says Robin Carhart-Harris, a neuropsychopharmacologist at Imperial College, London and first author of the latest study, which is published in The Lancet Psychiatry.

A Step In The Right Direction

Although many people may oppose regulation of this treatment by the FDA, we have to applaud how far this research has come in such a short time. If psilocybin assisted psychotherapy becomes legal, this has the potential to benefit millions who have not benefited from traditional methods of treatment for depression. This groundbreaking research has the ability to save lives.

Of course, many have benefited from doing their own research with themselves as guinea pigs, myself included. I am not suggesting anyone try this, as these treatments should be implemented under the guidance of professionals who have the proper tools to assist you through the process.

But speaking from experience, there is a tremendous opportunity available here, to help those who are suffering as the experience helps to take you outside of yourself. It often causes a major perspective shift and deep insights into ones life. Of course this isn’t always the case and it is very important to note that psychedelic therapies are not a one size fits all approach and they are not recommended for everyone. Furthermore, it’s simply a tool to be used and perhaps shouldn’t be looked at as a ‘cure.’ Ultimately, we all have to do the inner work in order to feel better instead of constantly relying on something outside of ourselves.

Once these laws are passed than this treatment will be more accessible and can be administered responsibly with the assistance of trained professionals.

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Awareness

Frankincense Shows The Ability To Alleviate Symptoms Of Anxiety & Depression

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In Brief

  • The Facts:

    Studies have proven the psychoactive effects the scent of frankincense has on the brain, alleviating symptoms of anxiety and depression.

  • Reflect On:

    With all the man-made chemical pharmaceutical drugs out there, perhaps solutions to what ails us are more simple than we may realize.

Gold and frankincense and myrrh… sound familiar? These were the gifts that were allegedly brought by the three kings when Jesus Christ was born. We all know that gold is valuable, but what about the others? Frankincense has long been touted as a magical, mystical medicine and has been regarded as such for millennia within many ancient cultures of the world. The same goes for myrrh, but for the purpose of this article we are going to stick to the medicinal properties of frankincense.

Frankincense starts out as a type of resinous sap that is found inside a special family of trees called Boswellia, which grow almost exclusively in the southern end of the Arabian Peninsula. When it is harvested at specific times of the year, the trees are cut carefully with special knives and the sap seeps out. This special sap is then dried in the sun until it is ready for use. More commonly, frankincense is burned simply as sweet smelling incense, but it has many other uses as well including the following…

Historical Uses Of Frankincense

  • As a part of ritual or religious ceremonies
  • Was used extensively during burial rituals as an embalming material to help mask the odor of the deceased body
  • Smoke from burnt incense can effectively drive away mosquitoes and other pests

Frankincense has also been used medicinally, treating various ailments such as arthritis (it has strong anti-inflammatory properties), gut disorders (like Crohn’s disease and ulcerative colitis), asthma, and maintenance of oral health.

And perhaps the most intriguing quality for our westernized modern culture is the psychoactive effects of this special resin, as studies have shown that burning frankincense can trigger an effect that can aid and even alleviate symptoms of anxiety and depression.

The Research

One study in particular, conducted by a team of researchers form John Hopkins University and Hebrew University in Jerusalem, explains how burning the resin from the Boswellia plant (frankincense) activates certain previously misunderstood ion channels in the brain in order to alleviate symptoms of anxiety and depression. This might explain why Roman emperor Nero once burned an entire year’s harvest of frankincense at his favorite mistress’ funeral.

“In spite of information stemming from ancient texts, constituents of Bosweilla had not been investigated for psychoactivity,” said Raphael Mechoulam, one of the research study’s co-authors. “We found that incensole acetate, a Boswellia resin constituent, when tested in mice lowers anxiety and causes antidepressive-like behavior. Apparently, most present day worshipers assume that incense burning has only a symbolic meaning.”

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The researchers administered incensole acetate to mice in order to determine its psychoactive effects. This compound they found drastically impacted the parts of the brain that generate emotions and the nerve circuits that have responded positively to current drugs used for depression and anxiety. The incensole that was administered activated a protein called TRPV3, which is connected to the ability to perceive warmth of the skin.

“Perhaps Marx wasn’t too wrong when he called religion the opium of the people: morphine comes from poppies, cannabinoids from marijuana, and LSD from mushrooms; each of these has been used in one or another religious ceremony,” said Gerald Weissmann, M.D., Editor-in-Chief of The FASEB Journal. “Studies of how those psychoactive drugs work have helped us understand modern neurobiology. The discovery of how incensole acetate, purified from frankincense, works on specific targets in the brain should also help us understand diseases of the nervous system. This study also provides a biological explanation for millennia-old spiritual practices that have persisted across time, distance, culture, language, and religion–burning incense really does make you feel warm and tingly all over!”

Can This Work For You?

Sure, this study was conducted using mice, which certainly aren’t the same as humans. However, many religious texts claim that this special resin had uplifting effects on the brain. So, the good thing is that if used appropriately, it really can’t hurt to try. You can typically buy the resin at health food stores and more commonly at stores that sell incense, crystals, sage and those sorts of spiritual ceremonial tools. It can also be found as an essential oil. I like to diffuse it in a diffuser, and sometimes I’ll burn the resin on charcoal pucks as well.

At the very least, you’ll get a nice and pleasant smelling aroma, and at best it can help turn that frown upside down, increase your mood, reduce your anxiety and maybe even put a smile on your face. Perhaps those three wise men were as wise as they’ve been made out to be, and frankincense really is as special as it’s been believed to be for millennia.

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Binge Watching Is Associated With a 12 Percent Increased Risk of Inflammatory-Related Death

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In Brief

  • The Facts:

    An Australian study published in the journal Medicine & Science in Sports & Exercise looked at more than 8,900 adults and found that each additional hour of TV viewing was associated with a 12% increased risk of inflammatory-related death.

  • Reflect On:

    How much TV do you watch? How active is your lifestyle?

I’m sure that you hesitated before choosing to read this article, as most of us have been sucked into a binge watching marathon on more than one occasion (myself included). While it may seem like we’re buckling down to give ourselves a break, we may actually be hurting ourselves far more than we realize. Sitting for prolonged periods of time has proven to be harmful to our bodies, especially for adults over 50, and when you match lounging with television, you create a deadly combo.

In an Australian study published in the journal Medicine & Science in Sports & Exercise, researchers examined more than 8,900 adults and found that each additional hour of TV viewing was associated with a 12% increased risk of inflammatory-related death, and those who spent more than four hours a day watching TV were at an even higher risk. This includes  diabetes, respiratory, cognitive, and kidney diseases. (source)

In general, watching television has proven to negatively impact mental health; it alters your brain, lowers your attention span, and has the potential to make you more aggressive. You don’t need to experience the “trance-like” state television can put us in, but I’m sure you’ve witnessed it before. This trance occurs roughly 30 seconds after you start watching TV. Your brain begins by producing alpha waves, leading to a light hypnotic state that makes the viewer less aware of their environment and more open to subtle messages — aka programming.

In the 1990s. Dr. Teresa Belton, a visiting fellow at the University of East Anglia, studied the effects that television has on the imagination of 10-12 year old children, ultimately concluding that television negatively impacts their development: “The ubiquity and ease of access to television and videos perhaps robs today’s children of the need to pursue their own thoughts and devise their own occupations, distracting them from inner processes and constantly demanding responses to external agendas, and suggests that this may have implications for the development of imaginative capacity.”

And these physical affects are becoming increasingly apparent. Not only does it eventually lead to immobility as you age, but with the risk of creating inflammation in the body, you are susceptible to a host of diseases including kidney disease, diabetes, asthma, Alzheimer’s, and even depression.

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Dr. Megan Grace is the lead investigator at the Baker Heart and Diabetes Institute in Melbourne. Between 1999 and 2000, her team quizzed adult participants about their viewing habits via a questionnaire. Again, this was before we had access to popular streaming websites like Netflix. The participants were separated into three groups based on their TV viewing habits: less than two hours per day, greater than two hours but less than four hours, and more than four hours.

“TV time was associated with increased risk of inflammatory-related mortality. This is consistent with the hypothesis that high TV viewing may be associated with a chronic inflammatory state,” the authors wrote.

They followed up with their participants 12 years later and found, of 909 deaths, 130 were inflammatory-related. Of the inflammatory-related deaths, 21 were from diseases of the respiratory system and 18 of the nervous system, and those who watched between two to four hours of TV a day showed a 54% higher risk of inflammatory-related death. Additionally, people who watched more than four hours of TV a day doubled their risk of dying from an inflammatory disease compared to those who watched two hours.

In addition to cutting down the amount of time you spend sitting in front of the TV and sitting or lying down, you can help combat inflammation with a number of foods like avocados, berries, sweet potato, onions, and watermelon, and herbs like, cloves, ginger, rosemary, and turmeric.

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The Science Of Healing Trauma With Plant Medicine – Dr. Jeff McNairy Explains

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In Brief

  • The Facts:

    Ayahuasca has assisted thousands of people with an array of mental health disorders. There is real science that can explain how this "medicine" is able to actually change the brain.

  • Reflect On:

    Ayahuasca is not for everyone, and it will not fix you. It might, however, show you what you need to see in order to release what is no longer serving you in life and holding you back.

Over the past decade or so, the use of ayahuasca by western cultures has absolutely blown up. Chances are you’ve either taken it yourself or know someone who has. You may have heard some incredible and transformative stories about how this indigenous plant medicine has assisted many of those struggling with depression, addiction, anxiety and many other ailments.

It has been difficult to explain how this plant actually works to help alleviate symptoms of trauma, and many stick to simply regarding it as a mystical experience that shows you whatever it is that you need to see in order to heal your wounds. However, there is a scientific way to explain what is actually happening within the brain and body when ayahuasca is ingested. Some people with a more logical method of receiving information might prefer to know the actual physical “why” as to what is happening. In the video below, Dr. Jeff McNairy explains this.

Dr. Jeff McNairy is part of the Rythmia family, the world’s first fully licensed medical facility that offers ayahuasca. The entire CE team had the opportunity to go back in 2016 and it was a wonderful experience for us all.

Personally, I have processed a lot of my own trauma with the assistance of this potent plant medicine. It was able to show me things that I hadn’t realized had such a profound impact on my life, things that I had simply written off as unimportant. There were many things that I had stuffed down, locked away and refused to look at over the years that ultimately were the cause for my struggle with depression, addictive behaviours and anxiety. With the assistance of ayahuasca, a light shined on these areas that I had locked away in my subconscious, which helped me to see where healing was still required.

Is Ayahuasca For You?

Whether you are drawn to ayahuasca or not is okay, it’s not for everyone. But if you have a serious desire to uncover more layers of who you are and why you are the way you are, and you’re drawn to this medicine, then it may be for you. Ayahuasca can be a great tool for those who have suffered trauma, but it is important to know that ayahuasca won’t fix you, however it can lead you to understand what it is you need to know in order to fix yourself. It has the capacity to show you whatever it is that you are not seeing from a different perspective, opening your eyes to what you may not have been able to see before.

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It is no coincidence that ayahuasca has emerged within westernized cultures around the globe during this important time of transition. Not only is it assisting people to reconnect back to their soul’s essence, but it is also increasing our regard for our environment and our Mother Earth as a whole.

On another note, here’s an interesting quote from Joe Martino:

Psychedelics were used back in a time when the level of consciousness of the planet was not as high, which helped give insight to shamans so they could share it with their communities. It was meant for use in extreme cases where heavy trauma or addictions existed and people could not use other ways to work through their emotional challenges. Here in present time, we use them in a western fashion as THE GO TO for moving through all of our challenges. I’m here to remind you that you have so much power and ability as a being that in most cases, you don’t need any of these things to evolve. I’m not suggesting don’t do it, I’m simply saying truly ask your heart what you want, and don’t get caught up in the grand allure and peer pressure. (source)

Use Responsibly

It is important to seek out and use ayahuasca that is harvested using sustainable practices and served by shamans who have the utmost respect for the sacred medicinal brew. As its popularity has increased, so has the opportunity to exploit it, so do your due diligence when it comes to determining if ayahuasca is right for you and who will be serving you this medicine.

Related CE Article: Why Psychedelic Drugs Are Not A Shortcut To Enlightenment

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