Category Archives: Psychedelics

In the midst of a global mental health crisis, hundreds of billions in funds are going into addiction therapy. The time is ripe for alternative forms of treatment. Psychedelics could be the answer to treating most patients.

But theyre nothing new.

Psychedelics are entheogens that are either naturally derived from plants (psilocybin, ayahuasca and ibogaine) or synthetically manufactured in the lab (LSD, ketamine and MDMA). Theyve been used to treat mental health issues ranging from anxiety to depression and ADHD. Once favored by the medical community, they took a serious hit with the backlash to 1960s counterculture.

In the U.S., psilocybin is still a Schedule 1 drug, meaning its been deemed to have zero medical value. In 2019, three cities voted to decriminalize psilocybin: Oakland and Santa Cruz in California, and Denver. New York and Iowa, meanwhile, have seen proposals either delayed or flatly rejected. The study of psychedelics and their applications in medicine and psychology are still in their infancy, hampered by Schedule 1 narcotics status and the United States decades-old War on Drugs. That said, shrooms have shown potential in treating depression, eating disorders and addiction, and theyve shown promise in combination with psychotherapy.

As marketers, in order to set this industry up for success, it is important to stay within any guidelines that come out for the industry.

Estimated to reach a whopping $6.85 billion worldwide by 2027, according to Data Bridge Market Research, the global market for legal psychedelics represents a genuine Shroom Boom. Key companies operating in this space are either still in startup mode or Series B funding rounds, with whispers that a number of them are set to open on international stock exchanges throughout 2020.

Similar to plant-based medicines that have been largely stigmatized, the cannabis and psychedelics industries have both required tremendous advocacy to change perceptions. While currently there are no CPG brands in the psychedelics space, one needs to look to cannabis brands for important lessons.

In terms of any marketing and communications for products, using a medical mindset is a must. Medical marijuana is now legal in 33 states, with a few states going as far legalizing recreational use of cannabis as wel. As a company in the space, it is imperative to have a solid foundation of research, awareness and education.

For marketing opportunities, such companies have creative needs like mass communication and branding. In order to set this industry up for success as marketers, it is important to stay within any guidelines that come out for the industry. It will be essential never to associate psychedelic medicines with the drug culture. That means staying clear of the notion of being under the influence, and certainly avoiding the impression that youre appealing to children at all costs.

Currently, it seems companies such as Champaignon have non-psychoactive mushroom subsidiaries, such as a mushroom tea brand. This is wise because they have CPG products and are creating a target audience base that could potentially converge once they are able to create a psychedelic product and already have an organically engaged audience.

Like the cannabis industry, we are going to have to climb over mountains to change public perception of psychedelic use for medicinal purposes because it has been so counterculture for so many years and brought into the underground market.

It will be very exciting to watch the progression that happens in this industry. Advancements in CPG products are a few years away, so being on the forefront will be exciting.

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An Introduction to Psychedelics in Marketing - Adweek

New research provides preliminary evidence that psychedelic drugs can improve mental health by making individuals more accepting of distressing experiences. The study, published in Frontiers in Psychiatry, adds to a growing body of literature that indicates using substances like psilocybin can result in sustain improvements in depressive symptoms.

Psychedelic therapy has shown promise as a novel treatment for a range of mental health concerns, including major depressive disorder, distress associated with a life-threatening illness, and substance use disorders, said study author Richard Zeifman, a PhD student at Ryerson University and research intern at the Centre for Psychedelic Research at Imperial College London.

In contrast with the traditional pharmacological interventions, the effects of psychedelic therapy appear to last months and even years after treatment has ended. Understanding how psychedelic therapy leads to long-lasting mental health improvements across a range of conditions is not yet fully understood but is important for enhancing and delivering psychedelic therapy to individuals that may benefit from it.

The researchers were particularly interested in the transdiagnostic construct known as experiential avoidance, meaning the tendency to avoid unpleasant thoughts and feelings. People who score high on a measure of experiential avoidance agree with statements such as I would give up a lot not to feel bad and I go out of my way to avoid uncomfortable situations.

For their study, the researchers used online advertisements to recruit a sample of 104 individuals who planned to use a psychedelic substance and a second sample of 254 individuals who planned to attend psychedelic ceremonies. Both samples completed measures of depression severity, experiential avoidance, and suicidal ideation one week before and 4 weeks after using their psychedelic substance of choice.

Zeifman and his colleagues found that the use of psychedelics in both ceremonial and non-ceremonial settings was associated with decreases in experiential avoidance, which in turn was associated with decreases in depression severity and suicidal ideation 4-weeks after psychedelic use. Psilocybin/magic mushrooms, LSD, and ayahuasca were the most commonly used substances in the study.

Our findings suggest that one of the reasons that psychedelic therapy has positive therapeutic effects is that it helps individuals to be less avoidant and more accepting of their emotions, thoughts, and memories (even though such experiences may be distressing in the short-term), Zeifman told PsyPost.

More broadly, our results provide further support for the negative mental health effects associated with avoidance. This can be summed up with a saying that is often used in the context of psychedelic therapy, that The only way out is through.'

But the study like all research includes some caveats.

There were important limitations to our study, including that our study was not conducted in the context of a controlled clinical trial or within a clinical sample. Accordingly, we are currently conducting research where we are comparing the effects of psychedelic therapy versus a traditional antidepressant (called escitalopram) on experiential avoidance. This research will help to further examine the possibility that psychedelic therapy leads to change through different mechanisms than do traditional pharmacological interventions for depression, Zeifman said.

The study, Post-Psychedelic Reductions in Experiential Avoidance Are Associated With Decreases in Depression Severity and Suicidal Ideation, was authored by Richard J. Zeifman, Anne C. Wagner, Ros Watts, Hannes Kettner, Lea J. Mertens, and Robin L. Carhart-Harris.

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Psychedelic drugs reduce depressive symptoms by helping individuals accept their emotions, study suggests - PsyPost

There's a new neurological case for doing hard drugs. No, this isn't Doctor Oz standing on his pseudoscientific soapbox and preaching about how opium suppositories can cure your male pattern baldness, it's a brand new study from the University of California, San Francisco in the Journal of Psychopharmacology that links ayahuasca usage to positive changes in higher-function brain networks. Journal of Psychopharmacology that links ayahuasca usage to positive changes in higher-function brain networks.

As if you needed another reason to dose up on ayahuasca today, right?

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Ayahuasca is a "brew" prepared using bark from the Banisteriopsis vine and leaves from the Psychotria viridis shrub, both of which have hallucinogenic properties. It is known for pairing well with loose fabrics and the Beach Boys' album Pet Sounds. The Ayahuasca brew was used by ancient Amazonian tribes for religious purposes, and is still used in rituals by some religious communities today.

Studies researching the effects and potential psychotherapeutic use of psychedelics were halted for nearly 70 years due to the taboos surrounding it as a drug with a high potential for abuse. Now, fortunately, researchers are reviving clinical research into psychedelic drugs like ayahuasca as being potentially beneficial to people afflicted with mood disorders.

This study used functional magnetic resonance imaging, which analyzes brain activity by tracking changes in blood flow. The neural activity of their brain was analyzed one day before and one day after 50 study participants were given either a low dose of ayahuasca or a placebo substitute. The results were exciting for psychotherapeutic researchers looking into the benefits of psychedelic use and really exciting for Trent from my organic chemistry class, who skipped the final exam to do shrooms with his brother in Vermont.

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It turns out ayahuasca alters two major brain networks that affect sensational, affective, and motivational functions, while not affecting primary sensory networks or motor functions after the drug has left the system. This is a huge win for the movement to decriminalize recreational and medical psychedelic use in the United States, which has seen many victories in the past decade.

Ayahuasca is only available, legally, for religious or spiritual purposes. It is not one of the DEA's many Schedule 1 Controlled Substances, although its active ingredient, Dimethyltryptamine (DMT), is a controlled scheduled drug. This means you have to go through an ayahuasca "church" to access the brew, and only two religions, Unio do Vegetal (UDV) and Santo Daime, have legal protection for ayahuasca use in the United States, so a large portion of ayahuasca use in the United States is going on without legal protection.

Studies like the one done at UCSF are important because they bolster both the scientific and legal cases for ayahuasca use. The UDV were granted their permission to import and partake in ayahuasca, albeit under strict DEA regulation, from the Supreme Court in 2006. They must register any shipments with more than two weeks notice and any congregation trying to cultivate plants for the ayahuasca cultivation must register with the DEA as a manufacturer of controlled substances. The restrictions on Sainto Daime are even more severe, so recognizing the potential long-term benefits of the drug is a step towards cutting through the red tape keeping a potentially life-changing treatment from people in the United States.

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Tripping on Ayahuasca has always been fun, but now it might be good for you - GOOD Magazine

Are shrooms the new cannabis in Canada?

In the U.S., the Washington D.C. Board of Elections is allowing an initiative to decriminalize psychedelic plants, including magic mushrooms, to appear on Novembers ballot, after supporters gathered more than 25,000 signatures, according to the Washington Post.

If approved, the U.S. capital would join Denver, Oakland, Calif., and Santa Cruz, Calif., which have decriminalized psychedelics.

But, not so fast, says Canadas federal government.

Yes, earlier this month, Health Minister Patty Hajdu allowed four incurable Canadian cancer patients to undergo therapy which used psilocybin the psychedelic ingredient in magic mushrooms to ease their distress.

But that doesnt mean magic mushrooms, and other psychedelics, currently banned and only allowed in clinical trials or research in Canada, are on the fast track to decriminalization or legalization.

The Government of Canada is not proposing to decriminalize psilocybin or other controlled substances at this time, said Public Health Agency of Canada spokesman Tammy Jarbeau.

In 2019, Health Canada authorized psilocybin for use in a clinical trial for patients with treatment-resistant depression.

Still, CNN reported that the Canadian governments decision marks the first time since 1974 a legal exemption cleared the way for patients in this country to use psychedelic treatment.

Local cannabis advocate Lisa Campbell believes medicinal mushrooms are following the path of medicinal marijuana in Canada with recreational mushroom use still years away.

There are so many companies that are pivoting from cannabis to psychedelics, were going to see a lot of research to not only decriminalize but legalize psychedelics, at first for medical use, but it could push them to recreational use, as cannabis has done, said Campbell, the Toronto-based CEO of Mercari Agency Ltd., a cannabis sales and marketing company.

A lot of universities are finally more open to psychedelic research. Its finally becoming mainstream, she added. Its really fascinating that this is being done in Canada. For many years, people have been preparing for this paradigm shift in drug policy so the fact that were finally here in 2020 is really progressive and inspiring to be at the forefront of this movement.

Campbell said a Toronto clinic recently opened to treat those suffering from drug-resistant depression and anxiety with ketamine. While abused as a party drug, ketamine is primarily utilized in veterinary surgery.

She also said there are also mushroom dispensaries popping up online.

In Vancouver, theres almost de facto decriminalization, said Campbell. Its much more progressive there.

It has been for years, she added. They had the medical cannabis dispensary movement that started in Vancouver on the West Coast. Its so interesting to see how the same trends that we saw with cannabis, with the medical (use), are happening as well with mushrooms.

CNN reported New York University Langone Health researchers published a study this year in which 29 patients suffering from cancer-related anxiety and depression were given a single dose of psilocybin with psychotherapy. According to the findings, and 60% to 80% showed improvement.

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From pot to shrooms: What's next for decriminalization? - The GrowthOp

Notes from Pim van Lommel,Consciousness Beyond Life: The Science of the Near-Death Experience(New York: HarperCollins, 2010), 119-121:

Oxygen deficiency is accompanied by an increase of carbon dioxide, and this increase has been suggested as a possible cause for near-death experiences. Patients breathing in unusual quantities of carbon dioxide have been known to experience a sense of separation from the body, and there have been occasional reports of a bright light, a tunnel, a sense of peace, and/or memory flashes. It should immediately be pointed out, though, that these memory images or flashes are quite rare, are extremely fragmented, and never involved either a life review or an encounter with deceased persons. Moreover, the sometimes dramatic life changes that have been extensively documented in connection with NDEs have not been reported in cases of carbon dioxide overload.

After a relatively technical discussion of medical resuscitations and the difficulties in measuring levels of oxygen and carbon dioxide during a frantic operating room emergency, Dr. van Lommel offers a simple summation:

The conclusion that a high concentration ofCO2 could be the cause of an NDE seems to be highly questionable, and at least very premature. (118)

But there are plenty of other hypotheses on offer. How about psychedelics such as LSD, DMT, psilocybin, and mescaline? Perhaps surprisingly, Dr. van Lommel is somewhat more friendly to this suggestion than he was to oxygen deprivation or even to carbon dioxide overload. The latter three of these substances can be found fairly abundantly in nature. Psilocybin and mescaline, particularly, occur in plants native to Latin America and in (magic) mushrooms and have been used in potions, powders, and inhalants for centuries to induce mind-expanding experiences. All of them are closely related to the neurotransmitter serotonin, which is easily found in the human body, and their chemical structure is related to tryptamine.

During times of major physical or psychological stress, the body activates large amounts of DMT, notably via the pineal gland. This is probably also true during the dying process, when the cells of the pineal gland are dying and, it is thought, releasing DMT.

The experience induced by psychoactive substances is often surprisingly similar to a near-death experience, especially in the case of DMT although, depending on the dosage, confusing or frightening perceptions may also occur. These substance-induced experiences include the following elements: a sense of detachment from the body, out-of-body experiences, lucid and accelerated thought, an encounter with a being of light, a sense of unconditional love, being in an unearthly environment, access to a profound wisdom, and wordless communication with immaterial beings. Sometimes the characteristic post-NDE transformation, including the loss of the fear of death, is also reported after administration of DMT or LSD.

It is a new and surprising hypothesis that DMT, which occurs naturally in the body, could play an important role in the experience of an enhanced consciousness during near-death experiences. Perhaps DMT, its release triggered or stimulated by events in our consciousness, lifts our bodys natural inhibitions against experiencing an enhanced consciousness, as if it is able to block or disrupt the interface between consciousness and our body (and brain). Mention should be made here of the fact that zinc is essential for the synthesis of serotonin and related substances such as DMT. At a more advanced age, the body has lower levels of this metal, and, as mentioned earlier, NDE reports are less common at an older age. (120-121)

I would point out, though, that attempts to reduce NDEs merely to subjective brain events caused by oxygen deficiency or DMT an option that Dr. van Lommel himself clearly does not embrace fail to account for what seem to be verifiable out-of-body experiences in which the experiencers witness events and observe people from a vantage point distinct from the location of their bodies.

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Are NDEs caused by carbon dioxide overload? And what about psychedelics? - Patheos

ATAI Life Sciences aims to transform mental health care, backing companies working on new treatments for depression, anxiety and addiction. Now, its adding digital tools to the mix through a new company called IntroSpect Digital Therapeutics.

IntroSpect will create digital tools and devices that will magnify the effects of drugs in development at ATAIs companies, David Keene, CEO of IntroSpect, told Fierce MedTech.

The use of digital biomarkers could help doctors tailor doses for each patient and improve their treatment: With improved understanding of how individual biological phenotypes align with responses to certain interventions, clinicians will be better able to predict patients recovery pathways, said Srinivas Rao, chief scientific officer of ATAI Life Sciences, in a statement. This, in turn, will cut down trial and error and shorten the time to therapeutic impact. And for those with difficult to treat mental illnesses, time is absolutely critical.

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Another use case is remote monitoring, which could make psychedelic treatments available for patients who live far away from treatment centers. The technology could come in handy at Compass Pathways, for example, which is working on a psilocybin therapy for people with treatment-resistant depression.

RELATED: ATAI backs Neuronasal's through-the-nose concussion treatment

What separates apart a recreational psychedelic experience versus a clinical one is the clinical setting and aftercare therapy, Keene said. This type of aftercare can help patients take advantage of the neuroplasticitythe brains ability to change itselfthat comes with a psychedelic experience and use it to make life changes, Keene said.

Digitizing aftercare can widen access to psychedelic treatment for ailments such as addiction or depression. But thats not allthe digital tools could also be treatments themselves, helping patients learn new behaviors in the window of opportunity after psychedelics treatment.

A lot of digital therapeutics are based on psychological education, like cognitive behavioral therapy They are far more effective when the brain is in a state it can learn new things, Keene said.

RELATED: ATAI Life Sciences, Cyclica team up for mental health JV

IntroSpect is working on a modular system so it can apply its digital tools to the various disease areas in ATAIs portfolio. In addition to Compass Pathways, the company has backed Perception Neuroscience, which is working on a ketamine-like drug for depression, and Neuronasal, which is working on a treatment for concussion that is given through the nose. Its also set up joint ventures aimed at developing a neurochemical reset for opioid addiction and artificial-intelligence-based drug discovery for illnesses such as depression, bipolar disorder and schizophrenia.

The company is building the technology for substance use disorder and treatment-resistant depression, Keene said. Its starting with two indications so it doesnt end up making something thats too specialized and cant be adapted to other diseases.

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ATAI dives into digital therapeutics to boost mental health care - FierceBiotech

When psychedelic drugs finally become legal in the United States and elsewhere around the world, the lion's share of the credit will go to Rick Doblin. Since founding the Multidisciplinary Association for Psychedelic Studies (MAPS) in 1986, Doblin has argued forcefully for the benefits of frequently demonized substances such as MDMA, LSD, psilocybin, and ibogaine in helping people cope with posttraumatic stress disorder (PTSD), depression, anxiety, and other debilitating problems. For decades, Doblin and MAPS have been pushing not just for social and cultural acceptance but also for legal and medical legitimacy.

MAPS is currently sponsoring Phase 3 clinical trials of MDMA-assisted psychotherapy as a treatment for PTSD. Within the next few years, if all goes well, the Food and Drug Administration (FDA) is expected to approve MDMAa.k.a. Ecstasy, which the federal government banned in 1985 as a dangerous party drugfor use by prescription as a psychotherapeutic catalyst. Further down the line, psychedelic drugs such as LSD and psilocybin, which the FDA has recognized as a "breakthrough therapy" for depression, could undergo a similar legal transformation.

The rehabilitation of these once-vilified substances is a remarkable development that signals growing recognition of their life-enhancing uses and perhaps growing tolerance of people who choose to explore that potential. During a late-February ride from Manhattan to the John F. Kennedy International Airport,ReasonEditor at Large Nick Gillespie talked with Doblin about his role in this psychedelic renaissance and the experiences that drew him to the movement.

"I'm very much a child of the Cold War," Doblin says, recalling how he was taught to "duck and cover" at school during the Cuban missile crisis. His fear of nuclear Armageddon, ecological catastrophe, and genocide was the initial impetus for his vision of "mass mental health" facilitated by psychedelics, which he believes can have a unifying effect when used properly.

Although MAPS is doing everything by the book in seeking approval of MDMA as a prescription drug, Doblin's vision goes beyond such doctor-approved uses. He aspires to a world in which people can use psychedelics responsibly without permission from physicians or priests. "Psychedelics are tools," Doblin says. "They're not good or bad in and of themselves. It's how they are used. It's the relationship you have with them."

Reason: Many people are attracted to psychedelics because they're fun. The approach that MAPS has taken, by contrast, suggests that psychedelics should not be taken lightly. Talk about the contrast between using psychedelics recreationally and using them by prescription as an FDA-approved medicine.

Doblin: I think that people should have the fundamental human right to change their consciousness. When we talk about the Bill of Rights, freedom of speech, freedom of assembly, and freedom of religion, underlying all of that is freedom of thought. Psychedelics are a good example of the freedom of thought that we should have.

At the same time, when people take these things for recreational purposes and they're only looking for positive experiences, that can be dangerous if difficult material comes up. If you suppress it, you could end up worse off.

So there's an aspect of it that's work. One of our big statements is thatdifficultis not the same asbad. A lot of times, when people approach this as a recreational experience and stuff that's difficult comes up, they think, "Oh, it's a bad trip." But it is also an opportunity. So medicalization is a strategy for achieving broader access and mass mental health.

When you talk about medicalization, are you saying we need to maintain the current power structure, dominated by big pharmaceutical companies and doctors who serve as the high priests, telling us what to do and how to think? Or do you have in mind a broader concept of mental health or well-being?

Our core approach is that we are not the guides. We don't know where people need to go. People are their own guides. One of the concerns I have about traditional medicine, psychiatry, and psychotherapy, is that even in certain shamanistic settings, the healers are the ones who do it to the person. The power is in their hands. They're like surgeons; you don't do your own surgery. But when we're talking about mental surgery, we're trying to empower people to heal themselves.

To give you a sense of how much progress we're making, one of our donors, Bo Shao of the Evolve Foundation, said that when we had the psychedelic revolution in America, his parents in China were suffering under the Cultural Revolution. His parents' whole generation is traumatized still from that. So he's helping us bring [MDMA-assisted] therapy to China. We've already brought Chinese psychiatrists and psychotherapists to the United States for training, and I've been to China.

We're trying to universalize it in that way. But unlike most pharmaceutical companies, since we're doing it in a nonprofit context, we're trying to help people learn how to heal themselves without having to come to doctors and therapists.

Give me an update about what's going on with FDA approval of MDMA-assisted psychotherapy for PTSD.

On November 29, 201630 years after I started MAPSwe had what's called an end-of-Phase-2 meeting. That's where we discussed the data we had gathered during Phase 2 of clinical trials and whether the FDA would permit us to go to Phase 3 [the final step before approval of a prescription drug]. The FDA said yes. Then we negotiated for eight months every aspect of the Phase 3 research protocol, the statistical analysis plan, all the other supplemental material that's required when you move into Phase 3.

Phase 1 usually involves healthy volunteers, and you're just trying to understand what the drug does. In Phase 2, you do pilot studies, exploring who is your patient population, what are your doses, what is your treatment, who do you exclude and include. Phase 2 enables you to figure out how to design Phase 3, where you do the large-scale, randomized, placebo-controlled studies that are required to prove safety and efficacy. Those are the pivotal studies that you need to get approval for marketing.

There are also Phase 4 studies, which the FDA can require after you've gotten permission to market the drug when there's additional information that the FDA wants. We've already negotiated some of the Phase 4 studies. If we succeed in Phase 3, the FDA wants more information about how we can tell ahead of time who will respond well to the treatment and what we can say about relapse rates. How long do the benefits last?

Another aspect of it is that many drugs are tested in adults, and then they're prescribed to adolescents or children. If we succeed in adults, which means 18 or over for PTSD, then we have to do studies in 12- to 17-year-olds. If that works, then we have to study 7- to 11-year-olds who are traumatized.

When do you expect the Phase 3 trials to be completed?

The FDA can come back and say, "You did everything right [and] it looks good, but we're going to screw you over and stretch it out a little bit." We don't expect that the FDA will screw us over, because, once we got permission for Phase 3, we entered into this eight-month process where we negotiated everything. That's called the special protocol assessment process. If you end up agreeing, you get what's called an agreement letter, and the FDA is legally bound to approve the drug, assuming you get statistically significant evidence of efficacy and no new safety problems arise. And since MDMA has been around for 40, 50 years, tens of millions of people have taken it. We have a very good idea of the safety profile.

The other thing the FDA did, after we got this agreement letter, was declare MDMA a breakthrough therapy [a designation that is supposed to facilitate approval of promising drugs for hard-to-treat conditions]. So I don't think that they want to screw us over in any way.

In Phase 3, we have to do a minimum of two studies, each with 100 people, and then we do what's called an interim analysis for each study. We have enrolled almost 100 people in the first of the Phase 3 studies, and the interim analysis will be sometime in late March or early April this year. Then we'll know whether we need to add anybody for statistical significance. We expect to start the second Phase 3 study in the summer of 2021, so we should have all the data from the studies near the end of 2021.

Then we submit that to the FDA, and sometime in 2022, depending on how long the review process is, we anticipate approval. We're also negotiating with the European Medicines Agency, and that process is a year or two behind the FDA process.

We will need to raise around $30 million to finish Phase 3 in Europe and a similar amount to finish Phase 3 in the United States. But in the history of MAPS, we've received donations of about $80 million, and we're trying to do this all through donations. We don't want investors. I'm sympathetic with for-profit people getting involved. The scale of the problem is so big. We need all sorts of people, sponsors, resources. But I think the profit motive has warped American health care.

You've created a public benefit corporation to market MDMA. How will that work?

For the first 25 years of MAPS, I just assumed that once MDMA became a medicine, it would be a generic medicine, and it would be sold for very little money. MDMA was invented by Merck in 1912, so the patents have expired.

Even though I wrote my Ph.D. thesis at the Kennedy School of Government on the regulation of Schedule I drugspsychedelics and marijuanaI missed something. I learned only in 2013 or so that President Reagan had signed a bill to provide incentives for developing drugs that are off patent. Since they couldn't give patents, they offered what was called data exclusivity, which means you're the only one who has the right to use your data in the U.S. for five years. If you do pediatric studies, you get an additional six months of data exclusivity, which blocks generic manufacturers from even applying, and it takes the FDA at least six months to review those applications.

So we'll have about six years of data exclusivity. Once I realized that we might actually be able to sell MDMA for more than cost as a medicine, I realized that we had a different story to tell our donors: We're not going to be perpetually asking you for money, and we might even be able to make money from the sale of MDMA and use that for more research.

Doing that is a taxable situation, and you can't stay inside the nonprofit. A public benefit corporation is a kind of corporation that explicitly seeks to maximize benefits for the public rather than the return to shareholders. So that's the approach we're taking.

This is kind of like a legal version of the Brotherhood of Eternal Love, which sold LSD for practically nothing in the '60s and '70s.

They are a big part of the story of psychedelics that not that many people know about. They really had a mission beyond making money, and the mission was consciousness change. That is our mission.

All of our research staff and all of the research money has been transferred to the public benefit corporation. We are taking not just a new approach to mental health, which is psychedelic-assisted psychotherapy, but a new approach to marketing medical treatments and drugs. We will charge somewhat more than the MDMA costs us, but we're not going to charge the maximum of what the market will bear, because that means that you have fewer people paying more for treatments. And our goal is mass mental health.

Where is the biggest pushback against what you're doing coming from these days?

So far we haven't had a whole lot of pushback. Veterans [with PTSD] have such support, particularly among Republicansthere's a libertarian strand of the Republican Party that has been a strong ally in looking at the benefits of illegal drugs. There's pushback from drug warriors who think that we need to demonize these drugs to justify the drug war. That's why there's been suppression of research into cannabis.

The pushback that I've received has not been from regulatory agencies. The FDA is aware that there are enormous numbers of people with mental conditions that are not adequately helped by the currently available medicines. That's why MDMA was declared a breakthrough therapy. Psilocybin has been declared a breakthrough therapy for treatment-resistant depression. The most important new development in mental health treatment over the last 20 or 30 years has been ketamine for the treatment of depression.

Traditional psychiatry is coming around. Yesterday, theAmerican Journal of Psychiatrypublished an article about psychedelic psychotherapy and how it was promising.

I've received pushback from some of our donors who ask, "Why did you accept money from [Republican] Rebecca Mercer, [libertarian Charles] Koch, or others? Just stick to medicine." Right now some of our big donors are telling me that I should shut up about drug policy reform and the fundamental human rights issue, that we want people to have access to these drugs with proper education and harm reduction, but outside of medicine and religion.

There is potential for pushback from fundamentalist Christians, although it doesn't seem to have happened yet. Classic psychedelics like psilocybin have been used for thousands of years for religious and medical purposes. Through ego dissolution, people have mystical experiences, which suggests there may be a common mystical core in all the world religions. There are fundamentalists in each religion who say, "My religion is the only true one. Everybody else is an infidel." The psychedelic mystical experience is a challenge to that. But I think the fundamentalists could benefit from a deeper appreciation of their own spirituality.

The other possible area of pushback is parents worrying about their kids. If you make this into a medicine, they might think, kids will get the message that it's a good thing.

What we've been doing in that regard is going to festivals around the world where young people are using these psychedelics. A lot of them are using them unwisely and irresponsibly and just trying to have a good time. Difficult material comes up, and they then try to suppress it or push it down. We've started what we call the Zendo Project, which does psychedelic harm reduction at Burning Man, the Boom Festival in Portugal, all over the world. The aim is to help people who have difficult trips work through them and process the material, so that they don't get tranquilized, don't go to the hospital, and don't have long-term mental disruptions because of it.

You once told a reporter, "We're not the counterculture; we are the culture." And I think there's some real truth to that. But you're also a parent. How old are your kids, and have you tripped with them?

My kids are 25, 23, and 21. We've wanted to take [psychedelics] together as a family.

That sounds both wonderful and kind of terrifying.

When I had my bar mitzvah at 13, that really opened the door to psychedelics for me. Because my bar mitzvah did nothing. I mean, it was a nice party. I was the oldest of four kids. I really did expect that there would be some kind of spiritual experience. And the next morning, I'm lying in bed, and God did not come. Nothing happened, but I was ready for it. I felt really bad, and I felt that traditional rituals didn't really work.

When our children turned 13, my wife and I spoke to them and said, "If you want to try marijuana or MDMA, come to us and, and we'll give it to you." It was the best anti-drug strategy that we could have had, this idea of doing drugs with your parent. They all said, "We're not ready yet."

This is a hot-button issue. But if you look at the traditional cultures that have successfully integrated psychedelics in America, we have half a million members of the Native American Church who use peyote. We have many people who are using ayahuasca in ritual settings, and they've successfully integrated ayahuasca. They believe that children who are interested in ceremonies with their families can try small amounts of these drugs, and they don't have age limits. I went to a Native American Church ceremony with my wife. It was to celebrate the wedding of a friend of ours. A Navajo man brought his 9-year-old son, who took peyote and stayed up the whole night. Now, the 9-year-old didn't take the full dose.

I am profamily values. When it comes to the education of children, we should leave that to the families, not to the government. In 23 states, the laws prohibiting the use of alcohol by young people have a parental override that allows parents to give alcohol to their children, even at restaurants, as long as there is parental supervision. So this idea is not foreign to America. I think that's the way it should be with other drugs as well.

One of the worst parts of the drug war is that parents are scared to be honest with their own children. To have the intrusion of the government in the most intimate situations, where you are trying to educate your children, is terrible. I know people who still hide the fact that they smoke marijuana from their children, even in legalization states like Massachusetts, where I live.

Do you worry about a backlash? In the 1960s, there was Diane Linkletter's suicide, which her father, the writer Art Linkletter, blamed on LSD. In the 1980s, there was the cocaine-related death of Len Bias, who had just been drafted by the Boston Celtics. His death helped inspire draconian anti-drug legislation. Do you worry about that sort of thing?

I very much worry about backlash. That's why we've reached out to the police, to try to educate them. That's why we are actively reaching out to bipartisan groups and why we have bipartisan financial support.

In the '80s and '90s, when the rave milieu was just starting, people were taking MDMA and overheating sometimes and dying from hyperthermia. Those stories were used to block the research, and then drug warriors could say there's no evidence of benefit. But now, because we have strong evidence of benefits, the situation is different.

Now we're able to say that in a medicalized context, we're getting more benefits than risks. When people take drugs in nonmedical settings and have tragic outcomes, I don't think that's going to boomerang back on the research. We have veterans who have attempted suicide multiple times but are now PTSD-free after MDMA-assisted therapy. I felt that it was necessary for us to work with the hardest cases and to show that there can be value for people who have unsuccessfully tried other treatments.

So we accept people [into our trials] who have attempted suicide in the past. We just have to create a very strong support system for people throughout the entire process of therapy. And so far there's only been one person who has attempted suicideunsuccessfullyduring our trials. The therapist thinks that was a person who was in the placebo group and was so disappointed she wasn't randomized to the MDMA group that she lost hope.

We have to be very careful not to exaggerate the benefits or minimize the risks. I think what happened with Timothy Leary and others in the '60s is that the government was exaggerating the risks and denying the benefits. And Tim and others, I think, did the opposite: exaggerated the benefits and minimized the risks.

We try to be clear that this doesn't work for everybody. This is not a panacea. It's not a one-dose miracle cure. What we're really doing is psychotherapy. It's not that you just take this pill and something changes for the better. That provides a level of comfort, when people understand that it's done in a therapeutic context.

The best way to think about drugs is that they're tools. Psychedelics are tools. They're not good or bad in and of themselves. It's how they are used. It's the relationship you have with them.

The government's survey data indicate that nearly half of Americans 12 or older have tried marijuana at least once, while about 10 percent have used it in the last month. With hallucinogens, which includes LSD, psilocybin, and mescaline, about 16 percent of Americans say they have tried them, and less than 1 percent report using them in the last month. Assuming everything is medicalized or legalized in the way you want, do you think psychedelics will ever be a mass phenomenon?

No. I think it will be something that more people will want to use, because it helps you with core aspects of being human: What's the meaning of my life? What do I think about death? Why do I have social anxiety? How do I deal with trauma? I think larger numbers of people will use psychedelics, but it's not going to be like weed. Psychedelics are used intermittently, and the emphasis is on what you bring back from the experience. There won't be a lot of frequent users, but there will be more occasional users.

Are you optimistic about the future? Not just for psychedelics, but for a broader vision of self-guided mental health?

I'm very optimistic. This idea of unification, of a common mystical core, of shared humanity and global spiritualityit also permits greater individuality. Sometimes people think that when you talk about global spirituality or shared mystical experiences, all the differences are washed out. I think it works both ways. The more we can understand our commonality, the more we will appreciate our differences and our uniqueness.

This interview has been condensed and edited for style and clarity. For an audio version, subscribe toThe Reason Interview With Nick Gillespie.

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'People Should Have the Fundamental Right To Change Their Consciousness' - Reason

The company is filing an Investigational New Drug application with the FDA for the Phase 3 confirmatory clinical trial of Bucillamine

Revive Therapeutics Ltd (CSE:RVV) (OTCMKTS:RVVTF) has come a long way in just six months under the stewardship ofCEOMichael Frank.That much is apparent from a casual glance at the share price for the year to date.

However, there is an argument to be made that suggests this may just be the start of the journey for this US and Canadian-listed life sciences innovator. For not only does Revive have a (coronavirus) COVID-19possible treatment headedtowards phase III clinical trials, but it also has some unique and interesting intellectual property (IP) that taps into the emerging area of psychedelics.

Also part of the story, but taking a back-seat for now, is its research around the potential uses of cannabidiol (CBD) to treat auto-immune hepatitis, ischemia and reperfusion injury from organ transplantation.

READ:Revive Therapeutics holds pre-CTA meeting with Health Canada for Bucillamine to treat COVID-19 patients

Revivehas a history of repurposing drugs and IP such asBucillamine,a cysteine derivativeanti-inflammatory that has been used for more than 30 years to treatrheumatoid arthritisin Japan and South Korea.

With an impeccable track record for safety, the companys researchers were assessingthe data fromits potential deployment in acute gout flareswhere ithad successfully completed a phase IIUS Food and Drug Administration (FDA)clinical trial.

Thats when more thoughts were given to the use of Bucillamine to treat lung inflammation.

The drug works by helping restore and enhance an antioxidant called glutathione. Revives team soon realized the same anti-inflammatory action that worked in gout and arthritis could possibly be deployed in people suffering lung inflammation as a result of seasonal flu, H1N1, SARS and, crucially, COVID-19.

In April, it applied to the US regulator to carry out a phase II trial in COVID-19and was surprised by the response.

BasedonBucillamines composition, efficacy, safety and history, as well as a previous, successful interaction with the FDA, the drugs watchdog asked Revive to prepare anInvestigational New Drug (IND) submissionfor a phase IIIconfirmatory trialin COVID-19.

Thats a very large milestone and a major study, says Frank.It gives the company a great deal of credibility.

The company is currently incorporating guidance provided by the US regulator intoits INDpackage, which should beready and submittedby the end of the month,Frank adds.

Another development that is exciting investors is the companys move into psychedelics, which appears incredibly well-timed.

Last year the FDA approvedesketamine to treat depression, making it the first-ever psychedelic drug to receive the regulatory green light in the US, with UK authorities giving their approval for the ketamine-like drug a few months later.

MDMA, meanwhile, has been given breakthrough therapy designation by the US regulator for post-traumatic stress disorder (PTSD), as has psilocybin, the psychoactive found in mushrooms, which is being developed as an alternative to traditional antidepressants.

In March, Revive announcedit was acquiring Psilocin Pharma Corp in an all-paper deal worth $2.75 million. Its focus is psilocybin-based treatments forvariousmedical needs, which includes rare and orphan indications.

Reviveis working with the University of Wisconsin on some new delivery technology that could add another dimension to the research and discoveries to date.

We want to build a better product, with more favorable onset and delivery of psilocybin and then move it down the clinical path, says Frank.

And thats crucial, because like many others in this new and flourishing area of drug discovery, the plan is to formally follow the highly regulated route to market.

In doing so the potential reward could be significant. The psychedelics industry itself is big enough to pique the interest of Big Pharma, with investment bank Canaccord Genuity, in a recent market report,estimating the total market size for all indications under investigation to be as much as $100 billion.

However, the smaller, more innovative players such as Revive, are likely toset the pace and make an impact.

Psychedelics have shown promising efficacy across a broad range of both mental and substance abuse disorders, said Canaccord inits report. Together, the targeted indications affect over one-billion people globally.

Frankstated:I think we have only scratched the surfacein a number of areas, and our team looks forward to educating the market more.

Contact the author Uttara Choudhury at[emailprotected]

Follow her onTwitter:@UttaraProactive

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Revive Therapeutics betting on psychedelics and potential COVID-19 treatment Bucillamine - Proactive Investors USA & Canada

Houston, Texas--(Newsfile Corp. - June 19, 2020) - The global obesity epidemic is only growing in size.

"New federal data show that the obesity rate in the U.S. has hit 42.4%, up from 30.5% in 1999-2000," according to The Wall Street Journal. Worse, according to the World Health Organization (WHO) obesity has tripled in size over the last 50 years.

By 2030, almost half of U.S. adults will be considered obese.

Unfortunately, with obesity comes issues such as heart disease, stroke, type 2 diabetes, and several types of cancer. Even worse, according to Energy Balance and Obesity: What are the Main Drivers? "There is convincing evidence for a role of obesity as a causal factor for many types of cancer including colorectum, endometrium, kidney, oesophagus, postmenopausal breast, gallbladder, pancreas, gastric cardia, liver, ovary, thyroid, meningioma, multiple myeloma, and prostate cancers."

However, a solution may be found in psychedelics such as DMT and psilocybin, both of which activate serotonin receptors, or "nature's own appetite suppressant," as noted by Psychology Today. "This powerful brain chemical curbs cravings and shuts off appetite. It makes you feel satisfied even if your stomach is not full. The result is eating less and losing weight."

Psychedelics, Like DMT Could Help Treat Eating Disorders

The Yield Growth Corp. (CSE: BOSS) (OTCQB: BOSQF) announced that its majority owned subsidiary NeonMind has filed an additional provisional patent application related to using psychedelics as medicine. The most recent patent application, filed on June 17, 2020 covers the administration of DMT to treat compulsive eating disorder and other illnesses.

DMT, or N,N-Dimethyltryptamine, is a derivative and structural analog of tryptamine, known for its hallucinogenic properties. It currently has no approved medical use, though DMT-containing plants are commonly used in indigenous Amazonian shamanic practice, and are sometimes found in the drink ayahuasca. DMT is found naturally in several plants including Mimosa tenuiflora, Diplopterys cabrerana, and Psychotria viridis. It is structurally similar to psilocin and its precursor psilocybin, a chemical found in so-called "magic mushrooms."

"DMT is a very interesting molecule that acts on the same type of serotonin receptors which are known to regulate appetite," says Dr. William Panenka, Chair of the NeonMind Scientific Advisory Board. "As part of our overall patent strategy, we are establishing defensible intellectual property around multiple compounds that act on these receptors and intend to follow this with rigorous clinical trial work to establish efficacy."

Psilocybin May be Key to Treating Obesity

NeonMind also filed a U.S. provisional patent application in the U.S. for the invention relating to therapeutic administration of psilocybin or psilocin, combined with supportive therapeutic treatment for a patient to provide weight loss benefits and treatment for related health issues.

The provisional patent is for a proposed guided psychedelic psilocybin therapy protocol using psychotherapy prior to, during and after the psychoactive effects of the Psilocybin are felt by the patient. The psychedelic assisted psychotherapy is designed to assist in gaining insights from positive psychedelic experiences, to be integrated into everyday life and to help plan, prepare and make sense of psychedelic experiences for a therapeutic result.

In addition, NeonMind has retained contract research organization Translational Life Sciences Inc. to design and plan an initial preclinical study using psilocybin which is anticipated to begin in the fall of 2020. The preclinical study is anticipated to provide data to design phase 2 human clinical trials to test Psilocybin as a weight loss treatment. The phase 2 clinical trials are anticipated to begin in 2021, subject to receiving all required regulatory approvals.

For more information, visit the company's website at https://yieldgrowth.com.

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These Psychedelic Drugs May Be Key to Revolutionizing Weight Loss Treatment - Yahoo Finance

The articles, looking at safety and efficacy of ketamine as a mental health therapy, were co-authored in conjunction with the Canadian Rapid Treatment Centre of Excellence

Champignon Brands Inc (CSE:SHRM) (OTCQB:SHRMF) said its CEO Dr Roger McIntyre and the Canadian Rapid Treatment Centre of Excellence (CRTCE) have authored two articles on the safety and efficacy of ketamine in major peer-reviewed journals.

The research-driven company studies psilocybin and other psychedelics as treatments for mental health conditions and addiction disorders.

The first article, Safety and tolerability of IV ketamine in adults with major depressive or bipolar disorder: Results from the Canadian rapid treatment center of excellence, was published in Expert Opinion on Drug Safetys latest edition.

Another study, The Effectiveness of Ketamine on Anxiety, Irritability, and Agitation: Implications for Treating Mixed Features in Adults with Major Depressive or Bipolar Disorder, appeared in the journal Bipolar Disorders.

McIntyre is a widely-renowned researcher on depression and founded the CRTCE, the first facility in Canada to provide rapid onset treatments for people with mood disorders.

The publications of data as it relates to ketamine treatment at the CRTCE continues to demonstrate the rapid and robust efficacy of ketamine in persons with depression and related disorders, Champignons CEO said in a statement.

Our data, for the first time in the field of psychiatry, shows that ketamine can improve a persons ability to function in their role and return to work within a few weeks. The significant efficacy of ketamine at our centre is also matched by stable side-effect profiles, as well as the acceptability of ketamine in people who are benefitting from this novel treatment, he added.

Champignon specializes in the formulation of a suite of medicinal mushrooms health products as well as novel ketamine, anaesthetics and adaptogenic delivery platforms for the nutritional, wellness and alternative medicine industries.

Contact Angela at [emailprotected]

Follow her on Twitter @AHarmantas

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Champignon Brands CEO Dr Roger McIntyre authors studies appearing in two leading scientific journals - Proactive Investors USA & Canada