Vancouver, British Columbia–(Newsfile Corp. – November 5, 2020) – Entheon Biomedical Corp. (CSE: MPV) (formerly, MPV Exploration Inc.) (“Entheon” or the “Company“) is pleased to announce that further to its news releases dated July 2, 2020, September 10, 2020 and October 28, 2020, the Company has completed the previously announced business combination with Entheon Holdings Corp. (formerly, Entheon Biomedical Corp.) and has received final approval to list the Resulting Issuer Shares (as defined below) on the Canadian Securities Exchange (“CSE“) pursuant to the amalgamation agreement (the “Amalgamation Agreement“) dated June 30, 2020, as amended, among the Company, Entheon Holdings Corp. and 1254912 B.C. Ltd.
Entheon will list 34,353,688 common shares (the “Resulting Issuer Shares“) on the CSE and the Resulting Issuer Shares are expected to begin trading on or about November 12, 2020 (the “Trading Resumption Date“) under the symbol “ENBI”.
Further Disclosure
Trading in the common shares of the Company was halted by the CSE on July 2, 2020 following the announcement of the Amalgamation Agreement and is expected to remain halted until the Trading Resumption Date.
Further, a total of 1,988,500 common share purchase warrants of the Company issued in connection with the Company’s Initial Public Offering in April 2018 (the “Warrants“) have been assigned a new CUSIP number and ISIN number, being 29383X111 and CA29383X1116, respectively, expected to be made eligible on or about November 10, 2020, with each Warrant now exercisable for one Resulting Issuer Share at a price of $0.90 per share until April 20, 2021.
For further information with respect to the Transaction and the business of Entheon, please refer to the listing statement of Entheon dated November 12, 2020 and posted under the Company’s issuer profile on SEDAR at www.sedar.com.
About Entheon Biomedical Corp.
Entheon is a biotechnology research and development company committed to developing and commercializing a portfolio of safe and effective Dimethyltryptamine based psychedelic therapeutic products (“DMT Products“) for the purposes of treating addiction and substance use disorders. Subject to obtaining all requisite regulatory approvals and permits, Entheon intends to generate revenue through the sale of its DMT Products to physicians, clinics and licensed psychiatrists in the United States, certain countries in the European Union and throughout Canada.
For more information, please contact the Company at:
Original Source https://www.newsfilecorp.com/release/67606
Cautionary Note on Forward Looking Information
This news release contains forward‐looking statements and forward‐looking information within the meaning of applicable securities laws. These statements relate to future events or future performance. All statements other than statements of historical fact may be forward‐looking statements or information. More particularly and without limitation, this news release contains forward‐looking statements and information relating to the commencement of trading of the Resulting Issuer Shares on the CSE, and other matters. The forward‐looking statements and information are based on certain key expectations and assumptions made by management of the Company. Although management of the Company believes that the expectations and assumptions on which such forward-looking statements and information are based are reasonable, undue reliance should not be placed on the forward‐looking statements and information since no assurance can be given that they will prove to be correct. Forward-looking statements and information are provided for the purpose of providing information about the current expectations and plans of management of the Company relating to the future. Readers are cautioned that reliance on such statements and information may not be appropriate for other purposes, such as making investment decisions. Since forward‐looking statements and information address future events and conditions, by their very nature they involve inherent risks and uncertainties. Actual results could differ materially from those currently anticipated due to a number of factors and risks. These include, but are not limited to, the Company’s ability to raise further capital and the Company’s ability to obtain regulatory and exchange approvals. Accordingly, readers should not place undue reliance on the forward‐looking statements and information contained in this news release. Readers are cautioned that the foregoing list of factors is not exhaustive. The forward‐looking statements and information contained in this news release are made as of the date hereof and no undertaking is given to update publicly or revise any forward‐looking statements or information, whether as a result of new information, future events or otherwise, unless so required by applicable securities laws. The forward-looking statements or information contained in this news release are expressly qualified by this cautionary statement. Neither the CSE nor the Investment Industry Regulatory Organization of Canada accepts responsibility for the adequacy or accuracy of this release.
With all eyes on the US election, we are sure that those in the psychedelic medicine sphere wonder what this could mean for the future of psychedelic medicine in the United States.
The US is home to many crucial networks and institutes that are moving the psychedelic agenda forward in any way they can. Among them, we spotted Dr. Bronner’s—a mighty wind beneath the wings of several psychedelic campaigns and initiatives—setting a great example by providing voter registration booths, giving workers a half-day off on November 3rd, with full day’s pay to encourage employees to vote.
We are in awe of these efforts and recognize the need for voters to ensure that these entities remain intact and that their funding and support don’t dry up post-election—no matter what the results.
When Will Psychedelics become Legal in the United States?
Polarized for decades, the American perception of psychedelics currently the gamut from novice, to skeptical, to overzealous. As a result, it can be challenging to zero in on which narrative is speaking the most to voters and politicians, many of whom have not voiced a definite opinion about psychedelics. Yet.
One politician who goes against the grain in regards to psychedelic medicine is Rep. Alexandria Ocasio-Cortez. Although the House of Representatives rejected it, Ocasio-Cortez did try to introduce a bill that would have removed an existing rider that scientists say inhibits research into the therapeutic potential of Schedule I controlled substances such as psilocybin, MDMA, and marijuana.
Nevertheless, the congresswoman, who has voiced support for groups like Decriminalize Nature NYC, promises to introduce more psychedelics legislation in Congress.
The FDA recently greenlit clinical trials for psilocybin and MDMA, designating both as “breakthrough therapy” for chronic conditions like depression and PTSD, respectively — with some wildly impressive results. Breakthrough therapy status essentially puts drugs on the fast-track to legality as medications for mental health. While voting for a president on November 3rd, the citizens of Oregon and the District of Columbia could also vote to decriminalize naturally-occurring psychedelics like psilocybin. For these reasons and more, Rolling Stone has published a prediction that psychedelics “will be legal as pharmaceuticals in the next decade.”
In a recent interview with PsyTech, Entheon’s CEO, Timothy Ko was asked what he thinks the impact of the election will be on the psychedelic industry. “With the election being so dynamic and divisive it is hard to get a grip through the noise on what the platforms for candidates are as they apply to psychedelic medicine. Much of the approvals and granting of breakthrough status have come under the current administration so there has been no indicator of cultural resistance, but the reasoning is often suggested that a democratic presidency would be more culturally lenient, and some of Biden’s platform positions indicate a relaxed attitude to cannabis. Whatever the case may be, the pandemic has highlighted a need for mental health treatments, and there we do require leadership when it comes to the effects of the lockdowns on mental health and substance use.”
As evidenced by increasing rates of substance-related overdoses and deaths, societies worldwide are ill-equipped and overburdened in managing and mitigating the growing mental health crisis.
Efforts to dampen the spread of COVID-19 through social distancing and shutdowns have kept the caseloads in those compliant areas relatively low compared to other jurisdictions globally. But the overall health of the global population has deteriorated over this year, with more people turning to drugs, alcohol, tobacco and other dopamine-stimulating “addictive” behaviours to cope with the stress.
The World Health Organization estimates that around 31 million people currently struggle with substance abuse issues alone. But that’s not the full story.
Addiction expert Dr. Gabor Maté defines addiction as any behaviour with negative consequences that one persists, pursues and craves despite those negative consequences. Dr. Maté’s definition helps to clarify why repetitive destructive behaviours – addictions and compulsions, with or without the involvement of a substance – are a massive, global problem.
The Entheon Biomedical team believes there are better recovery solutions out there, options that are rooted in innovations, new scientific findings, and the tremendous potential worth exploring in psychedelic medicines.
Studies show us that psychedelics can help create enduring positive changes to an individual’s mood, interpersonal relationships, attitudes, and beliefs. According to newly published results from MAPS, these substances are cost-effective too.
No matter which way the American election goes, Entheon Biomedical’s core mission will remain the same. We will continue to investigate, manufacture, and commercialize scientifically valid treatment options that are FDA, EMA and Health Canada approved to address the mounting public crisis of substance use disorders.
MONTREAL, Oct. 28, 2020 (GLOBE NEWSWIRE) – MPV Exploration Inc. (“MPV” or the “Company”) is pleased to announce that further to its press releases dated July 2, 2020 and September 10, 2020 (the “ initial press releases ”), the Company has received conditional approval from the Canadian Securities Exchange (“ CSE ”) to list the resulting issuer’s shares (as defined below) for trading in accordance with to the Merger Agreement (the “ Merger Agreement ”) dated June 30, 2020 and amended on October 9, 2020 between Entheon Biomedical Corp. (” Entheon “) and 1254912 BC Ltd. (” Subco “), Whereby the Company will acquire all of the issued and outstanding securities of Entheon in exchange for shares of the Company (the” Transaction “).
In addition and as part of the Transaction, the Company will change its name from “MPV Exploration Inc.” to “Entheon Biomedical Corp.” (The ” Name Change “). Simultaneously with the Change of name and as part of the Transaction, the Company will also consolidate its issued and outstanding ordinary shares at the rate of one (1) ordinary share subsequent to the Consolidation for three (3) ordinary shares in circulation of the Company’s capital (the “ C onsolidation “). Fractional shares will not be issued as any fractional shares will be rounded to the nearest whole number. In addition, the number, exercise price or exchange basis of all Warrants will be adjusted, from time to time, to reflect the Three-for-One Consolidation.
Following the simultaneous completion of the Transaction, Name Change and Consolidation, the new CUSIP number for the ordinary shares of the resulting entity (the “ Shares of the resulting issuer ”) Will be 29383X103 and the new ISIN number will be CA29383X1033. The Company will announce the symbol on the CSE for the shares of the resulting issuer no later than the closing of the Transaction. Currently, a total of 18,105,514 common shares of the Company are issued and outstanding and following Consolidation, the Company will have approximately 6,325,160 common shares of the resulting issuer issued and outstanding (assuming the exercise of options held by the officers and directors of MPV immediately before the completion of the Transaction). Following completion of the Transaction and having given effect to: (i) the 29,845,805 Shares of the resulting issuer to be issued to former Entheon shareholders; and (ii) the 4,217,886 1 resulting issuer shares to be issued to Subco shareholders, as part of the Concurrent Broker-less Private Placement conducted by Subco (as further detailed in the initial press releases), the Company will then have approximately 40,388,851 shares issued and outstanding.
In connection with the Consolidation, the shares of the resulting issuer after the Consolidation will be transferred to the registered shareholders of the Company by the Company’s transfer agent, Computershare Investor Services Inc. The Company expects the date of entry into effect. effect of the Consolidation and of the Name Change will take place on the date of completion of the Transaction.
Additional disclosure
Trading in the Company’s common shares was halted by the CSE on July 2, 2020 following the announcement of the merger agreement and will remain so until trading resumes after approval is obtained. final of the CSE.
For more information on the Transaction, please see the initial press releases. The Company will issue further press releases regarding the Transaction as the information becomes available.
About Entheon Biomedical Corp.
Entheon is a privately-held biotechnology research and development company engaged in the development and commercialization of a portfolio of safe and effective psychedelic therapeutics based on dimethyltryptamine (“DMT products”) for the treatment of substance abuse disorders and the use of substances. Subject to obtaining all required regulatory approvals and permits, Entheon intends to generate revenue through the sale of its DMT products to licensed physicians, clinics and psychiatrists in the United States, certain countries of the European Union and across Canada.
For more information on the Company or on Entheon, please visit:
MPV Exploration Inc. Jean-Francois Perras, President and Chief Executive Officer Telephone: (514) 667-7171
This press release contains forward-looking statements within the meaning of applicable securities laws. These statements relate to future events or future results. All statements other than those relating to historical facts may be informative or forward-looking statements. More particularly and without limitation, this press release contains forward-looking information and statements concerning the conclusion of the Transaction and the concomitant financing and the conditions relating thereto, the deadlines for the receipt of regulatory approvals, from the shareholders and the stock exchange as well as future plans and objectives of the Combined Company and others. Forward-looking information and statements are based on certain expectations and assumptions made by the management of the Company. As a result, no assurance has the effect that the proposed Transaction or related matters will be completed as advertised or even at all. Although the management of the Company believes that the expectations and assumptions on which the forward-looking statements are based are reasonable, undue reliance should not be placed on them as there is no assurance that they will be correct.
Forward-looking information and statements are presented for informational purposes regarding current expectations and management’s plans for the future of the Company. Readers are cautioned that reliance on statements and information may not be appropriate for other purposes such as investment decisions. The fact that statements and information relate to future events involves certain risks and uncertainties. Actual results could be materially different from anticipated results due to a number of factors and risks. These may include, among others, the ability of the Company to continue its activities in the eventuality or the Transaction would not take place to continue to operate its business, to conclude the concomitant financing or to obtain the approvals and authorizations required in order to conclude the Transaction as presently described. Therefore, the reader is cautioned not to place undue reliance on depressed-looking in this release. The reader is also cautioned not to consider the risk factors described herein as being exhaustive. Forward-looking statements and information contained in this press release are made as of this date and no commitment is made to release any update or revise forward-looking statements as a result of new information or future events unless required. under applicable securities law.
The Canadian Securities Exchange and the Information Services Provider have not reviewed and do not accept responsibility for the accuracy or adequacy of this version.
______________________ 1 Includes 100,000 shares of the resulting issuer as well as 100,000 intermediation units (the “Finding Units”) that were issued as part of the simultaneous broker-less private placement conducted by Subco. Please note that the amount of intermediation units was incorrectly stated at 37,500 in the press release of September 9, 2020 (and its corresponding English press release of September 19, 2020).
Worldwide, substance use disorders are on the rise, causing a high financial and social cost, yet the current model helps only a fraction of those suffering.
Substance use disorders have exacerbated overcrowding of the healthcare system, which has forced policymakers around the world to seek out more modern and compassionate healthcare alternatives and preventative harm-reduction measures.
Canada appears to be taking a progressive yet patchworked community healthcare approach to alleviating the current opioid and substance-use crisis. At the Federal level, Health Canada appears to be taking promising steps toward easing the surge in pandemic-related relapse rates and the troubling rise in overdose deaths that reached pandemic proportions before the arrival of COVID-19.
In February 2017, the Federation of Canadian Municipalities’ (FCM) Big-City Mayors’ Caucus (a collective of representatives from 22 of Canada’s biggest cities) launched a task force dedicated to curate best practices around substance use to prevent deaths and save more lives. This initiative has put together a comprehensive list of recommendations that call for a coordinated, nationwide approach requiring actions by all government levels.
To execute these proposed recommendations, the FCM recommends further action at the community-level would bolster the success of Canada’s drug strategy four-pronged approach: harm reduction, treatment, prevention and enforcement. As an alternative, they suggest replacing incarceration for possession of illegal substances with increased access to health care, treatment and social services. However, there is considerable debate regarding the efficacy of such a wide-scale change of legislation, suggesting that more research and discourse are first required.
Nevertheless, in addition to these efforts, Health Canada has released a letter that demands government ministries “conduct a thorough assessment of any barriers to access medicines that could contravene public health advice for social distancing and self-isolation, when appropriate.”
Multiple Barriers to Substance Use Disorder Treatments
As highlighted in at least one past entry, the barriers vary and come loaded with socio-economic nuance. They include:
Current regulations around illegal substances
Restrictions imposed by medicated-assisted treatment protocols
Costs associated with traditional treatment models
Lack of effectiveness associated with standard treatment models
Even using the “most effective” legal methods of treating alcohol dependence, long-term patient outcomes are limited, with most patients relapsing the first year following a purely psychosocial based intervention. It is usual for a patient to require repeated stays at 90-day treatment centres. Without insurance coverage, the modality is too costly for the average citizen to afford.
In Canada, programs exist covered by provincial health care; however, patients can find themselves wait-listed for treatment when demand for detox and in-patient programs rises. In the context of these harsh realities, many researchers are focused on drug discovery to find modern efficacious uses for known or overlooked psychedelic chemical compounds that may provide long-term symptom relief for specific use-cases.
Why Consider Psychedelics for Substance Use Disorders?
There are many programs in place to address substance use disorders (SUDs), including government-run programs, social programs run by non-government entities, and religious programs.
As a member of Entheon’s influential team of scientists and researchers, Dr. Christopher Gondi, Ph.D., M.Sc. seeks to explore the therapeutic benefits of psychedelic substances in helping patients reconcile their views and past traumas. From his lab at the University of Illinois College of Medicine Peoria, Dr. Gondi shared with us some insight into why religious-leaning programs like Alcoholics Anonymous (AA) and Narcotic Anonymous (NA), which require individuals to surrender to a higher power, are perceived to have a higher success rates (actual rate is challenging to determine due to the insistence on anonymity) than non-religious detox programs.
“Those programs help more than the structure where you go through a detox period for some time and then you’re kicked out. [Those patients] come back. Why? Because they have not reconciled their deep-seated emotional trauma and emotional need that needs to be addressed. For some reason – and I have no answer for this – the touching on the spiritual needs of an individual is something that psychedelics have helped.”
Indeed, one of tne of the naturally-occurring psychedelic molecules Entheon Biomedical is studying, called DMT or N, N-Dimethyltryptamine, is given the moniker “the spirit molecule.”
Johns Hopkins Magazine recently resurfaced findings from a DMT survey study, noting that:
“The vast majority of the respondents said DMT brought them into contact with a “conscious, intelligent, benevolent, and sacred entity,” most commonly described as a “being” or “guide” in an interaction that oozed joy, trust, love, and kindness. Eighty percent reported that the experience had fundamentally altered their perception of reality, and 72% said that the entity continued to exist after the experience “in a different plane of reality.” Perhaps most startling was that more than half of those who had previously self-identified as atheists—28% of the sample—described some type of belief in a higher power or God after taking DMT, according to Griffiths, director of the Johns Hopkins Center for Psychedelic and Consciousness Research.”
The advent of psychedelic-assisted therapy is a significant moment in human history, and the fact that it may be sparking an entheogenic-related religious curiosity seems to be part of the course with these powerful substances. However, insurance companies are not about to cover substances that are not legal, even if they result in a longer-lasting reduction of drug-seeking and drug-taking behaviours.
Who Will Prevail in Helping to Make Psychedelics Accessible to Patients in Canada?
We want to highlight two groups taking unique approaches to entheogenic (psychedelic) drug reform in Canada.
TheraPsil is a non-profit organization that supports Canadians in palliative care and experiencing end-of-life distress to exercise their charter right to seek compassionate treatment using psilocybin through an application for exemption of section 56(1) of the controlled substances and drug act (CDSA).
The palliative care patient’s use case is admittedly different from that of drug-dependent individuals, yet both sets of people are looking for some of the same things, relief from trauma being part of that.
On August 4th, 2020, four Canadians suffering from end-of-life distress became the first individuals to access an exemption to access psilocybin therapy legally. Today, the organization has secured six exemptions and is now asking Canada’s Ministry of Health to review physician requests to use psilocybin to better understanding patient outcomes. Not only has Federal Minister of Health Patty Hajdu been granting these exemptions, but she has also gone on record about her “open(ness)” to drug decriminalization.
Dr. Ryan Patchett-Marble from Marathon, Ontario (Thunder Bay district), is one such physician who recently told a local media outlet his reason for applying for the exemption through TheraPsil. “The reason I think it’s important for physicians or therapists themselves to have experiential training, this is not like when I prescribe antibiotics for an ear-tract infection, I don’t need experience with the antibiotic, this is prescribing,” he said. “This is more akin to a guide. You want the guide to have personal experience in what they are guiding you in.”
In a separate motion that could potentially increase access to entheogens to all Canadians, a petition to decriminalize plant medicines in Canada was presented in the House of Commons by Paul Manly MP on September 30th, 2020. The Canadian government has 45-days from then to respond to the petition from the Canadian Psychedelic Association that is now undersigned by 15,000 Canadians.
The toll of the opioid crisis begins in the home and community, destroying lives, picking away at the very fabric which holds us together as a people. From there, the collateral damage extends into the economy and our civic institutions, imposing a financial and economic burden that impacts many sectors.
The Canadian Centre on Substance Use and Addiction, and the Canadian Institute for Substance Use Research, published a collaborative paper on Canadian Substance Use Costs and Harms in 2018 that gave a snapshot of the price of “substance use (SU).” The report includes healthcare costs, lost productivity costs, criminal justice costs and other direct costs associated with substance use and its rippling effects.
In 2014, the cost of substance use in Canada was $38.4 billion—or approximately $1,100 spent for every Canadian, regardless of age. Opioids contributed to $3.5 billion or 9.1% of those total costs, representing the third-largest portion of the total, after alcohol and tobacco.
By 2017, substance use in Canada cost the country a whopping $46 billion, or $1260 per Canadian. Up to $6 billion of that, or $163 per person, is attributed to opioid use.
The Cost of Opioid-Related Lost Productivity and Death in Canada
While opioids trail behind alcohol and tobacco in total healthcare costs, according to the Canadian Substance Use Costs and Harms report, the largest per-person lost productivity costs are associated with opioids, which increased 20.6% from $43 per person in 2007 to $52 per person in 2014.
Estimates of substance use-related lost productivity costs represent the lost value of work due to premature mortality, long-term disability and short-term disability (absenteeism and impaired job performance). This increase is likely due to the increasing number of premature deaths related to opioid use.
Nationally, the rate of apparent opioid-related deaths was 7.9 per 100 000 population in 2016. However, there were pronounced differences between provinces, with western Canada reporting some of the highest death rates. Based on available data, British Columbia and Alberta account for the majority (56%) of opioid-related deaths in 2016.
Statistics indicate that most apparent opioid-related deaths in Canada occurred among males; individuals between 30 and 39 accounted for the most significant proportion, meaning young, working-age people are being taken from their families and the economy prematurely.
Today, the opioid crisis is experiencing a widely-reported spike and continues to affect a broadening section of the population. The consequences of this hastening crisis have the power to negatively impact individuals, their families, their employers, and their healthcare teams. We already know that opioid dependency indiscriminately crosses demographic and socioeconomic lines, although treatment modalities tend to draw those lines and create barriers based on who can afford the treatments.
Medicated-Assisted Treatment programs, in which a person consumes a daily maintenance dose of methadone, can cost up to $6000 a year – and that is in the best-case scenario. Addiction treatment centers that utilize the 12-step model can cost up to $650 per day, many of which require the patient to stay at the clinic for 60 to 90 days of detox, followed by recovery work. Many have wondered, due to the observed efficacy and safety profile of psychedelic medicines, if psychedelic-assisted therapy can ease the socioeconomic burden of addiction.
Are Psychedelics a Cost-Affordable Solution to the Opioid Epidemic?
Can a psychedelic substance be cost-effective, safe enough, and have enough positive patient outcomes that it helps reduce the amount of money needed to care for drug-dependent Canadians? It’s something that the Entheon wonders, and is working on.
Kenneth Tupper, Ph.D., is Entheon’s Advisor of Ethics as well as the Director of Substance Use Prevention & Harm Reduction at the British Columbia Ministry of Health. Dr. Tupper was one of the authors of a paper based on a 2013 study undertaken by the Centre for Addictions Research of British Columbia at the University of Victoria. The study set out to show the efficacy of ayahuasca-assisted therapy in addiction treatment, specifically for those with chronic addictive behaviours. In the study, patients made statistically significant improvements in several factors related to problematic substance use among the participants. These findings suggest that participants experienced substantial positive psychological and behavioural changes in response to this therapeutic approach.
Entheon is developing medicines based on DMT, the psychoactive ingredient within traditionally-brewed Ayahuasca tea. Entheon Biomedical is researching and developing a legal DMT therapeutic protocol that is being specifically designed to treat substance-abuse disorders, and will specifically focus on opioid-use disorder in coming pre-clinical and clinical trials The path of treating the underlying mechanisms of substance-use disorder with psychedelic therapies is well-known in the traditional and naturalistic psychedelic space, but this environment remains unregulated and cannot be easily scaled to serve the expanding group of substance-use sufferers who require treatment. Many mainstream medical practitioners are just now becoming aware of the potential of psychedelics to treat disorders of this nature, and much work is being done to further validate psychedelic-assisted psychotherapy, both privately and publicly, which is both crucial and exciting, for as the threat of opioid abuse grows in power and strength, so to must the solutions we develop and implement.
Learn More
Learn more about the personal and social costs associated with the opioid crisis here.
Dr. Andrew Hegle currently serves as Entheon Biomedical’s Director of Operations. He has been an adjunct professor of Pharmacology at the University of British Columbia since 2015. He has a background in molecular biology and biochemistry and has published research investigating membrane receptor proteins’ role in physiology, behaviour and disease. He was a co-founder of both Cannevert Therapeutics and Canalytic Laboratories in Vancouver. Andrew is responsible for putting all of the elements needed for Entheon to commence clinical trials. This involves planning, timelines, budgets, protocols for the drug development process, working with clinicians and more.
Tell me about your background and why you chose to work with Entheon Biomedical.
I did my Ph.D. in Molecular Biology at the University of Michigan before coming to Vancouver in 2007. I then spent six years working at the University of British Columbia (UBC) researching cardiovascular health, genetics, and neuroscience. I then decided to move away from academia and began working on a startup company in the cannabis space focused on pain relief, and even with all of the hype that there was in the sector, what was important to us was putting the science behind it and setting up clinical trials. I spent about five years doing that while getting involved with UBC’s pharmacology department before joining Entheon.
There seems to be an increasing amount of interest in the psychedelic therapy field now. Why do you think that is?
Firstly, I am a big believer in psychedelics’ therapeutic potential, and I believe that the increasing interest in the area is due to a confluence of things. Certainly, the decriminalization and reassessment of cannabis use for therapeutic purposes broke down some taboos around psychoactive drugs and their possibilities. But more generally, I think that because we live in a more connected world, people can more easily learn about how diverse cultures approach things. Consider, for example, how ayahuasca is understood and used in South America, which is in stark contrast to the war on the United States’ drug culture.
And at the same time, society is in the midst of a mental health crisis, and there is a desperate need for new tools to combat this. Incidence of depression, loneliness, and dependence on substances like opioids are all at an all-time high. In this urgent crisis, I think that psychedelics are a prominent tool that we should be leveraging for mental health treatments. We already know these drugs have many potential benefits, but no one has fully explored their potential in the clinic until recently. Steven Barker described this research as “forbidden fruit long ripening on the tree of knowledge,” which I think is a great metaphor.
Are psychedelics Cannabis 2.0?
I don’t really like this comparison because I think it’s very different. It’s genuinely apples and oranges. I can certainly understand that these could be put into a similar category and thought of as street drugs in the average person’s mind. But I believe that the therapeutic benefit that psychedelics have compared to cannabis will be much more impactful.
Why does DMT interest you in particular?
DMT is an endogenous molecule, meaning that it’s in our brains already. It wasn’t invented in a lab; our bodies naturally do so, so it’s not poison. When new drugs are created from scratch, we often don’t know what kinds of side effects they may have, so it’s exciting to work with an endogenous molecule because we already know that it has a good safety profile.
DMT is fascinating because it is a very simple molecule that can be metabolized quickly and isn’t complicated. We don’t have to worry about by-products or different metabolic artifacts that other drugs might have.
How important is an integrated approach with psychedelic therapy?
With psychedelics, it’s not just about the drug, it is everything around it too. The setting and the patient’s mental state are crucial, including psychotherapy and working with a therapist for multiple hours before and after so you can make sense of what has happened. It isn’t like most drugs where you develop it, improve it, and your doctor sends you home with it. It is an entirely different paradigm.
I see these substances being successful with addiction, treatment-resistant depression and a range of other issues. But it must be done with supervision in a clinic. That said, you don’t want to do it in a sterile hospital room with beeping machines and white walls. You have to have it in the right space, with therapy and with an integrative approach. And this is the kind of reality for which Entheon is developing tools.
Yaron has 15 years of experience in Life Sciences innovation. He has led efforts in development, regulatory compliance, and operations in the medical field. Yaron has worked within start-ups as well as consulted for them. He has navigated the U.S., European, Israeli and Australian regulatory agencies, including the registration of manufacturing facilities in the U.S., Central America, Israel and Australia to Good Manufacturing Practice (GMP) levels. Yaron has led clinical trials in the U.S., Europe, and Israel and worked with Clinical Research Organizations all over the world.
What made Entheon stand out to you as a unique opportunity compared to other psychedelic and pharmaceutical start-ups?
The people. Even some of the larger psychedelic pharmaceutical companies don’t have the calibre of team and advisors that we have working with us to develop our DMT addiction product. Robin Carhart-Harris and his team from Imperial College lead the way in DMT research, and Professor Matthew Johnson from Johns Hopkins has focused on addiction. More recently, he has shown the path for the therapeutic use of psychedelics in general and specifically in addiction treatment—what a powerful duo. We also have an experienced pharmaceutical development team, including Dr. Michael Walker and Dr. Andrew Hegle, both of whom have developed therapies through the FDA pathway from “bench to bedside,” and our ayahuasca roots are represented by ethnopharmacologist and researcher Dennis McKenna. We have an absolute all-star team.
What are your thoughts on the competitive landscape for Entheon? Do you feel that Entheon has competition with other start-ups to create a usable psychedelic drug?
I don’t know if the competition is the right word, because ultimately, there is just a real, urgent need to get psychedelics to patients. I don’t care if it’s MAPS (Multidisciplinary Association for Psychedelic Studies), Compass Pathways or our team at Entheon. Someone needs to get these treatments to patients. I hope that in 7 to 10 years, we see several companies with success in the industry. I don’t worry too much about the competition because we have a unique approach.
You’ve called Entheon “The FDA’s Dream,” what do you mean by that?
We are developing what we believe is the safest version of the powerful therapeutic products called “psychedelics.” Also, we aren’t generating a chronic model, meaning that instead of taking a tablet a day for the rest of your life, you only need three to five sessions. This reduces the chances of long term toxicity and drug on drug interactions and alike. “Cured” is a word that is rarely used when it comes to depression, anxiety and addiction. But with psychedelic therapy, how the patient sees the world becomes fundamentally changed, and recovery is indeed a possibility.
What makes DMT particularly useful in therapy?
Firstly, it is interesting because it exists endogenously. Our brains make DMT. This makes it different from MDMA, LSD and psilocybin. When DMT is taken, it is a much shorter experience than the other psychedelics, lasting minutes rather than hours. You can stop the psychedelic experience if the patient needs to or session time has run out. Compare this to LSD, which can last for the entire day – LSD isn’t a scalable situation. We will have a solution where the DMT experience lasts the length of time that a therapist determines appropriate- also, if the patient wants to stop, they can.
Do you think that the COVID-19 pandemic will influence the state of psychedelic medicine?
The need for these supportive treatments will increase. Mass unemployment and the psychological challenges of dealing with isolation will take its toll, and the world needs psychedelics to see things differently. The only things I have seen to help people to see the world differently are love and psychedelics.
Opioids don’t discriminate—opioid misuse affects all Canadians
On August 12, we wrote about the current opioid crisis and the uptick on opioid-related overdoses and deaths in Canada. This crisis does not discriminate against minority populations and can undoubtedly affect anyone. Indeed, a life-sentence to opioid drug dependency can start with a minor injury, followed by a doctor’s visit. This article addresses how the current medical system disproportionately provides aid to those in the throes of opiate addiction and provides an alternative to the currently available treatment options.
Although the number of Canadians using opioids decreased (from 13% of the population to 11.8% between 2015-2017), hospitalizations for opioid overdose or complications increased to about 17 admissions each day. Between 2016-2019, Canada lost 15,393 lives to the opioid crisis. These are our sisters, fathers, mothers and brothers.
While opioid misuse has affected every region of the country, western Canada (British Columbia and Alberta) and the northern territories (Yukon and Northwest Territories) have experienced the highest devastation levels. Furthermore, in the 2018 National report of the First Nations Regional Health Survey, 24.9% of adults and 10.4% of youth between the ages of 12 and 17 reported opioid-use.
The discrepancies in treatments for opioid dependency
Indeed, the opioid crisis does not discriminate against income, race, gender or cultural influences. There is an opiate out there to accommodate every socio-economic class. However, the treatments available for those seeking to maintain their dependence on opioid-maintenance programs or safe medication-assisted therapy vary from between socio-economic classes.
Medical anthropologist Helena Hansen (2012) describes how methadone clinics were created to serve Black and Latinx urban communities, while buprenorphine clinics concurrently target the growing opioid crisis in white, middle-class communities. She explicitly notes how much more effective buprenorphine is for opiate addiction treatment and discusses how those in minority populations are not receiving equally effective medications.
Compounding the problem is the lack of access to these opioid-maintenance programs during the pandemic. Nick Boyce, of the Ontario Harm Reduction Network, said the dramatic measures adopted to slow the spread of COVID-19 are limiting drug users’ access to support services that prevent overdose deaths. These types of support services are typically in place to aid those who are already at-risk: low-income, reliant on government-assistance programs, living with untreated mental health issues, and with little or no additional support from family.
Thus, those who rely most on government services – people of lower socio-economic populations who have suffered the most during this pandemic – will likely be the ones continuing to suffer long after the peak danger of COVID-19 passes.
Could psychedelic-assisted therapy present a fair, effective and democratic solution?
A recent study published in the PlosOne Journal found that people who use cannabis for therapeutic purposes are less likely to misuse opioids, adding to a growing body of evidence supporting the use of cannabis for pain as a harm reduction strategy. However, not everyone agrees with these findings and research at McMaster University has found that cannabis is not entirely effective in reducing opioid addiction.
At Entheon Biomedical, we believe that it is time to explore new approaches to managing addictive behaviours and addressing the current opioid crisis. We have found that psychedelic substances, mainly DMT, hold much more potential in successfully reducing opioid-dependence.
Our aim at Entheon Biomedical is to demonstrate the efficacy of DMT for the treatment of addiction. We hope to bring psychedelic substances to the biomedical and substance-use treatment market in the most responsible and scientifically-legitimate way.
It is necessary to address the current issue of access in the sphere of psychedelic-assisted therapy. Many important figures in the field, such as Bia Labate, have discussed the problems of privilege and access in psychedelic-assisted treatment. Once these medicines become more regulated, access to them will indeed be minimal as this approach to healing relies on many hours of psychotherapy sessions, which costs a lot of money.
At Entheon Biomedical, we are developing a DMT therapeutic protocol that is much shorter lasting and flexible than established MDMA or psilocybin-assisted therapies. This will ultimately reduce billable hours and decrease associated costs. Ultimately, we hope that these shortened sessions of psychedelic-assisted therapy can increase access to these medicines and reduce the systemic discrepancy found in opiate dependance.
Entheon is optimistic about future findings and is actively working towards addressing the issues in current treatment modalities, access to valuable medicines, and ultimately making a dent in the truly devastating crisis that the opioid epidemic has brought to our communities and families.
For more information on Canada’s current opioid crisis, you can find national data, surveillance, and research here.
5-methoxy-N,N-dimethyltryptamine (5-MeO-DMT) is a psychedelic substance that can be found in plants (Pachter et al. 1959), the secretion of the Incilius Alvarius toad (Weil and Davis 1994), and made synthetically (Hoshino 1936). The substance is well-known for its short-acting properties (depending on the route of administration) with subjective effects summarized in the following soundbite: ‘we are all one.’ This “sense of oneness” is similar to the experiences of ego dissolution (Nour et al. 2016) and mystical experiences (MacLean et al. 2011) evoked by other psychedelics which has been correlated with betterment in mental health-related symptoms (Barsuglia et al. 2017; Griffiths et al. 2006; Uthaug et al. 2019; Uthaug et al. 2018).
Despite being an understudied substance, current research suggests that the use of 5-MeO-DMT can evoke similar (therapeutic) effects as that of longer-acting psychedelics like psilocybin (magic mushrooms) (Barsuglia et al. 2017). Its ability to evoke the aforementioned subjective effects paired with its short-acting properties makes 5-MeO-DMT an attractive substance for Psychedelic Assisted Psychotherapy (PAP) as it could bypass some of the logistical and financial hurdles that stand in the way of individuals getting treatment. This is why I decided to study 5-MeO-DMT’s effects and its implications for aiding in the treatment of various mental health-related disorders, including substance use disorder.
My name is Malin Vedøy Uthaug, and I am currently working as a Postdoctoral Researcher at the Centre for Psychedelic Research at Imperial College in London. I recently joined Entheon Biomedical as a scientific advisor to aid in their quest to develop a treatment for substance use disorder using 5-MeO-DMT. For the past three years, as part of my Ph.D. work at Maastricht University in The Netherlands, I have conducted several studies on both ayahuasca and 5-MeO-DMT to explore their respective effect on mental health. Ayahuasca is a ‘psychedelic tea,’ a plant concoction containing N,N-Dimethyltryptamine (DMT) and monoamine oxidase inhibitors, used historically in a shamanic ceremonial context in the Amazon (Riba et al. 2003). 5-MeO-DMT is a similar substance to DMT known for its fast-acting properties, evoking a psychedelic experience within seconds that can last for 15-40 minutes (depending on the route of administration) (Uthaug et al. 2020; Weil and Davis 1994). I decided to write my Ph.D. on these substances primarily because ayahuasca is used in a ceremonial context, which I believe the scientific and medical communities can learn much from and that it will help us inform the design of PAP moving forward. Secondly, 5-MeO-DMT is a rather understudied substance that appears to have a similar therapeutic potential to longer-acting psychedelics such as ayahuasca and psilocybin (magic mushrooms). The fact that 5-MeO-DMT was and still is an unexplored territory compared to other entices my inner adventuress and fuels my motivation to pursue a career in psychedelic research.
My doctoral dissertation’s main objective was to explore whether the ingestion of ayahuasca and 5-MeO-DMT in a naturalistic setting was related to improvement in mental health-related variables. Those variables could include depression, anxiety, stress, mindfulness, satisfaction with life, creativity, empathy), and whether such an improvement depends on the magnitude of the psychedelic experience (i.e., the experience of ego dissolution). The five original studies I carried out are summarized in my thesis titled; “The Exploration of Naturalistically Used Ayahuasca and 5-MeO-DMT; An assessment of their respective Sub-acute and Long-term effects on Mental Health Related Variables”.
The thesis consists of seven chapters where Chapter 1 assesses the need for a new treatment option or mood-related disorders such as depression, while Chapter 2-3 and Chapter 4-6, summarizes the studies on ayahuasca and 5-MeO-DMT, respectively. Finally, Chapter 7 discusses the key findings of the studies in a broader perspective, explains the implications of the findings, and provides recommendations as we move into PAP’s future.
For all of my studies, I made use of ‘naturalistic observational design.’ This design makes observations and assessments (i.e., questionnaires and computer tasks) in individuals who voluntarily consume psychedelics like ayahuasca and 5-MeO-DMT in a naturalistic setting. There are drawbacks of this design, such as the lack of control for possible influencing non-pharmacological variables (i.e., set and setting, group dynamics, expectation, suggestibility, the potential bias of both researcher and participant). Despite those drawbacks, the design allowed me to collect valuable information that could engender future research and prospective clinical trials.
In a nutshell, my dissertation work suggests that both ayahuasca and 5-MeO-DMT used in a naturalistic setting is associated with persisting betterment (up to 4 weeks) in mental health-related variables (Chapter 2-6) and that this is correlated with the experience of ego dissolution (Uthaug 2020). Furthermore, the research suggests that 5-MeO-DMT may have immunomodulatory potential through the downregulation of cytokine IL-6 (a biomarker for inflammation) (Chapter 5). This echoes the findings of previously reported anti-inflammatory actions of 5-MeO-DMT (Dakic et al. 2017; Szabo et al. 2014) but warrants further longitudinal assessments. Additionally, a retrospective survey-study on the effects of different administration routes of 5-MeO-DMT (Chapter 6) indicated that there was no significant difference in impact and experiences of 5-MeO-DMT when administered through vaporization or intramuscular injection (IM). However, the results revealed that IM evoked the phenomenon of reactivation (defined as flashbacks/re-experiencing [parts of] the experience) less frequently, induces a slower onset of acute effects and had a strong potential to bring about the release of physical tension (somatic release). The results add weight to the clinical considerations of 5-MeO-DMT through IM by Sherwood and colleagues (2019), who identified IM as the most favourable route of administration of 5-MeO-DMT for the following reasons; 1) it avoids the first-pass metabolism; 2) has high bioavailability; 3) it allows for precise control of dosage, and 4) evokes a gentle onset with a slightly longer duration of effects.
Although the current scientific information about 5-MeO-DMT points to a similar (therapeutic) potential as other psychedelics (i.e. psilocybin), the findings from Chapter 3 (manuscript under review) in my dissertation work suggest that non-pharmacological factors such as set and setting may be steering some of the improvement in mental health-related variables. The “naturalistic placebo-control” study on the effects of ayahuasca ingested in a neo-shamanic setting signifies that while improvement in empathy was attributed to ayahuasca’s pharmacological actions, reductions in effect (depression, anxiety and stress) were moderated by non-pharmacological factors such as expectation and learning. Although we did not conduct a similar study on 5-MeO-DMT, it may very well be the case that such non-pharmacological factors played a role in the improvement in mental health-related variables following 5-MeO-DMT use too. Such factors may also include social desirability bias (Grimm 2010) and spiritual bypassing (Fox et al. 2017).
The latter is defined as the tendency to use spiritual ideas and practices to sidestep or avoid facing unresolved emotional issues, psychological wounds, and unfinished developmental tasks. Based on my observations in the field, and by watching over a hundred sessions in the underground, it seems that spiritual bypassing is a common occurrence in the underground where 5-MeO-DMT is used. My reasoning behind that is due to knowledge of the rapid onset and offset of 5-MeO-DMTs effects (through vaporization), and high doses used, which might push an individual to dissociate psychologically. Psychological dissociation is defined in Ralph Metzner’s book as ‘unconsciousness of one’s own bodily postures and gestures, vocalisations and verbalizations, as well as more or less disconnect of total awareness of ones surroundings‘ (2013). If a person dissociates during their experience with 5-MeO-DMT, they will not be ‘online’ to (somewhat) consciously work through material that may be causing them distress. Thus, there will be no resolution of unprocessed, unconscious material, and therefore it is very likely that the same pain will return. As Carl Jung once stated: what you resist persists.
Additionally, from speaking with many participants and facilitators before and after sessions, I became aware of romanticized ideas and expectations that they held about 5-MeO-DMT. Many believed that medicine would somehow set them free from various mental health-related difficulties. In other words, the substance would do the healing work for them. The idea of a “quick fix” is not unusual in our society and is evident in other areas besides mental health. If I go on this vacation, I’ll be happier! If I get this job, I’ll be more satisfied. However, these are nothing but fabricated subjective illusions. The only thing you need is to take full responsibility for yourself and so too for your healing. The solution isn’t externally, but internally. Psychedelics like 5-MeO-DMT may aid in that internal process, but it won’t do the work for you nor anyone else.
I believe it is about time that beliefs about a ‘quick fix’ are reconsidered, not only by participants and facilitators of such ceremonies but also by individuals on a societal level. The reason for this is because healing is hard. If it were easy, we wouldn’t have a worldwide mental health epidemic and an urgent need for a novel treatment option for mental health-related disorders like addiction.
Although more research is needed, there is scientific literature supporting 5-MeO-DMT as an adjunct in therapy for various mental disorders. The idea would be to use it as a catalyst for a therapeutic process (i.e., Psychedelic Assisted Psychotherapy). A person would be supported by a therapist to lean into painful and repressed thoughts. Ideally, the patient undergoes therapeutic sessions before and after to prepare for and integrate the therapy with 5-MeO-DMT. The latter is particularly important, for as the title of the book by Jack Kornfield reads; after the ecstasy, the laundry.
What makes the effects of 5-MeO-DMT any different from the effects of other psychedelics? What does 5-MeO-DMT do that psilocybin or ayahuasca can’t? We do not know yet, but what we do know is this: Previous reports from participants who received ayahuasca-assisted therapy stated that it helped them release the pain or trauma that was being masked by their substance use (Argento et al. 2019). Ayahuasca, it has been suggested, exerts its anti-addictive effect through biochemical, physiological, psychological, and transcendent pathways (Liester and Prickett 2012). Firstly, ayahuasca targets several brain regions associated with addiction, and secondly, reduces dopamine levels in mesolimbic pathways related to the development and maintenance of chronic substance use.
Furthermore, it has shown to help resolve trauma, and finally, induces transcendent experiences pathways (Liester and Prickett 2012).
Additionally, the setting (ritualistic) in which ayahuasca is used and the sense of community it facilitates has also been suggested as an essential factor in addiction cessation (Talin and Sanabria 2017). The latter, a group setting, has shown to be particularly important in the treatment of addiction (Flores 2001). 5-MeO-DMT might hold a similar potential as ayahuasca for the treatment of substance use disorder for similar reasons. Despite not being used in a similar group setting, research has shown that 5-MeO-DMT target several brain areas associated with addiction (Barsuglia et al. 2018; Dakic et al. 2017), and elicit profound mystical experiences akin to that of high-dose psilocybin experiences (Barsuglia et al. 2017). Furthermore, previous research suggests that 5-MeO-DMT has low addiction potential and excellent safety profile (Davis et al. 2018), anti-inflammatory properties through the sigma-1 receptor (Szabo et al. 2014; Uthaug et al. 2019a), the therapeutic potential for various mental health disorders (Davis et al. 2018).
This still doesn’t tap into what makes 5-MeO-DMT so different, but I hope that the following might explain why:
In my opinion, while being mindful of my own bias, it seems to me that 5-MeO-DMT has this unique ability to amplify a person’s interoception (sense of the internal state of the body) to a different, and yet to be understood extent which I think can have important implications for treatment of addiction as well as Post-traumatic Stress Disorder (PTSD). From my perspective, it seems that 5-MeO-DMT can pierce through the dissociative veil that is ‘protecting’ people with addiction or PTSD from unprocessed material like trauma and thus get them in contact with their body. Under the influence of 5-MeO-DMT, while in a supportive therapeutic context, a person could have a chance to get in touch with the reality of the autonomic nervous system and the dysregulation that may be in it. This provides an opportunity to work through material that has been repressed and caused “issues in the tissues” (trauma).
With regards to addiction and based on statements and writings by Dr. Gabor Maté, someone who is misusing a substance (or more) is doing so to dim away or run away from pain. In his view, the place to target in treatment is not the addiction but the illness that is causing it. According to Dr. Maté that pain needs to be felt through to go away for ‘addiction starts and ends with pain.’
Like Dr. Gabor Maté, I also believe that pain needs to be acknowledged and felt. If not, it will continue to return like ‘pop-up notifications’ on a smart-phone as a reminder that something needs attention. I also believe that 5-MeO-DMT may help individuals feel through these things if done in the right setting with proper support from a therapist. The therapeutic relationship is also a key component of treatment success.
That said, it is premature to make conclusions about the place for 5-MeO-DMT in mental health treatments at the current time. There are still many unanswered questions to address, which will require rigorous research designs, testing and analysis. To that end, I am delighted to have joined Entheon Biomedical as an advisor. As we continue to search for, investigate and find the answers to many of these lingering questions, with the ultimate aim of developing therapies that will support those recovering from substance use disorder.
References
Barsuglia J, Davis A, Palmer R (2017a) Characterization of mystical experiences occasioned by 5-MeO-DMT-containing toad bufotoxin and comparison with prior psilocybin studies. Psychedelic Sci 23
Barsuglia JP, Davis AK, Palmer R, Lancelotta R, Windham-Herman M, Peterson K, Polanco M, Grant R, griffiths R (2017b) Characterization of Mystical Experiences Occasioned by 5-MeO-DMT-Containing Toad Bufotoxin and Comparison with Prior Psilocybin Studies 3rd International Psychedelic Science Conference
Barsuglia JP, Polanco M, Palmer R, Malcolm BJ, Kelmendi B, Calvey T (2018) A case report SPECT study and theoretical rationale for the sequential administration of ibogaine and 5-MeO-DMT in the treatment of alcohol use disorder. Progress in brain research 242: 121-158
Dakic V, Nascimento JM, Sartore RC, de Moraes Maciel R, de Araujo DB, Ribeiro S, Martins-de-Souza D, Rehen SK (2017) Short term changes in the proteome of human cerebral organoids induced by 5-MeO-DMT. Scientific reports 7: 12863
Davis AK, Barsuglia JP, Lancelotta R, Grant RM, Renn E (2018) The epidemiology of 5-methoxy-N, N-dimethyltryptamine (5-MeO-DMT) use: benefits, consequences, patterns of use, subjective effects, and reasons for consumption. Journal of Psychopharmacology 32: 779-792
Flores PJ (2001) Addiction as an attachment disorder: Implications for group therapy. International Journal of Group Psychotherapy 51: 63-81
Fox J, Cashwell CS, Picciotto G (2017) The opiate of the masses: Measuring spiritual bypass and its relationship to spirituality, religion, mindfulness, psychological distress, and personality. Spirituality in Clinical Practice 4: 274
Griffiths RR, Richards WA, McCann U, Jesse R (2006) Psilocybin can occasion mystical-type experiences having substantial and sustained personal meaning and spiritual significance. Psychopharmacology 187: 268-283
Grimm P (2010) Social desirability bias. Wiley international encyclopedia of marketing
Hoshino TaS, K. (1936) Über die synthese des bufotenin-methyl-äthers (5-methoxy-n-dimethyl-tryptamin) und bufotenins (synthesen in der indol-gruppe. xv). Bull Chem Soc Jpn 11: 221-224
Liester MB, Prickett JI (2012) Hypotheses regarding the mechanisms of ayahuasca in the treatment of addictions. Journal of psychoactive drugs 44: 200-208
MacLean KA, Johnson MW, Griffiths RR (2011) Mystical experiences occasioned by the hallucinogen psilocybin lead to increases in the personality domain of openness. Journal of Psychopharmacology 25: 1453-1461
Metzner R (2013) The Toad and the Jaguar: a Field Report of Underground Research on a Visionary Medicine: Bufo alvarius and 5-Methoxy-dimethyltryptamine. Regent Press, Regent Press
Nour MM, Evans L, Nutt D, Carhart-Harris RL (2016) Ego-Dissolution and Psychedelics: Validation of the Ego-Dissolution Inventory (EDI). Frontiers in Human Neuroscience 10: 269
Pachter IJ, Zacharias DE, Ribeiro O (1959) Indole alkaloids of Acer saccharinum (the Silver Maple), Dictyoloma incanescens, Piptadenia colubrina, and Mimosa hostilis. The Journal of Organic Chemistry 24: 1285-1287
Sherwood A, Kaylo K, Kargbo R, Davis A, Lancelotta R, Uthaug M, Barrow B (2019) CLINICAL CONSIDERATION OF 5-MeO-DMT International Forum on Consciousness, Madison, Wisconsin
Szabo A, Kovacs A, Frecska E, Rajnavolgyi E (2014) Psychedelic N, N-dimethyltryptamine and 5-methoxy-N, N-dimethyltryptamine modulate innate and adaptive inflammatory responses through the sigma-1 receptor of human monocyte-derived dendritic cells. PloS one 9
Talin P, Sanabria E (2017) Ayahuasca’s entwined efficacy: An ethnographic study of ritual healing from ‘addiction’. International Journal of drug policy 44: 23-30
Uthaug M, Lancelotta R, Szabo A, Riba J, Ramaekers J (2019a) Prospective examination of synthetic 5-methoxy-N,N-dimethyltryptamine inhalation: effects on salivary IL-6, cortisol levels, affect, and non-judgement. Psychopharmacology: 1-13
Uthaug M, Lancelotta R, van Oorsouw K, Kuypers K, Mason N, Rak J, Šuláková A, Jurok R, Maryška M, Kuchař M (2019b) A single inhalation of vapor from dried toad secretion containing 5-methoxy-N, N-dimethyltryptamine (5-MeO-DMT) in a naturalistic setting is related to sustained enhancement of satisfaction with life, mindfulness-related capacities, and a decrement of psychopathological symptoms. Psychopharmacology: 1-14
Uthaug M, van Oorsouw K, Kuypers K, van Boxtel M, Broers N, Mason N, Toennes S, Riba J, Ramaekers J (2018) Sub-acute and long-term effects of ayahuasca on affect and cognitive thinking style and their association with ego dissolution. Psychopharmacology 235: 2979-2989
Uthaug MV (2020) The Exploration of Naturalistically used Ayahuasca and 5-MeO-DMT; An assessment of their respective Sub-acute and Long-Term effects on Mental Health Related Variables. Maastricht University
Weil AT, Davis W (1994) Bufo alvarius: a potent hallucinogen of animal origin. J Ethnopharmacol 41: 1-8
Oxycodone, Codeine, Morphine and Heroin are all classified opiates. These substances are procedurally offered by medical experts as painkillers and seek to relieve patients from deep suffering.
However, these substances are also highly addictive, and there is no thorough protocol to get patients off these substances once their prescription runs out. As a result, thousands of patients grow reliant on these medicines. Often, These individuals turn to illicitly-obtained opiates to support their increasing dependence on prescription medications. These alternatives include synthetically manufactured substances, some of which are up to thousands of times more potent than commonly-prescribed opioids. North America’s deadly opioid crisis has dominated countless news headlines over the past few years, but maybe you didn’t know precisely where it was born.
Advertised as the first ‘minimally addictive’ opioid, OxyContin (manufactured by Purdue Pharmaceuticals) managed to surpass heroin abuse rates in 2004. By 2010, prescription opiates “became the most abused class of substances among US high school seniors (National Institute of Drug Abuse [NIDA] 2011)… Purdue Pharmaceutical paid $634 million in fines for criminal charges based on misrepresentation of Oxycontin’s addictive potential (Van Zee 2009)”.
In the last six months, in the face of the COVID-19 pandemic, we have seen a dramatic spike in opioid overdoses, adding more layers of destruction and devastation on an already isolated, uncertain, and grieving society due to the distancing measures, deaths and job losses that hallmarked this pandemic.
Alberta’s EMS teams have responded to the spike in opioid use calls since the COVID-19 pandemic.
What is happening with opioid misuse in Canada?
Due to a culmination of factors that include closed borders, a subsequent dip in supply and a lack of availability to clean substances, opiate overdoses in Canada increased drastically during COVID-19 isolation mandates.
Ontario has reported a 25% rise in fatal overdoses. A severe spike in opioid-related deaths prompts warning that carfentanil, an analogue of the synthetic opioid, fentanyl, is present in Edmonton’s street drugs, and is reportedly 100 times more potent than fentanyl, 5,000 times more potent than heroin and 10,000 times more potent than morphine.
“We now know that carfentanil is circulating. It’s in injectables and smokables, both up and down. Don’t use alone, have naloxone nearby, use a fraction of your usual dose.” – StreetworksAB
Alberta’s EMS teams have responded to the spike in opioid use calls since the COVID-19 pandemic. Furthermore, after serious efforts to implement SIS (safe injections sites) in British Columbia, with a 39% increase in overdose deaths in April alone, they are bearing witness to a resurgence in the opioid crisis. Finally, in the Yukon, opioid-related overdoses have doubled in the last year. Unsurprisingly, Canada’s Chief Public Health Officer, Dr. Theresa Tam calls the current crisis an “increasing concern” and an “unintended negative consequence” from the pandemic response.
The opposite of addiction is believed by some not to be sobriety, but to be “connection.”
Canada’s opioid response options
Journalist and addiction specialist Johann Hari famously noted that the opposite of addiction is not sobriety, but connection.
Over the past 20 years, alongside the opioid crisis, there has been a resurgence in interest in researching the healing potentials of psychedelic substances such as MDMA, Psilocybin, and DMT to treat Addiction, PTSD, Depression, and end-of-life distress.
Before the creation of this questionnaire, in 1960, philosopher Walter Stace examined the qualities of a mystical experience, noting that “the core experience of unity was “the essence of all mystical experience” (Stace 1960:132)” (MacLean et al. 2012, 722).
Suppose substance use disorders stem partly from a loss of connection to self and community, as Hari notes, and psychedelic substances can foster these feelings of attachment to others, nature and self. Why then is psychedelic-assisted therapy for the treatment of addiction not more widely available for the treatment of addiction?
Bringing psychedelic substances into the world of Western Biomedicine is a long and slow endeavour. Many researchers are pooling their efforts towards making psychedelic-assisted therapy more accessible to those suffering from substance misuse.
Entheon Biomedical believes that it is time that the narrative around psychedelic-assisted therapy takes a sharp turn away from the stigma. We are committed to the legal development of safe & effective psychedelic medicines, particularly DMT. DMT, the active ingredient in ayahuasca, is a psychedelic that is traditionally used in spiritual practices by indigenous communities of the Amazon basin. Our researchers are confident that DMT can be beneficial to those who are dependent on harmful substances.
Contrary to other psychedelic substances undergoing FDA clinical trials in the US, DMT’s psychedelic onset is typically very rapid and intense, beginning within two minutes. Isolating DMT could result in a drug that delivers a much shorter psychedelic experience than the four to eight-hour type a patient would expect with ayahuasca, psilocybin, or MDMA.
A shorter experience could open up psychedelic-assisted treatment to more people at a fraction of the cost. One of the issues at the forefront of clinical trials and expanded access programs for psychedelic-assisted therapy is the financial accessibility of this therapy. Psychedelic-assisted therapy sessions with MDMA or with psilocybin-containing mushrooms last anywhere between 4-7 hours. Within these protocols, it is mandatory to have two therapists present during the therapy session. To compensate two therapists for 4-7 hours is a costly endeavour.
By isolating DMT, it may be possible to achieve shorter-lasting psychedelic experiences, which could lessen the length of psychedelic-assisted therapy sessions without diminishing efficacy. By shortening a patient’s time in the clinic, we would undoubtedly minimize the cost of this safe, effective, yet challenging to access therapy. With the opioid crisis worsening in Canada and beyond, we grow even more hopeful that Entheon Biomedical’s findings will help lay the groundwork for a more effective and compassionate treatment for substance use disorder.
“Having lost my brother to opiate addiction, I can attest to the devastation and chaos brought on by opiate use. As the lethality of these substances rises, the efficacy of currently available treatments remains unchanged, and hundreds of lives are lost each month in British Columbia alone. There should be an acceleration of efforts to provide new solutions rooted in a better understanding of the causes of addiction.” —Timothy Ko, Entheon CEO
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