Category Archives: Psychedelics

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Toronto, Ontario--(Newsfile Corp. - March 23, 2021) - Mindset Pharma Inc. (CSE: MSET) (FSE: 9DF) (OTCQB: MSSTF) ("Mindset" or the "Company"), a biotechnology company focused on developing next generation psychedelic medicines and related technologies, is pleased to announce that it has entered a co-development agreement with InterVivo Solutions Inc. ("InterVivo" or "IVS"), to co-develop a new translational testing platform that Mindset and InterVivo expect will introduce an industry standard against which the performance and efficacy of breakthrough psychedelic medicines are compared and assessed.

Management of each of Mindset and InterVivo believe that the psychedelic pharma industry will benefit greatly from a standardized reference data set to identify and develop medicines with enhanced therapeutic benefit and improved safety and pharmacological profiles. Mindset and InterVivo intend to establish the first comprehensive psychedelics benchmark reference data set by evaluating a broad range of psychedelic drugs through a proprietary program of in vivo tests conducted at InterVivo's facility. It is anticipated that the Co-operative Psychedelics Evaluation Platform ("COPE") will be an invaluable tool to guide the development of next-generation psychedelic compounds and improve patentability and value in new molecule drug assets. Mindset and InterVivo intend to make COPE available to InterVivo's clients who are pursuing psychedelics drug development projects; with first data compilations to be available on or before June 12, 2021.

The project will be co-led by IVS's Chief Scientific Officer, Dr. Guy Higgins, and VP R&D, Dr. Ins de Lannoy, and will focus on establishing both pharmacological and pharmacokinetics data sets using sophisticated behavioural assays as well as state-of-the art in vivo sampling and analytical techniques. Mindset will co-sponsor the project and will incorporate the testing technology and data sets into their own lead optimization programs.

Dr. Guy Higgins, Ph.D., Chief Scientific Officer of InterVivo and a Scientific Advisory Board member of Mindset, commented, "To design better and safer drugs, we must carefully establish the limitations of the current psychedelics. The combination of our behavioural pharmacology, pharmacokinetic and early (non-GLP) safety expertise puts us in an excellent position to characterise these for the purpose of identifying improved molecules, both for standard-dosing and micro-dosing purpose. Our vision is to bring significant value to our sponsors who are active in this field, with the ultimate goal of delivering next generation medicines to benefit both patients and practitioners."

James Lanthier, CEO of Mindset commented, "We are excited to partner with InterVivo in this innovative initiative. We believe that the COPE platform will be a unique asset and will create significant value for the emerging psychedelics drug development market. We expect that the data from COPE will help both Mindset and the broader psychedelics field to identify specific pharmacological improvements, strengthen intellectual property rights, and achieve key development milestones in a more efficient and cost-effective manner."

CONTACT:

James LanthierCEOjlanthier@mindsetpharma.com

Jason AtkinsonVP, Corporate Developmentjatkinson@mindsetpharma.com647-938-5266

About Mindset Pharma Inc.

Mindset Pharma Inc. is a drug discovery and development company focused on creating optimized and patentable next-generation psychedelic medicines to treat neurological and psychiatric disorders with unmet needs. Mindset was established in order to develop next generation pharmaceutical assets that leverage the breakthrough therapeutic potential of psychedelic drugs. Mindset is developing several novel families of next generation psychedelic compounds, as well as an innovative process to chemically synthesize psilocybin as well as its own proprietary compounds. http://www.mindsetpharma.com

About InterVivo Solutions

InterVivo Solutions (IVS) is Canada's top neuroscience contract research organization, offering translational research services with a focus on next-generation neuroscience drug discovery. IVS offers in vivo proof of concept efficacy, drug metabolism, pharmacokinetics and early safety research studies for a global client base.

http://www.intervivo.com

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Mindset Pharma and InterVivo Solutions to Jointly Develop Advanced Cooperative Psychedelics Evaluation Platform ("Cope"); Cope Expected to...

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Recent researchhas found that using psychedelic substances has been linked to better physical health. However, the cause of the link between the two is still not clear.

The studys corresponding author, Otto Simonsson, stated that while a lot of research on classic psychedelics had shown the various mental health benefits they possessed, little was known about how these psychedelics may impact long-term physical health outcomes. Simonsson, who is from theUniversity of Oxford, added that&

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Study Finds Users of Psychedelics Have Better Physical Health Than Non-Users - StreetInsider.com

Opening the door to insights.

Nick Watchorn had suffered for most of his adult life from severe post-traumatic stress disorder (PTSD) before he sought psychedelic treatments to deal with his chronic condition. He credits those psychoactive sessions, and particularly the work he did afterwards in a process known as integration a way of gleaning insights from the experience with saving his life. I thought I was too far gone, he says of himself before receiving therapeutic treatments using MDMA (aka ecstasy).

At 54 years old, Watchorn had suffered for 22 years from the terror of a mass shooting he experienced as a young cop. The year was 1996, in Port Arthur, Tasmania, after a gunman had gone on a deadly shooting spree that left 35 people killed and 23 wounded. It was, and still is to this day, the worst single gunman massacre in Australias history. For more than two decades after the terrible event, Watchorn was plagued by visions of the mass killing. His grief led to the classic PTSD symptoms of anxiety, depression, social isolation and destructive behavior. Repeatedly playing back the awful carnage of the crime scene in his mind, he continued to re-experience his trauma on an endless loop. In the years following Port Arthur, Watchorn would eventually quit the police force, saying in Your Neighbors Are Doing Psychedelics: MDMA, a book I wrote this year about his experience, I couldn't make decisions anymore. I just didn't trust my own thoughts.

Watchorn says he tamped down the brutal, recurring mental images for 22 long years, aided by alcohol, pain pills, and a revolving door of psychotherapists. Then one day he heard about a breakthrough clinical study being conducted to treat PTSD using MDMA. The trials, which combined the drug with psychotherapy sessions, were proving to be incredibly effective at treating the symptoms of emotional trauma. Trials were (and still are) steadily progressing through important phases with the U.S. Food and Drug Administration (FDA) to potentially become a legal, prescriptive medicine. Watchorn would eventually qualify to take part in the trials in 2018 through the Multidisciplinary Association for Psychedelic Studies (MAPS), having experienced symptoms of treatment-resistant PTSD for over two decades. Before his trials with MDMA, he had never in his life experienced a psychoactive drug. Not so much as a puff of marijuana, he laughs. He was making a brave choice to face his demons through a relatively new scientific experiment.

MDMA clinical trial recipient Nick Watchorn.

While under the influence of MDMA, which took place in three 8-hour clinical sessions with trained therapists, Watchorn assumed he would first confront memories of the horrible scenes he faced at Port Arthur. All the gore of dozens of people killed and wounded by a madman with a high-powered rifle. He was bracing himself to experience those raw emotions up close and personal, to finally deal with the sad and terrible memories. Instead, he would be surprised by what first appeared in his minds eye: a vision of himself at eight years old shivering alone by a poolside. Before tackling the events that he believed would be foremost in his wounded psyche the death and destruction he witnessed in 1996 he would first reel through a series of early, relatively benign childhood encounters. A place where he felt rejected, abandoned and at the mercy of his parents needs. Watchorn was starting at the beginning, where his trauma first rooted an uncomfortable place many people avoid. The place where he received the initial injuries of his life that later affected his ability to cope through the aftermath of the killings. He would not fully understand the meaning of all those buried mental images that came flooding back from his childhood until after his experience under the influence of MDMA. During integration therapy sessions, he would reflect on what emerged during his time on the drug and slowly patch together the meaning of it all. Only then would he have the true tools to begin healing himself of his PTSD.

Integration is an often-overlooked aspect of the psychedelic experience, yet it is one of the most important factors for success. Generally speaking, it is the wild and mystical moments that take center stage. Once a person returns to ordinary states of consciousness, the psychedelic trip whether perceived as positive or negative is often left in the rearview mirror to fade like a dream. One of the key points of integration is to not let significant parts of the experience fade out, but to examine the mental deep dive and mine it for valuable insights. This can also have the effect of reducing subsequent harm in the event of a challenging experience.

Because the majority of people who use psychedelics will not use them in controlled clinical settings like Watchorn his case and condition were so extreme that he qualified for the FDA trial over roughly 900 applicants who applied in his area a group of researchers and clinicians have recently laid out a framework defining integration and its importance in patient care. It is the first peer-reviewed paper of its kind, published in Frontiers in Psychology, and outlines how mental health providers may benefit from understanding the unique motivations, experiences and needs of people who use psychedelics. Still largely illegal in the U.S. and much of the world, psychedelic drugs can be a tricky topic for mental health professionals to come together and agree on standards and practices.

Dr. Ingmar Gorman, co-author of the paper on harm reduction and integration and co-founder of Fluence an organization focusing on psychedelic education and training mental health providers in psychedelic treatments saw the necessity to begin a dialogue around offering healthcare providers clinical skills and knowledge to provide effective, compassionate, evidence-based psychedelic therapy and integration services to patients. Many psychotherapists and other providers have encountered clients who use psychedelics already, but there hasnt been a consistent approach to working with these individuals, says Gorman. Were hoping that this publication will start a conversation thats been missing in the field, so that we can be most helpful to those who need us.

Gorman is in a unique position to discuss concepts around psychedelic integration and harm reduction, having served on Phase 3 clinical trial teams that employ MDMA for PTSD (the same FDA trials participated in by Watchorn), as well as serving as a therapist on FDA-approved clinical trials using psilocybin-assisted treatment for alcohol use disorder and treatment-resistant depression.

Co-author Dr. Elizabeth Nielson, who is also a co-founder of Fluence and has related FDA-approved clinical trial experience, underscores the need for honest and unbiased discussions around these stigmatized drugs. Our clinical experience and review of the literature offer a way forward for the field of psychotherapy to engage psychedelics, even when patients psychedelic experiences occur outside of psychotherapy, says Nielson. By learning how to have honest, respectful, and non-judgmental conversations with patients about psychedelics, clinicians can counter the harms of years of prohibition, misinformation and stigma associated with these experiences.

As the publics interest in psychedelic use continues to expand, ongoing studies in the field and peer-reviewed papers by informed researchers may provide therapists with another instrument in the clinician toolkit when working with patients who use, have ever used or are considering using psychedelics.

Checking in with Watchorn this week, now three years since his MDMA treatments have concluded, he shares his perspective on integration. My integration sessions were so confronting and profound, the feelings of relief and optimism were overwhelming for a long time, he says. Experiencing such radically different perspectives, feeling more universally connected than disconnected, noticing clarity in thoughts, colors, textures, smells. Id find myself in tears, often daily, over the next eighteen months. Some of it was sadness mourning the past. There was also the incredible sense of relief and strong unfamiliar feelings of freedom and optimism.

Watchorn says while he has frequently thought back on his experience through the MDMA treatments, he has not felt it necessary to have another MDMA treatment integration is enough. He is echoing a sentiment by MAPS founder Rick Doblin, who said, Its not just about the MDMA experience itself, its about what you do with it. The whole point is not to need any MDMA.

Watchorn can attest to that. In a nutshell, the treatment got me to a place where I could appreciate healthier perspectives and make conscious decisions, he says. The MDMA treatment wasn't a cure switch, although it initially felt like one. It was a window of opportunity. Integration has been a whole new challenge. These days my focus is on being more present, curious and authentic and it's making a world of difference.

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As More People Turn To Psychedelics, Integration Proves A Crucial Factor For Breakthroughs - Forbes

Oxnard-based Cure Pharmaceutical announced plans on March 16to use its oral film technology to deliver LSD and other psychedelic substancesto treat mental health disorders.

Cure owns the CBD company Sera Labs, and Cure has used its dissolving thin film platform, Curefilm, to deliver CBD and other cannabis compounds.

Cure has a license from the U.S. Drug EnforcementAdministration to develop treatments using substances classified under Schedule1 of the Controlled Substances Act. That includes psychedelics such as LSD; psilocybin,the psychoactive compound in hallucinogenic mushrooms; and MDMA, the pure formof the drug commonly known as ecstasy.

Some of those substances were first developed as psychiatrictreatments, and in recent years, researchers, doctors and patients have shownrenewed interest in using them in mental health treatment. Oregon legalizedpsylocibin mushrooms for therapeutic purposes last year and a number ofcompanies are pursuing FDA approval for therapeutic MDMA treatments.

In its March 16 news release, Cure cited a recentstudy published byData Bridge Market Researchthat projected theU.S. psychedelic drug market will grow from $2 billion in 2019 to $6.8 billion in2027.

Cure plans to study Curefilm as a platform for both microdoses and macrodoses of psychedelics, and expects to pursue Food and Drug Administration approval and commercialization of the products.

We are dedicated to applying our film technology to leadingcompounds in high-impact, unmet need areas, Jonathan Berlent, Cures chiefbusiness officer, said in the companys news release. Advancing thesepsychedelic product development programs helps ensure our end-goal of targetingthose patients who would have otherwise been left without an importanttreatment option. We plan to advance our programs in a strategic, thoughtful,and fiscally responsible way.

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Oxnard company to pursue therapeutic psychedelics - Pacific Coast Business Times

Photograph via iStock.

DC Initiative 81, which passed with overwhelming support last fall, goes into effect Monday, March 15. Under theEntheogenic Plant and Fungus Policy Act of 2020, natural psychedelics including magic mushrooms, ayahuasca, and mescaline are decriminalized, making arrests for their possession or use the lowest priority for DC police.

The law survived a 30-day Congressional review period and a threat by US Representative Andy Harris, whoprevented the District from fully legalizing cannabis following a 2014 ballot initiative that passed with support from 70 percent of DC voters, to derail it. Harris, who set off a metal detector near the House floor while carrying a concealed gun this January, had framed the matter as a public-safety issue.

Initiative 81 was put forward by Melissa Lavasani, who credits natural psychedelics with helping herovercome anxiety, severe depression, panic attacks, and suicidal ideation after the birth of her second child.David Bronner, the top executive at Dr. Bronners soap company, helped bankroll the campaign, which had to overcome pandemic restrictions to gather signatures and get on the ballot last fall.

Lavasanis Plant Medicine Coalition on Monday announced it would offer community grants to organizations that offer education, training, and other work that supports the use of natural psychedelics, which have shown intriguing results in the treatment of depression, anxiety, PTSD, and other conditions. Johns Hopkins opened its Center for Psychedelic and Consciousness Research last September.

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Magic Mushrooms Are Decriminalized in DC as of Today - Washingtonian

The federal government has announced it will pour millions of dollars into clinical trials using psychedelics like magic mushrooms and MDMA to see if they can help treat debilitating mental illnesses.

But why is the government forking out taxpayer dollars for magic mushrooms? And are there any risks in taking these, even in a trialled environment?

Here's what we know about the plan and whether psychedelics are a realistic option.

Psychedelics or hallucinogens are a class of psychoactive substances that can change your mood, senses and even cause hallucinations.

There are many different types and some occur naturally, like in mushrooms or leaves, while others are made in labs.

Some of the ones the government is talking about trialling in this instance include psilocybin (better known as magic mushrooms), ketamine (which is primarily used for starting and maintaining anaesthesia) and 3,4-methylenedioxymethamphetamine, which is also known as MDMA, molly or ecstasy.

Supplied: St Vincents Hospital

The government is investing $15 million in grants to support Australian-led research into the use of magic mushrooms, ecstasy and ketamine to combat illnesses like post-traumatic stress disorder (PTSD), major depressive disorder, addiction disorders and eating disorders.

Health Minister Greg Hunt said it was vital the government continued to search for new and better treatments for mental illness.

"The early results of trials in Australia and internationally are extremely encouraging," he said.

"But more research is desperately needed before these approaches can be used by psychiatrists outside of controlled clinical trials.

"This grant opportunity will boost local research into potentially life-saving therapies and offers hope to all those suffering from mental illness, including our veterans and emergency service personnel dealing with the devastating effects of PTSD."

It's estimated 4 million Australians experience a mental health disorder every year, and almost half of all Australians will be affected at some point in their lifetime.

Many of the standard treatments for these illnesses vary greatly in how effective they are, and there haven't been many major pharmaceutical discoveries in this area in recent years.

At the same time, once dismissed as dangerous party drugs, psychedelics are gaining mainstream acceptance in the medical world as ways to treat mental illnesses such as depression and PTSD.

The idea of treating mental illness with psychedelics has been around for a while (even centuries in some cultures), but there's been a gap in the research into their potential use as a treatment for mental illnesses because they were declared prohibited substances in the 1960s.

Australia's national medical regulator, the Therapeutic Goods Administration, currently doesn't recognise MDMA and psilocybin as legitimate medicines to treat psychiatric conditions.

But that could change, depending on these trial results.

A memorandum published by The Royal Australian and New Zealand College of Psychiatrists (RANZCP) last year noted there was an ongoing need to collect more data.

But it said so far, in controlled trials and when administered at therapeutic doses, psychedelic therapies demonstrated an initial high-safety and low-risk profile, with limited physiological concerns.

It did note though that MDMA could increase your heart rate and blood pressure.

It also said that when misused, psychedelics could cause psychosis a medical condition in which the mind is affected and there's some loss of contact with reality.

For this reason, current trials for psychedelic therapy generally exclude people with a personal or family history of psychosis or mania.

Reuters: DEA

But there's also a risk in not exploring this in clinical trials.

A recent Global Drug Survey found 6,500 of 110,000 respondents said they were self-treating their mental illness, particularly with ecstasy, magic mushrooms and LSD.

The head of the Australian arm of the survey, RMIT University's Monica Barratt, said the findings were a reminder people were already using psychedelics as a DIY mental health treatment.

"As Australia awaits the progress of clinical trials of these substances for mental health conditions, we need to recognise the demand for them is increasing and this demand may end up being filled outside of the medical setting," Dr Barratt said.

Worldwide, there are currently about 100 psychedelic trials for the treatment of depression, anxiety, alcohol and drug-use disorders, dementia, anorexia and chronic pain.

Psilocybin-assisted therapy for depression and MDMA-assisted therapy for PTSD have been given "breakthrough therapy" designation from the Food and Drug Administration (FDA) in the United States.

That means the FDA believes the therapies may offer substantial advantages over current therapies, and have therefore been expedited in their transition to prescribed medicines (although it hinges on the results from clinical trials).

RANZCP president John Allan said while further research was required to assess the safety and effectiveness of psychedelics, preliminary studies showed positive results.

"We are seeing limited but emerging evidence that psychedelic therapies may have therapeutic benefits in the treatment of a range of mental illnesses, such as PTSD substance abuse and depression," he said.

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The federal government is funding research into using psychedelics to treat mental illness. So, do they work? - ABC News

Lattice Biologics Ltd. (TSX-V: LBL) (OTCBB: LBLTF) ("Lattice Biologics" or the "Company") announced today that the Company will change its business strategy to focus on the fast growing psychedelics and cannabis markets through the creation of a new life sciences subsidiary. The Company will focus on the research and commercialization of psychedelic products in combination with its stem cell based regenerative compounds while leveraging the Companys distribution expertise.

The Company believes there is a sizeable legal market for psychedelic products and that there is a promising prospect for a strong, legal psychedelic industry to emerge globally. In November 2020, voters passed Oregon Ballot Measure 109, making Oregon the first state to both decriminalize psilocybin and also legalize it for therapeutic use. In August of 2020, the Canadian federal Minister of Health approved the use of psilocybin therapy in the treatment of end-of-life distress for certain patients. Lattice believes that the recent wave of deregulation and legalization of recreational cannabis across the globe will result in a new wave to psychedelics legalization. The Company believes that the new focus on psilocybin and psilocybin medicine may open up the approximately $15 billion-dollar global anti-depressant market to psilocybin.

The ability for neurons to regenerate with the use of psychedelics is a newly emerging area of research. We will utilize our knowledge of stem cells, and their potentiating effects, to create new and patentable technologies and medicines that improve health and alleviate suffering.

"Following a comprehensive strategic review of the Company, we have made the exciting decision to enter and focus on the fast growing psychedelic and Cannabis life sciences and to divest the Biologics business. With Lattices extensive knowledge of processing, purifying, and manipulating stem cells, we intend to be a leader in the emerging psychedelic market. The Company intends to announce key additions to its management and advisory board in the near future. Exiting Biologics allows the management team to reorganize the Biologics subsidiary and related debts while not affecting the holding and listed Company and to allow the Company and shareholders to focus on and benefit from future generated medicines and treatments. We believe the Biologics business is an attractive asset for someone who is better positioned to leverage the Biologics platform to build scale. During this transition period, we remain committed to our Biologics customers, and will continue to support our technologies and services," said Guy Cook, CEO.

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Beginning with the fiscal third quarter 2021, the Biologics Business will be presented as discontinued operations. As part of the reorganization, the wholly-owned subsidiary Lattice Biologics Inc. has filed a voluntary petition under Chapter 7 of the U.S. Bankruptcy Code. The Chapter 7 petition was filed March 12, 2021 with the U.S. Bankruptcy Court for the State of Montana. Chapter 7 will be administered under the oversight of a Court-appointed trustee. Additional information on the process can be obtained through the Court.

About Lattice Biologics Ltd.:

Lattice Biologics is traded on the TSX-V under the symbol: LBL.

Lattice Biologics develops and manufactures biologic products to domestic and international markets. The Companys products are used in a variety of surgical applications.

Lattice Biologics maintains its headquarters, laboratory and manufacturing facilities in Belgrade, Montana. The facility includes ISO Class 1000 and ISO Class 100 clean rooms, and specialized equipment capable of crafting traditional allografts and precision specialty allografts for various clinical applications. The Lattice Biologics team includes highly trained tissue bank specialists, surgical technicians, certified sterile processing and distribution technicians, and CNC operators who maintain the highest standards of aseptic technique throughout each step of the manufacturing process. From donor acceptance to the final packaging and distribution of finished allografts, Lattice is committed to maintaining the highest standards of allograft quality, innovation, and customer satisfaction.

Lattice Biologics maintains all necessary licensures to process and sell its tissue engineered products within the U.S. and internationally.

Neither TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.

Cautionary Statement on Forward-Looking Information:

Certain information contained in this news release constitutes "forward-looking statements" within the meaning of the safe harbour provisions of Canadian securities laws. All statements herein, other than statements of historical fact, are to be considered forward looking. Generally, forward-looking information can be identified by the use of forward-looking terminology such as "planned", "potential", "future", "expected", "could", "possible", "goal", "intends", "will" or similar expressions. Forward-looking statements in this news release include, without limitation: information pertaining to the Companys strategy, plans, or future financial performance, such as statements with respect to the Transaction, and other statements that express managements expectations or estimates of future performance. Forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause the actual results, level of activity, performance or achievements of Lattice to be materially different from those expressed or implied by such forward-looking statements.

Forward-looking statements are necessarily based upon a number of factors and assumptions that, while considered reasonable by management as of the date such statements are made, are inherently subject to significant business, economic and competitive uncertainties and contingencies. The factors and assumptions that could prove to be incorrect, include, but are not limited to: that market prices will be consistent with expectations, the continued availability of capital and financing, and that general economic, market and business conditions will be consistent with expectations. The forward-looking statements are not guarantees of future performance. We disclaim any obligation to update or revise any forward-looking statements, except as required by law. Readers are cautioned not to put undue reliance on these forward-looking statements.

United States Advisory: The securities referred to herein have not been and will not be registered under the United States Securities Act of 1933, as amended (the "U.S. Securities Act"), and may not be offered, sold, or resold in the United States or to, or for the account of or benefit of, a U.S. Person (as such term is defined in Regulation S under the U.S. Securities Act) unless an exemption from the registration requirements of the U.S. Securities Act is available. This press release shall not constitute an offer to sell or the solicitation of an offer to buy any securities, nor shall there be any sale of securities in the state in the United States in which such offer, solicitation or sale would be unlawful.

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Media Contact: Guy Cook, CEOLattice Biologics Ltd.(TSX-V: LBL) (OTCBB: LBLTF)512 E. Madison Ave. Suite#A1Belgrade, MT 59714480-563-0800 OfficeNews@LatticeBiologics.com http://www.LatticeBiologics.com

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Lattice Biologics Reorganizes to Focus on Psychedelics and Cannabis Therapies - Yahoo Finance

Meaghan Buisson agreed to take part in a clinical trial on the use of MDMA for treating post-traumatic stress disorder after what she calls a "year of darkness."

She was homeless in Vancouver and out of treatment options as she confronted the aftermath of sexual abuse and assault.

"It was a Hail Mary. It was like, well, what do I have to lose, really?" Buisson, now an instructor with Outward Bound Canada, recalled in an interview with CBC News.

In early 2015, Buisson embarked on a Phase II clinical trial sponsored by the Multidisciplinary Association for Psychedelic Studies (MAPS). Court documents show that her co-therapists were a married couple living on Cortes Island near Campbell River Richard Yensen, an unregulated psychotherapist, and psychiatrist Dr. Donna Dryer.

"What I had been told was that psychedelics open you up and there's deep healing," Buisson said.

"There was no mention ever of the risks of sexual abuse."

But there's a documented history of sexual violation within psychedelic therapy, and Buisson has alleged that Yensen took advantage of her vulnerability to do the same.

She believes there is potential for psychedelics to be healing and says they may have a place in the health-care system, but the risk of serious harm means safeguards are essential. That includes stronger oversight of clinical trials, better measures to prevent abuse and strict regulations for who can provide psychedelic therapy or, for that matter, any type of psychotherapy.

MDMA, also known as ecstasy, is a recreational drug that produces feelings of euphoria and enhances sensation and sexuality. It's one of several illicit substances, including ketamine, LSD and psilocybin mushrooms, that's currently being studied for potential uses in psychotherapy.

These substances are slowly making their way into mainstream patient care. Health Canada has begun granting exemptions for the legal use of magic mushrooms in therapy, and the College of Physicians and Surgeons of B.C. has opened the door for psychiatrists to prescribe ketamine for treatment of depression.

But Lily Kay Ross, an editor at the drug-focused publication Psymposia, who completed a PhD on social responses to sexual violence, cautions that there is a real danger of coercion in this type of treatment because of the power imbalance and the nature of the substances.

"In therapy, people take drugs to alter their consciousness and enter into a boundary dissolving state," she wrote in an email.

"They may report feeling and even appear quite lucid, but they are not able to make sound decisions about sexual engagement. And it is a violation of therapeutic trust to engage sexually."

In a civil claim filed in B.C. Supreme Court in 2018, Buisson alleges she was repeatedly sexually assaulted by Yensen, with Dryer's knowledge, while in treatment with the couple.

Yensen does not deny having sex with Buisson, but in his response to her lawsuit, he accuses her of initiating it, describing her as "a skilled manipulator." He also denies owing her the duty of care inherent in a doctor-patient relationship, suggesting they were merely fellow participants in a research study, albeit with different roles.

The civil claim has since been settled out of court on undisclosed terms, but MAPS has acknowledged that Yensen carried on an "unethical" sexual relationship with Buisson and said Dryer knew but failed to report it to any authorities. The organization has cut ties with both Yensen and Dryer.

Neither Yensen nor Dryer responded to requests for comment.

Buisson has also sought accountability in other ways.

She filed a sexual assault complaint with the Quadra Island detachment of the RCMP, who confirmed for CBC that an investigation is ongoing.

She also turned to the professional regulators, filing a complaint against Dryer with the College of Physicians and Surgeons of B.C., which has yet to be resolved after three years.

Finally, because Yensen was described as a psychologist on the website for MAPS Canada, Buisson filed a complaint with the College of Psychologists of B.C.

But it turns out Yensen is not a registered psychologist in this province, so the college had no power to investigate or discipline him. Officials did, however, ask him to stop calling himself a psychologist online, according to a letter provided to CBC.

There is no regulatory body governing people like Yensen in B.C. As it stands, literally anyone can call themselves a therapist or counsellor and start advertising their services to British Columbians.

In December, the Federation of Associations for Counselling Therapists in B.C. (FACTBC) submitted a formal application to Health Minister Adrian Dix, calling for urgent regulation of the profession.

But Dix has now rejected that effort, writing in a Feb. 9 letter that the government won't consider regulation of any new health professions until a new oversight body for health professional colleges is in place.

Glen Grigg, chair of FACTBC, described that decision as "tragically out of step with the gravity of Ms. Buisson's experience." In an email, he said lack of regulation was a major factor in what happened to Buisson.

Buisson is disappointed as well.

"Regulation alone is not going to fix the problem. Therapists can be regulated and still be deeply unethical. But the difference is when therapists are regulated and there's oversight and there's a college, patients have some kind of recourse," Buisson said.

The allegations against Yensen and Dryer are not outliers in the field of psychedelic therapy, where sexual abuse has long been acknowledged as a potential risk.

In fact, MAPS founder and executive director Rick Doblin wrote in his PhD dissertation that: "The loving and trusting feelings that can be induced by MDMA can make patients more vulnerable to sexual pressure."

One of the early American proponents for the use of MDMA in therapy, Richard Ingrasci, was permanently barred from practising psychiatry in 1989 after patients came forward to allege he'd sexually abused them while they were under the influence. Psychiatrist Francesco DiLeo of Maryland had been disciplined for similar violations just two years earlier.

In response to Buisson's experience, MAPS issued a statement in 2019 saying that its policies forbid sexual relationships between therapists and their patients, and "there was no prior indication that Richard Yensen or Donna Dryer would violate this policy."

The organization says its lawyers have determined MAPS was not legally responsible for what happened to Buisson, though it agreed to pay her $15,000 for therapy "on a compassionate basis."

Since Buisson's experience, MAPS has formalized a Code of Ethics that makes it clear practitioners must "avoid entering into dual relationships that are likely to lead to impaired professional judgment or exploitation."

The organization has not, however, tightened its policies on who can act as a therapist in clinical trials.

Protective measures including a requirement for two therapy providers to work together on each case were already in place when Buisson began treatment with Yensen and Dryer. MAPS still only requires one member of the team to be licensed, and there are still married couplesworking together, according to a spokesperson.

Buisson is deeply unsatisfied with the response.

"They didn't put the protocols in place to keep the patient safe. After a harm occurred, MAPS has taken no corrective measures to mitigate the harms," she said.

She urges anyone who is considering taking part in psychedelic therapy not to buy into the hype about psychedelics as miracle cures for psychological issues and to understand that there are risks as well. She also recommends bringing along a buddy who will stay sober and make sure the situation is safe.

"This is not a safe situation.What that does for patients is it puts us in a position of responsibility for our own care," Buisson said.

"Go into it with your eyes open and get informed, get educated."

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As psychedelic therapy goes mainstream, former patient warns of danger of sexual abuse - CBC.ca

Psychedelics are seeing a resurgence with a growing body of research exploring the potential of psychedelic-assisted therapy for a variety of clinical applications. But while progress around psychedelics has accelerated in a relatively brief period in recent years, their exploration has been a long-evolving process dating back to the late 1800s, and their earliest origins trace back to indigenous groups in North America as far back as 5,000 years ago.

The minds behind the Sana Symposium, a virtual conference scheduled for Sept. 17-19, have published a new infographic guiding readers through the history of the human relationship with psychedelics. The document chronicles the first psychedelic experience involving a purified compound in 1897, groundbreaking moments throughout the 20th century, and landmark breakthroughs of the past five years.

The infographic can be downloaded here.

For more information on the Sana Symposium, visit sanasymposium.com.

More here:

From Sacred Rituals to Breakthrough Therapies, History of Psychedelics a Long, Winding Road - Psych Congress Network

With recent landmark progress in legalization efforts around the world, its clear we are in a psychedelic renaissance. In its wake has come a wave of innovation and the emergence of new-age pioneers in the space. Mydecine Innovations Group (CSE:MYCO) (OTC:MYCOF) (FSE:0NFA) is an example of a company that is far ahead of the curve. Based out of Denver, Mydecine has established itself as a leader in the emerging field of psychedelic-assisted treatments for mental health.

Earlier this week, Director and CEO Josh Bartch sat down with the Dales Report to discuss how the past 12 months have been monumental to both the psychedelics industry and Mydecine.

There are a few key differentiators that place Mydecine in a league of its own. Whether its their R&D or the actual production of drugs, the company has a rare combination of capabilities. Josh explains these in more detail, One thing about Mydecine thats incredibly unique is that were fully vertically integrated, So as it pertains to psychedelic assisted psychotherapy, we really have an A-Z capability. This comprehensive pipeline gives Mydecine a unique advantage when it comes to clinical trials. With a full set of operations in-house Mydecine can rapidly innovate.

Evidently, Mydecine has taken full advantage of its integrated supply chain with a global clinical trial infrastructure with sites approved throughout Canada, Europe and the United States.

Despite Mydecines vast array of capabilities, the companys mission can be broken down into a few defining elements. As Josh lays it out, Mydecine Innovations Group really now has become a global company with really three main focuses: One is IP and R&D and our drug development pipeline is in that branch. Two is our clinical trial development and three is going to be our technology platform MindLeap.

During the last few months, the clinical pipeline has been in full swing with Mydecine announcing an upcoming phase 2A trial which will center around exploring psilocybin-assisted therapy for the treatment of PTSD in veterans and emergency personnel. In a global display of research capability, the clinical trials will take place across 3 continents with the goal of establishing the safety and efficacy of psychedelic administered psychotherapy in a supervised setting.

On the technological side, Mydecine has been continuing development of the Mindleap platform which will allow them to administer psychotherapy protocols remotely. With a growing number of people avoiding in person health services at the moment, the mindleap platform is proving to be especially relevant. The company believes this key differentiator will strengthen the connection between patients and healthcare providers.

Josh explains in more detail, So I think something thats really important to remember is that this is psychedelic-assisted psychotherapy. Seven-tenths or eight-tenths of the equation are one-on-one psychotherapy meetings between psychotherapists and patients with no substances taken at all So if we can aggregate with what weve been able to do with MindLeap, professionals that have been trained in the psychotherapy protocol under one roof and give patients access to be able to take the seven or eight-tenths of the equation, remotely, obvious vastly increases the scalability of the treatment.

Mydecine encompasses the new era of medicine, making it a one stop shop for psychedelic treatment and innovation. To watch for in 2021: Mindleap recently announced a 2.0 coming to the platform to deliver ancillary services that are complementary to the psychotherapy. In the coming months, Mydecine has its sights set on uplisting to the NEO and Nasdaq exchanges.

Published March 18th, 2021

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Mydecine CEO Josh Bartch on the Future of Psychedelics - Influencive