Psychedelics Archives - Green Market Report

StaffStaffSeptember 16, 2020
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4min1390

Tabula Rasa Ventures, an Energia company focused on incubation and investment in the psychedelic industry, announced the candidates of its Fall 2020 incubator program designed to: further the development of businesses in the psychedelic industry through executive mentorship; increase diversity and inclusion within the psychedelic ecosystem, and develop an infrastructure to assist entrepreneurs without access to traditional capital.

“For the Fall 2020 round of incubator candidates, we narrowed our scope to start-ups and entrepreneurs that will create a more direct, positive impact on the psychedelic industry and community,” said Energia Founder and CEO Marik Hazan. “The reality is, we are in the infancy stages of a psychedelic renaissance building an industry, and it is imperative we create an equitable, impact-driven psychedelic ecosystem and we believe these candidates will do just that.”

During the three-month program, recipients will experience: access to Tabula Rasa Ventures executives, advisors, connections and networking opportunities; high-level mentorship and training from experts in and outside of the psychedelic industry; unmatched visibility into trends, proprietary research, data and tools, and advice on managing growth, team development, investor relations, governance and strategic planning.

The incubator has taken on four participants.

The participants:

The Arcana Armada; Arcata, CA; Alessandra Nicole Russo; The Arcana Armada seeks to catalyze individual and collective healing through interactive, archetypal fantasy experiences and narrative therapy. These carefully curated experiences offer a safe and playful container to explore social ecology, power dynamics, ritual and myth in a group setting. The curriculum is designed to cultivate the awareness of an interdependent ecosystem,  highlighting the essentiality of biodiversity and the value of more-than-human life.

EPIC Wellness; Houston, TX; Alberto Farinez; Epic Wellness a science-driven company focused on developing advanced orthomolecular products, including myco-botanicals and entheogens. They support our customer’s quest to develop their own health potential. They do so by creating products that harness full-spectrum extracts, the benefits of microdosing select ingredients and the synergy that results from blending them.

Sacred Huachuma Retreats; Netherlands; Alice Sitar; Sacred Huachuma Retreats will be offering retreats in the Netherlands starting early 2021. These retreats support and develop emotional and physical wellbeing, and help cultivate better relationships with ourselves, our own bodies and energy, other people and nature. They will combine bodywork, group therapy and personal integration. They welcome all genders.

Priscilla C. Agoncillo; Austin, TX;  Priscilla has been an advocate for patient’s rights and an entrepreneur in the plant medicine industry for the last 15 years. Priscilla started in Cannabis and is a co-owner of an award-winning cannabis genetics farm. Priscilla is hoping to establish reliable, compliant and consistent pathways to legally cultivate, conduct R&D and develop integrated plant molecule-based medicines


StaffStaffSeptember 10, 2020
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6min4641

Havn Life Sciences announced that, on August 31, 2020, its wholly-owned subsidiary, HAVN Research Inc., was granted a Section 56 exemption by Health Canada, meaning it now has the ability to possess certain amounts of pure psilocybin for scientific purposes, specifically for the research and development of quality control methods.

Havn Life said it plans to immediately begin work on experiments with the objective of developing a set of methods for the safe, standardized, quality-controlled production of medical compounds extracted from the Psilocybe spp. mushroom.
“We are thrilled to be among the first to receive permission from the Canadian government to begin work with psilocybin”, stated Tim Moore, Co-CEO of Havn Life. “This important milestone will enable Havn to begin working toward creating method-validation and analytical chemistry to standardize methods for quality control and testing of these substances.”
“Having access to compounds is essential in order to further research in the medical field. This is the start of our journey into developing standardized protocols to ensure that as this industry grows, we understand efficient new methodology”, stated Susan Chapelle, Havn Life Co-CEO, noting the advent of new technology and variables in extraction have changed significantly in the last decade.

Havn recently began trading on the Canadian Securities Exchange using the ticker symbol “HAVN”. Havn Life said it is focused on the standardized, quality-controlled extraction of psychoactive compounds from plants and fungi to develop products for use in research. Havn Life is also developing natural healthcare products designed to unlock human potential, containing novel and natural psychoactive compounds. The company has no revenue as of yet.

“Listing on the Canadian Securities Exchange is an important step in Havn Life’s growth within the emerging global psychedelic space,” says Tim Moore, Havn Life Co-CEO. “There is a tremendous opportunity to transform and enhance the healthcare and wellness space with psychedelic medicine, and the time is now to lay the foundations for what is likely to be a significant industry. Our multidisciplinary team is focused on laying the groundwork by developing quality controls and methodology for research and the medical supply chain.”

Moore was the only employee of Havn when the prospectus was published. Havn Research has a staff of seven, comprising seven consultants and no fulltime employees. Havn Research said it has the qualified personnel required to operate its facility and to develop research protocols and formulate drug compounds

Psilocybin Research

According to the company’s prospectus, Havn Research plans to undertake research to develop the research protocols to cover the production of Psilocybe spp. mushrooms in sterile conditions, the extraction and purification of psilocybin, psilocin, baeocystin, and other compounds found in the genus, and quality control and testing necessary for safety and formulation protocols with Psilocybe spp. and/or constituents. Havn Research said it plans to develop a compound library designed to support the science of safe, quality-controlled psychoactive compounds for the formulation to supply researchers with compounds for clinical trials.
Havn Research said it expects that it will take one year to complete the development of research protocols, after which
approximately an additional four months will be required for the protocols to be published. Havn Research’s research is expected to be split into two 17-week phases and one 18-week phase. The company said it plans to build a dedicated lab facility for its research, formulation, extraction, and pilot-scale manufacturing purposes.
The phase 1 lab build-out is anticipated to cost $300,000 and to be completed by the beginning of the third quarter of 2020. Phase 1 will be designed to meet the requirements to operate under the Health Canada section 56 research exemption. The Corporation also plans to complete a phase 2 lab build-out designed to satisfy the requirements necessary for a Dealer’s License, which it aims to complete by the first quarter of 2021. The phase 2 lab build-out is anticipated to cost $500,000. Havn said it expects it will take an additional four months for the protocol to be published.
HAVN Research aims to have natural health products (NHP) ready for the market in early 2021. HAVN Research said it expects to market its proprietary NHP products under the HAVN brand through a direct to consumer market model and through third party point of sale locations of NHP products.

“We are currently working on a variety of projects including product formulation of effective microdosing of novel psychoactive compounds as well as the development of a state-of-the-art mycology lab for extraction,” said Susan Chapelle, Co-CEO of Havn Life.


Debra BorchardtDebra BorchardtSeptember 4, 2020
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4min3810

Numinus Wellness Inc. (TSXV: NUMI) has filed a final short form prospectus to offers up to 16,000,000 units at a price of $0.25 per Unit for gross proceeds of up to $4,000,000 in the offering jurisdictions of British ColumbiaAlberta, and Ontario. The offering is expected to close on or about September 10, 2020.

Numinus is a company that is creating an ecosystem of health solutions centered on developing and supporting the safe, evidence-based, accessible use of psychedelic-assisted therapies. The company said it would use the net proceeds of the Offering for MDMA and psilocybin Compassionate Access protocol implementation, to make these drugs accessible to specific patient groups before they are available on the market, as more particularly described in the Prospectus.  Additional funds will be used to secure therapy space and develop psychedelic integrative treatment models, support upgrades to its Lab infrastructure to support its Health Canada licenses, and for general operating expenses.

Deal Details

Each Unit will consist of one common share of the company and one-half of one common share purchase warrant.  Each Warrant will entitle the holder to purchase one additional common share of the company at a price of $0.35 per common share for a period of two years from issuance. The company said it has received conditional approval of the Offering from the TSX Venture Exchange, and for the listing of the common shares comprised within the Units, the common shares issuable on exercise of the Warrants and common shares associated with compensation to the Agent.

The Company

Numinus Bioscience includes a 7,000 square foot research and testing laboratory as well as numerous Health Canada licenses (through its wholly-owned subsidiary Salvation Botanicals), including a cannabis testing license that provides established and growing revenue. It is also a late-stage applicant for cannabis processing. Additionally, the company holds a dealer’s license which allows it to import, export, possess, and test MDMA, psilocybin, psilocin, DMT, and mescaline, and it is the first publicly listed company in Canada to be issued a Health Canada license to produce and extract psilocybin from mushrooms for the purpose of developing proprietary extraction methods.

These licenses will allow Numinus to support the growing number of studies on the potential benefits of psychedelic therapies through research projects, product development, and the supply and distribution of these substances. Numinus R&D leverages established relationships to position the Company for partnerships to host studies, develop medical and therapeutic protocols, and influence regulatory approval. Numinus Health, with one clinic already prototyping systems for efficiency and profitability, is dedicated to delivering therapies that enhance and supplement existing options—centered around psychedelic-assisted therapies when and where regulated—for people wanting lasting physical, mental, and emotional health.


Video StaffVideo StaffSeptember 2, 2020

1min2010

MAPS, the nonprofit organization whose moniker stands for Multidisciplinary Association For Psychedelic Studies recently raised $30 million as interest grows in the space. Simeon Schnapper, Managing Partner at JLS Fund has been investing the space for some time. He spoke with GMR’s Editor-in-Chief Debra Borchardt about the opportunities in the industry and why interest is building. Thank you for watching the Green Market Report! Be sure to subscribe to stay up to our channel.


Debra BorchardtDebra BorchardtSeptember 1, 2020
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5min9470

The UK-based mental health company known for its psychedelic treatments, Compass Pathways has filed to go public this week. The company said it plans to list its American depositary shares on the Nasdaq under the ticker “CMPS”. The company reported total net losses of $13.2 million, $19.6 million and $24.8 million, respectively, for the fiscal years ended December 31, 2018 and December 31, 2019 and the six months ended June 30, 2020.

The company has raised $116 million so far. As of June 30, 2020, it had an accumulated deficit of $62.4 million. Its largest shareholder is Atai Life Sciences, which owns 29% of the stock. Other large shareholders include founders George Goldsmith and Ekaterina Malievskaia each with 16.5% of the company. Entities affiliated with Peter Thiel own 7.5%.

Psilocybin Treatments

The company is known for its pioneering the development of a new model of psilocybin therapy, in which psilocybin is administered in conjunction with psychological support. “Our initial focus is on treatment-resistant depression, or TRD, a subset of major depressive disorder, or MDD, comprising patients who are inadequately served by the current treatment paradigm. The company noted in its filing that early signals from academic studies, using formulations of psilocybin not developed by us, have shown that psilocybin therapy may have the potential to improve outcomes for patients suffering with depression, with rapid reductions in depression symptoms and effects lasting up to six months, after administration of a single high dose.” The company noted that the depression market is seen as a $200 billion market.

“We have developed a proprietary, high-purity polymorphic crystalline formulation of psilocybin, COMP360. In 2019, we completed a Phase I clinical trial administering COMP360, along with psychological support, to 89 healthy volunteers, the largest randomized controlled clinical trial with psilocybin therapy to date. In this trial, we observed that COMP360 was generally well-tolerated. We are currently evaluating COMP360 in conjunction with psychological support in a Phase IIb trial and we plan to report data from this trial in late 2021.”

Use Of Proceeds

The company said it will use the proceeds raised to fund clinical trials, therapist training and other activities to support the development of its investigational COMP360 psilocybin therapy through completion of all ongoing trials through the end of Phase II meetings with the FDA. Compass will also fund research and clinical development activities related to its investigational COMP360 psilocybin therapy to support the progression of COMP360 as a therapy for other neuropsychiatric indications and further our mechanistic understanding of psilocybin. In addition, the money will be used to fund general business development activities, including strategic investments.

Phase 2 trials

Compass is currently conducting a randomized controlled Phase IIb clinical trial in 216 patients suffering with TRD, in 20 sites across North America and Europe. This dose-finding trial is investigating the safety and efficacy of COMP360 combined with psychological support, for the treatment of TRD, and aims to determine the optimal dose of COMP360, with three doses (1mg, 10mg, 25mg) being explored. The primary endpoint of this clinical trial is to evaluate the efficacy of COMP360, as assessed by the change in the Montgomery-Åsberg depression rating scale, or MADRS, a widely accepted scale for depression that has been used as a primary endpoint in pivotal trials of other depression treatments. This trial has been designed to capture a statistically significant reduction in MADRS. Compass plans to report data from this trial in late 2021.
“We are using digital technology in this Phase IIb trial, including an online portal to help patients prepare for their psilocybin experience, and a web-based “shared knowledge” interactive platform to complement therapist training. We are also collecting digital phenotyping information through the measurement of human-smartphone interactions. After the trial, these data will be compared with information collected from validated psychiatric scales, such as MADRS, to develop potential digital applications to help anticipate relapse of depression. In the future, we plan to expand our research into additional digital technologies to complement and augment our therapies.”

Debra BorchardtDebra BorchardtAugust 25, 2020
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4min3780

Mind Medicine (MindMed) Inc. (NEO: MMED)(OTCQB: MMEDF)announced that it is working with the University Hospital Basel’s Liechti Lab on a combination MDMA and LSD in Phase 1 clinical trial. The Phase 1 MDMA-LSD trial is scheduled to start in Q4 of this year in Basel, Switzerland.

“A new treatment paradigm combining MDMA and LSD may enhance the positive effects of LSD by inducing a positive psychological state with MDMA which is an empathogen to help counteract some known negative or less positive aspects of LSD or psilocybin,” said President of MindMed, Dr. Miri Halperin Wernli. “With this innovative treatment paradigm, we are looking to bring the participants outside the bounds of their everyday perceptions, bringing their mind into a very flexible state of mind facilitating new states of consciousness. This will provide the opportunity to step outside their usual sense of self and experience themselves from a radically different and new perspective.”

Psychedelic-assisted Therapy

The company said that combined MDMA-LSD treatments have the potential to create next-generation psychedelic-assisted therapy paradigms. When added to a psychedelic-assisted therapy session, MDMA has the potential to reduce some known rare negative side effects that may occur while using LSD or other classic psychedelics on their own. So it seems the theory here is that the MDMA may work towards lessening a “bad trip.”

Classic psychedelics such as psilocybin and LSD can sometimes induce short-term unpleasant effects for patients during a psychedelic-assisted therapy session. These symptoms may include negative thoughts, rumination, panic and paranoia or what is commonly called a “bad trip.”

According to the study description, MDMA is known to acutely induce feelings of increased well-being and trust. By combining LSD and MDMA within the same session, the Liechti Lab and MindMed are evaluating if the combination produces greater overall positive acute effects when compared to LSD or MDMA on their own. MDMA may reduce some of the negative mood effects of LSD and make the patient more comfortable during psychedelic-assisted therapy.

“The potential of MDMA-LSD is to create a psychological state that may have the benefits of both substances and have longer-lasting effects than standalone psilocybin or LSD,” said University Hospital Basel’s Liechti Lab’s Dr. Matthias Liechti. “Inducing an overall primarily positive acute response during psychedelic-assisted therapy is critical because several studies showed that a more positive acute experience is linked to a greater therapeutic long-term effect in patients.”

Phase 1 Trial Details

The Phase 1 Clinical Trial is intended to take around one year to complete. It is expected that 24 people will enroll in the study, which is expected to begin in January 2021. The study is expected to be completed in January 2022.

MindMed said that if it finds the results promising, the company may decide to undertake further studies with treatments combining MDMA and LSD and prepare patient trials for various indications.


Debra BorchardtDebra BorchardtAugust 17, 2020
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4min4020

Nutritional High International Inc. (CSE: EAT) said that it has completed the previously announced acquisition of Psychedelic Science Corp. In June, The company announced it was buying Kruzo LLC, a company focused on developing products and conducting research on the psychoactive cacti Peyote. Kruzo also develops other plant-based medicinal products derived from Asian herbal medicine as well as cannabis.

The company didn’t say the value of the deal, but it did plan to raise $1.5 million prior to the acquisition. The company though announced in July that it closed the offering with gross proceeds of only $1.0 million.

“The Transaction is part of our plan to continue to pivot Nutritional High’s focus to its highest-margin product categories,” said CEO John Durfy. “While we continue to develop, manufacture, and sell cannabis products, the PSC acquisition will give us a unique position in this emerging part of the plant-based wellness and medical market.”

The two companies then formed Psychedelic Science Corp. (PSC) to develop health and wellness products while performing research on the therapeutic effects of psychoactive and non-psychoactive plant-based compounds. PSC’s research as well as the initial development of products will be located in Thailand in partnership with Rangsit University (RSU).

Under its agreement with RSU, PSC is developing cultivation and extraction methodologies for cacti, mushrooms, and other plant-based compounds. Further, clinical trials are currently being designed to determine the safety and efficacy of full-plant extract from cacti for the treatment of various indications including, pain, anxiety, and depression. PSC is also working with RSU to source and develop non-psychoactive plant-based wellness products for sale in North America.

RSU is in the process of securing plant material and is expected to commence testing growth rates as compared to the levels of certain desirable alkaloids including the psychoactive compound mescaline. The company expects to cooperate with RSU to develop the commercial supply of certain psychedelic cacti for clinical use in Thailand and abroad. The company is also supporting efforts to legalize psilocybin for medical research purposes and will work with RSU, who has Asian GMP standard grow facilities, to grow various psychedelic mushrooms.

Calyx Brands Sold

Last week, the company said that it was selling Calyx Brands and NH Distribution California Inc. to a company listed as DB12 LLC. The deal was valued at $7 million and included minority ownership in the company DB12.

“Through retaining minority ownership in DB12, Nutritional High will continue to have access to the California market for distribution of our own brands, potentially significant upside associated with ownership of the larger and more integrated DB12 operation, while continuing to improve our balance sheet,” said Durfy. “We are very pleased to partner with DB12 and look forward to a successful partnership.”

Calyx is a distributor of cannabis and cannabis-derived products, which holds a Type 11 distribution license from the Bureau of Cannabis Control of the State of California, which permits the distribution of medical and adult-use cannabis, and cannabis products from manufacturers to dispensaries.

The company said in a statement that the sale of Calyx was a directive established by the company as part of the strategic review process. Through completing a sale to a strategic partner, Calyx will have access to funding and a significant source of flower products to supplement it’s product offering and profitably grow the business.

 

 

 


Noemi GonzalesNoemi GonzalesAugust 14, 2020
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4min5390

“Psychedelica Lex: The Law of Psychedelics” by Mr. Gary Smith Esq.

We have seen a rapid evolution in the social acceptance of psychedelic use for mental health befits and while it is amazing to see, it also creates a series of legal questions and potential pitfalls.

Don’t worry though, we got you covered on that score with today’s book review.

Author Gary Smith is a veteran attorney who has considerable experience when it comes to dealing with matters relating to cannabis and psychedelics.

Let’s get started and see for ourselves just what “Psychedelica Lex: The Law of Psychedelics” can teach us.

-Topic Focus-

This book offers serious value in terms of being able to peer inside the mind of a well-trained attorney who has invested serious effort and time to become an expert in the legalities surrounding psychedelic substances.

The is valuable content in this book regarding topics such as the controlled substances act, clinical trials, international drug laws, and so much more.

While these are complex topics to address, the book was written so that we, the uninitiated, can keep up and comprehend the legal content in the book.

-About the Author-

Author Gary Smith Esq. is a seasoned veteran when it comes to cannabis law and psychedelics and is also the general counsel to the nation’s oldest non-Native American peyote church.

Gary Smith is also the head of Guidant Law, a law firm that focuses on cannabis and psychedelic legal matters in Arizona.

Many organizations lean on his expertise as they request him to speak and educate on these topics.

You can learn more about Gary and his endeavors here:

https://www.businesswire.com/news/home/20200803005587/en

-Reading Experience-

One might think that the level of reading might be difficult on this one, considering the subject matter, but author Gary Smith does a fantastic job of making sure that the content is accessible to us normies who do not have degrees in law.

“Psychedelica Lex” is interesting, empowering, and is very clearly written by an experienced professional who is passionate and knowledgeable about the subject at hand.

The content is structured in such a way that it makes one topic flow to another very naturally so it feels like a natural progression of knowledge as you go.

-Summary-

Having the unique opportunity to get knowledge directly from the mind of an experienced professional is always incredibly fascinating and beneficial. Usually, you have to pay a considerable amount of money to pick the brain of such an expert so having the book at your fingertips is awesome.

The information presented is genuinely useful while also being written in a manner that allows us to keep up with and comprehend the topic matters being discussed.

“Pshyedlica Lex” is a potent addition to the bookshelf of anyone who is interested in learning more about the legalities surrounding psychedelics.

You can start your own education on the legalities of psychedelics by getting your own copy here:


Kaitlin DomangueKaitlin DomangueAugust 11, 2020
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4min12430

Revive Therapeutics is introducing dissolvable, oral psilocybin film-strips to their portfolio. The move comes by way of a sponsored research partnership agreement with the Reed Research Group out of the University of Wisconsin-Madison. 

Psilocybin is a compound that is found in hallucinogenic mushrooms, sometimes called magic mushrooms. It has been used for thousands of years across many cultures. Australian cave paintings are said to have been created in 10,000 BCE and are said to suggest the culture’s use of psilocybin mushrooms. Other Spanish rock paintings indicate that prehistoric people used magic mushrooms (or at least knew of their existence) around 4,000 BCE.

Three controlled trials exploring the use of psilocybin mushrooms for mood and anxiety have suggested that using magic mushrooms (properly dosed) may reduce the symptoms of depression in anxiety relating to psychiatric distress associated with cancer. The study shows that participants experienced relief for at least six months after taking just one dose! “A small, open-label study in patients with treatment-resistant depression showed reductions in depression and anxiety symptoms 3 months after two acute doses. For addiction, small, open-label pilot studies have shown promising success rates for both tobacco and alcohol addiction.”

Revive Therapeutics has determined tannin-chitosan composite as the number one candidate for their strips. The film strips will undergo further testing before being made available, but they will have dosages that range from 1 mg to 20 mg. There’s a number of benefits to using dissolvable oral strips, including a faster time to the bloodstream and the ease of use for patients who may not be able to swallow (plus there is no need for water). This drug delivery technology aspires to produce both natural and synthetic extract of psilocybin in a number of ways, including topical gels, transdermal patches, and oral foams. 

The CEO of Revive Therapeutics, Michael Frank, said “We are very pleased about the progress we have achieved to date and this technical milestone for our drug delivery technology specifically in the development of an orally dissolvable thin film strip for psilocybin, which will be used in future human clinical studies. This is the first time that we have applied our drug delivery technology to oral thin films and we see great promise in delivering psychedelic-based medicines to treat various diseases and disorders that would benefit from such a delivery method and in partnering with life sciences companies seeking to add unique offerings in their product pipeline.  We look forward to unveiling the final prototype in the coming weeks.”


StaffStaffAugust 4, 2020
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4min4930

Looking for ways to integrate psychedelics to your mental health regimen? As it turns out, there’s an app for that. Today, the North American-based research company Mydecine Innovations Group Inc. (CSE: MYCO) announced that it would be expanding its digital therapeutic platform with several new programs, including a program on psychedelic integration.

One of the many unfortunate side effects of the COVID-19 outbreak is the growing need for mental health services. According to a study conducted by Healthline, more Americans than ever are reporting increased mental stress as a result of the viral outbreak. Aiming to address this mental health crisis, companies like Mydecine have been looking for ways to increase the accessibility of mental health services.

Through the company’s platform, Mindleap, Mydecine is looking to redefine how both patients and healthcare professionals approach mental health. Part of the way the company hopes to change perceptions is through the integration of psychedelic medicines like psilocybin.

 The Psychedelic Integration program will be taught by Dr. Danielle Wise, a lifelong psychedelic advocate with more than two decades of experience as a psychotherapist and coach. Dr. Wise also serves on the advisory board of Unlimited Sciences, a psychedelic research non-profit, and has completed the Psychedelic Research and Training Institute’s (PRATI) comprehensive Ketamine and Psychedelic Medicine Training.

Although the field of research is still emerging, early evidence seems to indicate that psychedelic drugs may have the potential to help treat a number of mental health issues. One academic review found that classical psychedelics, like psilocybin, can produce significant and sustained anti-depressant and anxiolytic effects.

In addition to Mindleap’s psychedelic integration program, the company is also launching an addiction recovery program and a holistic wellness program.

The addiction recovery program will be led by Dr. Rick Barnett, a clinical psychologist and an alcohol and drug counselor with 20 years’ experience in treating addictive disorders. Leading the Holistic Wellness Program is Jeremey Hoffman, an internationally renowned holistic wellness coach known for helping C-Suite level executives and business leaders in their spiritual lives.

“Our focus is on creating real solutions for the mental health crisis and these new offerings will allow Mindleap to have international reach and affect more lives during these times of crisis. The pandemic has left people depressed, isolated and support is needed now more than ever,” commented Mindleap founder Nikolai Vassev.

 



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