From magic mushrooms to ketamine, psychedelic drugs are having a serious heyday across the planet. Currently seeing considerable interest and acceptance by the public to treat emotional distress, the so-called third wave of psychedelics is cresting. And with that swelling attention is the creation of the essential machinery to support the new medical model — including consistent protocols and training preparation for clinicians.
The first known incarnation of psychedelics use is thought to have happened over the past few thousand years across parts of the globe and led by healers in ritualistic settings. People taking psychedelics and convening with spirits to better understand their lives. The second wave peaked in the West with widespread experimentation during the counterculture era of the 1960s (namely using LSD and mescaline), alongside the miasma and expansion of Vietnam War protests and the civil rights movement, then unceremoniously fizzled out due to the protracted War on Drugs.
Today, the energy behind psychoactive drugs as medicine is being propelled in clinical settings — in the hallowed academic halls of research titans like Johns Hopkins, U.C. San Francisco and Imperial College London. Unlike the 1960s, there is now greater support for psychedelic research from governments in North America and Europe as many millions of dollars are being pumped into the field by enthusiastic donors and investors. That has put researchers firmly on a path to developing psychedelic meds and systems that may help people cope with — and potentially heal from — chronic emotional distress. Quantum leaps of change are occurring as scientists tinker with formulations, tweaking chemical compositions into better tools for mental health practitioners. They are creating and refining drugs to care for patients with debilitating conditions like anxiety, eating disorders, addiction and treatment-resistant depression.
Enter the substance 5-methoxy-N,N-dimethyltryptamine, known popularly as 5-MeO-DMT or toad. While it is naturally present in small quantities in a variety of plants and animals, the substance is most notably derived from the venomous secretions of the Sonoran Desert toad. Following a spark of popularity in the underground beginning in the 1980s with a man named Ken Nelson, who in 1984 wrote the cult classic pamphlet Bufo alvarius: The Psychedelic Toad of the Sonoran Desert (under the pseudonym Al Most), the drug remained in relative obscurity until about 2010 when another surge of popularity occurred. While there has yet to be a clinical trial completed on the effectiveness of 5-MeO-DMT as a medicine for emotional trauma, numerous anecdotal reports point to the drug’s ability to provide users with significant changes in contentment with life and easing of mental anguish. One study published in 2019 by Maastricht University, collected from 42 individuals, detailed how a single inhalation of 5-MeO-DMT vapor in a naturalistic setting was related to “sustained enhancement of satisfaction with life, mindfulness-related capacities, and a decrement of psychopathological symptoms.”
Today, there are a number of entities, including many serious practitioners in the underground (note that 5-MeO-DMT is a controlled substance in the U.S and U.K.) and both for-profit and non-profit groups seeking to harness the medicinal benefits of the 5-MeO-DMT molecule. One of those parties is Beckley Psytech, a strategic partner of the NGO the Beckley Foundation in the U.K., founded by psychedelic maverick Lady Amanda Feilding. The foundation has for over 20 years focused on evidence-based drug policy reform and scientific research into psychedelic medicines. “In 2020, we raised over $22 million in funding and developed an intranasal formulation of synthetic 5-MeO-DMT that’s set to be tested later this year,” says Cosmo Feilding Mellen, CEO and founder of Beckley Psytech. “We’ll be breaking new ground with the first clinical study on intranasal 5-MeO-DMT, conducting an initial Phase 1 trial with 42 participants.”
Dr. Fiona Dunbar, chief medical advisor at Beckley Psytech, who held a prior role as vice president of global medical affairs at drug maker Janssen (the pharmaceutical division of Johnson & Johnson), sees a future for 5-MeO-DMT in the psychotherapeutic toolkit. “From a classical regulated pharmaceutical drug development perspective, 5-MeO-DMT is a very interesting compound with a unique receptor binding profile,” says Dunbar. “The available data on its pharmacological effects are intriguing.”
Dunbar is in a position to speak on the subject. Her work at Janssen for over 29 years has included development of the drug esketamine, the first psychedelic-based psychiatric drug to be licensed by the U.S. Food and Drug Administration (FDA) in 2019. It was modeled after the drug ketamine, an anesthetic that has been used for many years to treat depression. Dunbar’s years of experience developing psychoactive drugs — as well as drug development across a range of therapeutic areas including neurosciences, immunology, oncology and infectious diseases — ultimately led her to her position at Beckley Psytech and to identifying the potential of 5-MeO-DMT as a medicine that could have a real impact on patients with treatment-resistant depression.
In tandem with preparing to prove their formulation of 5-MeO-DMT as an effective drug in clinical trials later this year, Beckley Psytech is now collaborating with clinicians from the group Fluence, an organization in the U.S. that focuses on psychedelic education and training of mental health providers in psychedelic treatments. A key part of Beckley Psytech’s clinical trial efforts will include the critical infrastructure that takes patients through preparation prior to taking the drug, assistance during the potentially destabilizing psychoactive experience, and subsequent integration following the typically expansive time on 5-MeO-DMT. That all requires a steady hand by qualified therapists.
Co-founders of Fluence, Dr. Ingmar Gorman and Dr. Elizabeth Nielson, will collaborate with the Beckley Psytech to create the new training program. Each of the therapists has experience working on FDA-approved clinical trials with MDMA to treat post-traumatic stress disorder (PTSD) and psilocybin used for treatment-resistant depression. The pair were also recently co-authors of the first peer-reviewed paper defining the framework of psychedelic integrationand its importance in patient care. Published in Frontiers in Psychology, the paper outlines how mental health providers may benefit from understanding the unique motivations, experiences and needs of people who use psychedelics.
“From a training perspective, training clinicians to do this work is something that is quite different for many clinicians than what they may have previously been trained to do,” says Nielson. She notes that therapists who come to this type of training will be skilled clinicians — with their own various skillsets and practices — however, they may have little to no frame of reference for working in psychedelic models.
“It could be a new paradigm for them,” she says of therapists working with patients using 5-MeO-DMT. “The very idea that they’re using something that they may not have considered medicinal or therapeutic as part of psychotherapy, and they’re being asked to see someone through that experience, that’s new for a lot of people.”
Beckley Psytech says their intention is also to develop a training program with Fluence that will enable therapists to interact with patients remotely, leveraging digital technologies to improve patient treatment and care, and reduce utilization of healthcare resources. That’s an important facet — providing access to the masses by keeping costs reasonably affordable for patients who wish to use psychedelic medicines.
“Developing a specific psychotherapy program for 5-MeO-DMT and the training materials to deliver it are vital steps in the progression of our lead formulation’s eventual journey to market,” says Dunbar. “Fluence is a leader in its field when it comes to psychedelic-assisted medical training and ensuring that patients can access the benefits of psychedelic medicines with confidence and surety, and we’re excited about the new doors this strategic partnership will open.”
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