The psychedelic movement is spreading to Europe with the first clinic to open in London this summer, and aiming to begin trial treatments in August. The clinic is run by Clerkenwell Health, an ambitious British start-up with the goal of establishing the U.K. as a leading psychedelic research and innovation centre.
“Psychedelic assisted therapy (PAT) could be ground-breaking for mental health treatment,” said Tom McDonald, CEO at Clerkenwell Health, adding that he believes the U.K. is well placed to pioneer the next generation of innovative treatments due to the country’s favourable regulatory framework.
In 2021, the government introduced a new pathway, called the Innovative Licensing and Access Pathway, as a way to reduce the time it takes to bring innovative therapies to market. This pathway makes the U.K. an attractive option for companies looking to research cutting-edge treatments for neurological and psychiatric disorders.
The first trial at Clerkenwell is scheduled to begin in August 2022, and will focus on the use of psilocybin to help people cope with a terminal illness diagnosis, and support them through palliative care. So far, recent research in the U.S. in this field has shown positive results, with PAT being called the “new frontier in end-of-life care.”
According to a 2019 review in the journal Current Oncology, researchers have identified a number of clinical benefits including reduced anxiety, depression, and fear of mortality. The research also showed that psychedelics are not toxic, don’t cause liver damage, and don’t interfere with other medications.
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The history of psychedelics dates back to prehistoric times, when plants and fungi were used for the hallucinogenic properties. In some cultures, these plants and fungi were used as part of religious ceremonies, or to perform healing rituals. Stoned Ape Theory argues that psychedelics are the reason the human brain tripled in size over the last 2 million years.
Psychedelics (also known as hallucinogens, entheogens, and psychotomimetics) are psychoactive drugs that have been shown to alter consciousness and cognitive processes. Though psychedelics and fungi have been used for thousands of years, it was only in the 1950s that the pharmacology of psychedelics was researched.
Psychedelics are typically grouped into three categories based on their pharmacological profiles and chemical structures: classic psychedelics, empathogens, and other psychedelics including anaesthetic agents and atypical hallucinogens. Classic psychedelics include mescaline, lysergic acid diethylamide (LSD), psilocybin, NN-Dimethyltryptamine (DMT), and ayahuasca. Psychedelics stimulate the serotonin 5-hydroxytryptamine 2A (5-HT2a) receptor, leading to a boost in glutamate release in the prefrontal cortex. Glutamate is the most abundant excitatory neurotransmitter in the brain, and plays an important role in shaping learning and memory.
Recent research also shows increased blood flow to the visual cortex, which explains the hallucinatory quality of LSD. Empathogens (Methylenedioxymethamphetamine, or MDMA) are different in this regard, as they affect the central nervous system, releasing calcium-independent 5-HT, leading to the expansion of 5-HT neurotransmission, which causes euphoria and feelings of connectedness.
In experiments, participants report experiences that are very different from other psychopharmacological agents. Reported effects include altered states of consciousness, changes in perception, visuals, and diminished sense of self or ego. It’s now believed these effects can be harnessed to produced clinical outcomes.
In one study by Griffiths et al. reported that “psilocybin can occasion mystical-type experiences having persistent positive effects on attitudes, mood, and behaviour among some participants.” Watts et al. found that psilocybin alleviated depression in some participants by helping them move from “disconnection to connection,” and “avoidance to acceptance.” Research from the 1960s also shows that in order to maximise the therapeutic benefits of psychedelics, both the “set and setting” are crucial, and have a profound influence on the overall experience. “Set” refers to the mind-set of the individual entering into a psychedelic experience, while “setting” is the environment in which the experience takes place.
The potential of psychedelics to help people suffering existential distress, PTSD, anxiety or depression has been known since the 1950s, when the research first took off. However, all research stopped in the 1970s when Nixon launched his War on Drugs, which criminalized psychedelics including LSD, MDMA, psilocybin and ketamine.
Despite setbacks to research, a resurgence in interest began in the 1990s, thanks mostly to the work of Rick Doblin Ph.D. who established the Multidisciplinary Association for Psychedelic Studies (MAPS) as non-profit research centre in 1986. Doblin has dedicated his life to “changing the way people think of, talk about, and consume psychedelics.”
In 2019, John Hopkins Medicine established a Center for Psychedelic and Consciousness Research backed by $17 million in grants. Today, drug developers all over the world are interested in exploring psychedelic compounds as potential treatment for a range of mental health conditions. However, the legal status of psychedelics has made the research process an expensive bureaucratic nightmare.
As a result, drug developers look to run trials in locations with a track record in vanguard research, which includes countries such as the U.K. But the trial process is not without its challenges, and that’s what makes services such as Clerkenwell Health so valuable. Their knowledge of the local regulatory process can help companies avoid unnecessary delays.
A number of drug developers have already signed on to utilize the facilities at Clerkenwell, which will be based near Harley Street and will initially employ a staff of 13. One of those companies is Toronto-based biotechnology company, Psyence, who is running a trial to examine the use of psilocybin for the treatment of adjustment disorder, an emotional or behavioural reaction to a stressful life event, in this case, a terminal diagnosis.
Clerkenwell Health is also working with the Canada and U.S.-based companies Mindset Pharma and Mydecine, to explore treatments for neurological and psychiatric disorders, as well as PAT for depression and nicotine addiction.
Professor David Nutt, director of neuropsychopharmacology unit at Imperial College London welcomed the addition of the new facility, pointing out the importance of the necessary “skill and expertise” required to carry out this cutting-edge and much-needed research.
In June 2022, the World Health Organisation released a detailed report on mental health status worldwide, showing a 25% rise in anxiety and depression in 2020, and calling for the urgent need to transform mental health care. Some experts predict that mental health will be the biggest challenge of the 21st century.
There’s no question that life after the 2020 pandemic seems to have become more intense, and there’s a notable increase in people admitting to mental health challenges. While this openness is a good thing, the response to it is equally important. Though psychedelics may offer a viable way to help people, much work needs to be done to make these therapies more widely available and affordable.
Right now, private psychedelics therapy can cost thousands. An example is one clinic in Norway that offers 42 hours of treatment with MDMA, and charges US$15,000. However, a recent study demonstrates the cost-effectiveness of PAT on PTSD, estimating millions in savings in annual healthcare costs as well as dramatically improving quality of life for patients.
This is another reason why the work at Clerkenwell is so important. The potential to provide life-changing treatments to millions of people, and save healthcare systems millions in costs, could literally change the future of medicine, and certainly change the landscape of mental health care. No more years of lying on a therapist’s couch discussing childhood events. Psychedelics can potentially do the same work in just a few sessions. In other words, psychedelics could be the future of mental health.
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