Inside a Ketamine Clinic: On the Frontiers of Psychedelic Therapy
Inside a Ketamine Clinic: On the Frontiers of Psychedelic Therapy
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Duke’s Road, one of London’s many winding capillaries sprawling out from Euston Station, is – in many ways – the city in miniature. A Premier Inn hotel is crammed into the lower floors of Somerton House, a 10-storey block of council flats. Opposite, high railings border the Greek Revival columns of St Pancras New Church. Next door, a Victorian Army Reserve building has been converted into a dance center.
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But something new has come to Duke’s Road, a venture unlike any other in this urban cornucopia. Past nondescript gates, down a cobbled alley, you reach the bright yellow doors of Awakn Clinics London, the city’s first foray into psychedelic psychotherapy.
A new enthusiasm for psychedelics
This spring, the clinic started accepting patients for an 11-session course that combines psychotherapy with intramuscular injections of ketamine. The clinic will consider patients with conditions like depression and anxiety disorders, but also post-traumatic stress disorder (PTSD) and a range of addiction disorders. Today, Technology Networks has been invited to take a look around the clinic’s facilities.
Psychedelic compounds, such as LSD, psilocybin and MDMA, have found a second wind almost 50 years after their use in research was largely neutered by legislation. From 1950 to 1965, over 1000 scientific papers were published on the effects and functions of psychedelic compounds. Part of this body of research focused on the compounds’ potential within psychiatry, such as testing the synthetic psychedelic LSD for improving abstinence in alcohol use disorder. This research became a casualty of the 1960s’ social and political shifts. Increasing governmental opposition to the drugs’ availability became codified by the 1970 US Controlled Substances Act, which put in place penalties for the use or manufacture of psychedelics, making such research nearly impossible to conduct.
But the last decade has seen both industry and academia take a second look at the potential of psychedelics. Existing treatments for mental health conditions have failed to produce any reduction in the number of cases of serious illnesses. Seventeen percent of US adults aged 18–25 reported a major depressive episode in 2020.
In turn, multiple small studies investigating psychedelics’ use in psychiatry have produced promising results. A trial of the magic mushroom-derived compound psilocybin showed that it could produce antidepressant effects similar to a commonly prescribed selective serotonin reuptake inhibitor (SSRI) antidepressant, escitalopram.
Of the psychedelics under investigation, the majority are “classical” psychedelics, that are thought to act via a neuronal receptor called the serotonin 5-HT2A receptor to induce their effects on the brain. Ketamine, on the other hand, appears to induce rapid-acting antidepressant effects via blockade of the NMDA receptor, which is activated by the neurotransmitter glutamate. As with SSRIs, however, the exact mechanism by which these molecular effects lead to mood alterations has not yet been fully detailed.
This need for further research, combined with the strict regulations on the use of classical psychedelics in research and clinic, has propelled ketamine to become the most-studied psychedelic therapeutic. As opposed to LSD and MDMA, ketamine has remained in widespread clinical use, primarily as an anesthetic, over the last 50 years. This has made it a far easier psychedelic for mental health researchers to investigate – over 450 published papers explored the drug’s antidepressant potential in 2021 alone.
An increasing number of researchers believe that psychedelics, either with or without the use of psychotherapy, could be a solution to rising rates of poor mental health disorders. The clinic’s opening therefore comes at a time where enthusiasm for psychedelic therapy is at an unprecedented high.
Psychedelics for addiction
Awakn Life Sciences, which runs the clinic, has ridden the crest of this latest wave of research interest. Straddling both clinical practice and research and development (R&D), the Toronto-based company has amassed a substantial drug development pipeline that focuses mainly on addiction, including alcohol use disorder, gambling disorder and even internet gaming disorder.
Psychedelic compounds, such as LSD, psilocybin and MDMA, have found a second wind almost 50 years after their use in research was largely neutered by legislation.
The company has signed a number of partnerships with universities in the UK, having announced an exclusive license to deliver a program of psychotherapy called KARE (Ketamine in the Reduction of Alcohol Relapse) from the University of Exeter. KARE reported results from a proof-of-concept study last year that suggested ketamine infusion was associated with more days of abstinence. Awakn hope to move KARE into Phase III trials in the near future.
Psychedelic drug pipelines are being developed across the industry, but Awakn’s complementary clinical offerings set them apart in the UK and Europe. While ketamine has not yet been formally approved for psychiatric indications by the UK’s medical regulator, the Medicines and Healthcare products Regulatory Agency (MHRA), Awakn’s clinicians can prescribe and dose their patients off-label.
The clinic is backed by a leadership team that includes influential researchers from across the psychedelics field. Chief research officer David Nutt is the Edmond J. Safra professor of neuropsychopharmacology at Imperial College London, and Celia Morgan, leader of the KARE study and a professor at the University of Exeter, is Awakn’s head of ketamine-assisted therapy.
Inside a ketamine clinic
Greeting me at the big yellow door is James Collins, Awakn’s chief operating officer, who shows me into a cool, serene space that looks more like a co-working destination than a medical clinic, featuring all light woods and accent chairs. In the main atrium of the clinic, the only hint that I’m not in a tech startup’s waiting room is the presence of a chaise longue, where patients can retire after a two-hour ketamine dosing session in one of the clinic’s eight treatment rooms, each named after a type of British tree.
The lobby space at Awakn Clinics London features accent chairs and greenery. Credit: Awakn Life Sciences
In these rooms, clinical features, negotiated in tandem with the Care Quality Commission (CQC), who granted Awakn permission to operate in March 2022, become more apparent. Angular furniture and modular lighting arrays nestle beside wash stations and pulse oximeters. One room has a window into a CCTV-monitored observation station, where the clinic’s ketamine supply is kept under strict conditions behind a key fob protected door. “We have to lock it in a box, and then lock that box in another box bolted to the floor,” says Collins. The clinic’s design has been a complicated balance, he explains. Feedback from the more “challenging” opening of Awakn’s first clinic, just over 100 miles away in Bristol, has been incorporated into the design. Patients wanted a space that was accessible but had enough clinical elements to remind them that they were taking a treatment under guidance of trained professionals.
"A high bar to clear"
Patients at Awakn will have four active dosing sessions over their 11 clinic visits. During these, they will receive ketamine injections into the deltoid muscle in the upper arm. For the first 15 minutes a nurse waits in the room with the patient and a trained psychotherapist, before leaving the room, says Karen Simpson, Awakn London’s clinic director. In the Awakn model, ketamine sessions are separated from therapy sessions. Ideally, after a ketamine session (and a stay on the chaise longue until they feel able to go home) patients return the next day for a 50-minute psychotherapy session to discuss their experiences.
Before a potential patient rolls up their sleeve and slides onto the couch, there are several steps they must go through to qualify for inclusion. “It’s quite a high bar to clear,” says Collins. Patients can self-refer, filling out a form that asks for any history of psychiatric diagnosis or cardiac disease. Any patients with a previous history of psychosis are excluded from the treatment. In line with most other psychedelic interventions, Awakn also ask that patients have previously been prescribed at least two different non-psychedelic drug treatments for their condition.
Applicants also need to share their medical records with Awakn before enrolling. While GPs are often involved, there is no requirement for a GP to be made aware that a patient is enrolling with a private clinic like Awakn, as medical records can be downloaded online. This has been criticized elsewhere as being emblematic of the loose system of regulation around private clinics. While Awakn’s facilities and protocols have close ties to leading academic research, ketamine-only dosing clinics have existed in the UK for years. I ask Collins whether Awakn have any way of tracking whether a patient has visited another ketamine clinic, apart from their own disclosure. “There’s no sort of imposed regulation. But that’s the kind of thing that emerges when there’s more of a presence, whereas at the moment where we’re sort of breaking new ground,” he responds.
Ketamine in the US
In the US, there’s a different picture. Ketamine dosing broke through years ago. There are now hundreds of clinics across the country. At many of them, ketamine is infused in the absence of any psychotherapy.
Dr. Abid Nazeer has been treating patients with ketamine since 2016. His Illinois-based APS Ketamine clinics were recently acquired by Wesana Health, a growing player in the psychedelics market, estimated to be worth over $6 billion. APS Ketamine doesn’t pair its ketamine infusions with psychotherapy, but each clinic does have a psychiatrist on hand, especially at the on-boarding process. Nazeer tells me that wasn’t always the case: “When I started the practice, I didn’t see how important that was right away,” he says. “But with time, I’ve seen that it is extremely important.” At APS Ketamine, says Nazeer, screening involves toxicology testing, cognitive testing and a 90-minute psychiatric interview. But in the US, ketamine clinics – where there is no psychiatric support present – are in the majority, says Nazeer. In Chicago, of the 37 clinics that emerged in the city after APS Ketamine, only two of them had psychiatric support available, he says, adding “That’s the kind of ratio I’m seeing in general for who runs a ketamine clinic.”
“It’s quite a high bar to clear,” says Collins. Patients can self-refer, filling out a form that asks for any history of psychiatric diagnosis or cardiac disease.
There is a federal precedent in the US for infusing ketamine in the absence of mental health support. In 2019, The US Food and Drug Administration (FDA) approved esketamine, a molecule closely related to ketamine, as an intervention for treatment-resistant depression. Esketamine, which has a short-term efficacy requiring regular dosing every few weeks, is delivered as a nasal spray, without any therapy involved in the process. I ask Nazeer if he thinks ketamine clinics that don’t offer therapy are missing a key element of the process. He says that while he doesn’t believe every patient requires therapy, ketamine “would show a higher success rate with psychotherapy, 100%.”
The risks of a therapy-free approach, says Nazeer, are clear, especially for patients who have a history of traumatic experiences. “If somebody is reliving a previous trauma with vivid clarity during the treatment of ketamine, and they weren’t prepared for that, and there’s no mental health professionals on site, to be honest, it can be another traumatic experience in itself.”
"A certain conservatism"
Back in the UK, the market for ketamine infusion is embryonic by comparison. There are currently just a handful of private clinics offering therapy-free ketamine dosing, but protocols and requirements vary between each of these settings. Unlike in the US, the presence of a nationalized healthcare system means that implementing country-wide regulation is a far simpler prospect. Awakn have been a leading voice in calls for ketamine therapy to be made available on the NHS. This would not only help bring industry-wide standards to the field, but would also bring down the treatment’s high cost, which is more than £6,000 for a full course.
But the NHS, like other large organizations, has a “certain conservatism” in its approach to new treatments, says Collins. A representative from the National Institutes for Health and Care Excellence (NICE), the body responsible for regulating treatment guidelines within the NHS, said that its current guidelines on treating depression haven’t been updated since 2009, and that the terms of an update to that guidance, to be released later this year, were set out way back in 2015. The evidence base around psychedelics has been revolutionized in the seven years since. It’s not clear that any approval in the UK would result in NHS-available psychedelics any time soon.
Power Trip raises concerns
Awakn’s clinic opening comes not just at a point where wider psychedelic research has never been more popular, but one where psychedelic-assisted psychotherapy has come under unprecedented scrutiny. An investigative podcast, Cover Story: Power Trip, produced by New York Magazine, recently revealed shocking ethical lapses by therapists involved in psychedelic trials conducted by the Multidisciplinary Association for Psychedelic Studies (MAPS), a Canadian non-profit that has often led the way on psychedelic clinical trials. MAPS’s Phase III trial into the use of MDMA for PTSD was one of the most hotly anticipated readouts of the recent psychedelic resurgence. The trial showed that patients given MDMA instead of placebo had a significantly greater chance of no longer qualifying for a PTSD diagnosis after two months. A follow-up trial, key to approval by the FDA, is underway.
But Power Trip spoke with multiple participants in a previous MAPS Phase II trial of MDMA for PTSD and shared footage of a therapy session in which a trial participant is pinned down, spooned and even blindfolded by two therapists during a session. MAPS have since acknowledged that one of these therapists carried out an “unethical” sexual relationship with the participant after their therapy sessions, while they were still registered as a participant on the trial. The backlash from Power Trip has filtered through the psychedelics industry and Health Canada, which approved the study, has announced a review of patient safety and compliance in all trials involving MDMA. The podcast’s co-hosts, Lily Kay Ross and David Nickles, have been highly critical of the responses made by leading figures. MAPS released an update regarding Power Trip that stated “misrepresentations” in the podcast had “led to a substantially incomplete and inaccurate picture of the work of MAPS and MAPS PBC’s teams, collaborators, and volunteer participants.”
Consent during psychedelic therapy
Collins acknowledges the “awful” reports that Power Trip puts forward, but also says that it’s a topic that is “rightfully being surfaced and debated”. At Awakn, he explains, decisions on the exact type of therapeutic intervention and what role touch might play during a session would be discussed between therapist and patient prior to a session. While the horrific ethical lapses committed during the MAPS trial are clear-cut, the more general topic of consent during psychedelic therapy is a muddy one. This was highlighted by a recent British Medical Journal article that discussed the need for further thought on how consent is handled during psychedelic interventions. The article points out that, even if a patient sets out certain rules prior to a session, those priorities may rapidly shift under the influence of compounds that can dissolute your sense of self or increase your desire for socialization. “To deprive a patient of touch in situations where touch is clinically indicated could replicate past experiences of neglect, but of equal importance, unwanted touch could retraumatize patients,” write the authors.
The importance of exploring new treatments for mental health disorders should not be understated. Current services are neither being delivered in a timely manner – half of referrals in certain areas of the UK are waiting up to 23 weeks to receive an initial consultation – nor are pharmacological treatments helping all patients. The prospect of psychedelics helping even a small number of patients failed by traditional treatments is hugely exciting.
Can psychedelic therapy meet the standard?
But what’s clear from my visit to Awakn is that following a gold-standard approach – and the clinic’s psychiatric provision and well-considered facilities are probably as close as you could get to a place where you’d want to take psychedelic drugs and be congruent about your fears and anxieties with a trained professional – is expensive and takes a lot of effort. If the field is to maximize the benefits of psychedelic therapy for its patients, and to answer critics, ethical disasters like the MAPS trial abuse will need to be eradicated. All stakeholders involved will also need to agree to set a standard of care that people taking psychedelics for their mental health should receive.
If those standards aren’t met, the psychedelic renaissance could follow a very predictable fate. As Collins sums up, “We’ve seen the pathways taken in the past where there was some wonderful research and therapy in the 50s and 60s, and how that then was shut down in the 70s. It’s been only a very recent reemergence. We don’t want to see that pattern repeat.”