Psychedelic Therapy | +80 articles

[mr peabody]

Inside Field Trip's Toronto clinic.

What is the best approach to Psychedelic Therapy?*

An Interview with Field Trip’s Ronan Levy

by Ruairi J Mackenzie | Technology Networks | 17 Dec 2021

The psychedelics boom has seen the number of classical and non-classical psychedelics being trialed for mental health conditions skyrocket. Virtually all these trials are yet to complete, but psychedelic clinics are already open. In these clinics, licensed psychedelic compounds like ketamine, which has avoided regulation as a sedative compound, are administered to patients. Field Trip Health, a Toronto-based provider, is developing its own compounds, like the tryptamine-based FT-104, while also offering therapy-paired psychedelic experiences with ketamine at its clinics. We spoke to co-founder and executive chairman, Ronan Levy, to find out more about Field Trip’s approach to psychedelic therapy and why 2021 has been such a significant year in psychedelics.

What have the biggest developments for field trip been in 2021?

RL: 2021 has been a big year for us. I think the biggest development was listing to the Toronto Stock Exchange, and then cross listing on to the NASDAQ, as well as the financing we completed in March, where we raised $95 million. I think that was pivotal for a number of reasons, the biggest one, I think, because we had heard from a number of friends and advisers that we'd never be able to raise money from traditional pharma and biotech investors, given our integrated model. We managed to prove them wrong with the biggest funding financing in Canadian psychedelic history, and one of the largest overall, which is great validation for our drug development strategy.

Beyond that, three things. The continued execution of our clinic rollout; we're at nine locations right now. The results we're seeing in our clinics are just fantastic. On average, most patients who come through our treatment programs see sustained benefits in terms of their depression and anxiety scores for 120 days or more post-treatment, which, as far as I know, makes it the single most effective treatment option out there.

Right now, I've never heard of any other treatment programs offering that kind of stat, especially when you compare it to say, IV ketamine infusion clinics, where the benefits tend to revert to the mean after about three weeks, I believe. So, our clinics have been tremendously successful in helping people and building awareness for Field Trip.

Our drug development efforts, I think, have been remarkable. We've made great progress. We've provided a lot of guidance about FT-104. It’s a tryptamine that is very similar to psilocybin, but with about half the duration of experience, addressing one of the key limitations around psilocybin, which is the time and the cost involved in the duration of experience. So that's very exciting. We launched our new pipeline program and the FT-200 series. We're continuing to evaluate other potential candidates to be a lead in the FT-200 series, though the first one that we've developed shows an incredible amount of promise in terms of maintaining the potency of classic psychedelics but addressing the [side effects] associated with potentially agonizing the 5-HT2B serotonin receptor. That’s really exciting as well.

RM: Why do you believe Field Trip’s approach has outperformed ketamine IV clinics?

RL: Ketamine IV clinics kind of treat ketamine like an antidepressant. They provide an IV on a slow drip, and they maintain a very mild level of ketamine for the duration of the experience. We know that ketamine can cause synaptogenesis; it causes the brain to grow new neural synapses, which is very positive. But the IV infusion approach, I think, misses out on some of the core elements of what makes psychedelic-assisted therapies so powerful.

What you miss is twofold. One; we give intramuscular injections as opposed to IV, so it's very quick onset with very high bioavailability. And it induces a very psychedelic-like experience, not too dissimilar from classic psychedelics, during which people are often able to go back and revisit past traumas, past experiences, past memories and see them from a different light. This is what people, I think, try to get to through conventional talk therapy or cognitive behavioral therapy. We just help people get there, in a very quick instance, with ketamine, and that's because we're giving intramuscular injections which have fast onset, whereas with ketamine IV, it's slow onset, so you don't have that similar psychedelic experience with ketamine IV.

The second thing is because we pair our programs so closely with psychotherapy, we get to take advantage more effectively of periods of neuroplasticity [induced by the drug], where people are able to make changes to habit, mindset, outlook and practices in their lives. Not only do they get the lift from the ketamine and the benefit of that emotional processing, they actually get to, it seems, adopt new lifestyle considerations that support these improvements of mental health.

We know that how you eat and exercise impacts on mental health. And during these windows, it seems people are more able to adopt those different decisions that support a better emotional and mental health outlook from their perspective. So that's why I think we're seeing much better results. It's really a function of the therapy and the protocol that we use.

RM: Do you think that, post-approval of psychedelic-assisted therapy approaches, there could be a push towards purely pharmacological interventions from pharma lobbies that are less effective? What do you think is the future of psychedelic drug development?

RL: I think if people benefit, it's wonderful. Just because they're not benefiting as much as they potentially could doesn't mean we should be critical; it just means we need to recognize that there's different approaches here and different desires.

I know there's a lot of interest in some groups in finding psychedelics that can be treated like antidepressants, you know, a pill that you take once a day, and it has significant improvements. I think that's wonderful. There's some people who want to do the work. And then some people don't want to do the work. Some people want to climb mountains, other people are content to sit at home and drink coffee at the kitchen table. I think the more robust options we have available for people, the better. I personally like to lean into the psychedelic experience. I think there's value in the work and the process. But that's me. And that's not everybody. And if somebody else says, “I'm not interested in that, I just want to feel better through a more conventional allopathic medical approach.” Great. They should have options as well. I don't see that as a conflict. Personally, I think at the end of the day, we're all working towards the same thing. Then we take different approaches, and as long as people aren't being harmed by it. I think it's wonderful.
​

"Some people want to climb mountains, other people are content to sit at home and drink coffee at the kitchen table."​

RM: You mentioned your programs for drug development, which is focused on compounds derived from classical psychedelics. Do you believe that the efficacy you'll see when using these classical 5-HT2A receptor agonists will be significantly different from the efficacy you see currently with ketamine?

RL: I think so. We're seeing wonderful results with ketamine. I'll be honest, when I first started in the industry, I had this vision that ketamine would eventually be leapfrogged by the other psychedelics because, at least on the face of it, the potential impact of, say, psilocybin looked greater.

However, I've changed my perspective. I think ketamine is going to remain a core part of psychedelic-assisted therapies and clinics like ours are going to be able to offer a number of different treatment protocols, some on-label some off-label, but I think ketamine will form a part of it. What's really nice about ketamine is that people don't have to give up their conventional treatments, such as [classical antidepressants] SSRIs or SNRIs to access ketamine assisted therapy. At least right now, the guidance is with psilocybin and MDMA that you want to be off antidepressants before you start treatments. Ketamine is actually a very nice onboarding for people looking to explore medicine in this respect.

That said, I do anticipate you're going to see better results with the classic psychedelics, and that's not based on just my opinion. I think if you look at the data coming out of a lot of the studies, the potential impact of psilocybin and classic tryptamines tend to be higher than what we've seen with ketamine.

But that's just my anticipation, and the data will speak for itself. I think, though, that you'll see the psychedelic medical industry start to resemble the underground psychedelic therapy industry right now. Yes, MDMA will be specifically approved for the treatment of post-traumatic stress disorder and psilocybin will be specifically approved for major depressive disorder or treatment-resistant depression (TRD). And FT-104 will be specifically approved for TRD and post-partum depression, which is the indications we're going after, but I think people will start with ketamine as probably the first onboard. They may use psilocybin to help treat their depression, but their psychiatrist may also say “We've used psilocybin to treat your depression and it’s very effective, but from our conversations, it seems that there's a lot of trauma underlying your depression. So even though you may not have a diagnosis of PTSD, MDMA may be a beneficial adjunct therapy,” I think people will continue to work in that kind of regard. I really do believe we're going to see a robust blend of options available to people. And I think that's going to lead to the best outcomes.

Ronan Levy was speaking to Ruairi J Mackenzie, Senior Science Writer for Technology Networks

Ruairi J Mackenzie
Senior Science Writer

*From the article here :

What Is the Best Approach to Psychedelic Therapy? An Interview With Field Trip’s Ronan Levy

We spoke to co-founder and executive chairman, Ronan Levy, to find out more about Field Trip’s approach to psychedelic therapy and why 2021 has been such a significant year in psychedelics.

www.technologynetworks.com

 

[mr peabody]

​

Challenges facing the adoption of Psychedelic Therapy

Times of great scientific discovery manifest enormous change. We offer solutions to streamline the adoption of psychedelic therapy.

by Adam Miezio | DoubleBlind | 30 Nov 2021

Like anything new, the adoption of psychedelic therapy will require many changes to our normal ways of addressing mental health conditions. Education and current information is necessary for the evolution of a healing ecosystem of trusted care.

Psychedelic therapy is about to give birth to a whole new world of healthcare. New to the Western world that is, as psychedelics have been used as powerful healing tools by native cultures around the world for thousands of years. In this way of modernizing the use of psychedelics, there are lessons to be found in the history of penicillin.

During the 1950s, penicillin was widely seen as a wonder drug. However, evidence that molds can heal wounds predates the “discovery” of penicillin in 1928 by decades, if not much further back into antiquity. Thus some say of penicillin that “The discovery was old science, but the drug itself required new ways of doing science.”

This same mindset can also be applied to the adoption of psychedelic therapy. Everything that is old is new again. The healthcare industry will have to create an entirely new therapeutic infrastructure from the ground up, and develop community support groups, while offering treatment at the same time. This creates exciting, albeit, chaotic times.

Embrace Change

Times of great scientific discovery manifest enormous change. One of the biggest changes comes in the form of mass adoption. A sudden, exponential increase in a healthcare treatment, or in this case a type of therapy, brings about its own unique set of challenges. There are 3 main challenges:

1. Training and upskilling entire ranks of healthcare workers and therapists nationwide to handle a surge in treatments and patients.

2. A potential overwhelming of existing mental healthcare and therapy infrastructure depending upon the adoption of the discovery or treatment, and popularity thereof, by the general public. This requires preemptive building of treatment centers and clinics, which in the end may still not meet the need because of long wait times and lack of affordable psychedelic treatments.

3. A shift in the mindset of the general public towards mental health which increases openness towards psychedelic therapy, putting further pressure on infrastructure, systems and healthcare workers and therapists to meet the demand. This type of change in attitude also occurred with the arrival of penicillin.

“Injunctions to the healthy were complemented by a moral disdain for those who lapsed and then succumbed to disease. The introduction of antibiotics in the 1940s converted illness into a strictly technical problem. In richer countries the avoidance of ‘germs’ gradually ceased to be a duty.”

Our current zeitgeist casts aspersions upon those struggling with mental health issues. This makes no sense as mental health is no different than physical health, yet a macho attitude to “eat the pain”, compartmentalize it and hide it in the closet, pervades our society. If the aftereffects of Covid-19 cause that attitude to dissolve out of sheer desperation, a tsunami of patients could flood the system.

Tsunami of Mental Health Crises

Where does that tsunami come from?

The 21st century mental health crisis afflicting the United States. The mental health crisis existed before Covid-19. Now that Covid-19 is running amok across the country and world, it’s hosing down the mental health crisis with kerosene. The lockdowns (unlockdowns and relockdowns), the quarantines, isolation, social distancing, disruption to habitual social routines and increased inability to connect with other human beings extracts a massive tax on mental health and wellness. As the United States stabilizes from the pandemic, do not doubt the coming high tide of people seeking healing from mental health issues, perhaps like nothing ever witnessed before.

In order to respond with agility, economy and force to this mental healthcare crisis, Psychedelic Support aims to establish a decentralized ecosystem of education for trusted providers, therapists, practitioners and community members to meet the learning needs for a super sensitive and novel field, where none has existed before. Learning something entirely new and creating it as time goes on, can be a daunting feeling.

Psychedelic Support is the go to source for top quality psychedelic therapy information, training, supervision, and learning so therapists and healthcare workers new to the field, have a trusted support resource to lean on, enabling them to follow the trail through the wilderness.

In a field that’s rapidly changing and shifting, relying on one’s peers, who also are the era’s leaders, visionaries and early adopters, assures access to the cutting edge information, knowledge and insights necessary to a successful therapy practice in a newly born world. The consequences for not responding to this imminent crisis will be catastrophic.

By applying the same solutions from an old system to a new problem, the healthcare system will fail spectacularly. The number of people needing mental health services and therapy in the near future may outstrip available infrastructure, resources and healthcare workers. The specter of mental health looms large and stands poised to burden the United States if not fully addressed. The adoption of psychedelic therapy must occur with considerations for access, affordability, and client-centric approaches.

Solutions for Adoption of Psychedelic Therapy

As the Psychedelic Support educational ecosystem and information network for psychedelic medicine blooms, and more therapists and healthcare workers join, it enables everyone to deliver the comprehensive, specialized care needed by the sufferers of the 21st century mental health crisis. The next step is to…

Find the others working in the field. Connect, collaborate, and learn with your peers.

Psychedelic Support offers solutions to streamline the adoption of psychedelic therapy:

1.) A free directory of licensed health providers and community groups. Private forums to discuss and connect around psychedelic topics.

2.) Accredited Ketamine, MDMA, and Psilocybin courses for continuing medical education (CE/CME) and general public education.

3.) Promotion of our educational partners for ketamine training for clinicians, setting up and operating psychedelic clinics, and deep dives into psychedelic-related clinical topics.

4.) Wide ranging resources at your disposal from plant medicine to integration practices, online workshops to in-person experiential trainings, as well as featured speaker and professional networking series.

5.) A library of articles from the Psychedelic Support Network and educational courses, including free courses on “Exploring Psychedelics” and “Harm Reduction Strategies”.

Plug into a trusted community of your peers to meet all your psychedelic therapy needs, save time and eliminate the hassle of scouring the mediascape. When a floodgate opening moment for psychedelic therapy arrives, Psychedelic Support will be the reliable, community and peer support network helping, forecasting problems and acting as a safety net during rapidly changing times.

Challenges Facing the Adoption of Psychedelic Therapy

Times of great scientific discovery manifest enormous change. We offer solutions to streamline the adoption of psychedelic therapy.

psychedelic.support

 

[mr peabody]

Inside London’s first Psychedelic Psychotherapy Clinic

by Alexandra Jones | Evening Standard | 22 Mar 2022

Psychedelics are being touted as a cure for depression, addiction and many other common mental health disorders — but will this new industry live up to the hype? Alexandra Jones visits the capital’s first clinic to find out.

At first glance, the clinic looks more like a spa than a mental healthcare facility.

Situated on a cobbled mews street in Bloomsbury, it is Awakn Life Sciences’ first London outpost, and London’s first psychedelic psychotherapy clinic. “It’s the moss,” says Awakn’s COO, James Collins, gesturing towards the lush green ‘feature wall’ growing behind the reception desk. “It gives it a warm, welcoming feel, I think.” Later he will take me to see a huge tree which is growing right through the middle of the clinic’s relaxation area (where patients unwind after their psychedelic experiences). It’s quite astounding to see a tree this big growing indoors — “fake, sadly,” he says — though, he continues, research suggests that after a trip being in the natural environment “promotes therapeutic healing — so we’ve tried to do that whole outside-inside thing.”

Psychedelic psychotherapy is one of the latest innovations in psychiatry; patients with anything from depression and PTSD to eating disorders and anxiety can be treated — and if evangelists are to be believed, actually cured — using a mix of traditional talking therapy and high dose psychedelic drugs. In 2018, psilocybin — the active ingredient in magic mushrooms — was given ‘breakthrough therapy status’ by the US Food and Drug Administration (FDA), when used as a treatment for depression.

The breakthrough therapy designation is reserved for drugs that “demonstrate substantial improvement over available therapy” — and indeed trials where patients were given a high dose of the drug, in conjunction with talking therapy, showed promising results on people who’d failed to respond to traditional antidepressants. In a similar study in 2020, after two sessions of psilocybin and eleven hours of talking therapy spread out over the weeks before and after the drugs were given, 71% of patients saw their depressive symptoms reduced by half — and half went into a remission, meaning they no longer qualified as being depressed.

Awakn’s Bloomsbury Clinic

Professor David Nutt is a psychiatrist, chief research officer at Awakn and one of the world’s leading researchers in the psychedelic space (he also holds the dubious honour of having been sacked from his job as chief drug advisor to Gordon Brown’s government after claiming that LSD and ecstasy were less dangerous than alcohol). “From a neurological perspective,” he explains, “conditions like depression, anxiety and all kinds of addictions are characterised by repetitive thinking.” The more we repeat a behaviour or thought, the deeper that particular neurological pathway becomes.

“Often there’s a trauma which sparks the negative thoughts or behaviours — but once they’ve become encoded in the brain, they’re very difficult to break out of.” He uses the metaphor of ‘defragging a computer’ to explain how psychedelic drugs work — “breaking down all those old systems, clogged by viruses and unuseful data, and allowing new ones to form. A kind of reset for the brain.” During a psychedelic ‘trip’, patients often experience powerful hallucination; in that state the brain becomes more malleable, and remains so for the days following, “which is where the talking therapy comes in,” says Nutt. “We can begin to assess the old behaviours and thought patterns more objectively - and try to form new, healthier ones.”

Professor David Nutt is a chief research officer at Awakn

Problematically for researchers, most psychedelics — including LSD, psilocybin and MDMA, (which has become one of the leading compounds in the treatment for severe PTSD) — remain illegal in most countries, including the UK. The only drug which can mimic these effects on the brain but is also currently licensed for medical use is ketamine (a dissociative hallucinogen, commonly used in hospitals as an anaesthetic — and the only drug used on patients who visit Awakn).

Still, while many clinicians agree that it’s not the ‘ideal’ psychedelic, it has shown some promising results: in recent months experts at the University of Exeter (running an NHS-funded clinical trial) found that alcoholics treated with the same ketamine-and-therapy combination that Awakn use at their clinic, were two-and-a-half times more likely to stay sober for six months following treatment compared to people who were offered just talking therapy.
​

Some patients have profound epiphanies, experiencing powerful hallucinations which centre on the trauma that’s been driving their addiction or depression.​

“When a patient comes to us, we begin with two one hour prep sessions a week apart,” says Collins. “In these, the patient gets to know the therapists they’ll be working with and begins to understand what’ll be involved in their treatment.” For the next four weeks, there is a pattern of ketamine sessions followed by ‘integration’ therapy. “We give the ketamine as an injection,” explains Collins. What happens when the drug takes effect differs from patient to patient — some have profound epiphanies, experiencing powerful hallucinations which centre on the trauma that’s been driving their addiction or depression.

Others report losing all sense of their bodies and feeling profound love and peace. One participant in the University of Exeter trial experienced a feeling of being back in the womb and born again. “At these points the therapists are there mainly just to oversee — the patients are largely laying down and incapacitated. We have some nice weighted blankets they can cover themselves with, to feel kind of safe and cocooned. With the integration sessions afterward, we’ve developed a new type of therapy which borrows principles from a number of disciples — CBT, mindfulness — which help people to process what they experienced, and what it means for their condition.”

The first intake of patients from their clinic in Bristol (which opened in 2021) have now completed their treatment course. “We’re seeing some really profound results,” says Collins. And with their Bloomsbury clinic, Awakn is continuing its mission to become Britain’s best-known purveyor of psychedelic psychotherapy. To call them the ‘McDonald’s of psychedelics’ risks making light of the scientific rigour with which they’re approaching this new frontier in mental healthcare — but their plan to open a clinic on major high streets across the country does have a ring of the golden arches about it. “It’s about normalising treatment for mental health conditions,” says Collins.

“People should have access to a treatment which is fast-acting and doesn’t require as much maintenance as taking a daily antidepressant, or years of talking therapy.” The cost is £7,500 for a course treatment (including the four drug-assisted sessions), though as Collins points out: “If someone has a problem with alcohol they might spend anywhere from £5,000 to £40,000 on a week of rehab. At Awakn we’re offering an eight week course of treatment and it has a much stronger efficacy; there’s the chance to make some genuine functional change in a patient’s life.”

It is claims like these — that psychedelics might offer truly curative solutions to mental health conditions that have long been considered incurable — which have prompted such huge interest in the industry. It also doesn’t hurt that a growing number of celebrities have come out in support of using psychedelics in therapeutic settings. Last year, former heavyweight champion Mike Tyson became an advisor for the board of Wesana Health, a Chicago-based company who’re developing psychedelic medicines for the treatment of repetitive brain injury (treatment of neurological conditions is a promising new avenue for psychedelics, which have more commonly been associated with mental health). “I believe if I’d been introduced to the benefit of psychedelics for therapeutic use early in my professional career, I would have been a lot more stable in life,” he said at the time. “I had a lot of public outbursts and they were all mental illness related. Prescription drugs meant I didn’t feel like myself but with psychedelics I feel I’m a happier, lighter version of me.”

Actor Megan Fox told American talk show host Jimmy Kimmel that a recent ayahuasca ceremony she participated in in Costa Rica “surpasses anything you could do with talk therapy or hypnotherapy, any of those things” (she also told him that it made her feel like she’d spent an eternity in hell — which perhaps brings the power of these drugs into stark relief). Hunter Biden — the President’s son — wrote candidly in his memoir Beautiful Things about being given ibogaine, a plant-based psychedelic at a clinic in Mexico, in a bid to curb his lifelong addiction to drugs and alcohol (he hallucinated a “slideshow” of his life — the experience kept him sober for a year). And of course, there is Joe Rogan. “A slightly contentious character,” says Clara Burtenshaw, Partner and Investor at Neo Kuma Ventures — Europe’s first psychedelics-focused venture capital fund which was founded in 2020. Rogan, Spotify’s most popular podcaster, has long been a supporter, often inviting some of the psychedelic industry’s best known scientists and advocates to be interviewed on his show. “Like all things,” continues Burtenshaw, who has spent the past two years seeking out and investing in companies which are operating in the psychedelic biotech space. “If there’s a person you connect with doing or saying something, you’re more likely to listen than if it’s just a random scientist or politician, so I think the fact that well-known figures are talking openly about their experiences is an important step… and Joe Rogan has a huge audience.”

Early promise in clinical trials has also translated into some astronomical valuations for the companies operating in this space, as investors sense a coming sea-change in the way we treat mental health and attempt to get in ‘on the ground floor’ at psychedelic biotech companies — often even before new drugs or treatments have gone into development. In the past two years many psychedelic companies (including Awakn) have floated on stock exchanges in London, New York and Canada. Most famously, Compass Pathways — the company whose research led to the ‘breakthrough therapy’ designation for psilocybin — was valued at $1.3bn just a month after it floated on the Nasdaq in 2020.

The sums involved have led some within the psychiatric community to question whether treatments are quite as effective as psychedelics evangelists would have us believe (more on this in a moment), but the fact that Awakn are already planning to open a third clinic is perhaps indicative of how ready we — as a society — are for a shake-up within the world of mental healthcare.

Problematically there doesn’t seem to be the same political appetite for the decriminalisation of those crucial compounds here in the UK as there is in the US, where some states have already legalised psilocybin for therapeutic use. In the UK, psilocybin, MDMA and LSD are all Class A drugs and possession alone carries up to a 7 year prison sentence. Even academic researchers who want to use it in clinical trials have to jump through so many regulatory hoops that it can make the trials prohibitively expensive. “I think Dominic Cummings was quite interested in making it easier for researchers,” says Professor Nutt, “and there were sensible conversations happening with Number 10 about accelerating British research in this field. But then, of course, he disappeared.”
​

He warns that this gold rush mentality is leading to “commercial opportunism” where some companies are putting profits ahead of their patients’ wellbeing.​

In the meantime, though, ketamine-assisted psychotherapy has been working really well, says Collins. And perhaps elsewhere, a slow and steady approach is no bad thing. Dr Jeffrey A. Lieberman is one of the world’s most pre-eminent psychiatrists — professor and chairman of Psychiatry at Columbia University in New York and the director of New York State Psychiatric Institute. As he points out: “psychedelic drugs are of potentially great value — and it’s important that we are able to study them in a deliberate and rigorous way. However, the genie’s got out of the bottle too fast — things are moving ahead too quickly.” He’s become an important voice in a growing movement which is attempting to dampen the furore around these new treatments. He warns that this gold rush mentality is leading to “commercial opportunism” where some companies are putting profits ahead of their patients’ wellbeing. He also argues that, if we drill down into the data, the studies which have caused the most excitement around, say, the treatment of depression using psychedelics, “showed not robust superiority to a standard antidepressant, it showed kind of marginal superiority on some things.”

While he’s not anti-psychedelics, he warns that attempting to roll out any kinds of mental healthcare treatments before they’ve gone through the usual years-long development process risks setting a promising industry back. “You look at some of the ketamine clinics operating in the US and they don’t have a methodology, there’s no standardisation. And [without enough data] how do you know that the therapy adds anything? If you just give the drug alone, will it work just as well? It all seems very ‘cart before the horse.’”

Still, it’s hard not to be excited about promising innovations in a facet of the medical field which hasn’t innovated in decades. In the days after my meeting with Collins, the royal college of psychiatry releases an analysis which shows a huge increase in referrals to NHS mental health services over the period of the pandemic. Collins admits that they are operating at the vanguard of the mental healthcare industry but argues that given the amount of unmet need it’s important to start offering these groundbreaking solutions to people now. “This is a true revolution,” he says. “And the potential for the people we could help is astronomical.”

Inside London’s first psychedelic psychotherapy clinic

Psychedelics are being touted as a cure for depression, addiction and many other common mental health disorders — but will this new industry live up to the hype? Alexandra Jones visits the capital’s first clinic to find out

www.standard.co.uk

​

 

[mr peabody]

What’s the Best Psychedelic Therapy Protocol?

by Floris Wolswijk | LUCID | 19 Apr 2022

What will psychedelic-assisted therapy look like when it becomes available? This is a hot debate within the psychedelics field.

One side, the maximalists, argues that psychedelic-assisted therapy needs much support. More than with any other medication, patients need to know what they are getting into. After treatment, integration requires more than just a debrief session.

The other side, the minimalists, argues that much less time investment might get us to similar outcomes. Patients don’t need to be burdened with repeated and expensive travel for multiple preparation sessions. They make a case for attendants that are present during a psychedelic session and leave the integration to the existing care network.

Two recent publications bring these different approaches to light. One, by Lea Mertens from the Central Institute of Mental Health in Mannheim and collaborators at the Charité Berlin and the MIND Foundation, describes the ongoing EPIsoDE trial, a phase II psilocybin trial for treatment-resistant depression. The other, by Neiloufar Family and colleagues from Eleusis, puts forward the Eleusis study design after gaining insights from a trial with LSD with healthy participants.

I spoke to both teams and found each had patient benefits top of mind. Though differing insights led the camps to design very different approaches.

Preparing the participants

We have come a long way from the psychedelic research of the ’60s. Back then, participants were given little to no instruction about what to expect from a psychedelic experience. Some were even dosed without their consent.

Today a participant receives a lot of information about the many ways a psychedelic experience might unfold. The guidelines on how to conduct psychedelic research, written in 2008 by Johns Hopkins researchers Matthew Johnson, Bill Richards and Roland Griffiths describe the preparation as follows: “A series of meetings [totalling eight hours] between the monitors and volunteers in order to build rapport and trust. The relationship between the monitors and the volunteers should be well established by the time of the first session.”

Eleusis’ Family agrees with this assessment, saying: “The key in psychedelic therapy is to make the volunteer or the patient feel as comfortable as possible, which helps them surrender to the experience.”

But unlike the more protracted study protocols used by the MAPS, Usona, or EPIsoDE trials, Eleusis compressed the preparation to a single day before the dosing session. To make psychedelic-assisted therapy practical, Family asks, “What is required to make someone feel supported and free to let go in the session?”

In the Eleusis study, the participants (healthy volunteers) spent only a day at the location where their session was to take place. There was room to meet other participants, a guided breathing session, and communal meals throughout the day.

Will this be enough preparation for a patient population? Peter Hendricks, also associated with Eleusis, argues that we have a duty to find out: “The assumption has been that we need extensive preparation to maximize the likelihood of therapeutic mystical-type experiences, but this assumption has not been scientifically interrogated. I think the available data, including from the study that we’re discussing now, would suggest that therapeutic experiences are indeed possible with paired down preparation.”

Tripping without the therapist?

In a psychedelic-assisted therapy session, it is standard practice to have two therapists present, a male and a female. These are the same therapists with whom rapport is built over multiple preparatory sessions. The therapists serve as an anchor, but active intervention during the session is rarely necessary, according to the Johns Hopkins team. Speaking from experience, Johnson and colleagues note in the safety paper that “reassurance has been sufficient to handle all cases of acute psychological distress that have arisen.”

Psychedelic-assisted therapy was developed during an era when the prevailing approach was psychoanalytical. In the years since new frameworks have been developed, such as CBT and ACT, that are being applied during psychedelic sessions. Still, many researchers feel a prolonged experience with two therapists is necessary.

Shlomi Raz, founder and CEO of Eleusis, approaches psychedelic therapy from a humanistic perspective, following in the footsteps of Carl Rogers. “In this different kind of psychotherapy framework, it is more about experiential learning and unconditional positive regard.” Raz argues that you don’t need a psychotherapist to do that work. The Eleusis protocol calls for “attendants rather than therapists.”

Psychedelic-assisted therapy is usually an inward-directed experience. Those supervising a session, be it attendants or therapists, are instructed to intervene as little as possible. Further minimizing the need for a therapist, Raz argues: “Any talk during the acute phase to my mind is a negative thing in so far as it may reflect avoiding. Furthermore, you want to make this a consistent therapy. Thus we want to avoid the variability of what a psychotherapist brings in.”

That is not to say that Eleusis or other minimalists don’t care about safety. A monitor is present that can watch multiple rooms at the same time. The company has implemented escalation protocols, and is considering the addition of a proactive review of video recordings based on parameters such as movement in the room.

Reducing trip length

Another point of debate among researchers is the duration of the session. Most of the research done this century has been with psilocybin, meaning a session can take an entire day.

The Eleusis study used LSD, known for even longer psychedelic effects. Family comments on the experience of one of their study’s participants: “She received her dose of LSD at 9 am. She was still under the effects the next day at 1 am. It’s a very long experience for both the participant and the staff. Shortening the psychedelic experience is important to avoid burnout in your employees.”

Psychedelic companies have a multitude of reasons for shortening the psychedelic trip. For one, developing a novel psychedelic may enable them to patent the molecule and its specific use. But shortening the trip is also beneficial for the personnel, who would sit through shorter, though sometimes still intense, experiences, as well as for participants who would rather complete their trips more quickly.

Eleusis plans to deliver psilocin, the active metabolite of psilocybin, directly via an IV infusion. “If you’re going to do something, then just do it rather than ruminate, wait, anticipate and not know,” Raz suggests, referring to the predicted immediate onset of the drug effects in this method of administration. If their formulation, Ele-Psilo, works as intended, the entire trip is complete within an hour.

Whether that is enough time to process deep trauma or complex beliefs is an open question. From a psychoanalytical perspective, a patient might want to dive more deeply into past experiences. Could a shorter trip lead to long-lasting changes? Some companies are betting the house on it.

Integrating the psychedelic experience

Insight without action is like wanting to stop smoking while puffing on a cigarette. Integrating the psychedelic experience and applying the lessons to behavior change may be the most challenging and crucial part of psychedelic-assisted therapy.

Speaking about one of the biggest lessons learned over the past five years, Rosalind Watts, in a Medium article, highlights the need for integration. “People were flocking to psychedelic retreats, many had wonderful experiences, but most of them did not receive the kind of aftercare they needed. After such an intense experience, they found themselves left alone to understand it, process it, and try and incorporate the teachings into their lives. This is the work of a healing community, but after their brief taste of one, they found themselves back home treading the same old pavements and feeling a bit disconnected from their new ‘medicine family’ that they had shared the ceremony with. Now they were left alone with all the emotions, insights and questions the ceremony had revealed.”

Even when multiple integration sessions are offered, CIMH’s Mertens thinks that’s still insufficient. “In terms of the study visits, I believe we have to find a system where we even increase the integration amount we have right now in the trial.” She sees that many participants need more than the four offered integration sessions. “We need more psychotherapy around the psilocybin sessions in most patients, not all, but in most patients to actually induce change.”

Both Watts and Mertens speak to the necessity of participants having the space to discuss their psychedelic experience, especially regarding how to induce lasting change. Many participants in psychedelic-assisted therapy trials do not see a therapist regularly. Finding an appropriate therapist can prove difficult, as in Germany, where the EPIsoDE trial is taking place; the waiting times are months long.

Eleusis’ Hendricks challenges the prevailing narrative. “We don’t know for a fact that these integration sessions are necessary, at least not for everyone. And questioning this is relevant because, ultimately, if we want to see these treatments made available to a wide range of people, including people with less income who are at disproportionate risk for mental health conditions, we have to reduce the burden on participants.“

While trial participants are asked to visit their study site up to ten times, that level of therapy may not be possible for a large part of the population, Hendricks suggests. “In the Deep South of the U.S., public transportation is limited, especially in comparison to places like Seattle, New York, San Francisco, Boston, Washington DC, and others. Many cities are just not walkable, and many lower-income people have limited access to reliable automobiles. Reducing the number of sessions required to attend alone could make this treatment paradigm available to many more people.”

One of the trials that reignited the psychedelic renaissance was the smoking cessation trial. Published in 2014 by Matthew Johnson and colleagues, the study lists only one hour of integration after each session. Five years later, 60% of participants remained smoking abstinent. The insights from the psychedelic experience stuck without the researchers providing continued integration.

“My clinical anecdotal evidence to date would generally suggest that many people would benefit in the absence of extensive integration psychotherapy. They get the message loud and clear,” says Hendricks. Instead of offering a lot of guidance, he trusts that participants can have a self-healing experience. Though Hendricks is following in the footsteps of Carl Rogers, this framing might find overlap with those seeking to maximize psychedelic-assisted therapy. Can participants be trusted to follow their “inner healing intelligence” following an acute psychedelic experience?

Putting psychedelics into practice

It may be unfair to pit the perspective of academic trials against the practical implications of the real world. But as different as these perspectives are, both the maximalists and the minimalists are dedicated to improving the lives of those they seek to serve.

Participant safety is front and center for both groups. The EPIsoDE trial offers a perspective on what the most rigorous scientific study of psychedelic-assisted therapy looks like. Results are expected by the end of 2023.

The answers aren’t all there yet, but Raz and colleagues ask the right questions. “Can we provide safety with an attendant with a minimal amount of psychotherapy and still see safety, tolerability and crucially effectiveness?” If yes, it could mean a more affordable and practical form of psychedelic drug therapy available for all who would like to pursue it.

*From the article here :

What’s the Best Psychedelic Therapy Protocol? It’s Debatable. - Lucid News

Some researchers claim psychedelic therapy requires a lot of support, while others argue that it’s better to be less hands on, so treatment can be more widely available.

www.lucid.news

 

[mr peabody]

​

Locating a practitioner for Psychedelic-Assisted Therapy*

by Ameila Walsh & Dr. Lynn Marie Morski, MD, Esq | Psychable | 3 Apr 2022

As a growing number of people seek help for conditions like treatment-resistant depression, post-traumatic stress disorder (PTSD), and anxiety, there has been a renewed interest in psychedelic substances while researchers explore new therapies.

Psychedelics have the potential to benefit the treatment of mental health conditions and help psychologically healthy individuals live more meaningfully due to the mind-altering nature of such substances. While traditional medications are taken every day (sometimes indefinitely), psychedelics are administered a limited number of times with potentially lifelong effects. Integration therapy can increase the likelihood that these treatments will offer longer-term relief.

Where can I get psychedelic-assisted therapy?

The legality and availability of psychedelic-assisted therapy depend on the geographic location and its laws pertaining to different substances. This has an impact on the accessibility of these treatments in certain areas, though further research has the potential to change federal and local laws in the future.

Federally approved studies and trials are an exception and are allowed to obtain or create substances that haven’t yet been approved for widespread use so they can be tested following specific protocols. Practitioners, organizations, healing centers, and institutions that are offering psychedelic-assisted therapy for research publicly post opportunities for participation.

Some underground therapists and researchers do provide guidance and psychedelic-assisted therapy in a clandestine manner; however, such a practice is not legal outside of a research setting. This factor can make it difficult for people to find what they are looking for in certain cases, but several psychedelic-assisted therapy options are legal in the United States.

Ketamine is legal and widely available with a prescription at clinics across the country. To get the most out of the experience, look for clinics that offer integration services and a therapist who will be present during the treatment itself. Another option is to work with a therapist who is able to attend treatments and provide integration services afterward.

Both psilocybin and MDMA have been designated as Breakthrough Therapies by the FDA for treatment-resistant depression and post-traumatic stress disorder (PTSD), with studies for additional uses underway. After a preparation process, these treatments are administered and then followed up with psychotherapy to process the experience, or at the same time as a psychotherapy session as a tool to facilitate progress and comfort for the seeker in processing difficult emotions.

Oregon recently voted to legalize the use of psilocybin and was the first jurisdiction in the world to outline specific laws for how it can be used therapeutically. While it remains a Schedule 1 controlled substance federally, advocates of psychedelic-assisted therapy are nonetheless optimistic that Oregon’s state-level decision will help bring awareness of and acceptance for the psychedelic therapy community, helping to create a path for greater accessibility.

Many mental health practitioners are beginning to offer integration therapy to people who have had MDMA, ayahuasca, mescaline, and LSD experiences independently and wish to process their experiences in a meaningful, intentional way with a therapist.

Qualifications of the practitioner

There are different types of practitioners who provide psychedelic-assisted therapy and integration therapy. Those who have an MD associated with their name are medical doctors who frequently specialize in psychology, and who can legally prescribe certain substances for therapeutic use. Other medical providers, like nurse practitioners, may also specialize in psychiatry and be able to prescribe certain medicines.

Licensed therapists, guides, and sitters can also be certified through programs like psychedelic-assisted psychotherapy training, therapist training, and specialty programs for working with certain substances as therapies. Training and certification programs are available from reputable organizations such as The California Institute of Integral Studies’ Center for Psychedelic Therapies and Research and MAPS.

Certification and training courses in these areas, while reputable, are considered preliminary because in many cases, it is unknown what the FDA will consider acceptable if and when further legalization of psychedelic substances occurs.

More information

Psychable’s directory is a great resource for discovering practitioners, guides, therapists, and doctors who offer psychedelic-assisted therapy and psychedelic integration services. Click here to check it out.

The U.S. National Library of Medicine also offers a plethora of information from scientific studies on the subject of psychedelic-assisted therapy. You might start here.

*From the article here :

Locating a Practitioner For Psychedelic-Assisted Therapy

Medical Editor: Dr. Lynn Marie Morski, MD, Esq As a growing number of people seek help for conditions like treatment-resistant depression, post-traumatic

psychable.com

 

[mr peabody]

​

“I’ve never seen anything as effective”
Exploring the combination of Psychedelics and Psychotherapy

by Ruairi J Mackenzie | Technology Networks | 28 May 2022

While most psychedelic drugs remain illegal in the United States, ketamine has been legal for use by registered practitioners since the 1960s. With the recent recognition of the compound’s use as an antidepressant, more and more clinics are rolling out ketamine-assisted psychotherapy programs.

Among the providers in this space is Toronto-based Novamind. Through their networks of Cedar Psychiatry clinics, Novamind recorded more than 20,000 sessions in 2020.

“Ketamine is helpful as a medicine, but there’s so much more to be gained by adding the psychotherapy component,” says Dr. Reid Robison, Novamind’s chief medical officer, in an interview with Technology Networks.

Psychedelic-assisted psychotherapy sees a client undergo work with a trained counsellor after taking a psychedelic substance. While use of psychedelics as a salve for mood disorders is not confined to clinics, as studies of recreational microdosing show, Robison is clear that taking psychedelics with a trained therapist will prove most helpful to people with specific mental health problems to tackle. “For certain conditions, whether it’s substance use disorders, PTSD can certainly unearth difficult things, you need a skilled team on board. I’m a big fan of ketamine if it's used in the right way, but it can certainly be a nightmare if used in the wrong way. It can be a godsend if used in the right setting or therapeutic context,” he explains.

But therapy comes in many modalities and formats. These fall in and out of fashion, with cognitive behavioral therapy (CBT) particularly in vogue in 2021.

Robison, however, says that emotion-based and mindfulness therapies are most commonly used in Novamind’s clinics in tandem with ketamine. “We’ve even developed specific ketamine-assisted psychotherapy protocol called EF-KAP, emotion-focused ketamine-assisted psychotherapy. We did a preliminary pilot study of it for depression and did a full-on clinical trial of it for eating disorders, for anorexia,” he says.

The use of mindfulness therapies is based, Robison says, on previous studies that have shown the benefits of this approach. One study that looked at ketamine’s effect on cocaine addiction showed that over a five-week monitoring period, volunteers with cocaine addictions treated with mindfulness and a single-infusion of ketamine were nearly five times as likely to remain abstinent as compared to people given a similar therapy course combined with a benzodiazepine.

Interestingly, when ketamine was approved by the FDA for treatment-resistant depression as the Janssen brand Spravato, therapy was not part of the equation, either in trial or in approval. Novamind’s clinics offer Spravato treatment as an option, in combination with a strong recommendation to engage with therapy. “Pretty much every dose we’ve given has been covered by insurance or patient assistance programs with leverage for the majority of folks through the manufacturer that makes it quite affordable. It’s not a cure. It’s not even a lasting solution for most, but it does seem to be in our experience a very important option that we now have available for people with severe depression or depression with suicidality,” says Robison.

Robison’s team are currently looking at data comparing the treatment potential of Spravato and ketamine and while conclusive findings aren’t yet available, Robison suggests that these drugs should be seen as a “bridge” to help shore up patients suffering from severe depression and get them to a place where they can more effectively engage in psychotherapy.

As much as the current focus is on the legal-to-prescribe ketamine, Robison expects other drugs to enter the scene very quickly. “The first FDA approved medicine plus psychotherapy combination will likely be MDMA.” Robison expects that this non-traditional psychedelic will be approved in the next year or two due to powerful evidence suggesting it can help with the symptoms of post-traumatic stress disorder (PTSD).

“I’ve never seen anything as effective as MDMA for PTSD,” says Robison, who points out that a recent study conducted by MAPS found that 67% of PTSD patients given MDMA-assisted psychotherapy showed no symptoms after three treatment sessions, as compared to only 32% of those given a placebo.

With these levels of efficacy, soon the bottleneck in treatment might not be available compounds, but the availability of therapists who are able to deliver the treatment. MDMA remains unapproved, meaning that any therapists who undergo training for therapy assisted with the drug will have to wait to practice. Nonetheless, Robison believes that therapists who have the option should take it.

“I think if you have the opportunity to participate in MDMA therapy training and the resources, great, go for it. Having done the training myself, it’s a very meaningful, rewarding process that I feel like gives you new skills as a therapist even above and beyond the MDMA.”

Reid Robison was speaking with Ruairi J Mackenzie, Senior Science Writer for Technology Networks

“I’ve Never Seen Anything as Effective”: Exploring the Combination of Psychedelics and Psychotherapy

While most psychedelic drugs remain illegal in the United States, ketamine has been legal for use by registered practitioners since the 1960s. With the recent recognition of the compound’s use as an antidepressant, more and more clinics are rolling out ketamine-assisted psychotherapy programs.

www.technologynetworks.com

 

[mr peabody]

Field Trip app brings psychedelic-assisted therapy into your home*

by Kristin Houser | FREETHINK | 10 Jun 2022

Suspect that a psychedelic trip might improve your mental wellbeing? There’s now an app to help you find out.

Research has shown that pairing traditional talk-therapy sessions with one or more sessions during which a patient takes a psychedelic drug, such as ketamine or MDMA, may help treat depression, PTSD, and other mental illnesses (although such research is generally still preliminary).

But the number of clinics offering psychedelic-assisted therapy is still low — particularly in the U.S., where many psychedelics are entirely illegal — meaning not everyone can access the experimental therapy.

Additionally, some people who think they might benefit from psychedelic-assisted therapy could simply be wary of tripping outside their home or with a stranger, even a trained therapist.

Now, Field Trip (a company that offers psychedelic-assisted therapy at clinics in New York, L.A., and Toronto) has developed Trip, an app designed to help people glean the mental health benefits of psychedelics without a therapist.

The Field Trip app

Psychedelic-assisted therapy is typically broken into three phases: preparation, the psychedelic experience, and integration.

In the first phase, the therapist and patient discuss the therapy and its purpose during one or more sessions, going over the patient’s traumas or goals.

The psychedelic experience phase is just that: the session(s) during which the patient actually takes the drugs under the supervision of the therapist.

The final phase, integration, is one or more follow-up sessions during which the therapist helps the (sober) patient process their trip, talking about their experience and ways to integrate it into their lives.
​

We’re like Home Depot for self-exploration. You can do it, we can help.
​

The Trip app guides the user through the same pattern.

During the prep stage, the user fixes their intentions for the trip (“to process,” “to heal,” etc.) and chooses music.

They then take their psychedelic drug of choice — they must procure that on their own and determine their own dosage — and once they start to trip, they can use the app to record audio notes of what they’re thinking or experiencing to review later.

After the trip ends, they can use the App’s trip journal feature to process the experience, answering such prompts as “What emotion came up for you?” and “Where in your body did you feel that?”

Psychedelic-Assisted Therapy at home

Field Trip doesn’t outright say on Trip’s website that the app is designed to be used with psychedelic drugs — that would violate the App Store’s rules — only that it’ll help users “make the most of (their) consciousness-expanding experiences,” such as meditation or breathwork.

But as the company’s cofounder Ronan Levy told Wired, it would be “naive” to think people wouldn’t use the app in conjunction with psychedelic drug trips.

“This way, at least, we can make sure you have well-considered instructions,” Levy said. “I like to say we’re like Home Depot for self-exploration. You can do it, we can help.”
​

Trip can help you make the most of your consciousness-expanding experiences.​

But just like how the DIY creations that result from Home Depot purchases are often a far cry from those made by professionals, psychedelic-assisted therapy guided by a trained therapist seems like a more effective way to combat mental illness than journaling on your phone after taking some black market shrooms.

Still, psychedelic-assisted therapy at Field Trip’s clinics comes with a hefty price tag — a package with one consultation, six ketamine-infusion sessions, and nine integration sessions costs $4,700, Wired reports.

The Trip app is still only available on an early-access basis and Field Trip hasn’t revealed the cost, but it’ll almost certainly be cheaper — another way the app could increase access to at least some of the benefits of psychedelic-assisted therapy.

App brings psychedelic-assisted therapy into your home

The Field Trip app aims to help people get some of the benefits of psychedelic-assisted therapy outside the confines of a clinic.

www.freethink.com