COSY does not endorse the use of illegal substances. The following article is intended strictly for educational and harm reduction purposes.

Psychedelics are finally catching mainstream attention around the world as powerful treatments for mental illnesses. Though the UK has some catching up to do, clinics are beginning to crop up where psychedelics have been decriminalised like US and Canada, steering the wheel into the future of mental health treatments.

One such company is Field Trip, who describe themselves as, "bring[ing] the world to life through psychedelics and psychedelic-enhanced psychotherapy". But rather than simply prescribing patients psychedelic drugs, Field Trip are going further by researching and manufacturing new psychedelic drugs, whilst promoting harm reduction tools even in places where psychedelics are illegal.

During the lockdown, they have released an app called 'Trip' which is intended to be a companion to one's consciousness-expanding journeys. It has a beautiful user interface, encouraging introspection and meditation, whilst including mental health resources similar to those used at their clinics.

After discovering Trip, I decided to get in touch with co-founder and executive chairman Ronan Levy for an interview about the exciting work he and his team are doing at Field Trip.

I spoke to Ronan as he was driving back from work - appearing tired, but ultimately having the confidence that his work could change the world.

Hi Ronan, thanks for agreeing to talk to me. Could you start by telling us about who you are, and what you guys do at Field Trip?

Ronan: Field Trip is a global leader in the development and delivery of psychedelic therapies. Our mission is to bring the world to life through psychedelics and psychedelic-assisted therapies. And I note that because the potential of psychedelics to treat mental health conditions, which is the focus of much of the research and excitement right now, is significant and meaningful. But it's really the tip of the iceberg.

Psychedelic therapies really have the potential to help a lot of people, even those who don't suffer from depression, anxiety, PTSD or other mental health conditions. It can be very transformative for just about everybody, to be quite honest.

One of the things that's really important when it comes to psychedelics is something known as 'Set and Setting', which is the mindset you bring into a psychedelic experience, as well as the actual location.

The studies have shown that having a psychedelic experience with for instance, a hospital with white walls and fluorescent lights, is more prone to lead to bad outcomes than if you're doing it in a safe environment where people are comfortable and feel at ease.

We've got locations in Toronto, New York, L.A., Chicago, Atlanta, opening up in Houston and in Amsterdam and Seattle, San Diego in the coming months using ketamine assisted therapy primarily, which is legal and approved. And then we'll work with the other molecules as they get legalised or approved as well.

Source: About Field Trip Health Ltd.

How would psychedelic-enhanced therapy typically differ from conventional types of therapy?

Ronan: Yeah, I mean, it's kind of implicit in the name. Psychedelic-assisted or psychedelic-enhanced therapies are using psychedelic molecules to really enhance the effects of psychotherapy.

What we're seeing is that the evidence really is quite profound when you look at the use of psilocybin assisted therapy to treat major depression or treatment-resistant depression or MDMA assisted therapy to treat PTSD.

We're talking orders of magnitude more effective than conventional approaches. And the reason they seem to be so effective is the intersection of three things happening.

The first is that most psychedelic molecules are rapid-acting anti-depressants, so people feel better. You have a flood of serotonin that lifts your mood. So even if you're in deep depression or anxiety, usually people will feel a fairly rapid onset of an improvement in mood.

Secondly, the way psychedelic therapies are administered is - you do a lot of work before a psychedelic session in terms of getting to know your therapist, and framing the underlying causes of your mental health drivers. And then when you receive the psychedelic drug, what you're invited to do is wear an eye mask, put on music, and just go inward and experience whatever comes up.

Usually, people develop and obtain a strong sense of objectivity towards some of the events in their lives that may have been traumatic, or that may have been underlying the depression or anxiety. And so they're able to revisit these moments with a new perspective and see them from a different light.

So they're not as traumatic. They're not as hard on their ego or their sense of self. They're able to start to change the narrative around those moments, much like how conventional psychotherapy works.

But you get there a lot faster when using a psychedelic, as opposed to having to slowly but surely break down the kind of 'ego walls' and defence mechanisms that come up in conventional therapy.

The third piece is that there's a period of neuroplasticity that seems to follow a psychedelic experience when your brain is actually more open to changing how it works on a neurochemical level.That's where the integration therapy becomes really important - following a psychedelic experience, people are actually a lot more open to adopting new habits, new outlooks, new mindsets.

Using that period of neuroplasticity after a psychedelic experience to help people adapt and change how they live, as well as starting that emotional processing that happens during the session, the combination of these factors seem to lead to all of these really amazing outcomes that the research is showing right now.

You mentioned one of your focuses of psychedelic-assisted therapy is ketamine administration. Here in the UK, Ketamine is generally considered to be a trashy recreational drug, and it would take some by surprise that it can be considered a viable medication for mental health.

Ketamine is also unusual as it doesn't work on the serotonin receptors like traditional psychedelics. So why Ket?

Ronan: A couple of reasons. One is, you're right, it doesn't work on the serotonin system the same way as the classic psychedelics. But it does offer a very similar experience to the classic psychedelics, which is to say people have a dissociative psychedelic experience.

If we look at the mechanisms of action we just talked about, which is rapid mood improvements, a degree of objectivity as you go inward to revisit past moments, past traumas and neuroplasticity, ketamine actually meets all of those criteria as well.

So it is actually quite a potent drug for treating mental health conditions. In fact, the former director of the National Institute of Mental Health, Dr. Tom Insel, actually said that he considered ketamine as the most important new antidepressant treatment in the last 50 years. It's quite an effective drug and it's quite safe, actually.

I mean, ketamine has been approved for use by the FDA, and the equivalent organisations around the world for the last 50 or 60 years. And it's been used quite effectively and safely. So it is actually a great treatment.

The results associated with ketamine assisted therapy don't seem to be quite as profound as we see with psilocybin, for example, where they're reporting that some studies suggest that psilocybin assisted therapy can lead to antidepressant effects for up to five years or more. With ketamine, we see people having improvements of a few months at a time.

So it's not quite as effective, but it is still extremely effective. It is very safe, and it's really improving the quality of lives for a lot of people. Because we can work with it now, it gives us an opportunity to help people now as well as to build the infrastructure that we need to work with all psychedelics in the future.

So what type of mental health conditions would benefit from all these different psychedelic substances? For example, when would you find it suitable to use psilocybin, MDMA, or LSD for potential patients? Because each drug is different, I'm assuming that each drug has its own particular benefits.

Ronan: Right now, we're working with ketamine in all of our North American locations. We're just about to open the location in Amsterdam where we'll be working with psilocybin truffles, because it's legal in the Netherlands to work with psilocybin truffles. As other jurisdictions start to legalise or approved psilocybin, we'll start working with those as well.

Certainly, once MDMA gets FDA approval, which we anticipate in the next one to two years, we'll start working with MDMA as well. But it's primarily ketamine right now.

We talk about ketamine for the use and depression primarily. We talk about MDMA for the use of PTSD, and primarily psilocybin for depression.

That's not to say that MDMA is only appropriate for depression, or psilocybin for for depression. I think there's a lot of cross-platform utilisation, but the studies tend to be indications specific. So when they look at suicide and for depression, they look at MDMA for PTSD.

Now you have to be conscious that people who have severe PTSD, particularly military veterans, may find a psilocybin experience to be a little too intense, particularly if it brings up incredibly intense memories. So it seems to make sense that MDMA may be a first-line agent.

Truthfully, if you look at the underground therapy industry as a model for what we can expect in a legal industry, you see many people trying different psychedelics as they go on their healing journey, and I think each different experience offers different insights, different awareness, different growth. And that's how you generate the best outcomes.

You just mentioned the underground therapy industry, which has recently cropped up in some mainstream news outlets. How would you say your clinic improves upon the underground therapy industry that's been happening for a good few years now?

Ronan: Well, I mean, I think it speaks for itself, which that it's underground. The use of these molecules is illegal and is in contravention of most narcotic control regulations. So the therapist working with this put themselves in individualised risk associated with that.

Similarly, many underground therapists are qualified psychotherapists or psychologists in their jurisdictions, and so they carry insurance to address any potential liability that may come up if there are bad experiences and an above-ground therapeutic session. But that wouldn't necessarily extend to underground therapy.

There are a number of wonderful therapists doing this work and being brave, taking on these risks because they think they can have a real impact by doing psychedelic-assisted therapies outside of a legal or regulated context. And I think that's very laudable. But given the risks, I think a lot of people will stay outside of that and won't work with it, even though it could be significantly beneficial to their patients that they work with.

Would you be able to give some insight into some of the potential legal challenges you are experiencing with pushing forwards with promoting psychedelic-assisted therapy, despite FDA approval?

Ronan: You know, we haven't had any legal challenges with the work we're doing. We're really focused on doing everything in compliance with the laws as a publicly-traded company. You know, there's strict scrutiny put on us. So everything we do is entirely legal.

Certainly, there's been some stigma we've had to overcome. It took a while to get some bank accounts set up. Certain landlords don't want to work with us because they think what we're doing is too out there, even though it's perfectly legal and compliance with laws, regulations, medical protocols, all that kind of stuff.

But it's changing very rapidly. I think minds are changing. People are seeing the potential. Alcohol is pretty well established to be one of the most dangerous drugs in our society, to the extent that people are using cannabis for therapeutic reasons. As attitudes change, I think we'll see some of the challenges we've faced so far start to dissipate.

What psychedelic assisted therapy typically looks like, with a comfortable environment over a clinical one. Photo: Polaris Insight Center, courtesy of Multidisciplinary Association for Psychedelic Studies (MAPS).

I want to move the conversation towards another exciting division of your company involved in manufacturing new psychedelic drugs. I read that Field Trip is also involved in manufacturing a substance called FT-104. Could you tell us a bit about that?

Ronan: First of all, it's a very long experience. A typical psilocybin trip is four to six hours. When you put therapy before and after that, you are basically committing someone to a full day experience, which makes it a very long, significant opportunity cost, because it probably means a day off work. It makes it very expensive, because you have to have a therapist and potentially a doctor present all day, which makes it a very challenging therapy to administer clinically, despite how effective it is.

Then there's the fact from a business perspective, there's not a lot of IP that can be generated around psilocybin. So we said, can we address the limitations of psilocybin from an application perspective, but also generate some meaningful IP around something new that could help us create a defensible business model?

Because to go through clinical trials to get a drug approved, you're looking at hundreds of millions of dollars. And if you don't have a patent, the period of time you have to actually try to recoup that investment is anywhere from five to seven years with a patent. It's more like 14 or 15 years. So much, much longer time frame.

We canvas the known anecdotal and scientific literature, and we realise that there's an interesting molecule (which we haven't disclosed what it is yet). And that is a very psilocybin-like experience. In our clinical and preclinical studies, we found that it hits the same receptors in the brain, with basically the same kind of constants as psilocybin.

So if you were to map the two, it looks almost identical in terms of what's happening in the brain. But it has a trip time of two to three hours, about half that of psilocybin. So we think that's a great psychedelic drug to move forward with in terms of drug development.

But this underlying drug is not very soluble, which means it's not easy to turn into a medicine that could get approved by the FDA, Health Canada, or whatever the oversight organisation is. So we did some chemistry work on that to enhance the solubility of the underlying molecule through a prodrug strategy. Through that work, we've developed a new molecule which is called FT-104.

Now, what's really nice about FT-104, again, is that when you administer the drug to rat models, the metabolism actually cleaves off the part of the molecule that we added to make it more soluble, thus creating the original psychedelic molecule in the body. So we know what the experience is going to be like with a good degree of certainty. We know which receptors in the brain are going to be engaged with a good degree of certainty because that underlying molecule that we built FT-104 from gets repopulated.

So what we have then, is a molecule that's very psilocybin-like, but with a shorter trip time, and for which we were able to develop meaningful IP. So it's kind of like the best of all worlds in terms of what we wanted to do. We hope to be in phase one human trials by the end of this year, and have a strategy that I think gets us to approval by about 2025/26, which is still a long time away. But when it comes to drug development work, it's actually a pretty short time frame. So we're quite excited about it.

Are you concerned about the potential stigma caused as a result of introducing new chemicals to the market? Whereas studies are only beginning to show the benefits of ‘traditional psychedelics’ like LSD and psilocybin, are you concerned that manufacturing a drug different to these might stunt the reputation of psychedelics in general?

No, I don't think so. I mean, my current view is that stigma always dies in the face of objective data, right? So what stigma exists around psychedelic molecules if we show them to be safe and effective, and for which we have FDA or Health Canada approval, then there's not a whole lot of stigma left to be had.

People can't make judgement calls about whether it's an effective medicine or not. It just becomes an effective medicine. I think that doesn't create increased stigma or risk, if anything it decreases it because more and more of these will be accepted just as medicines, like any other medicine that may get used in our society.

You mentioned it will be a long while until we hear more about FT-104, but can you foresee mass-market production of it? Or is it to be used exclusively during therapy at your clinics?

Absolutely. We see it as medicine, which means we want anyone who needs to access to these therapies to get it. So certainly, we hope it will be available through our own clinics, but it won't be restricted to our clinics.

That's amazing! It's so interesting to me that new psychedelics are still being created, and making a drug like FT-104 is even possible.

Yeah, absolutely. I think there are 40 or 50 publicly traded psychedelics companies right now that are actively working on developing new psychedelic drugs and more psychedelic molecules. Many of the psychedelic molecules we know were invented through chemistry. LSD was developed by Albert Hofmann in the 1930s. And there's no reason to think that all tryptamines that engage the 5HT2A serotonin receptors have been discovered. So I think there's there's plenty of opportunities.

The Trip app is available to download on the App Store and Google Play.

The final thing I want to talk about is your app, Trip, which was released during the 2020 pandemic. I've never seen an app quite like this before, and was wondering if you could tell us why you released it?

Ronan: So as you know, our primary initial effort was building out clinical infrastructure to deliver psychedelic therapies working primarily with ketamine.

But when Denver and Oakland decriminalised psychedelics in the US, we realised there was going to be hundreds of thousands, if not millions of people living in jurisdictions where, even though not legal, psychedelics would be kind of viewed as 'almost legal'. A lot of people would be going out and using psychedelics just given the kind of interest and the mainstream moment they're having.

We realised that all the work we were doing to build really powerful and informative protocols for our Field Trip health centres could be synthesised, simplified, and put into an app such that anybody doing their own self-guided consciousness expansion work could take advantage of those tools, and really work to have a good experience.

For us, it makes sense from a business perspective because it helps extend the brand, build the community, and promote harm reduction tools to make sure we're maximising the likelihood of someone having a good experience and minimising the likelihood of having a bad experience.

Now, we did recognise the concerns about getting it into the App Store, which is why we've consciously kept any description of drugs out of the app itself, such that it would meet the requirements of the App Store.

But it turns out at the same time as we were seeking approval for Trip, an app and social community built around DMT got approved. So I think the App Store policies are becoming more liberal. As long as you're not openly advocating for anything illegal, it seems like they're much more receptive to ideas like this.

Looking at the app, Trip seems to encompass more than facilitating psychedelic experiences. If not directly encouraging the use of psychedelic substances, what do you hope people will get from using the Trip app?

The truth is, you know, there are other ways to engage in psychedelic experiences. It's kind of core to our philosophy as a company that psychedelic experiences are anything that quiets the ego, shuts down or turns down the default mode network and opens people up to revisiting past experiences and changing the way they look at the world. So that can be meditation, that can be breathwork, that can be exercise, that can be any number of things.

I have to ask, what can people get from your clinics that they can't get from using the Trip app?

I mean, there's a number of things. But primarily, you'll have a therapist who will help you work through the entire process. There's only so much we can do from an app, right? The qualities of a therapist is that they can read people. They've worked with a lot of people, so they can see where people's sensitivities are and help shine a mirror on where you are or what you're struggling with, probably a lot better than people can do on their own. So really, that's the biggest advantage.

But using the Trip app is going to be much better than not having any guidance or direction at all.

Absolutely. I mean, you could go out and you could take a psychedelic, having done no preparation, not knowing what to expect or anticipate, not knowing how to make sense of the experience. Or you can go out and make sure you're informed and follow a process that has been validated in our clinics, and truthfully leverages the experience of the last 50 or 60 years of psychedelic use in the West to really position yourself to have the best experience possible.

With this great intention to reduce harm in countries that have not yet decriminalised psychedelics, what plans do you have in expanding the app?

Yeah, we do have a number of different plans. I mean, they're constantly evolving. But what we want Trip to be is the best resource for anybody using psychedelics without the benefit of a therapist. So we'll continue to expand the music repertoire. We'll continue to expand the meditations that are now available in the app, which are provided by some of the most recognised guides out there.

One last question Ronan. Have you received any reports from people using the app whilst going down these consciousness-expanding journeys?

I mean, I can only speak to the feedback we've received, which is almost uniformly positive. People find it to be a really great tool and really beneficial to their experiences. Whether they need the music, whether you need the integration questions or not, everybody finds some value from using the tool by and large. They're just usually experimenting with different psychedelic modalities to get to know themselves better and find out what drives them and what motivates them. And so far, people seem to like where they're getting to with it.

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