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Psychedelics are being explored for a myriad of neurological and psychiatric conditions. Recently, Technology Networks spoke with Professor David Nutt and Anthony Tennyson from Awakn Life Sciences, a Toronto-based company who focus on the use of psychedelics to treat addiction.
We discussed the unique considerations of treating addiction, the role of psychotherapy in psychedelic treatments and how regulation of psychedelics could change in the near future.
RM: What are the unique considerations that one must consider when designing and selecting compounds to treat addiction?
David Nutt (DN): A good start is to make sure they’re not addictive, so you don’t just switch one dependency to another. Traditionally it’s been very, very difficult to treat some addictions and if you think of something like heroin addiction, most of the treatments are putting people on something that is addictive, like methadone or buprenorphine, but which isn’t as dangerous.
We want to break away from that. We want to give people a treatment that disrupts the thinking processes, the repetitive, ruminative, habitual behaviors and thinking underlying addiction. By disrupting those, we think we can potentially cure people as opposed to simply ameliorating their condition. Psychedelics are really the only drugs that have that power to fundamentally disrupt what, for many people, is a decades-old form of behavior and lifestyle.
RM: Can the processes underlying different addictions be treated in the same way?
DN: We think they can be, yes. There are core features which all addictions share and those are things like compulsivity – you can’t stop – impulsivity – you start too fast – craving and stress sensitivity. Different people of course have different degrees of them, but those four elements are common to all addictions. The brain processes underpinning those we think can be disrupted, particularly the compulsivity and the habitual behavior. Those are common and we think we can potentially therefore target both behavioral addictions and also drug addictions and alcohol addictions.
RM: What clinical trials are Awakn planning?
Anthony Tennyson (AT): We do two things in Awakn Life Sciences – development and delivery. We do development of psychedelic drugs and therapies to better treat addiction and we deliver those therapies and in time we will deliver those drugs in clinics, specifically targeted at treating addiction. In the development side, we’ve got a near-term objective, a medium-term objective and a long-term objective. The near-term objective is focused on ketamine-assisted psychotherapy to better treat alcohol use disorder. What we’ve done is we’ve acquired the IP from the world’s only clinical trial for ketamine-assisted psychotherapy for alcohol use disorder under license from the University of Exeter. We’ll be bringing that forward from Phase II, IIA/B combined into Phase 3.
The medium-term objective is MDMA-assisted psychotherapy to treat alcohol use disorder. Professor Nutt, Dr. Ben Sessa and Dr. Laurie Higbed, who all now work with us at Awakn, they ran the world’s only clinical trial, a Phase IIA trial for MDMA-assisted psychotherapy for alcohol use disorder. The results were published in February of this year. We’re bringing that forward from Phase IIA to Phase IIB and we will, this calendar year, secure ethics approval and first time in human for that particular clinical trial and it will be the only Phase IIB clinical trial for MDMA in alcohol use disorder.
Our long-term objective is to develop our own range of compounds that we believe will be better suited to executing and enabling the treatment strategy that David mentioned – allowing the human brain to take control and overrule the compulsivity and impulsivity in the face of those stressors that lead to those behaviors occurring. We’ve initiated a research program with Evotec, running a 12-month hit-to-lead program with them.
RM: Do you believe that psychotherapy is an integral part of the process for psychedelic therapies?
AT: It’s common understanding that psychedelic-assisted psychotherapy requires four pillars to be executed correctly and in tandem. You need the compound, the therapy, a therapist and you need an appropriately designed clinical environment. That really forces people to realize that the requirements for treating mental health and addiction are different from the requirements for treating traditional medical issues. For traditional medical issues, medicine is prescribed, sent home or services are delivered in healthcare and they can be viewed separately. Psychedelic-assisted psychotherapy to treat mental health issues and addiction, you need those four core pillars delivered together.
DN: That’s exactly right. Part of our program is to train therapists, in some ways the biggest challenge for developing psychedelic therapy is having enough therapists. We’ve got a training program being developed so we can train both psychiatrists and psychologists to do the necessary psychotherapy to get the best out of the patient’s experience.
RM: Do you think that currently available compounds will come to dominate the market, or will these be replaced by new synthetic psychedelics?
AT: Our core purpose is to democratize psychedelic-assisted psychotherapy and psychedelics and what that means is integrating into the mainstream. That means the insurance markets need to reimburse and the public health care system needs to offer support because until that happens, this is an out-of-pocket payment from people’s disposable income and there aren’t actually that many people that have that level of disposable income. Particularly in the areas that we’re looking which are alcohol addiction, heroin addiction, opioid addiction, gambling addiction, tobacco addiction and other types of behavioral addictions.
To me, when you want to come up with a model that’s going to be commercially interesting from an insurance markets perspective and from the public health care system model, you need something that works in a shorter time window because as good as some psychedelics are, things that last six to eight hours and then require a six-to-eight-hour recovery window, that starts to get into a construct of requiring multiple shifts of staff, delivered over multiple instances.
Watch our full interview with Anthony and David here. Credit: LabTube
That’s very challenging from a capacity planning perspective and an economic perspective. What we want to do is take the best of the entactogen-type psychedelics that we’re interested in and make them available in a shorter window so that it can be more economically viable to be delivered at the scale it is required, to help as many people as possible.
Long term, I believe that it’s going to be a range of specifically designed psychedelic inspired or psychedelic compounds, specifically targeted at treating different indications.
We are not charging people out of pocket. We are totally engaged with the insurance markets and with the NHS as outsource provider. That to me is the future, and that’s what good looks like.
DN: We believe we have ways of partly accelerating onset, for instance you could potentially have an intravenous drug rather than an oral drug. We’re working with a chemist who’s got a very strong track record how you can rapidly limit the effect of drugs, using this particular kind of chemistry.
Of course one of the interesting things about psychedelics is that no one really knows how ketamine or MDMA work. We know a bit about it, we know something of their pharmacology, but we know way less than we would for a conventional pharmaceutical. One of the reasons Anthony has brought me in is because I made some discoveries about how MDMA works, which I’ve never published, largely because I didn’t have any resources to develop the data to get published.
Governments don’t give you funding to work on MDMA – they want you to forget about it, so Anthony was generous enough to engage with me, to help explore these other targets. There’s one particular target which I think is very exciting. We’re actually quite interested in some kind of hybrid ketamine-MDMA molecule which is a bit theoretical, but not impossible, that in itself would be a very interesting experience.
RM: Psychedelics are still heavily regulated. Do you believe that one of these lone trials will act as a breakthrough in regulation of psychedelics, or do you think a more gradual accumulation of evidence will be required?
DN: There’ll be both. The data in the trials are so good and governments are now realising when they do a cost benefit analysis – what have we saved in terms of healthcare costs by banning these drugs? Nothing. What are the opportunities for reducing healthcare costs if we make these drugs available? They’re enormous. The economists are saying it doesn’t really make a lot of sense really because you haven’t actually stopped people using them and they’re not very harmful anyway – the banning was political rather than scientific. The first thing to say.
The unmet need, as Anthony’s illuminated, and the patient reports and the fact that for addiction, even in the very best countries like Germany, many people never get treated. When they do get treated, the outcomes are awful. Basically, addiction is an untreated disorder and it’s killing tens of millions a year. The patient argument is very strong.
What’s really fascinating and exciting about what we’re seeing now is that you’ve got a new mechanism to treat addiction. It’s not simply a drug working on a receptor. You’ve got drugs which are affecting addiction in a novel way and the pre-clinical work is staggering. We’ve got papers coming out in Neuron and Cell on a weekly basis, showing how these drugs are transforming our understanding of the brain. That’s a pretty unstoppable train when you’ve got the patient benefit and the scientists saying wow, this is working in a novel way. I think within five years, MDMA and psilocybin will be medicines in some countries and hopefully in Britain.
Anthony Tennyson and David Nutt were speaking to Ruairi J Mackenzie, Senior Science Writer for Technology Networks.
The interview has been edited for length and clarity.