So Project T21 was launched in 2020 by Drug Science, which is this charity where I’m head of research and at the moment acting CEO as well. We launched Project T21 as it’s known with the overall aim of doing the research, establishing and furthering the scientific evidence base on medical cannabis, but also enabling patient access here in the UK, which I think is also a key area. The reason being that although medical cannabis was legalized in the UK as a medicine in 2018, there is still very limited access through the NHS, the National Health Service, and many patients who do want to receive medical cannabis still have to go through the private sector, which of course incurs quite a lot of costs and a lot of the conditions, as I’m sure we’re going to speak about, are chronic conditions...
So Project T21 was launched in 2020 by Drug Science, which is this charity where I’m head of research and at the moment acting CEO as well. We launched Project T21 as it’s known with the overall aim of doing the research, establishing and furthering the scientific evidence base on medical cannabis, but also enabling patient access here in the UK, which I think is also a key area. The reason being that although medical cannabis was legalized in the UK as a medicine in 2018, there is still very limited access through the NHS, the National Health Service, and many patients who do want to receive medical cannabis still have to go through the private sector, which of course incurs quite a lot of costs and a lot of the conditions, as I’m sure we’re going to speak about, are chronic conditions. So it’s not a one off payment that people are faced with, but really over the longer period. So these were the two aims of setting up Project 21, establishing and furthering the scientific evidence at the same time enabling patient access.
Today we have just over 3500 patients who have who are enrolled in the project and for whom we to an extent have the follow up data as well over three months, six months and so on. Within this I should say we have presented a summary of T21 as well as a summary specifically of the pain patients which may be relevant to the to the to your audience. What I spoke about at the conference was really the characteristics and the three month health outcomes for people
seeking treatment with prescribed cannabis and the real world evidence on that. Starting with the aims which were to follow up then to present the changes that people experience over the particular time frame. These changes were related to measures of health and well-being which are collected for all participants, general health, quality of life and mood. And we also wanted to present changes in condition specific symptoms for anxiety disorders, for chronic pain and for PTSD, post-traumatic stress disorder. In relation to chronic pain specifically, we aim to look at whether medicinal cannabis may reduce the use of prescribed opioids amongst the chronic pain patients, which obviously is a key area to look into. Our previous paper had shown that about half of the chronic pain patients were either on strong or weak opioids with all the risks and harms this potentially brings with it.
So we looked first at the patient characteristics which I think are always very interesting. To start with the kind of the age range, we have a very broad age range from 18 to 96. The mean age I think is around 40 years. So, these are not just young patients looking for some kind of alternative to recreational use. These are often quite old people and also people who are quite ill with a lot of comorbidities. You know that people have comorbidities from up to ten, and likewise in relation to using other medications, people also tend to use quite a broad range of other medications. The primary conditions we had and I think that’s interesting for many of the key reasons because looking back at the National Institute for Care and Excellence recommendation for medical cannabis prescriptions, these remain very narrow. So really medical cannabis is only recommended, they say, for main conditions which do not include pain. However, we have, as in other databases, both national and international, pain is actually the area, the condition where patients request medical cannabis for most frequently. So in our sample and that has remained
the same over the last couple of years is way over half of patients requesting medical cannabis for chronic pain conditions. Chronic pain is seen quite widely, including, for example, neurological conditions, fibromyalgia and so on as well. And the second most common primary conditions are the psychiatric conditions, which is also again is quite interesting because these are not conditions that medical cannabis is usually recommended for, for indeed it’s more seen that cannabis has a bit of the stigma attached to it, that it actually is detrimental to various psychiatric conditions. However, we find that patients the request medical cannabis for example, anxiety disorders, post-traumatic stress disorders as well as substance use disorders, ADHD and others. We have more males in the samples than females and we have about just over half who have actually used cannabis or medical cannabis before. So, less than half are actually cannabis naive patients, so to say.
So we looked for example, firstly at general health, we use the EQ-5D-5L scale which is assesses the general health on a 0 to 100 visual analog scale and the data was available for over a thousand people at the baseline and at the three months follow up – we are also planning to do 6 or 9 months follow up by the way – and the mean score at the baseline is 48.21 out of 100. So this is really low. Yeah. I think the average or from a representative sample in the UK it’s about 80 or even a bit more. So it really these are patients who have very low general health. However
the mean score at three months improved to nearly 60 out of 100. So this is a highly significant improvement which obviously is very important because general health is really what matters as well.
Within the quality of life, the individual items on the scale, we can look for example at the mobility, the ability to care for yourself, the ability to conduct your usual activities, as well as obviously the level of pain and discomfort experienced and also feelings of anxiety and depression. And you know, baseline data was quite bad so, you know, people were quite unwell, but all of the sub areas I just mentioned improved significantly at the three months follow up. So very exciting and very positive findings. And this obviously adds up when we look at quality of life, which is I guess the sum of the individual items on the scale, it also improved significantly. So that’s a very important factor I think, which is, you know, key in relation to medical cannabis that patients feel and have a better quality of life or able to live better. And similar and obviously related to that are also improvements in mood which we analyzed with PHQ9 and improvements in sleep quality which had items and they also came out very much significant and they also certainly contribute to improvements in quality of life. You know, if patients sleep better, they can function better the next day they feel more rested and so on. So yeah, we’re very excited and these were very positive findings.
What I do want to highlight very briefly because obviously that’s also important, I spoke about the positive sides and the positive impacts we have, but we do need to mention adverse events which are obviously also systematically and rigorously documented. Patients are asked to report any and all adverse events they may have experienced and also they asked to rate the severity of these adverse events as mild, moderate and severe, which is the standard practice really. The vast majority of these adverse events reported by patients, over 70% were rated as mild, which is a great thing. And I have a couple of the list. I’m not going to run through them in detail, but for example, the most common mild ones were the dry mouth, red and dry eyes, feeling drowsy, and also anxiety, for example, and headaches to an extent. So all, you know, fairly commonly expected things in relation to medical cannabis and in terms of dosing potential product change and so on, a lot of these that can potentially also be resolved fairly easily.
I think it is very important because obviously cannabis is still a stigmatized medicine and you know, this longitudinal real world data that we are presenting here at the BNA actually is key to really look at the adverse events ina longitudinal fashion, you know, And do they increase, do they decrease? How many of these adverse events are there? How serious are they, are there issues of dependance, which obviously is an issue that is mentioned in relation to recreational cannabis still frequently or psychosis, do they actually occur and if so, how often do they occur and with which severity? So I think that it is important that we do also address that and there’s additional evidence which we also want to look in further that some benefits of medical cannabis may vary by individual patient characteristics sometimes, but we don’t know that yet in detail.
But we look forward to analyzing this further and I think that’s where the complexity of cannabis is really comes in as well. We clearly need to look at what type of products are suitable for which type of patients and for which type of conditions. As you may be familiar with, with cannabis, consists of 120 different cannabinoids of which THC and CBD are so far the most common studied. However, there may well be and I’m pretty sure there are plenty more which may have an effect on patients health. So really that needs to be studied in much more detail and that’s something we’re looking into doing that as well. And we very much hope that, you know, the T21 data will really continue to understanding of these kind of issues that we’re still facing and we have much more data to be analyzed, I should say, and we’re very much hoping that we can also continue the project for quite a bit longer as well so that we really have the longitudinal data and can see the outcomes, say after a year.
