12 May Is the 5000-Person Medicinal Cannabis Trial Predicted to Take Place Significant?
The gates that shut off the British public from having access to medicinal cannabis on the NHS may be starting to creak open. In what may well end up being a development of significant importance, clinical trials consisting of thousands of volunteers could be set to take place in the near future. If the results of such a trial are positive, it could mark the beginning of patients having access to medicinal cannabis on the NHS.
The trials are yet to be approved as they’re currently still in the initial phases. The plan is to work out what affect, if any, medicinal cannabis could have for people who suffer with chronic pain.
What is Chronic Pain?
Chronic pain, which is also often referred to as long-term pain or persistent pain, is pain that usually lasts for 3 months or longer. You often find that this pain can be the result of an underlying condition or some kind of trauma that the patient has suffered. Common causes include:
- Post-trauma pain
- Post-surgical pain
- Pain related to cancer
- Pain as a result of arthritis
- Mental health
- Neuropathic pain
- Back pain
Chronic pain is a very common disease that is found throughout all of the UK. In fact, chronic pain is so common that recent data that was published by the government found that roughly one in every three people in the country suffer with chronic pain. Naturally, effective treatment is very much necessary in order to assist the plethora of people currently suffering throughout the country.
What Treatment is Currently Available for Sufferers of Chronic Pain?
Currently, there is not a great deal of treatment available for people who suffer with chronic pain. In fact, the majority of the treatment that is available tends to be more therapeutic in nature such as acupuncture. Patients are also often given advice such as “pace yourself” and “plan your day with your chronic pain in mind”. Granted, this advice may well be good natured, but it is hardly helpful for someone who suffers with serious chronic pain.
Aside from the above, the only effective medication available on the NHS are highly addictive opioids. It is these lack of treatment options that make the prospective trials so relevant as the majority of chronic pain patients are currently waiting desperately for pain relief medication that will produce results but won’t have adverse events when consumed in high doses.
Peer reviewed journals and researchers believe that if the clinical trials were to wield positive results, then this would be sufficient evidence in favour of the safe use of medicinal cannabis. Not only could it alleviate a patients pain but it would be safer than opioids and thanks to written prescriptions, patients could stop self-medicating using low quality products sold by drug dealers.
Tony Samios, a representative from LVL Health who are behind the clinical trials has commented on the limited restrictions that doctors in the UK have when treating chronic pain. He also acknowledges that currently there is insufficient evidence surrounding patients treating chronic pain with medical cannabis, all the more reason, he argues, why the trials are so necessary.
What Clinical Trial Studying Medical Cannabis for Pain Relief is Currently Being Conducted?
A “feasibility study” is currently being conducted, which consists of randomised control trials of about 100 people. This is being carried out by the aforementioned LVL Health. Once it has been completed and the findings are approved by the National Health Research Authority and the Healthcare Products Regulatory Agency, the trials will be able to move forward on to a much bigger scale.
What Will the Larger Clinical Trials Look Like?
Once the findings of the “feasibility study” have been approved by the relevant organisations, LVL Health will be ready to move on to the larger clinical trials, whose results could well set the foundation that medicinal cannabis treatment will be built on. These trials will be doubly blind and consist of 5000 volunteers and 5000 people in a control group. The volunteers taking medicinal cannabis are going to be inhaling cannabis-based medicine (whole flower and unprocessed) using inhalers. This would need to be taken once a day for at least a year, although the study will likely run for longer than that.
The vaping devices that will be used to take the medication will cost around £299 a month for patients who suffer with chronic pain conditions. The inhaler can only be used for one dose a day, so there is no risk of people using it to repeatedly take the medication all day.
The large-scale clinical trials are currently being referred to as CANPAIN. The participants will be between the ages of 18 – 85, all of whom have been diagnosed with chronic pain that is not cancer related.
Throughout these trials, in an effort to fully grasp just how much medicinal cannabis products are able to reduce pain, systematic reviews will be carried out frequently. The results of these reviews will be compared to those of the control group in order to assess whether or not those taking medicinal cannabis suffer with any kind of adverse side-effects. Those within the control group are going to be of a similar sex, age and health to their counterparts, which is very important in order to fully research the use of medicinal cannabis for chronic pain treatment.
Why Are These Clinical Trials So Important?
There are a number of reasons why these clinical trials and their subsequent results are so important. The main reason is because they are seriously in the interest of public health given how few treatment options are currently out there in order to treat chronic pain. If it can be proven that the treatment of chronic pain with authentic cannabinoids is effective without adverse side effects, then the doors could open for such treatment on the NHS. More evidence is still required in order to allow for such medication on the NHS but this evidence cannot be gathered if the trials don’t go ahead.
What Are Attitudes Like Towards the Proposed Clinical Trials?
The legalisation of medical cannabis and access to it on the NHS is usually a controversial topic; however, the announcement of these trials has had a fairly positive reaction. Ruby Deevoy, who is a CBD journalist, published a tweet following the news commenting how fantastic it was and that said news could well pave the way for access on the NHS for over a million people.
When Are the Large-Scale Trials Going to Be Approved?
Despite the enthusiasm surrounding the trials, it is still difficult knowing exactly when the large-scale trials might be approved. The feasibility study is underway and the results are in the process of being reviewed by the Health and Research Authority. It is them, paired with the Healthcare Products Regulatory Agency who will have to formally approve the CANPAIN clinical trials before they can go ahead. It is currently unclear how long that will take.
What Medicinal Cannabis is Currently Available on the NHS?
Currently in the UK, the view towards prescribing medicinal cannabis is not as open as other countries such as Germany, Israel, Canada and Australia. The only kind of medical cannabis which is available consists of cannabis extracts as opposed to whole-plant medicinal cannabis. Also, and most importantly, none of the medicinal cannabis that can be prescribed is used as a means to treat chronic pain.
One of the only forms of medicinal cannabis which is available on the NHS is Epidyolex, which was initially legalised back in 2018. This liquid is pure and contains CBD. It is used as a means to treat people who suffer with epilepsy and only a handful of people throughout the UK have managed to get prescriptions for it.
Are There Any Other Benefits to Legalising Medicinal Cannabis?
It is interesting to note that as well as alleviating the chronic pain that a lot of patients experience, there are other benefits that would come with the legalisation of medicinal cannabis as well. These include but are not limited to:
Benefits to the UK Economy
As well as personal benefits that patients would experience, there could be a number of benefits in terms of the UK economy too. The UK may be missing out on a significant investment opportunity with the medical cannabis market and this could be capitalised on, so long as the legalisation of such medication occurs.
The use of medicinal cannabis can be traced back centuries given it is a natural form of medication. It can often be safer than other medication that is available, for instance, the aforementioned opioids that are currently used as a means to treat chronic pain. These are highly addictive and can lead to significant adverse effects if their usage is not monitored properly.
It Would Be Much Safer for Patients
A lot of people that suffer with chronic neuropathic pain already look to use cannabis as a means to alleviate their symptoms. Of course, this is currently illegal and as such the product is purchased from drug dealers. When people subject themselves to this they are going to be ingesting a much lower quality product, which will have subsequent negative effects. It is also not a nice experience for sufferers of chronic pain to have to buy from drug dealers.
If the clinical trials prove successful then patients will no longer need to engage with drug dealers and instead will be a lot safer as a result. Patients will be taking the recommended medical dose and will be purchasing it from their doctor or pharmacist.
Is Medicinal Cannabis Ever Going to Be Used for Chronic Pain Treatment?
The progress made with getting medicinal cannabis available on the NHS for chronic pain has been slow; however, thanks to the new proposed CANPAIN trials, there could be significant steps made soon. This could not come at a better time as one in three people throughout the UK suffer with chronic pain and there is hardly any treatment available to them. The only significant medication out there are highly addictive opioids that can come with negative side effects.
Should the results of the clinical trial be positive then it could be the nudge officials need in order to pass legislation for the legalisation of medicinal cannabis for the treatment of chronic pain. There would be a number of subsequent benefits with this as well such as a boost for the UK economy, safer consumption for patients and the fact the drug being taken is natural.
We do not currently have any timeline for when the HRA will approve the clinical trials. Medicinal cannabis news sources will be keeping an eye out for potential updates.