A proposed UK study of whole plant cannabis as a treatment for chronic pain, hopes to pave the way for NHS access.
Regulators have approved a small, feasibility study to help researchers conduct future trials into the use of whole plant cannabis for chronic pain conditions, such as arthritis, back problems or fibromyalgia.
The study, which is being carried out by private cannabis clinic LVL Health, will initially recruit 100 patients, before plans to conduct a larger trial, which is yet to receive approval from the National Health Research Authority (HRA).
Up to 28 million people in the UK are thought to be living with some form of chronic pain, a number likely to increase in line with an ageing population and a rise in diseases such as rheumatoid arthritis.
Furthermore, according to government figures, some 14,000 people are diagnosed annually with hard to treat pain conditions such as fibromyalgia, which can have a debilitating impact on a patient’s quality of life.
In the UK more than 10,000 people are already prescribed cannabis medicines for a range of conditions, the majority of which are living with some form of chronic pain.
But while patients have been vocal about its impact, especially as an alternative to opioids, The National Institute for Health and Care Excellence (NICE) has called for more robust data before it recommends prescribing on the NHS.
LVL Health hopes to play an important step in accelerating patient access and bridging this evidence gap.
Speaking to Cannabis Health, clinical trial manager for LVL Health, Sophie Hayes, a registered nurse who has worked within the NHS and the cannabis industry, for several years, described it as a “pivotal moment” for cannabis medicine in the UK.
“I am very excited to be able to offer patients at LVL clinics the opportunity to take part in this groundbreaking regulatory approved feasibility study on chronic pain, which will inform the final design of a larger number and longer period study for chronic pain,” she commented.
“This is a pivotal moment for cannabis medicine research in the UK. If we can show the larger study to be efficient and robust, then we will be able to use the model to conduct an array of trials focusing on a wider variety of conditions.
Despite reporting from The Times and other news outlets this morning, that a larger clinical trial has been approved to recruit up to 5,000 patients, the HRA confirmed to Cannabis Health that no application for a large-scale trial has been received or approved at this stage.
A spokesperson for the HRA said: “The Health Research Authority has reviewed and approved the CANPAIN feasibility study. The small study, involving 100 patients, intends to help the research team understand how best to conduct a clinical trial in the future.
“Any clinical trial would need HRA Approval, and Clinical Trials Authorisation from the Medicine and Healthcare products Regulatory Agency (MHRA). Despite reports to the contrary, the HRA has not approved a clinical trial to investigate the use of cannabis for pain relief.”
Hayes stated that although it’s still early stages, if successful the trial could pave the way for further research into medical cannabis and ultimately, NHS access.
“The initial study will be the feasibility study involving 100 patients to test the design of the larger trial mentioned in major news publication headlines,” she continued.
“Once we collate the results of this smaller study then we will be ready to begin our main clinical trial. Patients in the feasibility study will be able to roll over into the larger study.”
She added: “I hope through this we will help thousands of people relieve their chronic pain symptoms, and provide the gold standard evidence that NICE requires for cannabis medicines to reach the NHS.”
Patients in the study will be given vaporised cannabis in a metered dose administered via an easy to use inhalation device.
The device will be connected to a mobile application to capture the data and upload patient health in real time.
Alex Fraser, patient access lead at Grow Pharma, a UK supplier of medical cannabis which will provide the devices alongside digital tech care firm, RYAH Group, commented: “Grow Pharma, with our pharmacy partners IPS, are proud to be involved as distribution partner for the Canpain clinical trial from LVL.
“It’s an intelligent and innovative trial design that we are hopeful may carve a path for whole cannabis flowers to reach the NHS.
He added: “This trial presents an opportunity to significantly progress access to cannabis medicines for all who need them.”
Tony Samios, managing director of LVL Health, said in a statement: “Regulatory bodies such as NICE (National Institute for Care & Excellence) have asked for more scientific data to support the benefits of medical cannabis. We are looking to deliver exactly what has been asked for in this regard.
“LVL Health are thrilled to be at the forefront of such an important step that could provide the reliable data and evidence needed to enable medical cannabis access on the NHS for chronic pain patients.
“Cannabis-based medical prescriptions on the NHS is a long-term goal, and only through the provision of this kind of data can we hope to move the dial in cannabis prescriptions and make a real impact to the health of patients.”