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.”
You can register your interest for the trial here
Largest ever cannabinoid trial on pain finds significant improvement
All formulations in the trial led to “clinically meaningful” improvements in pain after just 4 weeks.
Results have been released from what is claimed to be the largest ever randomised blinded clinical trial on cannabinoids and pain.
Results from a large-sale cannabinoid trial demonstrated “clinically meaningful” improvements in pain across the different formulations of CBD and rare cannabinoids studied.
Claimed to be history’s largest clinical trial on cannabinoids and pain, Radicle Science – an AI-driven healthtech firm – worked in partnership with cannabinoid manufacturer and distributor Open Book Extracts (OBX) to complete the study.
Involving more than 1600 participants from across the US, the companies said the study is the first of its kind to examine the synergistic impact of rare cannabinoids like Cannabichromene (CBC) and Cannabigerol (CBG) on pain.
All of the enhanced product formulations included in this clinical trial led to statistically significant improvements in pain, anxiety, sleep quality and overall quality of life. On average, nearly half (44.8 per cent) of participants who received any of the enhanced products experienced a clinically meaningful improvement in their pain, meaning they realised a distinct and palpable improvement in their quality of life through improved pain symptoms.
The trial was specifically designed to examine if adding other ingredients to a formulation in conjunction with CBD could lead to better outcomes than with CBD alone. The trial included 6 product arms, which all contained CBD at 40 mg per serving. Most arms also contained varying levels of rare cannabinoids, including CBG and CBC.
Overall, the formulations performed roughly the same for the improvement of pain, anxiety, sleep quality and quality of life. However, for people with moderate pain, there was evidence that the addition of 20mg CBC to a formulation containing 40mg of CBD could significantly improve its pain-relieving effects—particularly when this enhanced product was taken for two or more weeks.
“It’s a privilege to make history with OBX,” said Dr Jeff Chen, Radicle Science’s CEO and UCLA Cannabis Research Initiative’s founder. “Rare cannabinoids are present in a variety of health and wellness products containing cannabis and hemp, but there has been virtually no clinical data on their effectiveness for any medical condition, including pain.
“Radicle Science assessed for the first time in history the potential synergistic effects of certain rare cannabinoids on pain and demonstrated that these natural products can make a measurable positive impact.”
A diverse sample of 1629 pain sufferers from across the US were randomised to take one of the six product formulations for a month while reporting their pain relative to specific benchmarks that included severity, general activity, sleep quality, anxiety symptoms and overall quality of life.
All products tested were deemed safe to consume and only about 1 in 10 participants reported side effects, none of which were deemed severe.
“While existing studies suggest that cannabidiol and rare cannabinoids, including CBG and CBC, have considerable potential to support wellness, there has been a glaring gap in scientifically valid research dedicated to guiding effective product development,” said OBX CEO Dave Neundorfer.
“That’s why we collaborated with the renowned medical experts and data scientists at Radicle Science to better understand the potential of rare cannabinoids as an ingredient and, in particular, their ability to support better quality of life outcomes relating to pain.”
Radicle Science and OBX said they will continue their partnership with similar large-scale randomised controlled clinical trials on rare cannabinoids, including THCV, CBN, CBG and CBC. Radicle will be studying their effects on other health and lifestyle benchmarks, such as energy, focus, appetite, sleep disturbance, stress and anxiety, across thousands of study participants.
Pelin Thorogood, Radicle Science Co-founder and Executive Chair added: “It was promising to see that the addition of a rare cannabinoid could augment the effects of CBD.
“We will be further exploring the entourage effect with an upcoming study, Radicle Spectrum, which will be the first head-to-head study comparing full or broad-spectrum CBD to isolate and placebo. It is our hope this study will provide data to help the FDA ascertain whether CBD isolate is a drug.”
Project Twenty21 publishes first findings on chronic pain
Data from over 900 medical cannabis patients, living with chronic pain, has been published this week.
The first condition-specific findings from the UK observational study, Project Twenty21, have been published on chronic pain.
Data from over 900 chronic pain patients, enrolled on Drug Science’s Project Twenty21 (T21), has been published in the leading academic journal, Frontiers, this week.
The first of two papers, explores how cannabis-based medicines can be used in the treatment of chronic pain, and gives an overview of the current patient demographic, as well as highlighting the key challenges facing those living with persistent pain.
Project Twenty21 was launched by UK drug reform charity, Drug Science, in 2019 with the aim of building a database for the safety and efficacy of medical cannabis.
There are currently over 2,600 patients enrolled in the study, of which over 50 per cent are prescribed cannabis for chronic pain.
Who are pain patients in the UK?
According to this new paper, of the 949 people reporting chronic pain as a primary condition, just over half were male, with an average age of 42-years-old.
A range of cannabinoid products were prescribed to this group, with just under half being classified as high-THC flower.
In addition, 92 per cent of those with a primary condition of chronic pain reported experiencing at least one co-morbid secondary condition, with over a third reporting up to six.
These include psychiatric conditions including anxiety and depression, which can also be treated with medical cannabis products. The majority of patients also reported using at least one other prescribed medication (69 per cent).
According to lead author and head of research at Drug Science, Dr Anne Katrin Schlag, one of the key findings of the paper was the low quality of life among pain patients, compared to the general population.
Over half of the sample reported that they experience “severe or extreme problems due to pain”.
“The majority of patients have many co-morbid conditions and because of that suffer with a low quality of life,” Dr Schlag told Cannabis Health.
“The pain interference and pain intensity for the majority of these patients is very high. A lot of them are unable to live their life in the way they would like to do, because the pain is so dominant.
“The low quality of life of the patient was quite astounding in terms of the extent of their problems, in relation to mobility and being able to conduct their usual activities, self-care, as well as issues of anxiety and depression.”
This is significant, the paper says, as the low quality of life of patients, their high number of co-morbidities and wide age range shows that the “myth of medical cannabis patients as young, recreational users looking for a legal source of cannabis can be firmly dispelled”.
A further paper, due to be published later this year, will explore the effects of medical cannabis at a three and six month follow up appointment, including whether the treatment has enabled patients to reduce other prescription medicines, including opioids.
The researchers hope that these findings, which are already showing “promise” will go some way to encouraging regulators to consider real-world evidence.
“This is a huge patient group, chronic pain is a very prevalent condition in the population and NICE does not currently recommend the prescription of cannabis-based medicinal products for chronic pain,” said Dr Schlag.
“We wanted to show that there are lots of people using it already and it would most likely be very beneficial for them to get access through the NHS, as a lot of them need this for chronic conditions for longer periods of time.”
She continued: “If we can show in a follow up paper that cannabis medications have improved pain intensity and the amount that pain interferes in their life, as well as that opioid and other medication use declined, we hope this would influence regulators, including NICE, to perhaps reconsider their recommendations.”
Elsewhere in the world
The initial findings are said to be in line with other real-world data from elsewhere in the world, such as Canada and America.
Similar databases from countries such as Canada, Germany, and Denmark, also include thousands of patients, presenting “convincing findings” according to Dr Schlag.
“There’s so much already out there and findings tend to follow a pattern, especially in terms of pain patients and how beneficial medical cannabis can be to treat chronic pain,” she said.
“We’re hoping that this large-scale database will have an impact on regulators. Especially when you consider that there are more patients combined within all these databases than within all the randomised control trials in this area put together.”
Real-world evidence vs RCTs
Bodies such as NICE, which have called for more robust evidence on the use of medical cannabis in chronic pain, consider randomised control trials (RCTs) to be the “gold standard” of science, despite how restrictive they can be.
“RCTs take place in a very restrictive environment, over a short period of time, with a very small subsample of patients, and are usually not able to involve patients with the number of co-morbidities that we have in this study, ” explained Dr Schlag.
“When we are able to analyse the data over three months, six months, one year – hopefully we will be able to see the benefits, as well as any potential risks, which may or may not occur, and which may not be shown in a short-lived RCT.”
She added: “This is going to be extremely helpful for regulators and prescribers, and we’re very keen for T21 as well as other real world evidence, to be able to contribute to the scientific evidence-base on cannabis medicine.”
Medical cannabis reduces pain and opioid use in cancer patients – study
Findings suggest that medicinal cannabis can be carefully considered as an alternative to the pain relief medicines.
Medical cannabis reduces cancer-related pain and the need for opiate-based painkillers, reveals a new study in oncology patients.
A comprehensive assessment of the benefits of medical cannabis for cancer-related pain, has found that for most oncology patients, pain measures improved significantly, other cancer-related symptoms also decreased, the consumption of painkillers was reduced, and the side effects were minimal.
Published in Frontiers in Pain Research, these findings suggest that medicinal cannabis can be carefully considered as an alternative to the pain relief medicines that are usually prescribed to cancer patients.
Pain, along with depression, anxiety, and insomnia, are some of the most fundamental causes of oncology patient’s disability and suffering while undergoing treatment therapies, and may even lead to worsened prognosis.
Author, David Meiri, assistant professor at the Technion Israel Institute of Technology, explained: “Traditionally, cancer-related pain is mainly treated by opioid analgesics, but most oncologists perceive opioid treatment as hazardous, so alternative therapies are required.
“Our study is the first to assess the possible benefits of medical cannabis for cancer-related pain in oncology patients; gathering information from the start of treatment, and with repeated follow-ups for an extended period of time, to get a thorough analysis of its effectiveness.”
Need for alternative treatment
After talking to several cancer patients, who were looking for alternative options for pain and symptom relief, the researchers were keen to thoroughly test the potential benefits of medicinal cannabis.
“We encountered numerous cancer patients who asked us whether medical cannabis treatment can benefit their health,” said co-author Gil Bar-Sela, associate professor at the Ha’Emek Medical Center Afula.
“Our initial review of existing research revealed that actually not much was known regarding its effectiveness, particularly for the treatment of cancer-related pain, and of what was known, most findings were inconclusive.”
The researchers recruited certified oncologists who were able to issue a medical cannabis license to their cancer patients. These oncologists referred interested patients to the study and reported on their disease characteristics.
Bar-Sela said: “Patients completed anonymous questionnaires before starting treatment, and again at several time points during the following six months. We gathered data on a number of factors, including pain measures, analgesics consumption, cancer symptom burden, sexual problems, and side effects.”
An analysis of the data revealed that many of the outcome measures improved, with less pain and cancer symptoms. Importantly, the use of opioid and other pain analgesics decreased.
In fact, almost half of the patients studied stopped all analgesic medications following six months of medicinal cannabis treatment.
“Medical cannabis has been suggested as a possible remedy for appetite loss, however, most patients in this study still lost weight. As a substantial portion were diagnosed with progressive cancer, a weight decline is expected with disease progression,” reported Meiri.
He continued: “Interestingly, we found that sexual function improved for most men but worsened for most women.”
Meiri would like future studies to dig deeper and look at the effectiveness of medicinal cannabis in different groups of cancer patients.
“Although our study was very comprehensive and presented additional perspectives on medical cannabis, the sex, age, and ethnicity, as well as cancer types and the stage of the cancer meant the variety of patients in our study was wide-ranging. Therefore, future studies should investigate the level of effectiveness of medicinal cannabis in specific subgroups of cancer patients with more shared characteristics.”
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