THE UK’s Health Research Authority (HRA) has approved the country’s first clinical study using cannabis flower for the treatment of chronic pain.
While the study, dubbed Canpain, has received ‘conditional approval’ from the MHRA (Medicines and Healthcare products Regulatory Agency), it is not affiliated with the NHS as some reports have suggested.
Rather LVL Health, the company conducting the Canpain study, hopes its results could go towards providing the National Institute for Health and Care Excellence (NICE) with the evidence it needs to prescribe cannabis for pain on the NHS.
LVL Health’s managing director Tony Samios told BusinessCann that the study ‘will be a game changer in bridging the gap between evidence and making progressive change using a rigorous scientific approach’.
However, one industry insider said they believed the study was unlikely to see CBMPs (Cannabis-Based Medicinal Products) become available on the NHS anytime soon, suggesting the only way they will be approved by regulators is through a ‘double blinded study, which basically rules out ever getting cannabis flower authorised’.
LVL Health has received ‘conditional approval’ from the MHRA for a 5000 patient clinical cannabis pain study, however contrary to a number of media reports, this does not mean it has yet been given the green light.
The Research Ethics Committees (RECs) has requested that LVL Health complete a smaller ‘feasibility study’ before the larger study is approved.
According to the study protocol this will ‘aid in establishing likely rates of patient recruitment, duration of participant enrolment in the study, the demographic and geographic spread of patients, patient acceptability of data collection and identify any issues with technological and drug delivery logistics.’
This feasibility study will include a minimum of 100 participants and only existing patients of LVL will be considered for the trial.
Those wishing to become a patient of the clinic will have to pay a joining fee of £99, and then £299 a month.
Canpain partner Grow says that this does not mean patients will have to pay to take part in the trial, but rather they are paying to be a patient of an LVL access clinic, which includes a clinical service as well as their medication.
One industry insider speaking to BusinessCann said this was significantly more than many private patients are currently paying, going as far as to call it a ‘money grab’.
The company added that they have now begun the recruitment process, but that the three month period will not start until the first patient is put into the study, which is expected to happen within the next ‘couple of months’.
To be eligible for the study, patients will need to be between 18-85, have a non-cancer chronic pain diagnosis, and still be experiencing pain despite receiving a standard of care.
Mr Samios believes the feasibility study will have no problem demonstrating adequate patient recruitment and retention from a wide enough demographic, and Canpain will be approved for a full clinical study.
This will involve a minimal planned sample size of 5000 patients, who will need to have completed at least 12 months of treatment with a CBPM, alongside a control group of a further 5000.
Canpain is due to run for three years, however according to Mr Samios, the study could be ended earlier if it provides evidence of CBMP’s effectiveness at treating pain before that point.
Participants will start by inhaling one 250mg cartridge of dried flower per day via a vaporiser device provided by Ryah Group, before moving to two doses per day after one month.
The cannabis flower Equipose 8-8 will be provided by Aurora, featuring a balanced 8% THC and 8% CBD content, while Grow will handle the importation of the flower, grind it and fill the cartridges.
They will receive 30 250mg cartridges in the first month, equating to 7.5g of cannabis flower, rising to 15g via 60 cartridges in the proceeding months.
Ryah’s digital vaporiser will be connected to a specialised app in their mobile phone via bluetooth, and provide patients with a temperature controlled measured dose which will be recorded automatically.
Patients will then receive prompts to enter data themselves, and must do so to continue the study.
Prior to beginning treatment, patients will have their genetic data collected so LVL can ‘identify key treatment patterns’, and will be required to give a baseline NRS (Numeric Rating Score) for a number of factors including pain.
They will then be required to give daily tolerability NRS measurements for things like drowsiness, dizziness and shortness of breach 30 minutes after dosing, with any score over five triggering an alert for a physician to contact the subject.
Weekly assessments will measures pain, wellbeing, sleep quality, fatigue, nausea, depression and appetite, while further visits will be conducted by doctors every three months to assess a ‘global impression of change’.
Is it Likely to Lead to Prescriptions on the NHS?
According to the latest figures from Prohibition Partners, the number of privately prescribed medical cannabis items dispensed in the UK skyrocketed 425% last year, a 23,466 increase in 2020.
Despite the blistering growth rate of private prescriptions, the UK’s National Institute for Health and Care Excellence (NICE) continues to call for more scientific data to support the benefits of medical cannabis before it considers making products available via the NHS.
Mr Samios said he believes the study is ‘a massive step forward’, adding that NICE will not take data from existing studies because they are ‘essentially observation or registry studies’.
“We’ve heard and listened to what they’ve asked for, and we’re essentially providing the missing data to deliver impactful change.”
Conversely, one industry source explained that ‘in reality real world study data is not going to get a product licensed, all the data is subjective, that’s just not the way it works.’
They added that there are ‘millions of patients worth of observational study data out there in the global market’, citing Drug Science’s Project 21 initiative which has been gathering data on the efficacy of cannabis-based medicines for a wide range of conditions for a number of years.