CANPAIN feasibility study v1
Research type
Research Study
Full title
CANPAIN feasibility study: evaluating the feasibility of undertaking a pragmatic real world trial investigating CBMP in chronic pain patients
IRAS ID
304548
Contact name
Gregory Stoloff
Contact email
Sponsor organisation
Harley Street (CPC) Limited (trading as LVL Health)
Duration of Study in the UK
0 years, 3 months, 2 days
Research summary
Summary of Research
The purpose of this research is to collect information relating to patient experience in a private clinic undertaking clinical activities that mirror those proposed for future research. Participating in this study will enable the clinic to improve patient care and establish the feasibility of undertaking future clinical research studies exploring the effect of medical cannabis on pain.
Summary of Results
The CANPAIN Feasibility Study Pragmatic Real World Trial Investigating CBMP in Chronic Pain Patients (CANPAIN) was a study requested by the Research and Ethics committee to test the design of a ground-breaking and large scale clinical trial aiming to test the efficacy if inhaled cannabis medicines on the experience of chronic pain.
The study was conducted by LVL Health a clinic that is co-owned by companies Celadon Pharmaceuticals and SEEK. Celadon Pharmaceuticals is a UK based pharmaceutical company focused on growing indoor hydroponic high-quality cannabis initially for the management of chronic pain. SEEK is a research company that develops and sells over the counter and prescription medications to find solutions to major disease areas.
The study aimed to contribute to solving the problem of 8million patients in the UK currently living with unmanaged chronic pain.
The study involved 49 chronic pain patients whose medical records were assessed by a multi-disciplinary team of Consultants in pain medicine and specialist nurses to show patients had trialled multiple pharmaceutical and interventional treatments for their pain without success and therefore eligible to trial inhaled cannabis medicines. Patients would then be asked to provide a negative THC urine test prior to starting the medication to ensure that any benefits that they may experience could be attributed to the medication being prescribed by LVL Health. They were also asked to provide a salvia swab genetic test that would be processed by lab technicians to assess risk of potential side effects such as exacerbation of mental health disorders and to measure sensitivity to cannabis medicines.Patients would then have an appointment with one of the specialist pain doctors at the clinic via video consultation and receive their prescription. This meant that patients were not required to travel to a physical location which many would have found difficult given their chronic pain conditions.
Patients completed a daily safety questionnaire via a smartphone app, information that was received in real time to a central database that the nursing team were able to access 24/7 to monitor their safety. Patients were also asked to provide a weekly pain assessment and a 3 monthly quality of life questionnaire via the app that would ask patients to assess whether their daily lives had improved since starting the medication.Patients would inhale a single dose of 250mg of processed 8% THC: 8% CBD cannabis flower up to twice per day via a vaporiser. The vaporiser would heat to 200 degrees Celsius which was assessed to be the optimum temperature to release the full range of potential therapeutic compounds within the cannabis flower.
RESULTS
1.Recruitment Experience
The first patient was onboarded 30/08/22 and final patient was onboarded to the clinic 16/11/22. The majority of patients were consented between 01/09/22 – 28/09/22. Recruitment formally started in April 2022 and ended July 2022.2.Duration of Time in Study
59 patients were onboarded at the clinic. Of this 59, 49 of them enrolled in the study prior to its end date. 45% of total participants were enrolled in the study for the full 3 month period. The mean time spent in the study was 9 weeks. 2 participants ceased treatment after 1 month.3.Questionnaire Compliance
20% of participants completed over 100 daily questionnaires. Maximum total possible would have been 180 questionnaires for 2 doses per day for 3 months. 12% of participants completed over 50 daily questionnaires. The main reason for this was that all participants started on a regime of 1 dose per day. This was increased to 2 doses per day if necessary in month 2. 27% of participants did not complete any weekly questionnaires. When asked they reported that the LVL Health tracker app did not prompt them to complete a weekly questionnaire. 8% participants completed a quarterly quality of life questionnaire. This is likely due to only 45% of participants being enrolled in the study for the full 3 months which would be long enough to complete the quarterly questionnaire.4.Safety Questionnaire Results
14% participants scored 5 or above on the NRS safety questionnaire once during the 3 month study period. 18% of participants scored 5 or above 2-10 times during the 3 month study period. 2 participants scored 5 or above over 22 and 26 times during the 3 month study period. These were resolved quickly by the 24hr on call nursing team with clinical advice given. Majority of reported side effects self-resolved after 2 hours post administration. The 2 participants who scored high more than 20 times reported that they wished to continue despite experiencing higher levels of anxiety due to their pain levels improving.
There were no significant adverse events to report.5.Medication Logistics
The mean number of days between a participants prescription being written and the pharmacy arranging a delivery with the courier service was 14 days. The mean number of days between the date of the courier delivery being arranged and the participant receiving their medication was 2 days.6.Device Experience
25% patients reported issues with device hardware. This was usually resolved by nursing team arranging a new battery or device to be delivered within a 48hr period. 4% patients reported issues with software that were resolved by nursing team reporting to device manufacturer who advised solutions be Bluetooth connectivity issues. Advice given regarding how to resolve this issue within 48hr period.7.Onboarding Experience
Of 49 participants in study none reported issues with onboarding.8.Questionnaire Logistics and Satisfaction Of the 49 participants in study none reported issues with answering the questionnaires. Feedback following end of study from participants who did not complete weekly or quarterly studies showed that if patients were not prompted by the LVL Health tracker app to complete a questionnaire then the compliance was low. See endpoint 3.
9.Questionnaire Fatigue
See answers to primary endpoint number 3 and number 8.
10.Patient Satisfaction
1 participant out of 49 opted to complete the end of study feedback questionnaire which reported “excellent”. Through documentation of emails and phone calls with participants during the 3 months study period 90% reported feeling supported and well informed during the study.Demographic
16% of participants were from London postcodes. 12.5% from Norther Ireland. 25% from South East of England. 8% from South West of England. 18% from the Midlands. 4% from East of England. 4% from North East of England. 6% from North West of England. 2% from North of England.
Of the 49 participants 52% were female and 48% were male.
Of the 49 participants 90% were between the ages of 18-65 and 10% were aged 65 and over.Conversion to Registration
There were 3,689 visits to the website from April 6th 2022 until 1st December. There were 904 “register your interest” forms completed during this time period. During these same dates there were 100 further registrations of interest from social media sources such as linkedin.
13 patients registered at the clinic between April 6th and 27th July which is when LVL implemented a more affordable cost of a one off payment of £99 for 3 months of prescriptions. Following this reduction in cost, numbers increased to 36 new patients registering at the clinic between 28th July and 1st December. This indicated that if the study had been conducted for a longer period of time the number of patients in the study would have increased – improved recruitment rateThe CANPAIN feasibility study has helped patients who had run out of treatment options to lower their pain levels and helped doctors feel more confident that there is potential for cannabis medicines to be an option for patients in the management of chronic pain. LVL Health are hopeful that the Research and Ethics Committee and the Medicines and Health Regulation Authority will grant the opportunity to conduct the larger scale study of 5000 chronic pain patients to further establish the efficacy of the 8% THC : 8% CBD cannabis medicine on chronic pain.
For further information about the CANPAIN feasibility study please visit the results published on the clinicaltrials.gov website.REC name
South Central - Oxford A Research Ethics Committee
REC reference
21/SC/0302
Date of REC Opinion
3 Nov 2021
REC opinion
Further Information Favourable Opinion