Wednesday, May 29, 2024

Medical cannabis feasibility study—a piece of the missing piece?

Completing the jigsaw of regulation to let NHS patients access medicinal cannabis straightforwardly has proved very difficult owing to a ‘missing piece’. The lack of substantive clinical evidence has held up the process at every turn.

Small-scale studies in 2021 and 2020 of UK severe treatment-resistant epilepsy (STRE) patients (ten in each) using unlicensed cannabis-based medicinal products (CBMP) have demonstrated transformative effects—and eye-watering charges for private prescriptions. Such research, however, is not on the scale required by the NHS prescribing system which is based on procedures designed to ensure safety for patients and value for money. Since the legalisation of prescribing unlicensed CBMP in November 2018, only a handful of NHS prescriptions have been written, but private prescriptions have soared according to a report published by the Advisory Council on the Misuse of Drugs in November 2020.

Attention has been on the plight of children suffering from STRE, but recent Parliamentary debate also drew attention to other conditions which might benefit from CBMP including migraine and chronic pain.

News that LVL Health, a UK medical cannabis clinic for chronic pain, is proposing to undertake ‘CANPAIN’, a three-year clinical trial of whole-flower CBMP with upwards of 10,000 participants may be an indication that the tide is beginning to turn. The study would “evaluate the efficacy and safety of a defined CBMP delivered by inhalation to patients with chronic pain attending a private clinic”. It would compare the “tolerability and effectiveness of CBMP for the treatment of non-cancer pain…against matched controls receiving standard of care pain management”. Each group would have at least 5,000 participants who had “completed at least 12 months of treatment”.

It is not the sort of so-called ‘gold standard’ randomised controlled trial which some critics of CBMP call for. Instead it is designed as a real-world trial, non-randomised and non-blinded.

The CANPAIN protocol was submitted to Oxford A Research Ethics Committee (part of the NHS Health Research Authority approval process for research) for ethical review, which responded with “a non-acceptance opinion” according to documents submitted to by Harley Street (CPC) Ltd, which trades as LVL Health. Oxford A REC, it is stated, suggested that a feasibility study be carried out to address concerns about recruitment rates and the acceptability of the study. The documents set out the rationale of the feasibility study which 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.” 

The aim of the feasibility study is to follow a minimum target of 100 participants (all existing patients of the clinic) over a three-month period, assessing recruitment and patient experience, medication logistics, and data management. The chief investigator is Dr Shahpoor Sorooshian, who is the clinical lead of Harley Street (CPC).

The inclusion criteria for participants detail that they must be aged between 18 and 85 years old, diagnosed with chronic non-cancer pain and the following experience of ‘standard of care’:

“Is currently receiving standard of care but still has pain, has completed standard of care pain treatment, does not want standard of care treatment, or standard of care is contraindicated. An inadequate response is defined as the subject receiving standard analgesic agents and still has pain, has unpleasant side effects or wishes to reduce their intake of standard of care analgesic agents, eg a subject receiving opioids who wishes to dose reduce in light of the ‘opioid crisis’; despite being on or having received standard of care and has still pain.”

Pregnant and lactating women, and patients with various diseases, conditions or circumstances are excluded from the study.

Participants’ experiences are captured using comment forms. The study will tackle practical matters such as the usability of the inhalation device, and the average time taken for medication to reach patients after prescription, as well as how easy participants found it to take part.

So, maybe not yet the whole ‘missing piece’ that the regulatory process requires, but a feasibility study into making a start on constructing that missing piece.

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