Pragmatic real world trial on the use a CBMP in chronic pain patients
Research type
Research Study
Full title
A PRAGMATIC NON-RANDOMISED, NON-BLINDED REAL WORLD TRIAL OF THE SAFETY, TOLERABILITY AND EFFECTIVENESS OF CANNABIS BASED MEDICINAL PRODUCTS (CBMP) FOR THE TREATMENT OF CHRONIC NON-CANCER PAIN COMPARED AGAINST MATCHED CONTROLS RECEIVING STANDARD OF CARE PAIN RELIEF
IRAS ID
269029
Contact name
John Brew
Contact email
Sponsor organisation
Harley Street (CPC) Limited (Head of Biology)
Eudract number
2019-003035-34
Duration of Study in the UK
2 years, 0 months, 2 days
Research summary
Cannabis based medicinal products (CBMPs) can now be prescribed in the UK by Specialist Doctors. However, more clinical information is needed to give UK Specialists confidence that prescribing CBMPs represents a safe and effective approach for patients seeking treatment. This study will evaluate the safety and efficacy of a CBMP for the treatment of chronic pain within the context a private integrated pain clinic. We will study a unique blended CBMP, manufactured to offer a balanced risk-benefit profile for patients experiencing chronic pain. The CBMP will be given to patients as an adjunct therapy to supplement the pain medications given to them by their current clinical team. Safety and efficacy data will be collected and compared with matched controls from clinics offering standard of care alone. The clinic is based in London and will offer both physical and tele-medicine consultations. Patients with all types of non-cancer chronic pain will be eligible to attend the private clinic, if they are not excluded due to cannabis tolerability concerns. A genetic test will be performed to assess sensitivity to cannabis, this will guide the starting dose. Those that are suitable to take a CBMP will be sent a month’s supply to their home alongside a CE marked CBMP vaporiser. Each patient will be continuously assessed for efficacy response and tolerability via a mobile phone application with patients entering their own data on how the CBMP is working and how well they are tolerating it. Each patient will be studied for up to 18 months or until a sustained response is observed. If the CBMP is not working the patient will be offered an alternative CBMP or can leave the study. When they have finished the study but are continuing to receive benefit, patients will be offered ongoing CBMP treatment.
REC name
London - Riverside Research Ethics Committee
REC reference
19/LO/1761
Date of REC Opinion
29 Jan 2020
REC opinion
Further Information Unfavourable Opinion