Journal Club: The CANPAIN trial in focus

The latest issue of the Journal Club, by Grow Pharma, focuses on the recently announced CANPAIN trial.

Introduction

On the 1st of November 2018, the Home Office announced that cannabis-based medicinal products (CBMPs) were to be moved from Schedule 1 to Schedule 2 status in the misuse of drugs regulations, reflecting the view that these agents possess medical utility.

One of the conditions where the scientific literature contains evidence for the utility of medical cannabis is chronic non-cancer pain. Chronic non-cancer pain is also an often-cited reason for patients taking cannabis for medical purposes. Collecting further data on the effectiveness and tolerability of medical cannabis is key in order to potentially pave the way for its approval as an NHS treatment in the future.

Feasibility study

Prior to commencing the CANPAIN trial, a feasibility study will be conducted, with a minimum of 100 patients recruited and followed across a 3-month period. This has been granted REC approval and 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 CANPAIN clinical trial

If the feasibility study is successful and no changes are required then the CANPAIN study will be a pragmatic non-randomised, non-blinded real-world trial of the safety, tolerability and effectiveness of a CBMP for the treatment of chronic non-cancer pain compared against matched controls receiving standard of care pain management.

The study could run for 3 years but there will be an interim analysis after 12 months with a planned sample size of at least 5000 participants per group, with each patient completing a minimum of 12-months treatment. The CBMP used will be an 8:8 (8% THC, 8% CBD) balanced flower inhaled by steam using a handheld device with flow counting and Bluetooth connectivity.

The CANPAIN study will consist of an initiation visit (or call) to allow screening and baseline data to be collected and then a follow up visit (or call) every three months thereafter, until the end of the trial.

The primary end-point will be the difference in pain intensity scores among patients in the CBMP group compared to matched controls.

Secondary end-points will include quality of life, sleep, general well-being, and changes in concomitant medication intake. Safety and tolerability of the treatment regimen will also be monitored.

Grow Pharma and IPS pharma are to be the distribution partners for the CANPAIN trial launched by LVL Health alongside partners Aurora Cannabis Inc, Celadon Pharmaceuticals and RYAH group.

Pain consultants who would like to become involved in this clinical trial can contact LVL Health at info@lvlhealth.co.uk.

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