VER-CLBP-004 (RESPONSE)
Research type
Research Study
Full title
Multicenter, double-blind, randomized, placebo-controlled, dose response trial with the full-spectrum Cannabis Extract VER-01 in patients with chronic non-specific low back pain (RESPONSE).
IRAS ID
1008617
Contact name
Tobias Gruber
Contact email
Sponsor organisation
Vertanical GmbH
ISRCTN Number
To be confirmed after Ethical Approval
Clinicaltrials.gov Identifier
To be confirmed prior to FPFV.
Research summary
Low back pain is one of the most common musculoskeletal health problems, affecting 80%-85% of people over their lifetime. Specifically, with chronic lower back pain (CLBP), the only treatment option for these patients is opioids. However, long term use of opioids is associated with side affects such as constipation, nausea, vomiting and sleep disturbances. Because of this there is a great need to provide a more tolerable and safer drug therapy for the long term treatment of CLBP.
This trial aims to find out the effect of the study drug which is a cannabis extract (the trial drug, VER-01) in subjects with CLBP, and determine the best dose to provide the most benefit of pain reduction. Non-opioid treatments must have been used by the subject before and if these treatments have not worked or they have not been suitable (e.g. due to intolerance) they will be able to take part in the trial. Eligible subjects will be randomised to one of five groups to receive either one of four different doses of VER-01, or placebo. Subjects will start a titration period of between 9 and 27 days depending on the dose of VER-01 assigned to. In the titration period, the dose is increased in steps of 2.5 to 5mg every three days until the subject reaches the final dose of 12.5mg, 22.5mg, 32.5mg or 42.5mg. The full dose will be taken for 7 weeks in the Treatment Phase, then stopped, at which point a 2-week Wash-out Phase starts. VER-01 will be (self) administered orally with a dosing syringe (see administration instructions). There are 7 trial visits for each subject. The trial duration ranges between 12.5 and 15 weeks per subject, depending on the group they are assigned to. Subjects will have to complete questionnaires via an app on their smartphone throughout the study. Subjects will also have some blood and urine tests, physical examinations, body weight and vital signs recorded throughout the trial. The trial will be run in hospitals, GP centres and private research sites.REC name
East of England - Essex Research Ethics Committee
REC reference
23/EE/0267
Date of REC Opinion
4 Jan 2024
REC opinion
Further Information Favourable Opinion