NANABIS™ FOR MANAGEMENT OF CHRONIC PAIN FROM METASTATIC BONE CANCER
Research type
Research Study
Full title
NanaBis™ An Oro–Buccal Administered Equimolar THC and CBD Formulation as Monotherapy for the Management of Opioid-Requiring Chronic Pain – Due to Metastatic Bone Cancer: A Phase 3 Multi-Centre, Double-Blind, Randomised-Withdrawal Active and Placebo-Controlled Clinical Study.
IRAS ID
287151
Contact name
Larah Hall
Contact email
Sponsor organisation
Medlab Clinical Ltd
Eudract number
2021-001540-98
Duration of Study in the UK
2 years, 0 months, 1 days
Research summary
This trial uses a randomised withdrawal study design to demonstrate the analgesic efficacy of a cannabis-based medicine as mono-therapy in cancer patients presenting with primarily metastatic bone pain. Previous clinical trials with cannabis based medicines (CBMs) have investigated their use as adjunctive medicines because traditional delivery methods such as smoking cannabis provides plasma cannabis concentrations with high peaks and short half-lives that are well suited for breakthrough analgesia. Also, in general, demonstrating clinical efficacy of an analgesic as mono-therapy presents with significant ethical treatment issues in cancer patients.It is hence necessary to establish that the analgesic efficacy of CBMs is independent of other medicines and an orobuccal absorption route for CMBs provides cannabinoid plasma concentrations with lower peaks and longer half lives, which are more appropriate for maintenance analgesia.
REC name
London - Fulham Research Ethics Committee
REC reference
21/LO/0827
Date of REC Opinion
26 Jan 2022
REC opinion
Further Information Favourable Opinion