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NHS clinical trials to commence ‘as soon as possible’

According to information obtained by The CANNAVIST via a Freedom of Information request, the Department of Health is eager to embark on two clinical trials centred on medical cannabis and epilepsy.

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Almost a year since the National Institute for Health Research backed the first ever government-funded medical cannabis clinical trials in the UK, plans are in place to commence ‘as soon as possible’. 

This year, the NHS says it hopes to commence a set of trials to gather clinical data on medical cannabis in the UK in an area which is attracting more and more patients – epilepsy. 

Two randomised controlled clinical trials will explore the potential for medical cannabis in early onset and genetic generalised epilepsy, according to the Department of Health.

Following calls for more clinical data on the subject since medical cannabis legalisation in late 2018, the investigations received the backing of the National Institute for Health Research in April 2020. Once complete, the data will be published on the NIHR website. 

A spokesperson for the Department of Health and Social Care told The CANNAVIST

“This is a pioneering area of research and we hope the trials will start as soon as possible.

“The NIHR is working closely with NHS England, clinicians and patient representatives to develop this programme. 

“These trials will be critical in ensuring that evidence for cannabis-based medicinal products can be developed to plan future NHS commissioning decisions for the many hundreds of patients in the UK with refractory epilepsy.” 

According to the Pharmaceutical Journal, in October 2020 there had been no successful application to conduct any government-funded medical cannabis trials in Britain.

Across the channel, in Europe, several government-funded clinical trials have been underway since 2018.

The French government has authorised medical cannabis trials on 3,000 patients with serious ailments, which are said to include epilepsy, chronic pain and side effects from chemotherapy. 

In Denmark, the Ministry for Health commissioned an investigation into the effects of CBD when combined with a small dose of THC on central neuropathic pain and spasticity in 450 adult patients. 

The research application, submitted to The European Union Clinical Trials Register, shows the aim of this particular investigation is to, “evaluate the efficacy of the cannabinoids THC, CBD and a combination of CBD/THC on central neuropathic pain and spasticity in patients with multiple sclerosis and in patients with spinal cord injury.”

Medical Cannabis for Fibromyalgia

Meanwhile researchers from Denmark and Switzerland are collaborating on a randomized, double-blind, placebo-controlled trial on medical cannabis for fibromyalgia.

Over the course of 24 weeks, the 200 subjects will either be given a 50mg dose of CBD, or a placebo drug. 

While the main focus of this investigation is to establish whether this regular dose of CBD alone can reduce pain levels associated with fibromyalgia, it will also record fluctuations in sleep quality and duration, energy levels, depression, anxiety and stress among other lifestyle changes.

Project Twenty21

Separate to any NHS-commissioned data collection, the UK is home to Europe’s largest register of medical cannabis patients, Project Twenty21. 

Set up by Drug Science in 2019, the only completely independent, science-led drugs charity in the UK, Project Twenty21 aims to enrol 20,000 patients, creating the largest body of evidence for the effectiveness and tolerability of medical cannabis. 

It is hoped that the findings of this observation-style research will provide evidence for NHS funding where the benefits of treatment with medicinal cannabis is proven to outweigh the potential risks.

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