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Research we're funding: Exploring  Cannabis-Based Medicines To Treat Pain And Itch In EB

Research we're funding: Exploring Cannabis-Based Medicines To Treat Pain And Itch In EB

To progress our mission to improve the quality of life for people suffering from EB, in 2017 DEBRA UK chose to fund an international clinical trial to evaluate the impact of cannabinoids (a component of the cannabis plant) as a potential treatment for the debilitating pain and itch caused by EB.

Investigators: Nicholas Schräder and Professor Marcel Jonkman

Co-Investigator: Professor Wolff - Head of Pain Center, University Medical Center Groningen

Location: Center for Blistering Diseases, Department of Dermatology, University Medical Center Groningen, Netherlands

Funded by:  DEBRA, the only UK national charity supporting people suffering from  the potentially fatal skin blistering condition Epidermolysis Bullosa (EB) and funding research into the condition.

Duration: Three years (began in 2018 and will continue until  2021)

  • An effective treatment for the pain and itch caused by EB would transform the quality of life for thousands of people suffering from the condition here and now.
  • Existing treatments for the pain and itch caused by EB, including opiates and anti-inflammatories, have a limited effect.
  • DEBRA, the only UK national charity that supports people suffering from EB and funds research into the condition, is funding an international clinical trial  taking place in the Netherlands to evaluate the impact of cannabinoids (a component of the cannabis plant) as a potential treatment for the debilitating pain and itch caused by EB.

Why is this research important?

This research is a very important first step in gathering the scientific evidence needed to prove that a cannabis-based medicine could be a safe and effective form of pain relief for EB and  ultimately making an effective  form of cannabis-based pain relief available to  people suffering from EB.

Members of the EB Community in many countries around the world have widely reported that cannabis can reduce the impact of pain and itch caused by EB.

But recreational cannabis may be contaminated with dangerous impurities and highly toxic chemicals.

The clinical trial we are funding uses medical grade cannabis produced under strictly controlled conditions to ensure it is toxin free.

This trial is vital to help find the safest and healthiest way to deliver medicinal cannabinoids to people with EB, with the maximum alleviation of symptoms and the minimum of side effects.

The government has legalised medicinal cannabis. Why do we still need to do this research?

The government has legalised some forms of medicinal cannabis for use in treating some health conditions where cannabis-based medicines could have therapeutic benefits.

We welcome this decision, but more data needs to be collected before it can be proved that cannabinoid-based medicine could be an effective treatment for the pain and itch caused by EB and cannabinoid oil can be prescribed to relieve these symptoms.

 This clinical trial is a vital step in achieving this.

 What is the treatment being investigated in this trial?

The treatment being followed in this trial is a CBM oil, which contains naturally derived compounds, phytocannabinoids, from the cannabis plant. The measured cannabinoids are tetrahydrocannabinol (THC) and cannabidiol (CBD) at 1.3% and 2% respectively. Other phytocannabinoids will be present in the CBM oil, in smaller quantities.

 How do these cannabinoids work?

Research into THC and CBD has shown that these cannabinoids act on receptors in the brain and immune system as well as numerous other areas of the body. They are involved in and can modify signals that transmit messages for pain and itch, so it’s hoped that they can be used to control and reduce the itch and pain experienced in EB.

How will the CBM be given in this clinical trial?

Participants in the study will pipette the oil under their tongue four times daily (after breakfast, lunch, dinner and before sleeping). This is also known as a “sublingual” or “oromucosal” administration, allowing cannabinoids to enter the bloodstream under the tongue where they are absorbed faster than, for example, after swallowing them. Absorption under the tongue also minimises each individual’s metabolism of cannabinoids, reducing the likelihood of side effects.

What outcomes will participants report?

Participants in this study will report changes in levels of pain and itch and changes in their quality of life through a number of surveys. Current medications will not be stopped. During the course of the research the clinical team will also monitor any change in standard prescribed medications used to treat these symptoms, such as opioids.

 How many participants will take part in the trial?

 15 participants will take part in the trial.

Who can take part in the trial?

Only adults suffering from EB who live in the Netherlands can take part in the trial at the present time. As THC is an internationally controlled substance, and its effect on the developing nervous system is still being investigated, it is only available to patients over the age of 18. 

Cannabis has been used for pain relief for thousands of years. Why is this research important?

This research is important because it will help find the safest and healthiest way to deliver medicinal cannabinoids to people with EB, with the maximum alleviation of symptoms and the minimum of side effects.

Medicinal cannabis is produced under strictly controlled conditions to a specified standard with a high level of quality control to ensure it is toxin free. Recreational cannabis is not subject to the same controls – it may be contaminated with impurities and highly toxic chemicals.

All participants will be using the same composition of cannabis oil to ensure the study produces meaningful results that can be reproduced, and provide the scientific evidence needed to prove the treatment works.

Is this a cure for EB?

No. This study is designed to improve the quality of life for the half a million people suffering from EB worldwide by alleviating two of the most debilitating symptoms of the condition, pain and itch. We are funding research into EB, to improve the quality-of-life for people living with the condition here and now and find a cure in future. We also provide life changing care and support to people suffering from EB and their families.

Results of a preliminary study

Nicholas Schrader, Professor Wolff, Professor Marcel Jonkman and colleagues have recently had a paper published in the British Journal of Dermatology that looks at 3 case studies of patients who have administered the CBD oil. This is preliminary research conducted before the trial we're funding.

To read the recently published abstract in the British Journal of Dermatology about the 3 case studies: https://www.ncbi.nlm.nih.gov/pubmed/30347109

Where could this research lead?

We hope the trial we're funding will ultimately lead the way to a new and more effective pain and itch relief being made available to the EB Community, transforming the quality of life for thousands of people suffering from the condition as well as their families and loved ones:

  • The clinical trial will start to gather the scientific evidence needed to prove that CBMs are an effective treatment for pain and itch caused by EB
  • The trial will begin the work towards a new treatment protocol and evidence-based guidelines for the management of these debilitating symptoms

Read more about the trial we're funding here.

Together we #FightEB, together we will beat EB.