One of the most important focuses for the Realm of Caring Foundation is pursuing and furthering research with the use of cannabinoids. It is an exciting time to have the opportunity to be at the forefront for this science. There are currently three different research studies that RoC is involved with or pursuing funding to begin.
Project: “Interactive Network to Advance Scientific Knowledge: Use of Cannabidiol in Epilepsy, Pain, Cancer and Behavioral Disorders.” (IRB approved research study
Approximate cost: Immediate need to continue the current study is $50,000. To fully fund these studies with publishable research is $600,000 annually.
This Observational Research Registry (ORR) will allow researchers to determine accurate response rates, identify and quantify types of improvements, improve dosing recommendations, provide evidence of therapeutic potential and provide scientific research to present to Federal and State lawmakers. This is the research study that is being conducted in connection with section 7606 of the Agricultural Act of 2014. This project will carry out one or more studies in each of four diagnostic areas: epilepsy, pain, cancer and behavioral disorders. The database should generate dozens more scientific publications from which qualified researchers can recruit subjects for other studies. In this way, the Interactive Network will serve as a Colorado-based national and global research central resource.
Project: “A Placebo-Controlled Double-Blind Study of the Anticonvulsant Efficacy of CW in Treatment-Resistant Epilepsy: Leveraging Web-Based Clinical Research Management System for Study Team Workflow."
Approximate cost: $1.2 million per site study
The study design is a randomized double blind placebo-controlled study with CW as the target agent. The primary objective is to determine a change in the frequency and severity of seizures relative to the baseline as compared to placebo, through evaluating: number of seizures per month, number of episodes of status epilepticus, frequency of rescue medications, number of emergency room visits/hospitalizations, duration and intensity of crises. The secondary objective is to evaluate the safety and tolerability of CW in both children and adults.
Project: “Genetic Analysis Between Charlotte’s Web Responders Versus Non-Responders in a Dravet Population.”
Approximate cost: $700,000
Genetic analysis of the differences between Dravet Syndrome (SCN1A gene mutation) responders and non-responders and the use of CW, may prove useful for identifying patients likely to be helped by this therapy, as well as shed light on the putative mechanisms by which cannabis may exert any antiepileptic effect. Genetic difference between patients with Dravet who appear to respond to high concentration cannabidiol oil versus those who do not..