First Clinical Study Assessing Hemp-Derived Cannabinoid Supplementation in Recovery from Traumatic Brain Injury begins.
The Flowering HOPE Foundation (Boulder, CO) together with Clover Leaf University (Denver, CO) have just announced sponsorship and collaboration on the first US clinical study (ClinicalTrials.gov) to be approved to investigate a plant-derived cannabinoid supplements in recovery from brain injury. While there has been some research about cannabis and the brain, this is the first study of it's kind in our country.
The study will analyze quantitative EEG brain activity and a cannabinoid-sensitive salivary biomarker in 40 subjects with mild traumatic brain injury and controls who currently take hemp-derived botanical supplements on a regular basis (i.e. phytocannabinoids). The study is recruiting adults age 18 to 55 to participate in the year-long trial.
Jason Cranford, Founder of the Flowering HOPE Foundation (FHF), a Colorado registered 501(c)(3) nonprofit organization that supports the medicinal use of plant-derived cannabinoids, called phytocannabinoids, described the motivation for sponsoring the study...
“We hope to provide scientific support for the benefits of the natural plant-based compounds contained in hemp and move a step closer towards the unrestricted availability of non synthetic cannabinoid therapeutics,” Cranford explained.
Cranford is a pioneer in the emerging cannabis industry with more than 25 years experience in cultivation, extraction and formulations. His know-how allowed him to breed a unique hemp strain selected for a blend of phytoterpenes and phytocannabinoids designed to alleviate treatment-resistant epilepsy in children without psychoactive side effects. The resulting strain, called Haleigh’s Hope, was formulated into a supplement offered by the FHF (2013).
The FHF has partnered with Clover Leaf University (CLU) to study brain injury. The President and Founder, Chloe Villano, received accredited approval for CLU in 2013 by the Colorado Department of Higher Education’s Private Occupational School Board. Villano is a pioneer in the cannabis and hemp industry and prioritized brain injury for the study.
“This historic study is the first of its kind and it is a privilege to work with the Flowering HOPE Foundation to address the problem of brain injury and collaborate with a neuroscientist who understands the brain endocannabinoid system, such as Dr. Cooper. There are currently no effective treatments for traumatic brain injury or chronic traumatic encephalopathy, but phytocannabinoids may be a good candidate, based on the established science of anti-inflammatory and neuroprotective mechanisms. Clover Leaf University is excited to take the lead in clinical studies that will improve and save lives,” said Villano.
The lead neuroscientist responsible for the study, Don Cooper Ph.D. is President of Real-Time Diagnostics Ventures Inc. He has published 45 peer reviewed papers on neuronal memory formation/plasticity and has studied brain cannabinoids since 2000, when he received his first NIH grant.
“I never thought it would take almost 20 years from when I started working on the brain cannabinoid system to have the first approved clinical study on phytocannabinoids and brain injury. We have convincing preclinical data showing that phytocannabinoids are neuroprotective and may be critically important for restoring neuronal function after brain injury,” stated Cooper.
We look forward to learning more about the process of the study and of course the results!
For more information contact the study Clinical Coordinator at TBIstudy@protonmail.com.
How Does CBD Work to Combat Symptoms of Allergies?
Most people are well aware that CBD is an anti-inflammatory all-star. But how exactly does it work its magic to suppress allergic reactions in the body?
As the body tries to fight off irritants and allergens, it activates the immune system to remove these harmful agents. The immune system then triggers mast cells, which release inflammatory chemicals, like histamines. As a result, you may suffer from a range of adverse reactions, from a runny nose, to skin rashes, to sinus pain and pressure.
Based on research, CBD can suppress the immune system, calm mast cell activation, and reduce inflammatory chemical levels in the body, making it a promising treatment for seasonal allergies. CBD may also prevent the closing of airways, which can result in common allergy symptoms like coughing and difficulty breathing.
Remember that to get all these benefits, as well as relief from pain and pressure, you’ll want to use ingestible CBD oil from a tincture, taken sublingually (under the tongue).
I am sharing articles as I find them that are relevant regarding the FDA's policy on Hemp derived CBD. This will be an ongoing share, so please check back for updates as this new government entity takes the reins.
FDA Plans Hearings on CBD Policy Following hemp legalization in the U.S., the FDA must now figure out how to regulate hemp-derived CBD as a food and beverage ingredient. March 1, 2019 Eric Sandy
When the U.S. Congress passed the 2018 Farm Bill in December, legalizing domestic hemp production and sales, the Food and Drug Administration abruptly interjected to say that hemp-derived CBD would not be permitted as an ingredient in food or beverages—the very thing that many companies and consumers had been celebrating as Congress cast its votes on the bill. CBD, according to FDA Commissioner Scott Gottlieb, must be treated as any other pharmaceutical compound.
The administration took a hardline stance, but signs are pointing toward a softening approach to setting new CBD policy in the future.
“It’s unlawful under the [Federal Food, Drug, and Cosmetic Act] to introduce food containing added CBD or THC into interstate commerce, or to market CBD or THC products as, or in, dietary supplements, regardless of whether the substances are hemp-derived,” Gottlieb wrote in December. “This is because both CBD and THC are active ingredients in FDA-approved drugs and were the subject of substantial clinical investigations before they were marketed as foods or dietary supplements.” CBD is an active ingredient in the FDA-approved Epidiolex. As such, a precedent had been set on this chemical constituent of cannabis; any products containing CBD would need to work through a “pathway” to FDA approval, which includes clinical trials.
Now, in testimony presented before the House Appropriations Committee on Feb. 27, Gottlieb said that his administration will revisit the CBD question. He said that plans are in the works for a public meeting in April to develop a set of rules for CBD regulation. “I’ll say at the outset that we heard Congress loud and clear with respect to [the Farm Bill]. … We believe it does have therapeutic value and has been demonstrated,” he said. “But I will tell you this is not a straightforward process. There’s not a good proxy for us doing this through regulation.”
Jonathan Havens, partner at Saul Ewing Arnstein and Lehr, told Cannabis Business Times that the rulemaking process at the FDA is complex, and, ultimately, may demand legislative intervention from Congress. The hearing in April will suss out the protocol here.
What’s happening in the immediate sense is that hemp-derived CBD (cannabidiol extracted from a cannabis plant containing less than 0.3-percent THC) is set on a distinct regulatory track from state-licensed cannabis businesses. CBD that’s been tested and is being sold as a concentrate in a licensed dispensary in, say, California, is going to be treated much differently than mysteriously-sourced CBD pens that show up at your local gas station. Even CBD concentrates extracted from legal hemp plants grown on a licensed farm in North Carolina: Because that chemical constituent is under the province of FDA oversight (because of the Epidiolex clinical trials), they can’t be openly sold in the consumer goods marketplace.
“If something is studied in a substantial clinical trial, and/or if it's the subject of an approved drug application, then it's not a permissible dietary ingredient,” Havens said. “The FDA’s position has nothing to do with the [former] federal illegality [of hemp], although I think they would probably tell you that you shouldn't put a federally illegal substance into anything else—and then sell it to interstate commerce—because then you've got a problem on your hands.”
The FDA has issued stern warnings on this subject, including Gottlieb’s December letter. State and local authorities in some jurisdictions, including Ohio, have preemptively begun confiscating CBD products in stores (not licensed dispensaries).
Despite those warnings from the federal administration, uncertainty is a driving force in how CBD policy is enacted.
“I will tell you that we’re deeply focused on this. We have taken on other hard challenges before,” Gottlieb told the House Appropriations Committee this week. “I think we have a good track record of trying to come to resolution on other challenges. You have my commitment that I’m focused on this one.”