Clinical trial for a CBD pill for concussions

Aug 19

The first US-based clinical trial on CBD treatment for concussion is being conducted by the University of Miami. The five-year, three-stage study is funded by a $16 million grant from Canadian company Scythian Biosciences. The clinical trial will conduct research on a pill that combines CBD and dexanabiol, which researchers believe will reduce brain inflammation. See also the Miami Herald article.

In a University of Miami video interview with researcher Dr. Michael E. Hoffer, M.D., Dr. Hoffer explains: "Mild TBI or concussion (they're synonymous terms) is an epidemic in this country...We need to find countermeasures, things we can do for individuals early on, to help them in the short term and prevent longer-term consequences. This project is examining one of the potential pharmaceutical countermeasures to give the individual after they have had a head injury.

The substance itself is a cannabinoid, and so when you say that term it conjures up in peoples' mind, the root substance of cannabinoid which is marijuana. But there is an extract of the marijuana, cannabidiod, that is not hallucinogenic, it doesn't have any "feel good" effects, it just has the cannabidiol chemical inside. Now, endocannabinoids are actually natural substances, we turn cholesterol in our body into these chemicals that act on the brain, and we're extracting a natural version of that from the plant in this study...

Now if we take people that have a concussion, that get a sports head injury, 70% of them are doing well by 7-10 days out -- that means 30% are not. And of that 30% that are not doing well, many of them go on to have long-term consequences. We hope to find a medicine, a pill that's safe, that can be given to people after either a suspected or definitive head injury and at the end of a few days or a week, they have very few side effects from the injury."

As of Spring 2018, researchers have begun pre-clinical studies (stage one of the study) with rodent models. Stage two will be a small human pilot study, testing the pill with patients with acute (very recent onset) and chronic (longer term) TBI. The third stage will be a full clinical trial with FDA oversight to determine whether the pill is effective for those with different severities of TBI and concussion.

Scythian Biosciences, an R&D firm based in Calgary, is funding the University of Miami study, which is exploring cannabinoid-based methods of "reducing post-concussion brain cell inflammation, which causes headaches and other neurological complications."

The two-part pill that the University of Miami will be testing is a combination of CBD (derived from hemp) and dexanabinol (a synthetic cannabinoid). The pill contains no THC. "CBD activates receptors that trigger a cellular repair mechanism in the brain, while dexanabinol prevents calcium from accumulating in the cells and draining their energy." According to Dr. Hoffer, “What that pill would do is stabilize the brain, so that when you get a head injury, there may only be a few brain cells that are injured to the point of no return.”

The NFL Alumni and the World Boxing Association are program partners in the Scythian Biosciences/University of Miami collaboration.

The Scythian Biosciences CEO is Jonathan Gilbert, who spoke with InnovateLI in a December 2016 interview: "Cannabinoid-derived treatments for concussions could be an enormous breakthrough."

"There is currently no pharmaceutical treatment for concussions. When you got to the emergency room with a concussion, they basically tell you to go home and rest, and maybe give you some ibuprofen. We are in a white space here,” Gilbert added. “That’s what makes this so unbelievably compelling.”

“Our goal is to have a commercialized drug that treats concussions, and solves a traumatic brain injury problem that is not being adequately addressed.”

For additional information about research on CBD that relates to treatments for concussions, see our section on CBD.