Concussion AllianceAugust 19, 2018
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.https://www.youtube.com/embed/DwgmyKzrUbM?wmode=opaque&enablejsapi=1
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.”