“Our mission is to develop and implement the first accepted drug regimen for the treatment of concussions.”
- Jonathan Gilbert, CEO of Scythian Biosciences
Unbeknownst to many people, the University of Miami (UM) has become one of the most comprehensive concussion clinics in the U.S., and soon, it may become the leader in the treatment of concussions and traumatic brain injury (TBI) as well – thanks to a newly developed CBD pill.
In an October 2016 press release, the University of Miami announced that they received a $16 million research grant from Canadian-based Scythian Biosciences which would be used to fund cannabinoid research in hopes of discovering the first real treatment option for concussions. More specifically, a multi-disciplinary team of researchers from UM’s The Miami Project to Cure Paralysis and Miller School of Medicine are setting out to see if a simple CBD pill can be successfully developed to treat concussions and TBI. Their hypothesis is that CBD combined with an NMDA antagonist could reduce the body’s immune response to TBI which includes post-injury brain cell inflammation, headache, pain, and other symptoms associated with concussion.
As you’re probably aware, cannabidiol or CBD is one of the main components found in the cannabis sativa plant. It is a chemical compound that doesn’t get you high, and has been shown to have an excellent safety profile for use in medicine. It has also been demonstrated in numerous preclinical trials to possess neuroprotective, anti-inflammatory, and anti-nociceptive (anti-pain) properties.
N-Methyl-D-aspartate (NMDA) receptor antagonists are anesthetics. They work by antagonizing or inhibiting the action/functioning of NMDA receptors to produce their painkilling effects. Although not a cure, these drugs are currently being prescribed to treat some neurological disorders including Alzheimer’s disease, vascular dementia and Parkinson’s disease.
The researchers believe that a combination of the two could be the key to treating concussions and TBI and they’re embarking on a massive 5-year study to find out. If the study proves to be successful, this may lead to the development of the world’s first therapeutic pill for the treatment of concussions.
The dangers of TBI
Here at iwantmycbd.org, we’ve written extensively about TBI’s role in the development of the condition known as chronic traumatic encephalopathy (CTE). Trauma that’s associated with sports-related concussions in athletes and blast-induced TBI in soldiers elevates the risk for future development of chronic neurodegenerative diseases such as CTE.
A traumatic brain injury is caused by a bump, blow, or jolt to the head that disrupts the normal function of the brain. TBIs range from “mild” (i.e., a brief change in mental status or consciousness) to “severe” (i.e., an extended period of unconsciousness or memory loss after the injury). Most TBIs that occur each year are mild and are commonly called concussions.
According to the Centers for Disease Control and Prevention (CDC), TBI is a major cause of death and disability in the United States. TBIs contribute to about 30% of all injury deaths. Every day, 153 people in the United States die from injuries that include TBI. Those who survive a TBI can face effects that last a few days, or the rest of their lives. Effects of TBI can include impaired thinking or memory, movement, sensation (e.g., vision or hearing), or emotional functioning (e.g., personality changes, depression). These issues not only affect individuals but can have lasting effects on families and communities.
Here are some more TBI stats from the CDC:
- In 2013, about 2.8 million TBI-related emergency department (ED) visits, hospitalizations, and deaths occurred in the United States.
- TBI contributed to the deaths of nearly 50,000 people.
- TBI was a diagnosis in more than 282,000 hospitalizations and 2.5 million ED visits. These consisted of TBI alone or TBI in combination with other injuries.
- Over the span of six years (2007–2013), while rates of TBI-related ED visits increased by 47%, hospitalization rates decreased by 2.5% and death rates decreased by 5%.
- In 2012, an estimated 329,290 children (age 19 or younger) were treated in U.S. EDs for sports and recreation-related injuries that included a diagnosis of concussion or TBI.
- From 2001 to 2012, the rate of ED visits for sports and recreation-related injuries with a diagnosis of concussion or TBI, alone or in combination with other injuries, more than doubled among children (age 19 or younger).
Unfortunately, treatment options for TBI are nearly non-existent and research is still very much in its infancy – both issues that the UM researchers are hoping to address with their new study.
3 phases over 5 years
This project is a giant undertaking that will involve some of the nation’s top experts in the fields of neurology, neurological surgery and otolaryngology (a surgical subspecialty that deals with conditions of the ear, nose, and throat and related structures of the head and neck).
It will be broken down in 3 phases to be completed over the course of 5 years.
According to the UM press release, in years one and two of the study, researchers will begin pre-clinical studies evaluating several rodent models of TBI.
In parallel, the researchers will conduce separate studies to test nine proposed outcome fields. These will include the review and evaluation of cognitive, behavioral, psychosocial, sleep, pain, sensorimotor, cardiovascular, inflammatory biomarkers, as well as neuroimaging studies. During this time the research team will address any shortcomings in methodology. Once data comes back conclusive, they will enter year two and phase two of the study.
Phase two will involve a small human pilot study. The team will likely administer the CBD pill to a control group and two groups of TBI patients, acute and chronic. Researchers will use the nine outcome measures listed above to evaluate the drug’s efficacy. Once completed, data will be analyzed and any safety concerns will be addressed.
If deemed safe and effective, the third phase of the research will begin a fully powered clinical trial over the next three years. With FDA oversight, data will reveal whether the compound is an effective therapeutic treatment for those suffering from different severities of TBI and concussion.
The effort will be led by Gillian Hotz, Ph.D., research professor of neurological surgery, director of the KIDZ Neuroscience Center at The Miami Project to Cure Paralysis and director of the concussion program at University of Miami Health System Sports Medicine. Dr. Hotz has been at the forefront of TBI and concussion research, and has already developed a national model which includes a widely accepted concussion protocol along with a comprehensive assessment and treatment program.
She is joined by Michael Hoffer, M.D., professor of otolaryngology at the Miller School of Medicine, W. Dalton Dietrich, Ph.D., scientific director of The Miami Project and professor of neurological surgery at the Miller School, Barth Green, M.D., chairman of The Miami Project and professor of neurological surgery, Helen Bramlett, Ph.D., professor of neurological surgery, Bonnie Levin, Ph.D., director of neuropsychology and professor of neurology, and a team of neuro-outcome experts.
According to Hotz, “This is our chance to explore a therapeutic pill for the treatment of concussion. The scientific community and public know the risks associated with TBI, and because of the funding graciously provided by Scythian, we will soon know more about how the brain can respond to compounds that include cannabinoids designed to treat concussion. We can only hope that our hypotheses and trials lead us to the ending we all desire – a simple pill to treat concussion.”
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