“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 October 2016, 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 the Miller School of Medicine are setting out to see if a simple CBD pill or oil product can be successfully developed to treat concussions and TBI.
CBD Does Not Get You Stoned
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 neuro-protective, anti-inflammatory, and with anti-pain properties.
N-Methyl-D-aspartate (NMDA) receptor antagonists are anesthetics. They work by inhibiting the action 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
Dangers of Traumatic Brain Injury (TBI)
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” (like a brief change in mental status or consciousness) to “severe” 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.
- 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 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).
Researchers will – over five years of ongoing study – conduct 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.
Major Studies for CBD and Concussions
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.
According to researchers, “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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