Cannabis Research and Clinical Trials

In the United States, the first big study on cannabinoid treatment for concussion is being done by the University of Miami which received a $16 million grant for the research. The study is a five-year, three-stage study that will “assess the effectiveness of a new cannabinoid-based pill to treat concussion injuries. This partnership aims to propel this research and potential treatment forward by using two classes of drugs in a combination that scientists believe will reduce brain inflammation and the immune response.” See also the Miami Herald article.

As reported in UHealth in July 2018, the “findings of a pre-clinical pilot study were recently released, and they show that the combination therapy improved the cognitive functions of animals, compared with those treated with a single vehicle. In addition, there were no adverse effects from either the combination therapy or the individual components.”

The cannabinoid combination therapy is made up of CBD (Cannabidiol, an element of cannabis) and Dexanabinol (HU-211) which is synthetic cannabinoid which is an “anticonvulsant and neuroprotective, and is widely used in scientific research as well as currently being studied for applications such as treating head injury, stroke, or cancer.”

Phase 2 of the study is currently underway. The University of Miami is testing the cannabinoid-based pill on a small pilot study with people, including “a control group and two groups of TBI patients, acute and chronic.” More information can be found on our blog: an interview with Dr. Hoffer.

Dr. Hoffer began a new study in February 2020 to research if “using a pill form of cannabidiol (CBD) and the psychedelic drug psilocybin effectively treats and possibly prevents symptoms of two conditions that commonly occur together: mild traumatic brain injury (mTBI) and posttraumatic stress disorder (PTSD).” “Up to 40% of people impacted by mTBI [or TBI] also suffer from PTSD,” according to a University of Miami press release.

A pre-clinical trial on animals is in progress. Dr. Hoffer expects this phase to last around 9 to 12 months. He hopes to transition to human clinical trials and file the treatment with the FDA in early 2021.

In Canada, a new study led by NEEKA Health Canada will “test if CBD-based therapies can reduce the severity of post-concussion brain disorders in former NHL players.” The National Hockey League Alumni Association and Canopy Growth Corp. (a cannabis and hemp company) are partnering with NEEKA for the clinical research; approximately 100 former players will be enrolled in the randomized, double-blind study. Researchers hope to finish the study by the end of 2020 according to an article in Green Entrepreneur.

In Australia, the medical cannabis company Impression Healthcare began a new clinical trial in mid-2020 to access its new cannabinoid formula IHL-216A on “its ability to protect the brain against the main injury mechanisms which cause cell death and other negative consequences in the days and weeks following head trauma.” Impression will test IHL-216A with in-human and animal trials.

Up to 50 Australian MMA fighters who “receive head knocks and show symptoms of moderate to severe head concussions” will participate in the study. Participants will either receive IHL-216A or a placebo. The effectiveness of the CBD formula will be tested by participants’ baseline neurocognitive tests, which will be repeated throughout the study in both the experiment and placebo groups, and EEG and blood biomarker assessments. Impression Healthcare hopes to have IHL-216A fully approved for market by 2024.

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