Today, medical cannabis is approved for use in 33 U.S. states plus the District of Columbia, and several other states have medical or recreational cannabis legalization on the fall election ballot. While many valid arguments can support the notion that foods and beverages infused with tetrahydrocannabinol (THC) are acceptable adult-use alternatives to alcohol, we wouldn’t be at this stage in today’s cannabis marketplace without its widely recognized health, wellness, and medical benefits. Cannabidiol (CBD), in particular, has captured international attention for its potential as a non-psychoactive, natural ingredient suited to widespread use in everything from generally healthy products to highly specified and functional foods and beverages.
As more people get used to the idea of cannabis serving as part of a healthy diet and lifestyle, product development will continue in various advantageous directions. Meanwhile, the research sector of cannabis has been busy studying the way individual constituents of cannabis interact with our bodies, potentially leading to new business opportunities for cannabis-infused products.
Brain Sciences, an international neuroscience journal, recently dedicated a special issue to “Cannabis: Neuropsychiatry and Its Effects on Brain and Behavior.” One of the articles in that issue, “Migraine frequency decrease following prolonged medical cannabis treatment: A cross-sectional study,” reported on the clinical use of cannabis to treat migraine headaches. The study’s authors work at the Israel Institute of Technology and Institute of Pain Medicine, both in Haifa, Israel.
The authors of the study sought to investigate the associations between cannabinoid treatment and migraine frequency. Results showed medical cannabis use can result in long-term reduction of migraine frequency. Cannabis use also reduced any disability related to migraine headaches, as well as reduced anti-migraine medication intake. Traditional preventive treatments for migraine headaches can include taking antidepressants, beta-blockers, and calcitonin gene-related peptide (CRGP) agents. Tryptamine-based drugs (triptans) are frequently prescribed to help stop migraine and cluster headaches. However, triptans are reportedly inefficacious in 30 to 40 percent of patients (see “How is triptan response related to quality of life among migraineurs?”). Opioids are also commonly prescribed for migraine headaches, but those drugs have a host of downsides (see “Opioid use, economic burdens of migraine detailed in pair of studies at ISPOR”).
Overall, the study found that use of medical cannabis resulted in long-term reduction of migraine frequency in over 60 percent of treated patients. “Migraine is classified as a pain condition,” wrote the authors in the study. “Mechanistically, endocannabinoids have been shown to have an inhibitory effect on serotonin receptors in vivo, which is shown to modulate pain and emetic responses.” The researchers suggested that a future study with a larger sample size and more-comprehensive approach would be useful in translating the findings to clinical settings.
Researchers have also been looking at the potential for using CBD to help reduce severe behavioral problems in children and adolescents who have an intellectual disability. Researchers at the Murdoch Children’s Research Institute, Melbourne, Australia, recorded a clinically significant change in participants’ irritability, aggression, self-injury, and yelling (see “A pilot randomised placebo‐controlled trial of cannabidiol to reduce severe behavioural problems in children and adolescents with intellectual disability”). The majority of participants in the study were on the autism spectrum.
Although this pilot study wasn’t large enough to make any definitive statements about CBD and its impact on behavior, the researchers note that these early findings strongly support organizing a larger trial, which is reportedly in the planning stages now.
Daryl Efron, senior research fellow, Murdoch Children’s Research Institute, led the study and notes that this was the first investigation of how CBD might have a role in helping manage severe behavioral problems in children and adolescents who have intellectual disabilities.
The researchers found that the CBD administered for the study was tolerated well by the subjects without any serious side effects.
“Current medications carry a high risk of side effects, with vulnerable people with intellectual disability being less able to report side-effects,” said Efron, commenting on the study. “Common side effects of antipsychotics, such as weight gain and metabolic syndrome, have huge health effects for a patient group already at increased risk of chronic illness.” (See “CBD could reduce behavioural problems in children with intellectual disability.”)
Efron and his colleagues are reportedly seeking funding for additional research into the effectiveness of using medicinal cannabis and CBD to help those with developmental disorders such as autism and Tourette syndrome.
David Shurtleff, Ph.D., deputy director, National Center for Complementary and Integrative Health, National Institutes of Health, Bethesda, MD, recently discussed new funding opportunities for cannabinoid research related to pain (see “Expanding the portfolio of rigorous cannabinoid research with new funding opportunities”).
“Both the chronic pain and opioid epidemics pose public health challenges for the research community,” he said. For the National Center for Complementary and Integrative Health, part of the National Institutes of Health, he notes that this challenge has informed their investment in pain research, which accounts for 40 percent of the center’s overall research portfolio. “The urgency behind this investment is clear: There is not an adequate range of options to help clinicians and patients treat and manage pain,” he wrote. “The lack of options has taken a toll on millions of American adults who suffer from chronic pain, impacting quality of life and ability to work, and increasing risk of depression, anxiety, and addiction.”
In order to seek new solutions for pain management, the National Center for Complementary and Integrative Health announced $3 million in funding in 2019 to support studies investigating the potential pain-relieving properties of cannabis, focusing specifically on minor cannabinoids and terpenes.
Recent research at Johns Hopkins University, Baltimore, shows promise for further investigations on the use of CBD for pain management—and overall quality of life. Ryan Gregory Vandrey, Ph.D., associate professor of psychiatry and behavioral sciences, Johns Hopkins University, recently noted that his group is conducting long-term observational research on people who are using cannabis, hemp, and CBD products for medicinal purposes (see “What we know—and don’t know—about CBD”).
“We found that, among individuals with a variety of health problems, such as epilepsy, chronic pain, autism, anxiety, and other serious health conditions, those who were using a cannabis product—people predominantly used CBD products—reported a better quality of life and satisfaction with health, pain, sleep, and mood compared with those who were not using cannabis products,” said Vandrey, discussing the study in the November/December 2019 issue of Dome, a Johns Hopkins Medicine publication. “When those who were not using cannabis at the time of our first survey later started using cannabis, they showed improvements in those same health measures that mirrored the differences between the cannabis users and nonusers in the beginning.”
Vandrey notes that the outcomes of this study highlight the need for additional research on hemp and CBD products in controlled clinical trials, especially for autism, anxiety, depression, multiple sclerosis, chronic pain, and epilepsy.
Seeking a Pathway
In March, Dr. Stephen M. Hahn, commissioner, FDA, addressed the public with an update on the agency’s current positioning on use of CBD in foods and beverages. He noted: “Over the past year, the U.S. Food and Drug Administration has embarked on a comprehensive evaluation of cannabidiol (CBD) products, with a focus on educating the public about the risks and unknowns of these products, gathering the science needed to better understand both these safety concerns and potential benefits to inform our regulatory approach, as well as taking steps when necessary to address products that violate the law in ways that raise a variety of public health concerns.” (See “FDA advances work related to cannabidiol products with focus on protecting public health, providing market clarity.”)
FDA’s work toward building a body of evidence for the safe and beneficial use of cannabis continues. In his March statement, Hahn reported that FDA has awarded a grant to the National Center for Toxicological Research to study the effects of CBD exposure during pregnancy.
The industry is also doing its part. In June, a group of seven CBD companies—Boulder Botanicals & Bioscience Labs, CBDistillery, CBD American Shaman, Charlotte’s Web Holdings, Columbia Care, HempFusion, and Kannaway—announced a new research project to evaluate the impact of daily CBD use on the liver function of healthy adults.
“This research will provide important clinical data to guide our entire industry while also showing the FDA we’ve heard their requests and are answering their questions with precise data,” said Deanie Elsner, CEO, Charlotte’s Web, Boulder, CO, in a statement announcing the research.
“This is a particularly important time for research on the science behind hemp-derived CBD as we advocate for FDA regulation of our category,” said Tim Orr, vice president of innovation, Charlotte’s Web.
“As we move forward, we are currently evaluating issuance of a risk-based enforcement policy that would provide greater transparency and clarity regarding factors the agency intends to take into account in prioritizing enforcement decisions,” said Hahn. “Any enforcement policy would need to further the goals of protecting the public and providing more clarity to industry and the public regarding the FDA’s enforcement priorities while we take potential steps to establish a clear regulatory pathway.”