At Care By Design, we have a passion for science. Our team has supported various canna-scientific endeavors over the years. We’re excited to tell you about the results of our latest research venture.
Last year, hundreds of Care By Design customers volunteered to participate in a clinical study designed to assess the liver safety of daily CBD consumption. That study recently underwent the peer-review process and was published in the Journal of Cannabis and Cannabinoid Research!
We parse the science-y jargon of the publication for you below, but before getting into the details, let’s start off with a bit of background:
When we take a drug or medication, our bodies “metabolize” it –meaning we break down the drug into forms that are easier to absorb or excrete. The liver is the main place within the body where this happens for most drugs, medications, and supplements. Cannabinoids, including THC and CBD, are no exception; they are also primarily processed by our liver.
Some common medications are known to interfere with normal liver function, but the extent to which this occurred with CBD was largely unknown. When clinical trials for Epidiolex (pharmaceutical CBD) were performed, there were some deficits in liver function noted which caused the U.S. Food and Drug Administration (FDA) concern. However, all the participants in these Epidiolex clinical trials suffered from severe forms of epilepsy, and as such they were concurrently taking several powerful medications in addition to their CBD.
Thus, it was impossible to determine whether the abnormal liver tests resulted from the high-dose CBD or from the cocktails of medications. Partially due to this uncertainty, in March 2020, the FDA requested more science-based data around CBD and liver health to help inform and guide future federal regulatory pathways for consumer CBD products.
The cannabis industry stepped up in a big way to meet the FDA’s request! Care By Design and 11 other cannabis companies funded a >$1 million clinical study focused on CBD liver safety. The study was coordinated by an independent third party, the clinical research outsourcing (CRO) group Validcare. It was designed by a team of reputable research doctors including clinicians, pharmacologists, and a biostatistician.
Each cannabis brand enrolled volunteers to consume oral CBD for at least 60 consecutive days and monitor their daily usage via a phone app. The participants were allowed to take as much or as little CBD as they wanted each day. At the end of ≥60 days of daily CBD consumption, each participant went to a lab to provide a blood draw. Their blood was tested for common markers of liver health. This liver function data from chronic CBD users was compared to that of a control group of non-CBD users to assess whether there may be any risk.
Last year we invited our patients and customers to help by applying to enroll in this study. Your response was amazing. Over one thousand of you applied. About one in ten people met the extensive inclusion criteria and became formally enrolled into the study (receiving a free 3-month supply of a full-spectrum Care By Design CBD product of your choice).
The anonymized data from our Care By Design cohort were pooled together with data from all the study participants. The more people that band together in a clinical study, the more confidence we can gain in the significance of its conclusions and the more meaningful the results become. Across all twelve brands, there were a total of 839 participants that completed the study through the blood draw endpoint, making this the largest liver toxicology study on CBD.
Overall, the results from the study were promising, and the participants were found to self-dose about 50mg CBD per day on average. The researchers uncovered no significant differences in the prevalence of worrisome liver test elevations between this CBD-taking group and a normal ‘non-CBD’ general population. There was also no sign of liver disease in any of the study’s 839 participants. Based on the data, the study authors concluded that oral CBD use is not associated with abnormal liver function in normal healthy adults. The team of research doctors that oversaw this study recently met with the FDA’s Cannabis Product Council to apprise them of these significant clinical findings.
We’re proud to have played a part in this real-world cannabis research initiative. We’re grateful to our amazing community for your role in bringing this vital work to fruition.