With the increasing popularity of Cannabidiol or CBD, the issue of safe consumption has emerged as a primary concern. While CBD is generally regarded as safe via anecdotal evidence, little scientific research exists to back up this claim and leaves a lot of unanswered questions:
Does CBD have any adverse side effects?
How severe are these side effects?
What dosage represents a safe level of consumption?
On the heels of the first government-approved CBD-containing pharmaceutical product, a recent study was published that answers all of these questions. In this article, we’ll discuss CBD’s rise in popularity, recent government approval of CBD for the treatment of seizures, and how this new study addresses the safety of CBD as a drug treatment.
CBD as a Medicinal Therapeutic Drug
Medical cannabis has become increasingly accepted in the U.S. and around the world in recent years. As of November 2018, there are 33 states and the District of Columbia, in the United States that have passed legislation legalizing medical cannabis.
Cannabidiol in particular, has gained widespread popularity. CBD is a naturally occurring component of the cannabis plant and belongs to the cannabinoid family of chemicals. While CBD has a number of therapeutic benefits, it lacks the perception-altering effects of Tetrahydrocannabinol (THC), another cannabinoid family member and the primary psychoactive component of cannabis.
As more companies are creating CBD infused products and touting their therapeutic benefits, the U.S. Food and Drug Administration (FDA) has recently cracked down on companies making unsubstantiated claims that CBD can cure cancer. Cancer-claims notwithstanding, there is a growing body of scientific research showing CBD’s ability to ease inflammation, anxiety, and seizures.
Ground-breaking Approval of CBD for Seizure Treatment
With the evidence mounting, CBD is becoming increasingly regarded as a safe and effective drug treatment. In June 2018, the U.S. FDA made history by approving the first cannabis-based, CBD containing pharmaceutical drug product, Epidiolex. The company Greenwich Biosciences, a subsidiary of GW Pharmaceuticals, developed Epidiolex as an oral CBD solution. After several successful clinical trials, Epidiolex was approved for treating seizures associated with Lennox-Gastaut syndrome and Dravet syndrome, two rare and severe forms of epilepsy.
New Clinical Study Evaluates Safety of CBD
As part of the FDA-approval process, the makers of Epidiolex funded a pharmacokinetic or PK study of its oral CBD formulation. Pharmacokinetics is the study of determining the safe and effective administration of drugs to living beings.
The study was published in the journal CNS Drugs
Clinical PK studies are becoming increasingly important for the drug development and approval process. They provide crucial quantitative data that sheds light on to how a drug is absorbed, metabolized, distributed, and excreted by the body. PK also closely evaluates side effects associated with the drug of interest. The PK study published in CNS Drugs explores the effects of CBD on healthy individuals and is one of the most rigorous safety evaluations of CBD to date.
How Safe is CBD? The Results
The results of this study confirm the relative safety of CBD as a therapeutic drug treatment. While patients experienced some adverse side effects — the most common being diarrhea and headache — all of the effects were mild or moderate in severity.
All of the study participants were able to complete the study safely and successfully. Aside from the reported adverse symptoms, the researchers did not find any significant changes in the participants’ vital signs, body weight, or physical examinations.
How much CBD is safe?
According to a randomized, double-blind study published in CNS drugs, patients taking CBD oil reported only mild to moderate side effects even at very high doses.
Effects of Food on CBD Metabolism
Another interesting takeaway from this study is the effect of food intake on CBD bioavailability. The researchers found that if CBD was consumed with a high-fat meal, the drug’s bioavailability increased by up to fivefold. An increase in bioavailability means that more of the ingested drug enters the bloodstream and has an active effect.
A Note About Dosage
It’s also important to note that the dosages given to the study participants were very high. The purpose of the study was to evaluate the effects of CBD when used as a treatment for epileptic seizures. Treating epileptic seizures requires a much higher dose than less severe ailments such as anxiety.
For example, participants were given up to 6000 milligrams of CBD in a single dose and up to 1500 milligrams of CBD twice daily as part of a recurring dose administered over seven days. However, CBD taken for the treatment of anxiety symptoms has been shown to be effective with as little as a few milligrams or up to several hundred milligrams, much less than what was used in this study.
How Safe is CBD For You?
What does this mean for you? The big take-home message of this study is that CBD consumption is relatively safe with only mild to moderate side effects even at very high doses.
Average CBD user are likely taking much smaller doses than what was evaluated in this study. Therefore, you’re probably less likely to experience adverse side effects.
Additionally, taking CBD with food can help increase its bioavailability, meaning you’ll get more active CBD per dose. It may also help your dose stay more evenly active throughout the day.
Lastly, what does this mean for the future of CBD and medical cannabis as a whole?
This study demonstrates that with rigorous scientific evaluation, cannabis-based drug therapies can be considered safe and effective even by the exhaustive standards of the U.S. FDA.