Advancing Cannabinoid Science

written by James Baumgartner, PhD​

Working with cannabinoids is both extremely exciting but also frustrating.There is so much potential on how cannabinoids may provide medical solutions for many unmet medical needs or improved solutions without side effects.  However, due to a lack of appropriate studies it is difficult to currently provide the right information on dosing and whether cannabidiol (CBD) will alleviate specific conditions. 

The key to answering many of the question surrounding CBD are to appropriately conduct research.  Much of why these questions exist has been restrictions on the ability to conduct biological discovery, pharmaceutical research and clinical trials. Although dosing and which conditions CBD will truly help with remain unclear, properly designed clinical trials are in process that will begin to address how cannabinoids alone and in combination may address unmet medical need. Through properly designed studies, scientists and clinicians will be able to begin to better answer many questions surrounding CBD and other cannabinoids.

Restrictions on Research

In the Unites States, the 2018 Farm Bill, an agricultural improvement bill that is revised every five years, legalized the growth of industrial hemp and for products derived from hemp such as CBD oil to be produced and commercialized in the U.S  market. Industrial hemp by definition has low amounts of tetrahydrocannabinol (THC), the cannabinoid that produces the euphoric high associated with marijuana use. Until 2018, research on any cannabis strain, regardless of the THC content, was severely restricted as marijuana was classified as a schedule 1 controlled substance. Schedule 1 substances are those such as heroin that have no medicinal use, have addictive properties, and have a large propensity to cause harm.  Performing basic research with controlled substances includes obtaining a license from the Drug Enforcement Agency, then sourcing the material through approved sources.  The approved source for cannabis research was grown at a government facility in Mississippi. The plant material that was made available did not have large enough levels of cannabinoids compared to strains grown today.  Taken together,CBD research was very difficult to perform and progressed very slowly.

Cannabidiol (CBD)

CBD is one of 120 cannabinoids found in the cannabis plant. Industrial hemp strains have been selectively bred to produce high levels of CBD while maintaining low levels of THC. Unlike THC, the other major cannabinoid found in cannabis, CBD does not have psychogenic properties, instead is primarily considered an anti-inflammatory and exerts anti-anxiety activity.

CBD and Health

Although research and clinical trials on CBD are just beginning, CBD has been claimed to have effects on everything from Alzheimer’s Disease to yeast infections. Web searches on CBD and health yield over 10 million hits making various health claims, some of which may be true and some not.  Currently it is clear that CBD has effects on anxiety. CBD also has positive effects on joint health. CBD has many effects on skin health as well with clinical results demonstrated positive effects on acne, and hair growth.  Cannabinoids have also been shown to have anti-microbial activity that may provide better infection treatments than antibiotics for hard to kill organisms such as methicillin resistant staphylococcus aureus (MRSA), Clostridium difficile (C. diff.) and even antibiotic resistant strains of Neisseria gonorrhoeae (the bacterium that causes Gonorrhea).

Part of the reason that CBD has been claimed or described to have such wide-ranging activities may be due to the anti-inflammatory activity. Inflammation is a component of almost all disease states and in some cases imbalance of an inflammatory response is the main cause of disease (e.g. psoriasis). By normalizing inflammatory responses cannabinoids may decrease other symptoms as well as improve responses to conditions to bring the body back to health. 

Dosing and Safety

One of the largest questions that the scientific and medical community needs to address is how much cannabinoid is needed to have desired effects. Americans are used to taking a pill prescribed by doctors of X mg to reduce cholesterol or blood pressure. With CBD the amount needed to be taken for specific conditions is unclear and will depend on a large variety of factors including the type and severity of the condition. Part of the complexity on dosing also has to do with how much CBD gets into the blood stream from a given dose which is termed bioavailability. Bioavailability of cannabinoids will vary on the dosage form taken (e.g. smoking, oral, or topical), the strength taken, body weight, percent body fat and the individual make up of liver enzymes that break down exogenous compounds. Taken together the highest bioavailable dose formats are smoking or oral dissolving tablets with the lowest bioavailability (5-10%) with edibles or oral soft gels. Note here that soft gel formulations can be optimized to increase bioavailability such as with Panacea Life Sciences soft gels that have enhancers to increase digestive system absorption up to 5-fold over CBD itself. Most consumers achieve positive health benefits with 25-75 mg of CBD taken daily.

While dosing is confusing, the good news is that consumers can experiment with how much CBD to consume to produce desired effects as CBD is extremely safe.  Safety studies from Epidiolex, a CBD tincture product approved by the Food and Drug Administration (FDA) for severe epilepsy, indicates that there are no adverse effects until doses exceed 10 mg/kg/day.  For a 100Kg person this is one gram per day!  Compare this to typical cholesterol lowering medications which are 10 mg per day.  At levels of CBD that exceed this high amount, side effects may include lethargy, sleepiness, stomach ache, diarrhea, and elevation of liver enzymes. This latter symptom is an early sign of potential liver toxicity.  Side effects rapidly disappear when the dose of CBD is lowered or stopped.  Because of the safety of CBD, consumers can determine the dose of CBD to be used along with a dose format that produces individual results. 

While CBD by itself is very safe, it is possible that when taken with other medications that there may be drug-drug interactions that are detrimental to health. When starting a CBD regimen it is recommended to speak with a health care provider to better understand potential side effects that may occur from prescription medications.

Clinical Trials

Unfortunately, clinical studies take time to design and conduct appropriately.  Each study, unless an open label study with a physician’s own patients, need to have institutional review board approval to ensure the study has merit, is ethically conducted and patient consent and privacy is obtained.  A key element in many clinical studies is to ensure that subjective measurements are properly controlled through double blind studies or including an objective measure such as a biological measure from serum.  As an example, measuring stress or anxiety when the subject knows they are taking a CBD product will automatically result in an improvement, but when blinded and when a surrogate measure of anxiety such as cortisol in blood is measured, the study may provide improved conclusions on the true effectiveness of cannabinoids.

Basic research is focused on industry issues such as isolation of rare cannabinoids that will allow the future understanding of how additional cannabinoids effect health. Two clinical studies that have launched are a canine translational model for Alzheimer’s disease and an open label study to evaluate CBD/CBG in irritable bowel syndrome.   The Alzheimer’s study is a three-year study so results will not be reported until 2024.  The open label IBS study however, has started with results expected before the end of the year.  Should the results form the IBS study show promise a double blind (where the subject nor the physician know whether the subject is taking placebo or study article) will follow. With topical studies, before and after photographs will provide evidence on whether the products improve conditions or not. 

The potential of cannabinoids to improve many aspects of human and animal health is immense.  Unfortunately, there has been much misinformation and aggressive claims made on what CBD does.   Any questions or comments regarding how cannabinoids as supplements benefit health should be directed to costumercare@alltavidarx.com which will be  answered by our support team.