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Can Ethics Review Catch Up to the CBD Craze?

Cannabidiol, often abbreviated as CBD, is a phytocannabinoid found in both the psychoactive marijuana plant as well as the non-psychoactive hemp plant. Over the last several years, CBD has piqued the interest of researchers by demonstrating some degree of efficacy in treating diverse complaints including pain, inflammation, nausea and anxiety.

More recently, the public has noticed the benefits of medical marijuana as can be seen in the growing number of state approved medical marijuana dispensaries and laws permitting recreational marijuana. General interest in CBD supplements has risen, leading to the production of many CBD-infused products ranging from oils to creams to candy. Stories of personal experiences with CBD-infused products abound on social media, and a growing public acceptance of cannabis has likewise brought growing attention to the plant and its derivatives. Unlike other recent health crazes including glucosamine drinks and CoQ 10, there is data which demonstrates that CBD has a consistent pharmacokinetic effect, so individuals using these supplements may experience physical effects on their body or interactions with prescribed pharmaceuticals. Unfortunately, a number of factors continue to obstruct exploration of CBD’s potential through appropriate research oversight.

Research on CBD encounters a convergence of two highly complicating fields of study: botanical medicines and research of controlled substances. Researchers and IRBs are still grappling with effective ways to study herbal medicines. Among the pitfalls is regionalism in how people respond to the herbs, a prime example being Kava, for which studies have found to be more hepatotoxic to Europeans than the Polynesian population near the region of cultivation. Determining the pharmacologically active components of the herb (which may require whole-herb cofactors to function) makes deriving a marketable drug from the process challenging and expensive. In addition, supplements are not regulated as drugs by the FDA and frequently do not contain consistent amounts of the active ingredient, thus impacting the ability to identify appropriate and consistent doses for an individual and adding additional labor to procuring accurate dosages in research efforts.

Further complicating matters is the fact that CBD is a derivative of marijuana. As a Schedule I drug (defined as “having little to no therapeutic benefit and a high potential for abuse”), researching marijuana and any derivatives requires a significant administrative burden. Even in states that have legalized medical and/or recreational marijuana, organizations that accept federal funding may not research marijuana without the same restrictive administrative process. Although the FDA has approved a drug with CBD as the active ingredient to treat epilepsy (and individually re-scheduled the drug as Schedule V instead of Schedule I), research on CBD remains largely inaccessible to most US researchers.

Schedule 1 Substances: Impact on Cannabis Research:
Are defined as having “no medically accepted uses” and “a high potential for abuse.” Available evidence does not support these conclusions for cannabis, but no rescheduling initiatives have succeeded.
May only be procured from approved government sources. Only one facility (University of Mississippi) supplies cannabis for US research.
Research must be approved by National Institute on Drug Abuse (NIDA) panel and Drug Enforcement Agency (DEA). Researchers find this process unreasonably difficult, especially for studying medical applications.
Research funded by NIDA may only study abuse, not medical application. NIDA-funded studies tend to take precedence over medical use studies.

Consumers, however, are not waiting for IRB-reviewed research. Curious shoppers have pushed Google search results for “biohacking” (trying to optimize one’s health through technology, supplements, and lifestyle changes) and “microdosing” (attempting to gain positive effects by taking sub-intoxicating amounts of cannabis or LSD) into the highest possible Google Trends popularity rating, a measure of a search term’s popularity over time. Blogs, news stories, and YouTube channels featuring self-experimentation with these substances abound, with the goal of improving one’s health with minimal side effects. However, these experiments are not without risk, and the problems of purity, safety, and consistency mentioned above will only exert a greater effect until research catches up with society.

It is clear that research into botanical and botanically derived therapies remains a worthwhile and necessary endeavor. Many well-tolerated and effective therapies have resulted from studies investigating remedies prompted by personal anecdote and folklore, including:

Researchers undertaking studies on botanical and controlled-substance therapies must equip themselves to handle new botanical medicines as well as research into substances subject to federal scheduling.

Need assistance submitting your CBD study for IRB review? Contact businessdevelopment@advarra.com for support!

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