A Cross-Sectional Study of Cannabidiol Users
Abstract
Introduction: Preclinical and clinical studies suggest that cannabidiol (CBD) found in Cannabis spp. has broad therapeutic value. CBD products can currently be purchased online, over the counter and at Cannabis-specific dispensaries throughout most of the country, despite the fact that CBD is generally deemed a Schedule I controlled substance by the U.S. Drug Enforcement Administration and renounced as a dietary supplement ingredient by the U.S. Food and Drug Administration. Consumer demand for CBD is high and growing, but few studies have examined the reasons for increasing CBD use.
Materials and Methods: A self-selected convenience sample (n = 2409) was recruited via an online survey designed to characterize whom, how, and why individuals are currently using CBD. The anonymous questionnaire was accessed from October 25, 2017 to January 25, 2018. Participants were recruited through social media.
Results: Almost 62% of CBD users reported using CBD to treat a medical condition. The top three medical conditions were pain, anxiety, and depression. Almost 36% of respondents reported that CBD treats their medical condition(s) “very well by itself,” while only 4.3% reported “not very well.” One out of every three users reported a nonserious adverse effect. The odds of using CBD to treat a medical condition were 1.44 (95% confidence interval, 1.16–1.79) times greater among nonregular users of Cannabis than among regular users.
Conclusion: Consumers are using CBD as a specific therapy for multiple diverse medical conditions—particularly pain, anxiety, depression, and sleep disorders. These data provide a compelling rationale for further research to better understand the therapeutic potential of CBD.
Introduction
Cannabidiol (CBD) is one of more than a hundred cannabinoids found in Cannabis sativa L (Cannabis spp. or Cannabis), a plant more well known colloquially as marijuana and hemp. CBD is typically the second most abundant cannabinoid found in Cannabis after tetrahydrocannabinol (THC).1 CBD was first isolated in 1940 and characterized structurally in 1963.2,3
CBD is well tolerated in humans and maintains a good safety profile.4,5 Neither abuse nor dependence has been demonstrated.5 In preclinical studies, CBD shows potential therapeutic efficacy against a diverse assortment of medical conditions. These include seizure disorders, psychotic symptoms, anxiety, depression, inflammation, cancer, cardiovascular diseases, neurodegeneration, symptoms of multiple sclerosis, and chronic pain, either used alone or when coadministered with THC.5–20
In October of 2017, a New Drug Application was submitted to the U.S. Food and Drug Administration (FDA) to seek approval of CBD isolated from marijuana for the treatment of two pediatric seizure disorders. Approval was granted in June, 2018, making Epidiolex (cannabidiol) the first plant-derived Cannabis compound approved as a drug by the FDA. Availability of Epidiolex is pending Drug Enforcement Administration (DEA) rescheduling of cannabidiol, which is expected to occur within 90 days.21–23 Sativex (nabiximols), a combination drug with equal parts CBD and THC extracted from marijuana, is currently approved to treat spasticity due to multiple sclerosis in >30 countries worldwide but is not approved in the United States.17,21
The worldwide regulatory status of CBD is complex and constantly changing.5 While CBD is legal in many countries as a component of prescription Sativex (nabiximols), it may be simultaneously illegal as a component of a nonapproved Cannabis extract containing >0.2% (particularly in European countries) or 0.3% THC. In Europe, individual European Union Member States currently determine the legality of CBD within their borders. Most allow prescription CBD products, as do Australia and New Zealand.5,24 Canada became the second nation in the world to legalize Cannabis for recreational use in June 2018.25 The World Health Organization’s Expert Committee on Drug Dependence recommended that CBD should not be controlled by Schedule I of the 1961 UN Single Convention on Narcotic Drugs.5 Their comprehensive report is expected this year.
In the United States, until such time as it is rescheduled, CBD from marijuana is deemed by the DEA to fall within the purview of the “marihuana extract rule” (Rule). A dispute over the scope of the Rule was litigated in federal court. The Court found that the Rule applies to extracts of marijuana but that the industrial hemp provisions of the 2014 Farm Act (i.e., “The 2014 Farm Bill”) preempt the Controlled Substances Act (CSA), which the DEA enforces.26 Thus, hemp cultivated in compliance with the Farm Bill is not a controlled substance. The Court did not address the issue of CBD directly, however, and left open the issue of the legal status of CBD derived from industrial hemp, from imported “nonpsychoactive hemp” or from parts of the Cannabis sativa plant excluded from the legal definition of marijuana in the Controlled Substances Act of 1970.27–35 Despite conflicting legal interpretations, and DEA prohibition, hemp-derived CBD products can currently be purchased as dietary supplements both online and over the counter throughout most of the country. To complicate matters further, the FDA does not recognize CBD as a dietary supplement ingredient because of its status as an Investigational New Drug.36
This regulatory confusion has not deterred consumers from exploring the purported benefits of CBD. Retail sales of hemp-derived CBD products in the United States reached $170 million in 2016, and are projected to grow at a 55% compound annual growth rate over the next 5 years to reach >$1 billion. These estimates do not include marijuana-derived CBD.37 Although Cannabis users have been extensively studied data characterizing the individual use of CBD are scarce. The goal of this study was to collect survey data to elucidate how, and why, individuals are using CBD.
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can.2018.0006