Cannabidiol Drugs Clinical Trial Outcomes and Adverse Effects

Abstract

This review aims to present completed clinical trial data surrounding the medicinal benefits and potential side effects of the increasingly popular cannabidiol (CBD)-based drug products, specifically Epidiolex. The article is divided into two sections based on if the ailment being treated by this cannabinoid is classified as either physiological or neurological conditions. In addition to describing the current status, we also examined the different primary and secondary outcomes recorded for each study, which varies greatly depending on the funding source of the clinical trial. With the recent FDA-approval of Epidiolex, this review mainly focused on trials involving this specific formulation since it is the only CBD-based drug currently available to clinicians, although all other clinically trialed CBD(A) drugs were also examined. We hope this review will help guide future research and clinical trials by providing the various outcomes measured in a single review.

Medical cannabis use in the Australian community following introduction of legal access: the 2018–2019 Online Cross-Sectional Cannabis as Medicine Survey (CAMS-18)

“…This represents a fundamental issue given that the two cannabinoids have very distinct clinical indications and therapeutic effects. Specifically, CBD-only products having no intoxicating or euphorogenic properties, and when dosed appropriately have demonstrated efficacy in treating epilepsy, anxiety and psychosis [31,32]. Even for those who thought they knew the composition of their cannabis products, it is worth noting that there is essentially no capacity for consumers to determine the strength or composition of illicit cannabis products in Australia, with no ability for laboratory testing of illicit cannabis products.…”

Fish Oil, Cannabidiol and the Gut Microbiota: An Investigation in a Murine Model of Colitis

“…Nevertheless, several studies in animal models of colitis have highlighted that purified plant-derived cannabinoids can be efficacious, although, of these compounds, purified plant-derived CBD, appeared to be the most studied and the least promising ( Borrelli et al, 2009 ; Borrelli et al, 2013 ; Romano et al, 2013 ; Pagano et al, 2016 ; Couch et al, 2018 ; Pagano et al, 2019 ). However, a formulation of highly purified plant-derived CBD was recently approved by the Food and Drug Administration (as Epidiolex ® ) and European Medicines Authority (as Epidyloex ® , as an adjunctive therapy with clobazam) for the treatment of seizures associated with Dravet and Lennox Gastaut syndromes (two rare forms of pediatric epilepsy); while generally well tolerated, diarrhea is a common adverse event ( Pauli et al, 2020 ). Importantly, while FO and n-3 PUFAs have been tested in experimental colitis also with regard to their effects on the gut microbiota, no preclinical or clinical study has ever been conducted with CBD in this context.…”

“…Also, plant cannabinoids from Cannabis sativa , and in particular: 1) Δ 9 -tetrahydrocannabinol (THC), which activates cannabinoid receptor of type-1 (CB1) or, particularly, type-2 (CB2) [see ( Ibeas Bih et al, 2015 ; Turner et al, 2017 ) for review], and 2) cannabidiol (CBD), which modulates several pro-inflammatory targets [see ( Burstein, 2015 ) for review] have been shown to produce anti-inflammatory effects in animal models of several inflammatory disorders, including IBDs ( Gotfried et al, 2020 ; Williamson et al, 2020 ). Importantly, purified plant-derived CBD is now currently approved in both the USA (as Epidiolex ® ) and Europe (as Epidyolex ® , as an adjunctive therapy with clobazam) as an effective treatment for seizures associated with Dravet syndrome and Lennox-Gastaut syndrome (intractable rare pediatric epilepsies); while generally well tolerated, diarrhea is a common adverse event ( Pauli et al, 2020 ).…”

Medical cannabis use in the Australian community following introduction of legal access: The 2018-2019 Online Cross-Sectional Cannabis as Medicine Survey (CAMS-18)

“…This represents a fundamental issue given that the two cannabinoids have very distinct clinical indications and therapeutic effects. Specifically, CBD-only products having no intoxicating or euphorogenic properties, and when dosed appropriately have demonstrated efficacy in treating epilepsy, anxiety and psychosis [32,33]. Even for those who thought they knew the composition of their cannabis products, it is worth noting that there is essentially no capacity for consumers to determine the strength or composition of illicit cannabis products in Australia, with no ability for laboratory testing of illicit cannabis products.…”