Clinical Study to Evaluate Cannabidiol Liver Enzyme Elevations and Drug Interactions
Status:
Recruiting
Trial end date:
2024-09-01
Target enrollment:
Participant gender:
Summary
Cannabidiol (CBD) is available as a prescription drug product for the treatment of seizures
associated with Lennox-Gastaut syndrome, Dravet syndrome, or tuberous sclerosis complex. At
labeled doses up to 25 mg/kg/day, an increased risk of liver enzyme elevation and
drug-induced liver injury has been observed. However, only limited evaluations of the risk of
liver enzyme elevation of daily, lower dose CBD use are available. The potential for liver
enzyme elevations with lower CBD doses with unapproved consumer products highlights a need
for further research. In addition, CBD has the capacity to inhibit cytochrome P450 enzymes
and uridine 5'-diphospho-glucuronosyltransferases, leading to potential drug-drug
interactions with multiple common medications. The clinical significance of many of these
interactions is also unclear. Furthermore, nonclinical studies have suggested the potential
for CBD to cause reproductive and endocrine effects. As such, additional high-quality
clinical pharmacology studies are needed to further characterize CBD's safety profile.
The objective of this study is to characterize the effects of daily CBD use at a dose within
the range of what consumers are taking as unapproved CBD products on liver enzyme elevations,
drug interactions, and endocrine measures.