Principal Investigator: Jonathan Thornburg (CTP Contact: Marcella Ferlito)
Funding Mechanism: Research Contract
ID Number: HHSF223201810194C
Award Date: 11/1/2018
Institution: Research Triangle Institute (RTI), International
The goal of this study is to identify and confirm a biomarker specific to e-cigarette use and secondhand exposure. Study aims are: (1) to confirm that the exact oligomer compounds formed by the thermal degradation of propylene glycol (PG) and vegetable glycerin (VG) are unique to e-cigarettes and not common in other tobacco products; and (2) to determine whether these chemicals or their metabolites are found in urine and/or blood specimens of e-cigarette users and bystanders who experience secondhand exposure. Researchers will confirm the chemical structure of the VG and PG oligomers formed during e-cigarette use. This information will guide a review of the literature to identify metabolites and metabolic pathways in urine and adducts in blood specimens and to inform the selection of the most appropriate biospecimen analytical approach. Researchers will then collect and analyze blood (serum and plasma) and urine from 63 e-cigarette users, conventional cigarette smokers, and non-users (ages 18 and older) to determine whether the biomarker is unique to e-cigarette users and present at measurable concentrations in the aerosol produced from 20 e-liquids. Upon agreement from FDA that a biomarker unique to e-cigarette aerosol has been identified, researchers will proceed with additional experiments to develop an empirical model that predicts the mass of the biomarker produced per puff. This model will correlate e-cigarette use with biomarker intensity in the biospecimens collected as part of a later study of e-cigarette user exposure and secondhand exposure. Study findings may provide the identification of a unique biomarker of e-cigarette use to be used in epidemiological and clinical studies that evaluate the acute and chronic health effects from e-cigarette use and secondhand exposure.