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Evaluation of E-Cigarette Aerosol in In Vivo Nonclinical Models

Principal Investigators: Jake McDonald and Gladys V. Erives 

Funding Mechanism: Research Contract

ID number: HHS223201510032I

Award Date: 8/14/2017

Institution: Lovelace Biomedical and Environmental Research Institute

Additional information about inhaled e-cigarette aerosol toxicity would be useful. In this study, researchers will first conduct a seven-day pharmacokinetic nose-only inhalation study in female rats exposed to e-cigarette aerosol generated by three commercially-available devices. Researchers will test low, medium, and high nicotine doses based on potential human exposure with e-cigarette use. Blood and urine nicotine biomarkers will be collected to determine e-cigarette aerosol nicotine dose exposure levels. Researchers will also conduct a 90-day nose-only inhalation sub-chronic study in female rats to examine in vivo aerosol toxicity using three e-cigarette devices; exposure concentrations will be based on the data from seven-day study. Data gathered will include aerosol concentration measurements; measurements such as food consumption, body weight and food/water consumption; clinical observations; and urinary biomarkers of exposure. Study findings will inform characterization of the dose-response relationship and potentially identify a maximum tolerated dose without substantial toxicity.

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