U.S. flag An official website of the United States government

U.S. Food and Drug Administration
  1. Home
  2. Tobacco Products
  3. Tobacco Science & Research
  4. Research
  5. The Effects of Flavors on Nicotine PK/PD and Use Topography in E-Cigarette Users
  1. Research

The Effects of Flavors on Nicotine PK/PD and Use Topography in E-Cigarette Users

Principal Investigators: Michael McGuire, Olga Rass, and Lingling Guan

Funding Mechanism: Research Contract

ID number: HHSF223201310033I

Award Date: 8/23/2016

Institution: Lovelace Scientific Resources, Inc.

Clinical studies investigating the effects of e-liquid flavors on nicotine exposure, pharmacokinetics (the body’s effects on the absorption, distribution, metabolism, and elimination of nicotine), pharmacodynamics (the effects of nicotine on the body), and use behaviors may increase knowledge regarding the health effects of e-cigarettes. The goal of this study is to investigate the effects of e-liquid flavors on topography (use behaviors) and nicotine pharmacokinetics and pharmacodynamics, and to begin to establish the effects of flavors on biomarkers of exposure in experienced e-cigarette users. Researchers will conduct a clinical study where experienced adult e-cigarette users will complete four sessions where they will use e-liquids of different flavors (e.g., tobacco, menthol, fruit) in nicotine and nicotine-free conditions. During these sessions, researchers will collect blood and urine samples, vital signs, topography, abuse liability measures, subjective effects, and other self-report measures. The study will yield information on the effects of e-liquid flavors on nicotine pharmacokinetics and pharmacodynamics, biomarkers of exposure, and topography, and may provide useful information on the impact of these tobacco products on public health.