The Effects of Modest Changes in Cigarette Menthol Content on Nicotine Pharmacology and Smoking Topography
Principal Investigator: Wallace Pickworth, Kia Jackson, and Megan Schroeder
Funding Mechanism: Research Contract
ID number: HHSF223201310030I
Award Date: 8/4/2016
Institution: Battelle Memorial Institute
Recent research on cigarettes and other tobacco products indicates that flavors, including menthol, may play an important role in user liking and sensation, and may directly or indirectly influence the pharmacology of nicotine and its associated abuse liability. In this study, researchers will investigate the impact of smoking cigarettes with four menthol concentrations on nicotine exposure, pharmacokinetics (the movement of nicotine in the body), metabolism, pharmacodynamics (the effects of nicotine on the body), and topography (use behavior). Forty-eight experienced adult (aged 18-65) menthol smokers will complete a screening visit and four clinical laboratory sessions where they will smoke one of four products: either a non-mentholated research 0.8 mg nicotine yield cigarette or the same research cigarettes that have been modified to achieve concentrations of low, medium, and high menthol levels (3, 6, and 12 mg, respectively) that bracket the menthol content of most commercially-available cigarettes. All laboratory sessions will include prescribed use and ad libitum use sessions. Researchers will measure the impact of menthol on smoking topography, nicotine pharmacokinetics, pharmacodynamics, and subjective assessments of abuse liability, risk perceptions, and product characteristics (e.g., strength, harshness). The study will provide a comprehensive assessment of menthol level on the acute effects of cigarette smoking, including effects on exposure, behavior and subjective effects.