This clinical trial evaluates how the content of waterpipe (WP) tobacco affects the appeal, puffing behavior, and toxicity of WP tobacco smoking. The data from the proposed study will provide direct links between WP tobacco's primary additives (sugars and humectants), CO and nicotine biomarkers, smoker preferences, perceptions of harm and puffing behaviors, and the subsequent range of toxicant exposures associated with these additives and behaviors. Study outcomes include waterpipe puffing behaviors, exhaled carbon monoxide levels, nicotine uptake, spirometry, sensory perceptions, smoking appeal, and risk perception. Waterpipe tobacco smoking is often the first combustible tobacco product tried by adolescents and young adults, possibly due to the widespread availability of heavily sweetened waterpipe tobacco and the perception that waterpipe smoking is a safer alternative to cigarette smoking. However, waterpipe tobacco smoking is associated with lung disease, carbon monoxide poisoning, and precursor conditions for oral and other cancers in adolescents and young adults. There is currently little data available on how the primary additives (by weight) in waterpipe tobacco affect puffing behaviors, toxicant exposures, pulmonary function and appeal. This clinical trial uses established waterpipe tobacco smokers, four investigational tobacco products with precisely manipulated levels of humectants and natural sugars in a single-blind, crossover (repeated measures) study design to determine how waterpipe tobacco additives effect human puffing behavior, nicotine uptake, flavor perceptions, lung function, and biomarkers of exposure.
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Change in Exhaled Breath Carbon Monoxide (CO)
Timeframe: Approximately 30 to 90 minutes
Change in Plasma Nicotine
Timeframe: Approximately 30 to 90 minutes
Change in Forced Vital Capacity (FVC)
Timeframe: Approximately 30 to 90 minutes
Change in Forced Expiratory Volume in 1 Second (FEV1)
Timeframe: Approximately 30 to 90 minutes
Change in FEV1/FVC; The Ratio of the Forced Expiratory Volume in the First One Second to the Forced Vital Capacity of the Lungs.
Timeframe: Approximately 30 to 90 minutes
Change in Peak Expiratory Flow (PEF)
Timeframe: Approximately 30 to 90 minutes
Change in Forced Expiratory Flow at 25-75% of FVC
Timeframe: Approximately 30 to 90 minutes
Tobacco Use History
Timeframe: Baseline
Nicotine Dependence (HONC)
Timeframe: Baseline
Nicotine Dependence (LWDS)
Timeframe: Baseline
General Harm and Health Risk Perceptions
Timeframe: Post Smoking Session
Subjective Effects of Smoking Tobacco
Timeframe: Post Smoking Session
Change in Subjective Effects of Smoking Tobacco - Direct Effects of Nicotine
Timeframe: Approximately 30 to 90 minutes
Change in Subjective Effects of Smoking Tobacco (QSU)
Timeframe: Approximately 30 to 90 minutes
Change in Nicotine Withdrawal Assessment (MNWS)
Timeframe: Approximately 30 to 90 minutes
Tobacco Flavor Perception (gLMS)
Timeframe: Post Smoking Session
Tobacco Flavors Perception, Degree of Liking or Disliking (LHS)
Timeframe: Post Smoking Session
Puffing Topography - Puff Volume
Timeframe: Up to 60 minutes
Puffing Topography - Puff Duration
Timeframe: Up to 60 minutes
Puffing Topography - Flow Rate
Timeframe: Up to 60 minutes
Puffing Topography - Peak Flow Rate
Timeframe: Up to 60 minutes
Puffing Topography - Interpuff Interval
Timeframe: Up to 60 minutes