Hookah Additive Research to Inform Product Standards

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.

Sex

All

Minimum age

21 Years

Maximum age

50 Years

Inclusion Criteria:

* Sufficient understanding of consent form and study procedures
* Age 21-50 years old
* Experienced WP smokers defined as having smoked a WP at least 3 times per month in the last month
* Willing/able to abstain from nicotine product use for at least 12 hours prior to the laboratory visits
* Willing to attend four laboratory sessions at the same time of day lasting approximately 3 hours (h) each
* Read and speak English

Exclusion Criteria:

* Evident intoxication on any visit
* Exhaled breath CO \> 10 ppm
* Pregnancy (known or suspected), trying to become pregnant, breastfeeding, unwillingness to use contraception for the duration of the study
* Significant smoking-related disease (by history)
* Any of the following in the past 30 days (self-report):

  * Uncontrolled asthma or asthma that is worse than usual
  * Severe respiratory allergies, such as wheezing, coughing, shortness of breath when exposed to known allergens
  * Acute upper or lower respiratory illnesses like the flu, common cold, or pneumonia
  * Any other serious lung infection or disease, such as tuberculosis, cystic fibrosis, or lung cancer
  * Hospitalization for difficulty breathing
* Currently engaging in a WP tobacco smoking quit attempt