Understanding the Effect of Flavor on Hookah Smoking Experience
Condition: Waterpipe Smoking
Study type: Interventional

Summary: 
      This project addresses the need for evidence about the effect of flavoring manipulation on
      waterpipe smokers' satisfaction, dependence, harm perception, and toxicants exposure.
      Specifically, in this clinical study investigators will compare the effect on flavored and
      non-flavored waterpipe tobacco on smoking behavior, subjective experiences and toxicant
      exposure among waterpipe users. Findings from this study will help informing flavor-based
      product regulation by the FDA.
    

Detailed description: 
      Waterpipe (WP) tobacco smoking (a.k.a. hookah, shisha, narghile) is increasing rapidly in the
      United States (US), particularly among young people. Evidence suggests that WP smoking can
      lead to dependence, other tobacco use, and many of the known smoking-related diseases
      including cancer, cardiovascular disease and adverse pregnancy outcomes. These alarming
      trends led the Food and Drug Administration (FDA) in 2014 to propose including the WP under
      its regulatory authority, allowing the FDA to apply evidence-based regulatory approaches to
      control WP spread in the US. Given the salience of flavored tobacco in shaping the "WP
      experience", regulating WP tobacco flavor represents a promising approach for the FDA to curb
      WP use among US youth. This project aims to assist the FDA in these efforts by providing
      answers to specific questions pertinent to the potential of WP regulation through flavor.
      These include: - How would flavor manipulation affect the smoking experience and satisfaction
      of WP users at different stages of their smoking trajectory - How would smoking non-preferred
      flavor or unflavored WP tobacco reflects on smokers' exposure to nicotine, and dependence;
      and - How would flavor manipulation influence puffing behavior and exposure to toxicants such
      as carbon monoxide (CO) among WP smokers. Answers to these questions will help the FDA
      predict the impact of flavor regulation on WP experimentation and continued use. In this
      study, investigators will use clinical laboratory methods to answer these questions. Two
      groups of WP smokers will be recruited based on their use frequency: low (Beginners) vs. high
      frequency (Experienced) smokers (72/group; total 144; age 18-30). Each participant will
      undergo 2 WP smoking sessions that differ by flavor (preferred flavor; unflavored), while
      measurement of WP satisfaction, dependence, harm perception, and exposure to nicotine and
      toxicants will be conducted. The response of WP smokers at different stages of their WP
      smoking trajectory (Beginners vs. Experienced) to flavor manipulation, will allow to predict
      the effect of limiting flavors on a wide range of WP smokers. This project promises to
      provide the first evidence to guide the FDA in terms of the potential of regulating WP
      flavored tobacco on WP uptake and use in the US.
    

Intervention name(s): Flavored tobacco; Non-flavored tobacco
Intervention type(s): Other; Other
Intervention description(s): Effects of flavored tobacco; Effects of non-flavored tobacco
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other