Hookah Additive Research to Inform Product Standards
Condition: Tobacco-Related Carcinoma
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      Currently there are no regulations governing the content of WP tobacco. Because mandated
      changes in tobacco content may lead to unintended consequences that ultimately result in
      public health declines, human use behaviors must be well understood prior to implementing
      regulatory product standards. The proposed study will include preparing and characterizing
      the content of 4 investigational tobacco products (ITPs) (Aim 1); characterizing the
      mainstream smoke toxicant emissions from machine smoking the 4 ITPs using a single,
      established puffing regimen (Aim 2); measuring human puffing behavior, general harm and
      specific health risk and flavor perceptions, lung function, and biomarkers of exposure in a
      group of established WP smokers smoking the 4 ITPs in the laboratory (Aim 3), and estimating
      toxicant exposure ranges using machine smoking and puffing regimens derived from the human
      laboratory testing (Aim 4).

      The clinical trial (Aim 3) will focus on using a group of established adult and young adult
      WP smokers, a cross-over study design, CO and nicotine biomarkers, spirometry, cutting edge
      psychophysical measurement tools, and risk perception instruments to map the relationship
      between sensory experiences and preferences of sweetness and flavor to specific additive
      content in WP tobacco that affect these experiences, preferences, acute health effects, and
      toxicant exposures. Study subjects will participate in a series of 4 clinic sessions, each
      visit separated by at least a week, in which they smoke one of 4 tobacco preparations
      (single-blind) using a research grade waterpipe in a randomly assigned sequence in a smoking
      room with sufficiently controlled ventilation rate to keep ambient air CO levels below 25
      ppm. Exhaled CO, whole blood samples and spirometry measures will be collected before and
      immediately after the smoking session. Taste perceptions, liking/disliking, and risk
      perceptions will be determined via questionnaires before, during, and after smoking.
    

Intervention name(s): Questionnaire Administration; Tobacco Smoking
Intervention type(s): Other; Behavioral
Intervention description(s): Ancillary studies; Smoke waterpipe tobacco
Other intervention name(s): Smoking; Tobacco, Smoking
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Single (Participant)
Primary purpose: Other