The Impact of Waterpipe Tobacco Flavors on Waterpipe Smoking Intentions, Perceptions, Patterns, and Toxicant Exposure
Condition: Smoking, Hookah; Waterpipe Smoking
Study type: Interventional

Summary: 
      The overall aim of the current study is to determine if flavorings contribute to the
      initiation and maintenance of waterpipe (WP) smoking and also influence how a WP is smoked,
      which has implications for both risk of dependence but also smokers' level of exposure to
      tobacco-related toxicants. A total of 94 current WP smokers (47 low dependent, 47 high
      dependent) will be recruited. Based on our team's previous studies we conservatively assume a
      20% attrition rate; thus, we will need to recruit 94 participants to have 76 complete all
      four sessions. Consistent with other laboratory studies of waterpipe smoking, participants
      who meet the following eligibility criteria will be asked to take part in the study.
    

Detailed description: 
      After completing the initial screening by phone, participants will be informed of the study
      procedures and invited to the lab to complete three WP smoking sessions. Participants will
      perform exhaled carbon monoxide testing (eCO< 10ppm) and confirm that they have not used any
      nicotine/tobacco/marijuana products over the last 12 hours. Pregnancy exclusion will also be
      confirmed with a urine test, and pregnancy tests will be completed at each visit throughout
      the study. Participants will be randomized and complete study procedures in self-selected
      dyads. The sessions will be counterbalanced and include: 1) smoking preferred
      flavored-sweetened WP tobacco, 2) smoking unflavored-sweetened WP tobacco, and 3) smoking
      unflavored-very low sweetened WP tobacco. Participants will complete all three study visits
      in the laboratory. Pre-session abstinence from tobacco for at least 12 hours will be
      mandatory for all participants. Abstinence will be confirmed via participant self-report and
      an exhaled carbon monoxide monitor (< 20 ppm) for tobacco use. Participant dyads will smoke
      hookah ad libitum for up to 1 hour. This procedure will be completed for all visits.
      Participants will also complete a minimum 48-hour washout period between sessions.

      Participants will not be allowed to eat, drink or use their phone during the session.
      Initially, one piece of charcoal will be lit and placed on top of the foil. Our preliminary
      studies, as well as other WP laboratory trials, indicate that one piece of charcoal will not
      be sufficient for one WP session; thus, participants will be provided additional pre-weighed
      pieces to use as they wish. Use of additional charcoal will be recorded. Participants will
      smoke ad libitum and a WP puff topography device will discretely record smoking behavior
      throughout the session, including puff duration, number of puffs, puff volume, puff flow
      rate, and time between puffs. Blood samples (15mL per sample) and eCO will be collected
      immediately pre- and post-waterpipe session. Self-report measures will be administered.
    

Intervention name(s): Flavored-Sweetened Waterpipe Tobacco; Unflavored-sweetened waterpipe tobacco; Unflavored-very low sweetened waterpipe tobacco; Flavored-very low sweetened waterpipe
Intervention type(s): Behavioral; Behavioral; Behavioral; Behavioral
Intervention description(s): Pre-weighed flavored-sweetened waterpipe tobacco will be prepared.; Pre-weighed unflavored-sweetened waterpipe tobacco will be prepared.; Pre-weighed unflavored-very low sweetened waterpipe tobacco will be prepared.; Pre-weighed flavored-very low sweetened waterpipe tobacco will be prepared.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Health Services Research