Waterpipe Smoking Clinical Trial
Official title:
The Impact of Waterpipe Tobacco Flavors on Waterpipe Smoking Intentions, Perceptions, Patterns, and Toxicant Exposure
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.
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.
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