N/A
N=80
The Impact of Waterpipe Tobacco Flavors on Waterpipe Smoking Intentions, Perceptions, Patterns, and Toxicant Exposure
Smoking, Hookah · Waterpipe Smoking
Bottom Line
View on ClinicalTrials.gov: NCT03232827 ↗Enrolled (actual)
80
Serious AEs
0.0%
Results posted
Jun 2019
Primary outcome: Primary: Level of Smoke Inhalation Measured by Topography Device — 50.96; 77.79; 63.17; 51.60 Liters
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Flavored-Sweetened Waterpipe Tobacco (Behavioral); Unflavored-sweetened waterpipe tobacco (Behavioral); Unflavored-very low sweetened waterpipe tobacco (Behavioral); Flavored-very low sweetened waterpipe (Behavioral)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Oklahoma
- Primary completion
- Mar 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Level of Smoke Inhalation Measured by Topography Device |
50.96; 77.79; 63.17; 51.60 | — |
| SECONDARY Levels of Smoke Inhalation Between High vs. Low Dependent WP |
42.18; 55.85; 46.18; 39.43; 32.15; 57.31 | — |
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.
Eligibility Criteria
Inclusion Criteria
- current water pipe smoker for at least the past 6 months
- smoke water pipe at least 3 times in the last 6 months
- Lebanese Waterpipe Dependence Scale-11 (LWDS-11) score of ≤9 (Low Dependence) or ≥10 (High Dependence)
- between 18-50 years old
- willing to provide informed consent
- abstain from all tobacco, nicotine, and marijuana use for at least 12 hours prior to each of the three sessions
Exclusion Criteria
- self-reported diagnosis of lung disease including asthma, cystic fibrosis, or chronic obstructive pulmonary disease
- currently pregnant, planning to become pregnant, or breastfeeding
- history of cardiac event or distress within the last 3 months
- any use of other illicit drugs during the last 30 days.
Data sourced from ClinicalTrials.gov (NCT03232827). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.