Use and Harm Exposure in New Low Nicotine Cigarettes
The proposed research extends previous research on Quest® cigarette smoking behavior by testing whether compensatory smoking occurs as cigarette nicotine level decreases, and whether, as a result, biomarkers of harm exposure increase. This hypothesis will be tested in 210 smokers who report smoking at least 15 cigarettes per day and have been smoking for at least five years and are not currently interested in quitting, but interested in trying a new cigarette product. Participants will be randomized to one of three conditions: 1) smoke their own preferred brand (control group); 2) smoke Quest® cigarettes in progressively decreasing cigarette nicotine level (step-down); or 3) Quest® cigarette non-step-down condition, where they will smoke Quest® cigarettes in a random order. The study will consist of 4 stages beginning with a 5-day preferred own brand cigarette smoking phase for all participants, followed by one of the three cigarette conditions. For those smoking Quest® cigarettes, cigarette nicotine level will change every 10 days, either in a step-down or random fashion. The primary behavioral outcome is smoking topography, a quantitative measurement of smoke exposure. Alveolar carbon monoxide (CO), a validated assessment of smoke exposure, and urine samples to assess carcinogen exposure, specifically NNAL (4-(methylnitrosamino)-1-(3-pyridyl)-1-butanol) and 1-HOP (1-hydroxypyrere), and exhaled breath condensate will also be collected at the laboratory visits. At the initiation of the study, participants will view the Quest® print advertisement and complete a survey related to product expectations in order to determine the impact marketing and advertisement has on beliefs, attitudes and behaviors related to Quest® cigarettes.
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
|Official Title:||Smoking Topography and Harm Exposure in a New Potentially Reduced Exposure Product|
- Smoking topography measures increase as nicotine levels decrease [ Time Frame: Every five days over 35 day study participation ] [ Designated as safety issue: Yes ]
- Nicotine levels effects on smoking topography [ Time Frame: Every 5 days over 35 day study participation. ] [ Designated as safety issue: Yes ]
- Whether smokers' inferences from advertising affect smoking behavior [ Time Frame: Every 5 days over 35 day study participation. ] [ Designated as safety issue: Yes ]
- Whether carbon monoxide boost and biomarkers of harm increase as cigarette nicotine levels decrease [ Time Frame: Every 5 days over 35 day study participation. ] [ Designated as safety issue: Yes ]
|Study Start Date:||July 2007|
|Study Completion Date:||June 2013|
|Primary Completion Date:||May 2013 (Final data collection date for primary outcome measure)|
Participants smoke Quest cigarettes level 1 for 10 days, followed by level 2 for 10 days, and finally by level 3 for 10 days.
Participants smoke Quest cigarettes level 1 for 10 days, level 2 for 10 days, level 3 for 10 days.
No Intervention: Preferred brand
Participants smoke their preferred brand of cigarettes for the duration of the study.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01202942
|United States, Pennsylvania|
|Tobacco Use Research Center, UPenn|
|Philadelphia, Pennsylvania, United States, 19104|