The purpose of this study is to examine the effect of changes in cigarette package color on smoking behaviors, harm exposure, and risk perceptions when using low nicotine content (LNC) cigarettes.
This project will utilize a randomized, parallel-design trial to examine the effects of low nicotine content (LNC) cigarette packaging on smoking behaviors, harm exposure, risk perceptions, and subjective ratings of cigarettes. The investigators will aim to recruit and randomize 500 daily smokers (\~250 male, \~250 female) in a 35-day protocol. After completing a 5-day baseline period of smoking their own brand, participants will be randomized to a 30-day experimental period when they will receive either their own preferred brand (control), or LNC cigarettes in one of four types of packaging: standard investigational (gray packaging); red, or blue (tobacco industry strategy); or plain packaging (tobacco control strategy). Participants will be asked to attend 5 in-person sessions at the Center for Interdisciplinary Research on Nicotine Addiction (CIRNA) on Days 0, 5, 10, 20 \& 35. At Intake and Days 15, 25 and 30 participants will complete sessions with research staff remotely (i.e. by video call). Sessions will occur every 4-6 days, for a total of 5 in-person and 4 remote sessions across 35 days.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Enrollment
219
After completing a 5-day baseline period of smoking their own brand, participants will be randomized to a 30-day experimental period when they will receive low nicotine content cigarettes in one of four types of packaging: gray, red, blue, or plain.
After completing a 5-day baseline period of smoking their own brand, participants will be randomized to a 30-day experimental period when they will receive their own preferred brand of cigarette (i.e., control).
Center for Interdisciplinary Research for Nicotine Addiction
Philadelphia, Pennsylvania, United States
Daily Cigarette Consumption
Daily cigarette consumption will be assessed by participant self-report and verified through collection of spent filters for all cigarettes smoked throughout the entire 35-day study.
Time frame: Day 0 through Day 35
Total Puff Volume/Puff Duration
Total puff volume/puff duration (the sum of all puff volumes/duration per cigarette) will be collected for each cigarette smoked during each laboratory session using a standardized video scoring procedure. Total puff volume will be assessed for each cigarette smoked at in-person and remote sessions throughout the entire 35-day study.
Time frame: Day 0 through Day 35
Carbon Monoxide (CO)
The investigators will assess CO (measured in parts per million \[ppm\]), a measure of toxicant exposure, at the onset of each session, as well as before and after each cigarette smoked during each in-person laboratory session. CO collected at the onset of each session represents daily exposure, while CO boost - the change in CO values before and after smoking a cigarette - estimates smoke exposure due to smoking an individual cigarette.
Time frame: Days 0, 5, 10, 20 and 35
Total Nicotine Equivalents
Urine collected at Day 5 and Day 35 will be assessed for changes in total nicotine equivalents, nicotine plus its primary metabolites, across the experimental study period (Days 5-35). Total nicotine equivalents will be measured in nanograms per milliliter (ng per mL).
Time frame: Days 5 and 35
Total NNAL
Urine collected at D5 and D35 will be assessed for changes in NNAL, a biomarker of carcinogen exposure, across the experimental study period (Days 5-35). Total NNAL will be measured in nanograms per milliliter (ng per mL).
Time frame: Days 5 and 35
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Subjective Cigarette Ratings (Visual Analog Scale [VAS] of Cigarette Characteristics)
Participants will provide subjective ratings of each cigarette smoked during each in-person laboratory session using a 14-item, 100 mm visual analog scale (VAS) of cigarette characteristics. Anchors are item-specific (e.g., taste: 0 = "very bad," 100 = "very good"), with lower scores indicating less favorable ratings.
Time frame: Days 0, 5, 10, 20 and 35
Cigarette Risk Beliefs
To assess risk beliefs about the assigned cigarettes, the investigators will use an 8-item, 5-point scale (1 = definitely untrue; 5 = definitely true) including previously validated items (i.e., "Compared to your own cigarettes, the cigarettes you are currently smoking: are lower in nicotine"). The Cigarette Risk Beliefs questionnaire will be administered at Session 1 (Day 0) before the lab cigarette (18-item baseline version), Session 2 (Day 5) before lab cigarette 1 and 2, Session 5 (Day 20) before the lab cigarette, and Session 8 (Day 35) before the lab cigarette.
Time frame: Days 0, 5, 20, and 35
Cigarette Craving (Questionnaire on Smoking Urges [QSU])
Participants will report cigarette craving at the onset of each in-person session. Craving will be assessed using a summary score and two factor subscales (i.e., desire to smoke and craving due to anticipation of negative affect relief) from a 32-item Questionnaire on Smoking Urges (QSU). Participants will respond to each item along a 7-point scale (1=Strongly disagree; 7=Strongly agree).
Time frame: Days 0, 5, 10, 20 and 35
Cigarette Withdrawal (Withdrawal Symptom Checklist [WSC])
Participants will report cigarette withdrawal at the onset of each in-person session. Withdrawal will be assessed using a summary score from the 20-item (21 items at Session 1 \[Day 0\]) revised version of the Withdrawal Symptom Checklist with a one-week frame of reference (WSC-W). Specifically, participants will respond regarding to how they felt in regards to each potential withdrawal symptom along a 4-point scale (0=Not Present; 3=Severe).
Time frame: : Days 0, 5, 10, 20 and 35
Total Puff Count
Participants will be video recorded while smoking each lab cigarette in order to collect smoking topography data. During remote sessions, participants will be asked to record a video of their smoking to collect smoking topography data. We have previously used a procedure where we score digital files (video recorded) smoking sessions that has good reliability and consistency (ICCs \>.55) for number of puffs taken, interpuff interval, total time lit, and amount smoked (by mass and length), and propose to quantify cigarette smoking behavior using the same procedures.
Time frame: Day 0 through Day 35
Puff Duration
Participants will be video recorded while smoking each lab cigarette in order to collect smoking topography data. During remote sessions, participants will be asked to record a video of their smoking to collect smoking topography data. We have previously used a procedure where we score digital files (video recorded) smoking sessions that has good reliability and consistency (ICCs \>.55) for number of puffs taken, interpuff interval, total time lit, and amount smoked (by mass and length), and propose to quantify cigarette smoking behavior using the same procedures.
Time frame: Day 0 through Day 35