Effects of Implicit Messaging by Cigarette Pack Color on Smoking Behaviors
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|ClinicalTrials.gov Identifier: NCT02301351|
Recruitment Status : Completed
First Posted : November 25, 2014
Last Update Posted : April 16, 2019
|Condition or disease||Intervention/treatment||Phase|
|Cigarette Smoking Behavior||Other: Graphic Warning Label Other: Text Warning Label||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||316 participants|
|Intervention Model:||Factorial Assignment|
|Official Title:||Effects of Implicit Messaging by Cigarette Pack Color on Smoking Behaviors|
|Actual Study Start Date :||October 2014|
|Actual Primary Completion Date :||April 2019|
|Actual Study Completion Date :||April 12, 2019|
Graphic Warning Label
Days 5-50: Participants will receive cigarette packs as per the study randomization schema (e.g. three15-day periods of red, gold, and plain packs; order counterbalanced within subject) with FDA-approved graphic warning labels.
Other: Graphic Warning Label
All packs provided will include FDA-approved graphic warning labels
Text Warning Label
Days 5-50: Participants will receive cigarette packs as per the study randomization schema (e.g. three15-day periods of red, gold, and plain packs; order counterbalanced within subject) with standard text warning labels.
Other: Text Warning Label
All packs provided will include standard text warning labels
- Daily Cigarette Rate (smoking behavior) [ Time Frame: Days 0-50 ]Daily cigarette consumption will be determined by the difference of unused cigarettes and used cigarette filters returned to the Center every Session after Day 0.The number of used cigarette filters and self-reported daily smoking rate will be recorded on a Smoking Rate Data Collection Form. We will examine changes in daily cigarette consumption averaged over each of the three 15-day pack periods.
- Smoking Topography [ Time Frame: Days 0, 5, 10, 15, 20, 25, 30, 35, 40, 45, & 50 ]All lab cigarettes will be smoked using a smoking topography machine. This device is specifically designed to collect smoking topography variables. A cigarette is placed in a sterilized mouthpiece, and the internal pressure transducer measures pressure changes that occur during inhalation. The pressure changes are amplified, digitized and sampled at 1000 Hz, then software converts the signal to airflow (ml/s) in real time (s), and from this provides number of puffs, puff volume, puff duration, maximum flow, and interpuff interval (time between puffs). The primary topography outcome is total puff volume, due to its well- characterized responsiveness to changes in cigarette type. However, the smoking topography device collects additional measures that will be considered for exploratory analyses. The primary analyses to test study hypotheses will use average puff volume across clinic days within each period.
- Subjective Cigarette Ratings [ Time Frame: Days 0, 5, 10, 15, 20, 25, 30, 35, 40, 45, & 50 ]We will use our previous visual analog scale (VAS) to examine changes in subjective ratings using a 100 mm scale that has been used in previous smoking studies, including those used by the tobacco industry. Items include: strength, heat, draw, smoke smell, and burn rate. Composite ratings will be calculated in identical fashion to those described for the smoking topography outcome measures. Subjective cigarette ratings will be assessed after each cigarette smoked in the laboratory across all sessions.
- Carbon Monoxide (CO) [ Time Frame: Days 0, 5, 10, 15, 20, 25, 30, 35, 40, 45, & 50 ]CO measures will be assessed at the onset of each session, and then before and after each cigarette smoked in the lab. The device has a digital screen which reports CO in parts per million (ppm). Participants will provide a CO breath sample using standard procedures; the largest steady reading will be recorded as the recorded CO level.
- Attitudes and Intentions (to use product) [ Time Frame: Days 0, 5, 20, 35, & 50 ]We will assess participants' attitudes and intentions toward the cigarette packs and their using the 'new' cigarette, similar to our previous work on cigarette smoking that applied the Reasoned Action Approach. We will use Likert-type semantic differential scales (likely to use/not use, using product is enjoyable/non enjoyable, harmful/not harmful). Because the study is designed to assess changes in smoking behavior and beliefs, the Theory of Reasoned Action would postulate that changes in product use would be mediated by changes in attitudes, and then intentions.
- Cigarette Risk Beliefs [ Time Frame: Days 0, 5, 20, 35, & 50 ]To assess risk beliefs about participants' own brand of cigarettes on Day 0, we will use an 18-item, 5-point scale (1 = definitely not true; 5 = definitely true) including previously validated items assessing smokers' beliefs on cigarette harm. During applicable sessions post Day 0, participants will complete an 8-item, 5-point scale based on their assigned cigarettes. The Cigarette Risk Beliefs questionnaire will be administered on Day 0 before lab cigarette 1 (18-item baseline version), Day 5 before lab cigarette 1 and 2, Day 20 before lab cigarette 1 and 2, Day 35 before lab cigarette 1 and 2, and Day 50 before lab cigarette 1. The Cigarette Risk Beliefs questionnaire will be completed as the participant physically views a pack of their cigarette pack assignment (or own brand on Day 0) as per the randomization schema.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02301351
|United States, Pennsylvania|
|Center for Interdisciplinary Research on Nicotine Addiction, University of Pennsylvania|
|Philadelphia, Pennsylvania, United States, 19104|
|Principal Investigator:||Andrew Strasser, Ph.D.||University of Pennsylvania|