Effects of Filter Ventilation and Ventilation Information on Product Use Behaviors in Cigarette Smokers

Study Overview
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Brief Summary
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This clinical trial collects data to see how filter ventilation and ventilation information affects product use behaviors in cigarette smokers. Providing ventilation information on the cigarette package may affect smokers' rating of product appeal, perceptions of health risk, and changes in cigarette consumption.

Detailed Description
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PRIMARY OBJECTIVE: I. To assess how adding messaging to cigarette packages about filter vents and filters influences respondents awareness of filter ventilation, beliefs about the function of filter vents and filters, smoking behavior, ratings of cigarette satisfaction, smoking topography, exposure to nicotine and carbon monoxide, perceptions about the risk of smoking, and intention to stop smoking. OUTLINE: Participants are randomized to 1 of 4 conditions. CONDITION I: Participants receive regular package cigarettes for 2 weeks. Participants attend 3 video sessions over 0.5 hour each at baseline, 1, and 2 weeks respectively for data collection. CONDITION II: Participants receive cigarettes with neutral message Nothing about this product's color or name means that it will protect a smoker from the health risks of smoking on package for 2 weeks. Participants attend 3 video sessions over 0.5 hour each at baseline, 1, and 2 weeks respectively for data collection. CONDITION III: Participants receive cigarettes with compensation message This product has a ventilated filter. Filter vents increase how deeply a smoker inhales without them knowing, which can increase the health risks of smoking on package for 2 weeks. Participants attend 3 video sessions over 0.5 hour each at baseline, 1, and 2 weeks respectively for data collection. CONDITION IV: Participants receive cigarettes with blocking message This product has a ventilated filter. Be sure not to block the vent holes with your fingers or lips, which can increase the health risks of smoking for 2 weeks. Participants attend 3 video sessions over 0.5 hour each at baseline, 1, and 2 weeks respectively for data collection.

Official Title
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Effects of Filter Ventilation and Ventilation Information on Product Use Behaviors in Cigarette Smokers (COMET 2 3 1)

Conditions
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Cigarette Smoking-Related Carcinoma

Intervention / Treatment
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* Other: Cigarette packaging
* Other: Data capture
* Other: Questionnaire administration


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Aged 21-69 years old Currently smoking daily, at least 5 cigarettes per day, for the past year: * Primarily using factory-made filtered cigarettes Fair and above self-rated physical health (self-rated) Fair and above self-rated mental health (self-rated) Not planning to quit smoking in the next 30 days Able to converse, read, and write in English Access to smartphone (e.g., iPhone, Android) for Ecological Momentary Assessment (EMA) component Access to a smartphone/tablet/computer with video capabilities and internet access for remote videoconferencing (EMA check-ins) Alcohol Use Disorders Identification Test (AUDIT)-C <7 (i.e., no problematic alcohol consumption) Cannibis use less than or equal to 5 days in the past month No other illegal drug use in the past month (allow for prescription) Not pregnant or breastfeeding or planning to become pregnant during the study period Participant must understand the investigational nature of this study and sign an Independent Ethics Committee/Institutional Review Board approved written informed consent form prior to receiving any study related procedure Exclusion Criteria: Age < 21 or > 69 Using roll-your-own cigarettes or usual brand of cigarettes is unfiltered Planning to quit smoking in the next 30 days Adults unable to consent Minors (any persons under age 21) Prisoners Poor physical health by self-report Poor mental health by self-report: * Exclude Dx psychosis, Dx bipolar, K6 score indicating serious psychological distress AUDIT-C score >=7 (i.e. problematic alcohol consumption) Cannabis use >5 days in past month Other illegal drug use in past month Pregnant or breastfeeding by self-report No access to smartphone or videoconferencing

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 69 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Condition 1 (normal cigarettes)<br>Participants receive regular package cigarettes for 2 weeks. Participants attend 3 video sessions over 0.5 hour each at baseline, 1, and 2 weeks respectively for data collection. | Other: Cigarette packaging<br>* receive normal packet cigarette<br>Other: Data capture<br>* Attend video sessions<br>Other: Questionnaire administration<br>* Ancillary studies<br>|
| Experimental: Condition II (cigarettes with neutral message)<br>Participants receive cigarettes with neutral message Nothing about this product's color or name means that it will protect a smoker from the health risks of smoking on package for 2 weeks. Participants attend 3 video sessions over 0.5 hour each at baseline, 1, and 2 weeks respectively for data collection. | Other: Cigarette packaging<br>* receive normal packet cigarette<br>Other: Data capture<br>* Attend video sessions<br>Other: Questionnaire administration<br>* Ancillary studies<br>|
| Experimental: Condition III (cigarettes with compensation message)<br>Participants receive cigarettes with compensation message This product has a ventilated filter. Filter vents increase how deeply a smoker inhales without them knowing, which can increase the health risks of smoking on package for 2 weeks. Participants attend 3 video sessions over 0.5 hour each at baseline, 1, and 2 weeks respectively for data collection | Other: Cigarette packaging<br>* receive normal packet cigarette<br>Other: Data capture<br>* Attend video sessions<br>Other: Questionnaire administration<br>* Ancillary studies<br>|
| Experimental: Condition IV cigarettes with blocking message<br>Participants receive cigarettes with blocking message This product has a ventilated filter. Be sure not to block the vent holes with your fingers or lips, which can increase the health risks of smoking for 2 weeks. Participants attend 3 video sessions over 0.5 hour each at baseline, 1, and 2 weeks respectively for data collection | Other: Cigarette packaging<br>* receive normal packet cigarette<br>Other: Data capture<br>* Attend video sessions<br>Other: Questionnaire administration<br>* Ancillary studies<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subjective Questionnaires of Product Evaluation | Will be assessed by Duke Sensory Scale. A 9 item questionnaire with nine items that assess participants' sensory experience All questions are rated on a 7-point Likert scale (with 1 meaning -not at all to 7 - meaning extremely). | At 2 weeks | 
| Readiness to Quit | Will be assessed by contemplation ladder. This is a 0 to 10 scale, where 0 indicates no willingness/readiness to quit and 10 indicates willing/ready to quit immediately. | At 2 weeks | 
| Withdrawal | Will be assessed by Minnesota Tobacco Withdrawal Scale - a 15 item question scale - with scale of 0 -4, 0=Not at all - 4=Severe. A total score is obtained by summing all 15 items. | At 2 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Level of Exhaled Carbon Monoxide (CO) | level of CO measured in exhaled breath after a 15 seconds breathhold | At 2 weeks |