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

Not Applicable

Completed

Conditions: Cigarette Smoking-Related Carcinoma

Interventions: Other: Cigarette packaging
Other: Data capture
Other: Questionnaire administration

Registration Number: NCT04744285

Lead Sponsor: Roswell Park Cancer Institute

Brief Summary: 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: 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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 115

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Condition 1 (normal cigarettes)	Data capture	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 III (cigarettes with compensation message)	Cigarette packaging	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 cigarettes with blocking message	Questionnaire administration	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
Condition 1 (normal cigarettes)	Cigarette packaging	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 1 (normal cigarettes)	Questionnaire administration	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 (cigarettes with neutral message)	Cigarette packaging	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 II (cigarettes with neutral message)	Data capture	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 II (cigarettes with neutral message)	Questionnaire administration	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 (cigarettes with compensation message)	Data capture	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 III (cigarettes with compensation message)	Questionnaire administration	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 cigarettes with blocking message	Cigarette packaging	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
Condition IV cigarettes with blocking message	Data capture	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

Primary Outcome Measures

Name	Time	Method
Subjective Questionnaires of Product Evaluation	At 2 weeks	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).
Readiness to Quit	At 2 weeks	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.
Withdrawal	At 2 weeks	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.