COMET 2 3 1: Effects of Filter Ventilation and Ventilation Information on Product Use Behaviors in Cigarette Smokers
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
PRIMARY OBJECTIVE:
- 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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Condition 1 (normal cigarettes) 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
receive normal packet cigarette
Other: Data capture
Attend video sessions
Other: Questionnaire administration
Ancillary studies
|
| Experimental: Condition II (cigarettes with neutral message) 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
receive normal packet cigarette
Other: Data capture
Attend video sessions
Other: Questionnaire administration
Ancillary studies
|
| Experimental: Condition III (cigarettes with compensation message) 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
receive normal packet cigarette
Other: Data capture
Attend video sessions
Other: Questionnaire administration
Ancillary studies
|
| Experimental: Condition IV cigarettes with blocking message 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
receive normal packet cigarette
Other: Data capture
Attend video sessions
Other: Questionnaire administration
Ancillary studies
|
Outcome Measures
Primary Outcome Measures
- 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 (not at all to extremely).
- Readiness to quit [At 2 weeks]
Will be assessed by contemplation ladder
- 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
Secondary Outcome Measures
- Level of exhaled Carbon Monoxide (CO) [At 2 weeks]
level of CO measured in exhaled breath after a 15 seconds breathhold
Eligibility Criteria
Criteria
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
-
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Roswell Park Comprehensive Cancer Center | Buffalo | New York | United States | 14263 |
Sponsors and Collaborators
- Roswell Park Cancer Institute
- National Cancer Institute (NCI)
Investigators
- Principal Investigator: Richard O'Connor, Roswell Park Cancer Institute
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- I 757820
- P01CA217806