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

Cigarette Smoking-Related Carcinoma Clinical Trial

— COMET 2 3 1  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04744285
• Other study ID #: I 757820
• Secondary ID: P01CA217806
• Status: Completed
• Phase: N/A
• Start date: December 4, 2020
• Est. completion date: November 18, 2022

Study information

• Verified date: December 2023
• Source: Roswell Park Cancer Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 115
• Est. completion date: November 18, 2022
• Est. primary completion date: November 18, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 69 Years

Eligibility

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

Related Conditions & MeSH terms

• Cigarette Smoking-Related Carcinoma

Intervention

Other:
• Cigarette packaging
receive normal packet cigarette
• Data capture
Attend video sessions
• Questionnaire administration
Ancillary studies

Locations

Country	Name	City	State
United States	Roswell Park Comprehensive Cancer Center	Buffalo	New York

Sponsors (2)

Lead Sponsor	Collaborator
Roswell Park Cancer Institute	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	Level of Exhaled Carbon Monoxide (CO)	level of CO measured in exhaled breath after a 15 seconds breathhold	At 2 weeks