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

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

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.

Study Overview

• Status: Completed
• Conditions: Cigarette Smoking-Related Carcinoma
• Intervention / Treatment: Other: Questionnaire administration; Other: Cigarette packaging; Other: Data capture

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.

• Study Type: Interventional
• Enrollment (Actual): 115
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • Buffalo, New York, United States, 14263
      • Roswell Park Comprehensive Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 69 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

4

Arms and Interventions

Participant Group / 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: Questionnaire administration; Ancillary studies; Other: Cigarette packaging; receive normal packet cigarette; Other: Data capture; Attend video sessions
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: Questionnaire administration; Ancillary studies; Other: Cigarette packaging; receive normal packet cigarette; Other: Data capture; Attend video sessions
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: Questionnaire administration; Ancillary studies; Other: Cigarette packaging; receive normal packet cigarette; Other: Data capture; Attend video sessions
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: Questionnaire administration; Ancillary studies; Other: Cigarette packaging; receive normal packet cigarette; Other: Data capture; Attend video sessions

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Roswell Park Cancer Institute
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Richard O'Connor, Roswell Park Cancer Institute

Study record dates

Study Major Dates

• Study Start (Actual): December 4, 2020
• Primary Completion (Actual): November 18, 2022
• Study Completion (Actual): November 18, 2022

Study Registration Dates

• First Submitted: January 28, 2021
• First Submitted That Met QC Criteria: February 4, 2021
• First Posted (Actual): February 8, 2021

Study Record Updates

• Last Update Posted (Actual): December 26, 2023
• Last Update Submitted That Met QC Criteria: December 14, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: I 757820; P01CA217806 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No