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Completed

NCT Number: NCT04744285

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

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.

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Key information

Age range

21 year–69 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Roswell Park Comprehensive Cancer Center

Buffalo, New York, 14263, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cigarette packaging

Other

receive normal packet cigarette

Data Capture

Other

Attend video sessions

Questionnaire Administration

Other

Ancillary studies

Primary outcomes

  1. Subjective Questionnaires of Product Evaluation

    Time frame: 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).

  2. Readiness to Quit

    Time frame: 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.

  3. Withdrawal

    Time frame: 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.

Secondary outcomes

  1. Level of Exhaled Carbon Monoxide (CO)

    Time frame: At 2 weeks

    level of CO measured in exhaled breath after a 15 seconds breathhold

Sponsors and collaborators

Lead sponsor

Roswell Park Cancer Institute

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

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

Acronym: COMET 2 3 1

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Feb 8, 2021
Registry last updated
Dec 26, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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