Clinical trial NCT04744285: Effects of Filter Ventilation and Ventilation Information on Product Use Behaviors in Cigarette Smokers
Official title: Effects of Filter Ventilation and Ventilation Information on Product Use Behaviors in Cigarette Smokers (COMET 2 3 1)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cigarette Smoking-Related Carcinoma
Lead sponsor: Roswell Park Cancer Institute
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2021-02-08
Enrollment: 115
Sex: ALL
Minimum age (years): 21
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility 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
  * 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

Primary outcomes:
measure: Subjective Questionnaires of Product Evaluation
timeFrame: At 2 weeks
measure: Readiness to Quit
timeFrame: At 2 weeks
measure: Withdrawal
timeFrame: At 2 weeks
Secondary outcomes:
measure: Level of Exhaled Carbon Monoxide (CO)
timeFrame: At 2 weeks
Other outcomes:
Locations:
city: Buffalo
country: United States
facility: Roswell Park Comprehensive Cancer Center
state: New York
Study officials:
affiliation: Roswell Park Cancer Institute
name: Richard O'Connor
role: PRINCIPAL_INVESTIGATOR
References: