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

NCT04744285 | Completed Results

• 2 other identifiers: I 757820P01CA217806
• Study Type: interventional
• Target: 115
• Locations: 1 country
• Sites: 1

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.

Conditions

Cigarette Smoking-Related Carcinoma

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (1)

• Level of Exhaled Carbon Monoxide (CO)

  At 2 weeks

Study Arms (4)

Condition 1 (normal cigarettes)

ACTIVE COMPARATOR

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; Other: Data capture; Other: Questionnaire administration

Condition II (cigarettes with neutral message)

EXPERIMENTAL

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; Other: Data capture; Other: Questionnaire administration

Condition III (cigarettes with compensation message)

EXPERIMENTAL

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; Other: Data capture; Other: Questionnaire administration

Condition IV cigarettes with blocking message

EXPERIMENTAL

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; Other: Data capture; Other: Questionnaire administration

Interventions

Cigarette packaging OTHER

receive normal packet cigarette

Condition 1 (normal cigarettes); Condition II (cigarettes with neutral message); Condition III (cigarettes with compensation message); Condition IV cigarettes with blocking message

Data capture OTHER

Attend video sessions

Condition 1 (normal cigarettes); Condition II (cigarettes with neutral message); Condition III (cigarettes with compensation message); Condition IV cigarettes with blocking message

Questionnaire administration OTHER

Ancillary studies

Condition 1 (normal cigarettes); Condition II (cigarettes with neutral message); Condition III (cigarettes with compensation message); Condition IV cigarettes with blocking message

Eligibility Criteria

• Age: 21 Years - 69 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Roswell Park Cancer Institute: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Roswell Park Comprehensive Cancer Center

Buffalo, New York, 14263, United States

Location

Results Point of Contact

• Title: Kris Attwood
• Organization: Roswell Park Comprehensive Cancer Center

askroswell@roswellpark.org

877-275-7724

Study Officials

• Richard O'Connor

  Roswell Park Cancer Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 28, 2021
• First Posted: February 8, 2021
• Study Start: December 4, 2020
• Primary Completion: November 18, 2022
• Study Completion: November 18, 2022
• Last Updated: December 26, 2023
• Results First Posted: December 26, 2023

Record last verified: 2023-12

Locations

US (1)