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

NCT ID: NCT04744285

Last Updated: 2023-12-26

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

115 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-12-04

Study Completion Date

2022-11-18

Brief Summary

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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

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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.

Conditions

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Cigarette Smoking-Related Carcinoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Cigarette packaging

Intervention Type OTHER

receive normal packet cigarette

Data capture

Intervention Type OTHER

Attend video sessions

Questionnaire administration

Intervention Type OTHER

Ancillary studies

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.

Group Type EXPERIMENTAL

Cigarette packaging

Intervention Type OTHER

receive normal packet cigarette

Data capture

Intervention Type OTHER

Attend video sessions

Questionnaire administration

Intervention Type OTHER

Ancillary studies

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

Group Type EXPERIMENTAL

Cigarette packaging

Intervention Type OTHER

receive normal packet cigarette

Data capture

Intervention Type OTHER

Attend video sessions

Questionnaire administration

Intervention Type OTHER

Ancillary studies

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

Group Type EXPERIMENTAL

Cigarette packaging

Intervention Type OTHER

receive normal packet cigarette

Data capture

Intervention Type OTHER

Attend video sessions

Questionnaire administration

Intervention Type OTHER

Ancillary studies

Interventions

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Cigarette packaging

receive normal packet cigarette

Intervention Type OTHER

Data capture

Attend video sessions

Intervention Type OTHER

Questionnaire administration

Ancillary studies

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

21 Years

Maximum Eligible Age

69 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

Roswell Park Cancer Institute

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Richard O'Connor

Role: PRINCIPAL_INVESTIGATOR

Roswell Park Cancer Institute

Locations

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Roswell Park Comprehensive Cancer Center

Buffalo, New York, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

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P01CA217806

Identifier Type: NIH

Identifier Source: secondary_id

View Link

I 757820

Identifier Type: -

Identifier Source: org_study_id