C-FLASH (Cigarillo Flavor and Abuse Liability, Attention, and Substitution in youtH)

NCT04358705 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 658

Last updated 2024-03-06

No results posted yet for this study

Summary

The purpose of this research is to understand how flavor affects young adult's perceptions of little cigar or cigarillo use.

Conditions

  • Smoking Behaviors

Interventions

OTHER

Aim 1: Online survey

This survey will evaluate perceptions of flavors on appeal, purchasing and risk perceptions of cigarillo products among young adult and adolescent cigarillo users. This survey will be used to inform survey design for further aims. As a proxy for biological verification of tobacco use status, data on brand, frequency, and pricing will be collected to confirm user status Participants will rate the role of flavor and report perceptions of product appeal, health risk, advertising exposure and use intentions. Participants will also complete purchase and substitution tasks.

BEHAVIORAL

Eye Tracking Activity

The eye tracking activity consists of a single in-person eye tracking activity that will take place in a private office in Columbus, Ohio where the participant will be seated in a chair within a typical viewing distance from a computer monitor equipped with an infrared camera on the monitor to capture precise eye movements. Participants will have their gaze monitored continuously by the camera on the computer monitor while a randomized set of stimuli (e.g., tobacco product images) are viewed (n=30) for 10 seconds per image. Following each image, an on-screen closed response question will re-center the participant's gaze for standardization prior to the next image.

OTHER

Eye tracking survey

Other Names: Participants will complete a survey using Qualtrics immediately after the eye tracking activity and one week following completion of the activity via email to measure recall of brand name, product flavors, perceptions of cigarillo harm, and tobacco use behaviors and intentions.

BEHAVIORAL

Online Experimental Marketplace (ETM)

Administered online via Qualtrics Participants are given an account balance for use during their assigned ETM based on their average weekly tobacco use calculated from previous interview. Participants will view all four price conditions and all four flavor conditions in random order for a total of 16 rounds Cigarillo price conditions: 1) market price 2) ½ market price 3) 2X market price 4) 4X market price Flavor condition: 1) flavored cigarillos and fruit-flavored disposable-cigarettes available 2) unflavored cigarillos and fruit-flavored ecigarettes available 3) flavored cigarillos and tobacco-flavored e-cigarettes available 4) unflavored cigarillos and tobacco-flavored e-cigarettes available. Participants will purchase cigarillos with their account balance. During all ETM conditions, constant-priced alternative tobacco products (smokeless tobacco, nicotine lozenges, nicotine gum, and the nicotine patch) will be available in addition to the cigarillos and e-cigarettes.

OTHER

Aim 3 survey

Consists of: * A screener and demographic data collection. * A tobacco product withdrawal scale * Upon completion of the ETM, participants will be asked to respond to a quality assurance question regarding the conditions that varied. Participants will be shown a list of 8 possible conditions and must chose one of the three that varied in order to be eligible to receive compensation. * The tobacco product withdrawal scale again * Measurements of nicotine dependence and flavor preferences

OTHER

Cognitive Interviews

Cognitive Interviews will be done in-person, using Zoom, or over the phone. Interviews will be video or audio recorded. . The participant will be given a select section of the survey questions from Aim 1. The survey will be uploaded to Qualtrics to reflect the way that survey would be conducted in Aim 1. With the survey questions in front of the participant on the computer screen, research personnel will ask probing questions about each one of the survey questions. If the participant is not able to participate in person or via Zoom, they will be allowed to be interview over the phone with access to the Qualtrics survey or a paper form. If the participant is unable to access the internet, the participant will be read the questions by research personnel. The participant will provide feedback about the questions and walk the research personnel through their thought process for approaching each survey question.

OTHER

Supplemental Aim 1 Interviews

Participants from the preceding online survey (who identify as women from Aim 1/supplemental aim 1 survey) who agreed to be contacted for future study will be emailed an invitation to the eligibility screener. Individuals interested will complete a screener to ensure participants identify as women and to verify that they have ever used cigarillos. Eligible participants will be contacted to schedule a 60- to 90-minute Zoom interview about their tobacco, nicotine, and cannabis product use experiences, with particular focus on flavored cigarillo usage initiation, current use, and responses to potential flavor restrictions.

Sponsors & Collaborators

  • Case Comprehensive Cancer Center

    lead OTHER

Principal Investigators

  • Erika Trapl, PhD · Case Western Reserve University, Case Comprehensive Cancer Center

Study Design

Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
16 Years
Max Age
28 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-05-29
Primary Completion
2023-02-10
Completion
2023-02-10

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04358705 on ClinicalTrials.gov