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

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

Detailed Description
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The overall goal of this study is to examine and better understand adolescent and young adult perceptions, visual attention, use intentions and purchasing behaviors among users and non-users of cigarillos. Supplemental Aim 1: Consists of evaluation of the differences in perceptions of flavors on appeal, purchasing and risk perceptions of cigarillo products between young adult sexual and gender minorities (SGM) and heterosexual females. A convenience sample of SGM females will be recruited using online social media platforms with targeted advertising. From the parent survey (or Aim 1), an existing sample of female heterosexual cigarillo users will be leveraged. Both samples will receive the same survey, Aim 1, to compare perceptions of appeal, risk, and purchasing across cigarillos and other tobacco products. Aim 1 of this study is exploratory and will consist of an online survey. Findings from Aim 1 will inform the questions asked about advertising and product use in Aim 2 and 3. Both Aim 2 and 3 are randomized sections. Participants in Aim 2 are either tobacco users or non-users. Participants will be asked to view a series of tobacco related images. The sequence of those images is randomized. In Aim 3, participants will be randomized in terms of the options they are presented within the Experimental Tobacco Marketplace (ETM) (i.e. which tobacco items they can purchase and at what price). Supplemental Aim 3 consists of evaluating the differences in the abuse liability/addictive potential of flavored versus unflavored cigarillos and the substitutability of flavored versus unflavored disposable e-cigarettes between young adult sexual and gender minorities (SGM) and heterosexual females. SGM female cigarillousers will be recruited from participants of the Supplemental Aim 1 sample and be compared to heterosexual female participants of the parent study (or Aim 3). Both samples will receive the same questions and be exposed to the same ETM conditions tocompare perceptions of appeal of flavors and substitutability between cigarillos, e-cigarettes, and other tobacco products.

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

Conditions
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Smoking Behaviors

Intervention / Treatment
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* Other: Aim 1: Online survey
* Behavioral: Eye Tracking Activity
* Other: Eye tracking survey
* Behavioral: Online Experimental Marketplace (ETM)
* Other: Aim 3 survey
* Other: Cognitive Interviews


Participation Criteria
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Eligibility Criteria
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Aim 1: Inclusion Criteria: Individuals who have smoked an average of 2 cigarillos per week over the past month. Individuals willing to provide informed consent and participate in the online survey. Exclusion Criteria - Individuals who have never smoked a cigarillo Supplemental Aim 1: Inclusion Criteria: Individuals who have smoked an average of 2 cigarillos per week over the past month. Individuals willing to provide informed consent and participate in the online survey. Individuals who identify as female, trans-female/woman, or non-binary Individuals who identify as not heterosexual Exclusion Criteria: Individuals who currently do not smoke at least 2 cigarillos per week Individuals who identify as male or trans-man Individuals who identify as heterosexual Cognitive Interviews: Inclusion Criteria Sample 1: Individuals who have smoked an average of 2 cigarillos per week over the past month and did not smoke an average of 2 e-cigarettes per week over the past month Sample 2: Individuals who have smoked an average of 2 e-cigarettes per week over the past month and did not smoke an average of 2 cigarillos per week over the past month Sample 3: Individuals who have smoked an average of 2 cigarillos AND 2 e-cigarettes per week over the past month Sample 4: Individuals who have never smoked tobacco or used nicotine products Individuals willing to provide informed consent and participate in a qualitative interview. Aim 2: Inclusion Criteria Individuals not having chronic eye diseases known to interfere with eye tracking equipment (i.e. glaucoma, regression lenses, cataracts, etc.) Individuals currently living in Cuyahoga County, Ohio Individuals willing to provide informed consent or assent and participate in the online survey. Exclusion Criteria: Individuals with chronic eye diseases that could interfere with eye tracking equipment Pregnant females Individuals unable to use the CO2 monitor Aim 3: Inclusion Criteria: - Individuals who smoked 2 cigarillos per week over the past month. Exclusion Criteria: Individuals who currently do not smoke at least 2 cigarillos per week Females who are pregnant or lactating Supplemental Aim 3: Inclusion Criteria: Individuals who smoked 2 cigarillos a week over the past month Individuals who identify as female, trans-female/woman, or non-binary Individuals who identify as lesbian, bisexual, pansexual, or queer Exclusion Criteria: Individuals who currently do not smoke at least 2 cigarillos per week Individuals who identify as male or transman Individuals who identify as heterosexual Females who are pregnant or lactating

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 28 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Young Cigarillo User (YCU) Sample<br>Aim 1: Online survey. 392 participants from the full YCU sample Supplemental Aim 1: A sample of 196 heterosexual females from the Aim 1 survey will be compared to the SGM females Aim 2: Eye tracking activity - A total of 152 participants divided between current/past cigarillo users and non-cigarillo users. These 76 cigarillo users will be accrued from YCU sample participants who participated in Aim 1 and live in the Cleveland, Ohio Aim 3: (A total of 162 participants from Aim 1 survey). Consists of the Online Electronic Tobacco Marketplace (ETM) and the aim 3 survey components in the following order: Demographic screener questions Tobacco product withdrawal scale ETM Quality Assurance Question Tobacco product withdrawal scale Survey (nicotine dependence & flavor preferences) A sample of 88 heterosexual females from the 162 Aim 3 participants will be compared with 88 SGM participants from supplemental Aim 1 | Other: Aim 1: Online survey<br>* 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.<br>Behavioral: Eye Tracking Activity<br>* The eye tracking activity consists of a single in-person eye tracking activity that will take place in a private office 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 (product advertisements) are viewed (n=30) for 10 seconds per image. Following each advertisement, an on-screen closed response question will re-center the participant's gaze for standardization prior to the next image<br>Other: Eye tracking survey<br>* 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.<br>Behavioral: Online Experimental Marketplace (ETM)<br>* 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.<br>Other: Aim 3 survey<br>* 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<br>|
| Experimental: Sexual and Gender Minority (SGM) Female Cigarillo Users<br>Supplemental Aim 1: An online convenience sample of 196 SGM females will complete the Aim 1 online survey and will be compared to sample of 196 heterosexual females from the YCU sample Supplemental Aim 3: (88 SGM females who participated in the Supplemental Aim 1 survey). Consists of the ETM and the aim 3 survey components in the following order: Demographic screener questions Tobacco product withdrawal scale ETM Quality Assurance Question Tobacco product withdrawal scale Survey (nicotine dependence & flavor preferences) | Other: Aim 1: Online survey<br>* 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.<br>Behavioral: Eye Tracking Activity<br>* The eye tracking activity consists of a single in-person eye tracking activity that will take place in a private office 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 (product advertisements) are viewed (n=30) for 10 seconds per image. Following each advertisement, an on-screen closed response question will re-center the participant's gaze for standardization prior to the next image<br>Other: Eye tracking survey<br>* 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.<br>Behavioral: Online Experimental Marketplace (ETM)<br>* 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.<br>Other: Aim 3 survey<br>* 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<br>|
| Experimental: Aim 2 - Non-cigarillo users<br>Aim 2: (Eye tracking activity) A total of 152 participants divided between current/past cigarillo users and non-cigarillo users. These 76 non-cigarillo users will be accrued by means of social media posts and flyers at places that youth most likely frequent | Behavioral: Eye Tracking Activity<br>* The eye tracking activity consists of a single in-person eye tracking activity that will take place in a private office 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 (product advertisements) are viewed (n=30) for 10 seconds per image. Following each advertisement, an on-screen closed response question will re-center the participant's gaze for standardization prior to the next image<br>Other: Eye tracking survey<br>* 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.<br>|
| Other: Cognitive interview<br>Separate population of participants (n=29) who were a mix of cigarillo users, dual e-cigarette and cigarillo users, e-cigarette users, and non-users. The cognitive interviews informed the Aim 1 survey | Other: Cognitive Interviews<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Appeal scores of flavored versus unflavored cigarillos in cigarillo users based on initial online survey scores | Within-subjects analyses (one sample paired t-tests) will be used to assess appeal scores of flavored versus unflavored cigarillos in cigarillo users based on initial online survey scores. Appeal Scores are on a 7-point LIKERT Scale from Strongly Disagree to Strongly Agree for three indicators. High values indicate higher greater appeal while low values indicate lower appeal. | At baseline | 
| Appeal scores of flavored cigarillos versus flavored e-cigarettes in cigarillo users based on initial online survey scores | Within-subjects analyses (one sample paired t-tests) will be used to assess appeal scores of flavored cigarillos versus flavored e-cigarettes in cigarillo users based on initial online survey scores. Appeal Scores are on a 7-point LIKERT Scale from Strongly Disagree to Strongly Agree for three indicators. High values indicate higher greater appeal while low values indicate lower appeal. | At baseline | 
| Perceptions of harm of flavored cigarillos versus unflavored cigarillos in cigarillo users as assessed by initial online survey scores | Within-subjects analyses (one sample paired t-tests) will be used to assess perceptions of harm of flavored cigarillos versus unflavored cigarillos in cigarillo users as assessed by initial online survey scores. Perception of Harm scores are on a 3-point scale: Less harmful, about the same level (or as harmful), and more harmful. Higher values indicate more perceived harm while lower values indicate less perceived harm. | At baseline | 
| Visual attention as assessed by dwell time visual attention on product packages | Visual attention as assessed by dwell time visual attention on product packages across a set of only flavored, only unflavored or mixed flavor advertisements | Immediately after exposure to product advertisements | 
| Attentional bias in flavored cigarillos products versus unflavored cigarillo advertisements | Attentional bias in flavored cigarillos products versus unflavored cigarillo advertisements. Attentional bias is defined as greater duration of attention to flavored stimuli. | Immediately after exposure to product advertisements | 
| Abuse liability of flavored cigarillos products versus unflavored cigarillo as measured by Sensitivity (alpha) | Abuse liability of flavored cigarillos products versus unflavored cigarillo as measured by sensitivity (alpha): The sensitivity of demand and the measure of cigarillo purchasing across the price function. | One week after exposure to product advertisements | 
| Abuse liability of flavored cigarillos products versus unflavored cigarillo as measured by intensity (Q0) | Abuse liability of flavored cigarillos products versus unflavored cigarillo as measured by Intensity (Q0): The intensity of demand and level of cigarillo purchasing at the lowest cost | One week after exposure to product advertisements | 
| Substitutability of flavored e-cigarettes versus unflavored e-cigarettes | Substitutability of flavored e-cigarettes versus unflavored e-cigarettes. To analyze the level of substitution of alternative tobacco products, the study team will fit linear regressions for each product type. Consistent with previous research slopes that significantly differ from zero will be considered substitutes. | One week after exposure to product advertisements | 
| Degree of substitutability of flavored e-cigarettes when compared to various cigarillo flavors | Degree of substitutability of flavored e-cigarettes when compared to various cigarillo flavors. To analyze the level of substitution of alternative tobacco products, the study team will fit linear regressions for each product type. Consistent with previous research slopes that significantly differ from zero will be considered substitutes. To compare substitutability in the four flavors, slopes will be compared across the four ETM conditions using one-way ANOVA | One week after exposure to product advertisements | 
| Future use intentions of flavored cigarillos products versus unflavored cigarillo advertisements | Future use intentions of flavored cigarillos products versus unflavored cigarillo advertisements. Future Use Intentions are scored on a 4-point scale: Definitely not, probably not, probably yes, definitely yes. Higher values indicate greater intention to use tobacco product(s) and lower values indicate lower intention to use tobacco product(s) | One week after exposure to product advertisements | 
| Perceptions of harm of flavored cigarillos products versus unflavored cigarillo advertisements | Perceptions of harm of flavored cigarillos products versus unflavored cigarillo advertisements (assessed on absolute and relative risk scales). Perception of Harm scores are on a 3-point scale: Less harmful, about the same level (or as harmful), and more harmful. Higher values indicate more perceived harm while lower values indicate less perceived harm. | Immediately after exposure to product advertisements | 
| Perceptions of harm of flavored cigarillos products versus unflavored cigarillo advertisements | Perceptions of harm of flavored cigarillos products versus unflavored cigarillo advertisements (assessed on absolute and relative risk scales). Perception of Harm scores are on a 3-point scale: Less harmful, about the same level (or as harmful), and more harmful. Higher values indicate more perceived harm while lower values indicate less perceived harm. | One week after exposure to product advertisements | 
| Product use intentions at the one- week follow-up survey | Product use intentions (any/none) at the one- week follow-up survey | One week after exposure to product advertisements | 
| Appeal ratings of flavored cigarillos products versus unflavored cigarillo advertisements | Appeal ratings of flavored cigarillos products versus unflavored cigarillo advertisements. Appeal Scores are on a 7-point LIKERT Scale from Strongly Disagree to Strongly Agree for three indicators. High values indicate higher greater appeal while low values indicate lower appeal. | One week after exposure to product advertisements | 
| Minnesota Tobacco Withdrawal Scale | Participants evaluate themselves on eight DSM-5 symptoms associated with tobacco withdrawal on a five-point scale from None to Severe and each item is scored from 0 (None) to 4 (Severe). Total scores range from 0 to 32 on this scale with higher scores indicating greater levels of withdrawal. | At baseline and immediately after ETM | 
| Nicotine Dependence - Aim 1 survey | Participants report their level of agreement with twelve statements related to nicotine dependence on a five-point Likert scale from Never to Always. Total scores range from 0 to 60 with higher scores indicating greater nicotine dependence. Also asked on Aim 1 Survey | At baseline | 
| Nicotine Dependence - Aim 3/Supplemental Aim 3 group | Participants report their level of agreement with twelve statements related to nicotine dependence on a five-point Likert scale from Never to Always. Total scores range from 0 to 60 with higher scores indicating greater nicotine dependence. Also asked on Aim 1 Survey | At baseline and immediately after ETM | 
| Likelihood of flavor use - Aim 1 survey | Participants are asked how likely they are to use six flavors of cigarillos on a four-point scale from Definitely Never Use to Regularly Use. | At baseline | 
| Likelihood of flavor use - Aim 3/Supplemental Aim 3 group | Participants are asked how likely they are to use six flavors of cigarillos on a four-point scale from Definitely Never Use to Regularly Use. | At baseline and immediately after ETM | 
| Perceptions of flavors - Aim 1 survey | Participants are asked their perceptions of six different cigarillo flavors on a six-point scale from Very Bad (1) to Very Good (6). Also asked on Aim 1 Survey. Each item will receive a rating from 1 (Very Bad) to 6 (Very Good), but these will not be added together in a scale | At baseline | 
| Perceptions of flavors - Aim 3/Supplemental Aim 3 group | Participants are asked their perceptions of six different cigarillo flavors on a six-point scale from Very Bad (1) to Very Good (6). Also asked on Aim 1 Survey. Each item will receive a rating from 1 (Very Bad) to 6 (Very Good), but these will not be added together in a scale | At baseline and immediately after ETM |