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

Not Applicable

Completed

• Conditions: Smoking Behaviors
• Interventions: Behavioral: Eye Tracking Activity; Other: Cognitive Interviews; Other: Eye tracking survey; Behavioral: Online Experimental Marketplace (ETM); Other: Aim 3 survey; Other: Supplemental Aim 1 Interviews

• Registration Number: NCT04358705
• Lead Sponsor: Case Comprehensive Cancer Center

Brief Summary

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

Detailed Description

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.

Study Timeline

• Study First Submitted: 2020-04-20
• Study First Submitted QC: 2020-04-21
• Study First Posted: 2020-04-24
• Study Start: 2020-05-29
• Primary Completion: 2023-02-10
• Study Completion: 2023-02-10
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-05
• Last Update Posted: 2024-03-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 658

Inclusion Criteria

• Age range: 21-28 years
• 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:

• Age range: 21-28 years
• 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

Supplemental Aim 1 Interviews:

Inclusion Criteria

• Previous participant in Supplemental Aim 1 or Aim 1 survey.
• Participant agreed to be contacted to participate in future studies.
• Individuals who have ever used a cigarillo.
• Individuals willing to provide informed consent and participate in the interview.
• Individuals who identify as women (cis- or transwomen)

Exclusion Criteria:

• Individuals who have never used a cigarillo.
• Individuals who do not identify as women (cis- or transwomen)
• Individuals unwilling to provide informed consent and participate in the interview

Cognitive Interviews:

Inclusion Criteria:

• Age range: 21-28 years
• 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

• Age range: 16-28 years
• Individuals not having chronic eye diseases known to interfere with eye tracking equipment (i.e. glaucoma, regression lenses, cataracts, etc.)
• Individuals willing to meet in-person at lab in Columbus, Ohio to complete study procedures.
• Individuals willing to provide informed consent or assent and participate in the online survey.

Exclusion Criteria:

• Pregnant females

Aim 3:

Inclusion Criteria:

• Age range: 21-28 years
• 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:

• Age range: 21-28 years
• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Young Cigarillo User (YCU) Sample	Aim 3 survey	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: 150 participants from Columbus, Ohio, and surrounding areas will be recruited for an Eye Tracking Activity to capture visual attention to cigarillo packaging. Visual attention will be examined in 3 conditions: 1) flavored product images, 2) unflavored product images, and 3) a mixture of flavored and unflavored product images. Aim 3: (162 participants from Aim 1 survey). Consists of the Online Electronic Tobacco Marketplace (ETM) and the aim 3 survey components: * Demographic screener questions * Tobacco product withdrawal scale * ETM * Quality Assurance Question * Tobacco product withdrawal scale * Survey (nicotine dependence \& flavor preferences) A sample of 88 from the 162 Aim 3 participants will be compared with 88 SGM participants from supplemental Aim 1.
Sexual and Gender Minority (SGM) Female Cigarillo Users	Eye tracking survey	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)
Young Cigarillo User (YCU) Sample	Online Experimental Marketplace (ETM)	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: 150 participants from Columbus, Ohio, and surrounding areas will be recruited for an Eye Tracking Activity to capture visual attention to cigarillo packaging. Visual attention will be examined in 3 conditions: 1) flavored product images, 2) unflavored product images, and 3) a mixture of flavored and unflavored product images. Aim 3: (162 participants from Aim 1 survey). Consists of the Online Electronic Tobacco Marketplace (ETM) and the aim 3 survey components: * Demographic screener questions * Tobacco product withdrawal scale * ETM * Quality Assurance Question * Tobacco product withdrawal scale * Survey (nicotine dependence \& flavor preferences) A sample of 88 from the 162 Aim 3 participants will be compared with 88 SGM participants from supplemental Aim 1.
Sexual and Gender Minority (SGM) Female Cigarillo Users	Eye Tracking Activity	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)
Sexual and Gender Minority (SGM) Female Cigarillo Users	Aim 3 survey	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)
Young Cigarillo User (YCU) Sample	Eye Tracking Activity	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: 150 participants from Columbus, Ohio, and surrounding areas will be recruited for an Eye Tracking Activity to capture visual attention to cigarillo packaging. Visual attention will be examined in 3 conditions: 1) flavored product images, 2) unflavored product images, and 3) a mixture of flavored and unflavored product images. Aim 3: (162 participants from Aim 1 survey). Consists of the Online Electronic Tobacco Marketplace (ETM) and the aim 3 survey components: * Demographic screener questions * Tobacco product withdrawal scale * ETM * Quality Assurance Question * Tobacco product withdrawal scale * Survey (nicotine dependence \& flavor preferences) A sample of 88 from the 162 Aim 3 participants will be compared with 88 SGM participants from supplemental Aim 1.
Young Cigarillo User (YCU) Sample	Eye tracking survey	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: 150 participants from Columbus, Ohio, and surrounding areas will be recruited for an Eye Tracking Activity to capture visual attention to cigarillo packaging. Visual attention will be examined in 3 conditions: 1) flavored product images, 2) unflavored product images, and 3) a mixture of flavored and unflavored product images. Aim 3: (162 participants from Aim 1 survey). Consists of the Online Electronic Tobacco Marketplace (ETM) and the aim 3 survey components: * Demographic screener questions * Tobacco product withdrawal scale * ETM * Quality Assurance Question * Tobacco product withdrawal scale * Survey (nicotine dependence \& flavor preferences) A sample of 88 from the 162 Aim 3 participants will be compared with 88 SGM participants from supplemental Aim 1.
Cognitive interview	Cognitive Interviews	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
Young Cigarillo User (YCU) Sample	Supplemental Aim 1 Interviews	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: 150 participants from Columbus, Ohio, and surrounding areas will be recruited for an Eye Tracking Activity to capture visual attention to cigarillo packaging. Visual attention will be examined in 3 conditions: 1) flavored product images, 2) unflavored product images, and 3) a mixture of flavored and unflavored product images. Aim 3: (162 participants from Aim 1 survey). Consists of the Online Electronic Tobacco Marketplace (ETM) and the aim 3 survey components: * Demographic screener questions * Tobacco product withdrawal scale * ETM * Quality Assurance Question * Tobacco product withdrawal scale * Survey (nicotine dependence \& flavor preferences) A sample of 88 from the 162 Aim 3 participants will be compared with 88 SGM participants from supplemental Aim 1.
Sexual and Gender Minority (SGM) Female Cigarillo Users	Online Experimental Marketplace (ETM)	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)

Primary Outcome Measures

Name	Time	Method
Perceptions of harm of flavored cigarillos products versus unflavored cigarillo advertisements	One week after exposure to product 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.
Likelihood of flavor use - Aim 1 survey	At baseline	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.
Appeal scores of flavored versus unflavored cigarillos in cigarillo users based on initial online survey scores	At baseline	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.
Visual attention as assessed by dwell time visual attention on product packages	Immediately after exposure to product advertisements	Visual attention as assessed by dwell time visual attention on product packages across a set of only flavored, only unflavored or mixed flavor advertisements
Attentional bias in flavored cigarillos products versus unflavored cigarillo advertisements	Immediately after exposure to product advertisements	Attentional bias in flavored cigarillos products versus unflavored cigarillo advertisements. Attentional bias is defined as greater duration of attention to flavored stimuli.
Abuse liability of flavored cigarillos products versus unflavored cigarillo as measured by Sensitivity (alpha)	One week after exposure to product advertisements	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.
Perceptions of harm of flavored cigarillos versus unflavored cigarillos in cigarillo users as assessed by initial online survey scores	At baseline	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.
Abuse liability of flavored cigarillos products versus unflavored cigarillo as measured by intensity (Q0)	One week after exposure to product advertisements	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
Degree of substitutability of flavored e-cigarettes when compared to various cigarillo flavors	One week after exposure to product advertisements	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
Product use intentions at the one- week follow-up survey	One week after exposure to product advertisements	Product use intentions (any/none) at the one- week follow-up survey
Nicotine Dependence - Aim 1 survey	At baseline	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
Perceptions of flavors - Aim 3/Supplemental Aim 3 group	At baseline and immediately after ETM	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
Appeal scores of flavored cigarillos versus flavored e-cigarettes in cigarillo users based on initial online survey scores	At baseline	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.
Appeal ratings of flavored cigarillos products versus unflavored cigarillo advertisements	One week after exposure to product 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.
Minnesota Tobacco Withdrawal Scale	At baseline and immediately after ETM	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.
Likelihood of flavor use - Aim 3/Supplemental Aim 3 group	At baseline and immediately after ETM	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.
Perceptions of flavors - Aim 1 survey	At baseline	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
Substitutability of flavored e-cigarettes versus unflavored e-cigarettes	One week after exposure to product advertisements	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.
Future use intentions of flavored cigarillos products versus unflavored cigarillo advertisements	One week after exposure to product 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)
Nicotine Dependence - Aim 3/Supplemental Aim 3 group	At baseline and immediately after ETM	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

Trial Locations

Locations (1)

Case Western Reserve University, Case Comprehensive Cancer Center; 🇺🇸 Cleveland, Ohio, United States