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Completed

NCT Number: NCT04358705

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

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

Completed

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Key information

Conditions

Smoking Behaviors Behavior Smoking

Age range

16 year–28 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Case Western Reserve University, Case Comprehensive Cancer Center

Cleveland, Ohio, 44106, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

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

Treatment and study plan

Aim 1: Online survey

Other

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.

Eye Tracking Activity

Behavioral

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.

Eye tracking survey

Other

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.

Online Experimental Marketplace (ETM)

Behavioral

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.

Aim 3 survey

Other

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

Cognitive Interviews

Other

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.

Supplemental Aim 1 Interviews

Other

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.

Primary outcomes

  1. Appeal scores of flavored versus unflavored cigarillos in cigarillo users based on initial online survey scores

    Time frame: 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.

  2. Appeal scores of flavored cigarillos versus flavored e-cigarettes in cigarillo users based on initial online survey scores

    Time frame: 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.

  3. Perceptions of harm of flavored cigarillos versus unflavored cigarillos in cigarillo users as assessed by initial online survey scores

    Time frame: 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.

  4. Visual attention as assessed by dwell time visual attention on product packages

    Time frame: 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

  5. Attentional bias in flavored cigarillos products versus unflavored cigarillo advertisements

    Time frame: 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.

  6. Abuse liability of flavored cigarillos products versus unflavored cigarillo as measured by Sensitivity (alpha)

    Time frame: 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.

  7. Abuse liability of flavored cigarillos products versus unflavored cigarillo as measured by intensity (Q0)

    Time frame: 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

  8. Substitutability of flavored e-cigarettes versus unflavored e-cigarettes

    Time frame: 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.

  9. Degree of substitutability of flavored e-cigarettes when compared to various cigarillo flavors

    Time frame: 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

  10. Future use intentions of flavored cigarillos products versus unflavored cigarillo advertisements

    Time frame: 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)

  11. Perceptions of harm of flavored cigarillos products versus unflavored cigarillo advertisements

    Time frame: Immediately 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.

  12. Perceptions of harm of flavored cigarillos products versus unflavored cigarillo advertisements

    Time frame: 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.

  13. Product use intentions at the one- week follow-up survey

    Time frame: One week after exposure to product advertisements

    Product use intentions (any/none) at the one- week follow-up survey

  14. Appeal ratings of flavored cigarillos products versus unflavored cigarillo advertisements

    Time frame: 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.

  15. Minnesota Tobacco Withdrawal Scale

    Time frame: 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.

  16. Nicotine Dependence - Aim 1 survey

    Time frame: 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

  17. Nicotine Dependence - Aim 3/Supplemental Aim 3 group

    Time frame: 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

  18. Likelihood of flavor use - Aim 1 survey

    Time frame: 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.

  19. Likelihood of flavor use - Aim 3/Supplemental Aim 3 group

    Time frame: 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.

  20. Perceptions of flavors - Aim 1 survey

    Time frame: 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

  21. Perceptions of flavors - Aim 3/Supplemental Aim 3 group

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Case Comprehensive Cancer Center

Other

Registry information

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Apr 24, 2020
Registry last updated
Mar 6, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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