Smoking BehaviorsNCT04358705
C-FLASH (Cigarillo Flavor and Abuse Liability, Attention, and Substitution in youtH)
A study testing Aim 1: Online survey, Eye Tracking Activity and Eye tracking survey in people with Smoking Behaviors, run by Case Comprehensive Cancer Center at 1 site in United States.
Trial summary
The purpose of this research is to understand how flavor affects young adult's perceptions of little cigar or cigarillo use. Read more about this study
- Who is it for?
- Ages 16 to 28 years
- Conditions the study is for
- Smoking Behaviors
- What is being tested?
- Aim 1: Online survey, Eye Tracking Activity and Eye tracking survey
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 658 participants
- Where
- 1 siteUnited States
- Study dates
- 29 May 2020to 10 Feb 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 28 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
- 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.
Show all 30Show fewer
- Individuals who identify as female, trans-female/woman, or non-binary
- Individuals who identify as not heterosexual
- 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)
- 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:
- 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.
- Age range: 21-28 years
- Individuals who smoked 2 cigarillos per week over the past month.
- 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
Who cannot join
- Individuals who have never smoked a cigarillo
- Supplemental Aim 1:
- 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:
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- 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:
- Pregnant females
- Aim 3:
- Individuals who currently do not smoke at least 2 cigarillos per week
- Females who are pregnant or lactating
- Supplemental Aim 3:
- Individuals who currently do not smoke at least 2 cigarillos per week
- Individuals who identify as male or transman
- Individuals who identify as heterosexual
Trial locations and contacts
1 site in 1 country.
United States1 site
Case Western Reserve University, Case Comprehensive Cancer Center
Cleveland, Ohio, 44106
About this study
The purpose of this research is to understand how flavor affects young adult's perceptions of little cigar or cigarillo use.
Read the 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.
- Conditions
- Smoking Behaviors
- Being tested
- Aim 1: Online survey, Eye Tracking Activity, Eye tracking survey, Online Experimental Marketplace (ETM), Aim 3 survey
- Medical subject headings
- Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aim 1: Online surveyOther
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 ActivityBehavioural
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 surveyOther
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)Behavioural
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 surveyOther
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 InterviewsOther
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 InterviewsOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Young Cigarillo User (YCU) Sample | Experimental | 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. Receives: Other: Aim 1: Online survey; Behavioral: Eye Tracking Activity; Other: Eye tracking survey; Behavioral: Online Experimental Marketplace (ETM); Other: Aim 3 survey; Other: Supplemental Aim 1 Interviews |
| Sexual and Gender Minority (SGM) Female Cigarillo Users | Experimental | 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) Receives: Other: Aim 1: Online survey; Behavioral: Eye Tracking Activity; Other: Eye tracking survey; Behavioral: Online Experimental Marketplace (ETM); Other: Aim 3 survey |
| Cognitive interview | Other | 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 Receives: Other: Cognitive Interviews |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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
Measured: 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)
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: At baseline and immediately after ETM
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2020
- Study start29 May 2020
- Primary completion10 Feb 2023
- Study completion10 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Smoking BehaviorsStudies of the same condition, open and under way.
- More trials run by Case Comprehensive Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 658 participants (actual)
Sponsor and investigators
- Lead sponsor
- Case Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Erika Trapl, PhD, Principal investigator, Case Western Reserve University, Case Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04358705
- Sponsor's protocol ID
- CASE13Z19
- Status last verified
- Mar 2024
- First submitted
- 20 Apr 2020
- Last updated
- 6 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- C-FLASH (Cigarillo Flavor and Abuse Liability, Attention, and Substitution in youtH)
- ClinicalTrials.gov ID
- NCT04358705
- Acronym / sponsor ID
- CASE13Z19
- Conditions
- Smoking Behaviors
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 658 participants (actual)
- Lead sponsor
- Case Comprehensive Cancer CenterUniversity, hospital or other
- Study start
- 29 May 2020 (actual)
- Primary completion
- 10 Feb 2023 (actual)
- Study completion
- 10 Feb 2023 (actual)
- First posted
- 24 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Young Cigarillo User (YCU) Sample | Experimental | Other: Aim 1: Online survey, Behavioral: Eye Tracking Activity, Other: Eye tracking survey, Behavioral: Online Experimental Marketplace (ETM), Other: Aim 3 survey, Other: Supplemental Aim 1 InterviewsAim 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 | Experimental | Other: Aim 1: Online survey, Behavioral: Eye Tracking Activity, Other: Eye tracking survey, Behavioral: Online Experimental Marketplace (ETM), Other: Aim 3 surveySupplemental 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) |
| Cognitive interview | Other | Other: Cognitive InterviewsSeparate 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 |
Who may qualify
- Ages
- 16 to 28 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (30 listed)
- 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.
- Age range: 21-28 years
- Individuals who have smoked an average of 2 cigarillos per week over the past month.
Key exclusion criteria (18 listed)
- Individuals who have never smoked a cigarillo
- 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
- Individuals who have never used a cigarillo.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aim 1: Online surveyThis 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. | Other | Sexual and Gender Minority (SGM) Female Cigarillo Users, Young Cigarillo User (YCU) Sample |
| Eye Tracking ActivityThe 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. | Behavioural | Sexual and Gender Minority (SGM) Female Cigarillo Users, Young Cigarillo User (YCU) Sample |
| Eye tracking surveyOther 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. | Other | Sexual and Gender Minority (SGM) Female Cigarillo Users, Young Cigarillo User (YCU) Sample |
| 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. | Behavioural | Sexual and Gender Minority (SGM) Female Cigarillo Users, Young Cigarillo User (YCU) Sample |
| Aim 3 surveyConsists 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 | Sexual and Gender Minority (SGM) Female Cigarillo Users, Young Cigarillo User (YCU) Sample |
| Cognitive InterviewsCognitive 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 | Cognitive interview |
| Supplemental Aim 1 InterviewsParticipants 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. | Other | Young Cigarillo User (YCU) Sample |
Primary outcome
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.
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.
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.
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
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.
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.
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
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.
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
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)
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.
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.
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
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.
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.
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
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
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.
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.
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Erika Trapl, PhD principal investigator
Case Western Reserve University, Case Comprehensive Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aim 1: Online survey, Eye Tracking Activity and Eye tracking survey in people with Smoking Behaviors, run by Case Comprehensive Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 30 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Appeal scores of flavored versus unflavored cigarillos in cigarillo users based on initial online survey scores (time frame: At baseline). The study lists 21 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2024.