C-FLASH (Cigarillo Flavor and Abuse Liability, Attention, and Substitution in youtH)
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About
The purpose of this research is to understand how flavor affects young adult's perceptions of little cigar or cigarillo use.
Full 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.
Enrollment
Sex
Ages
Volunteers
Inclusion and exclusion criteria
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
Trial design
Primary purpose
Allocation
Interventional model
Masking
658 participants in 3 patient groups
Trial contacts and locations
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Central trial contact
Erika Trapl, PhD
Data sourced from clinicaltrials.gov
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