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

Case Comprehensive Cancer Center (Case CCC) logo

Case Comprehensive Cancer Center (Case CCC)

Status

Completed

Conditions

Smoking Behaviors

Treatments

Other: Aim 3 survey
Other: Eye tracking survey
Behavioral: Online Experimental Marketplace (ETM)
Other: Supplemental Aim 1 Interviews
Behavioral: Eye Tracking Activity
Other: Aim 1: Online survey
Other: Cognitive Interviews

Study type

Interventional

Funder types

Other

Identifiers

NCT04358705
CASE13Z19

Details and patient eligibility

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

658 patients

Sex

All

Ages

16 to 28 years old

Volunteers

No Healthy 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

Prevention

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

658 participants in 3 patient groups

Young Cigarillo User (YCU) Sample
Experimental group
Description:
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.
Treatment:
Other: Aim 3 survey
Behavioral: Eye Tracking Activity
Other: Aim 1: Online survey
Other: Eye tracking survey
Other: Supplemental Aim 1 Interviews
Behavioral: Online Experimental Marketplace (ETM)
Sexual and Gender Minority (SGM) Female Cigarillo Users
Experimental group
Description:
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)
Treatment:
Other: Aim 3 survey
Behavioral: Eye Tracking Activity
Other: Aim 1: Online survey
Other: Eye tracking survey
Behavioral: Online Experimental Marketplace (ETM)
Cognitive interview
Other group
Description:
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
Treatment:
Other: Cognitive Interviews

Trial contacts and locations

1

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Central trial contact

Erika Trapl, PhD

Data sourced from clinicaltrials.gov

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