Clinical trial NCT04358705: C-FLASH (Cigarillo Flavor and Abuse Liability, Attention, and Substitution in youtH)
Official title: C-FLASH (Cigarillo Flavor and Abuse Liability, Attention, and Substitution in youtH)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Smoking Behaviors
Lead sponsor: Case Comprehensive Cancer Center
Sponsor class: OTHER
First posted: 2020-04-24
Enrollment: 658
Sex: ALL
Minimum age (years): 16
Maximum age (years): 28
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility 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

Primary outcomes:
measure: Appeal scores of flavored versus unflavored cigarillos in cigarillo users based on initial online survey scores
timeFrame: At baseline
measure: Appeal scores of flavored cigarillos versus flavored e-cigarettes in cigarillo users based on initial online survey scores
timeFrame: At baseline
measure: Perceptions of harm of flavored cigarillos versus unflavored cigarillos in cigarillo users as assessed by initial online survey scores
timeFrame: At baseline
measure: Visual attention as assessed by dwell time visual attention on product packages
timeFrame: Immediately after exposure to product advertisements
measure: Attentional bias in flavored cigarillos products versus unflavored cigarillo advertisements
timeFrame: Immediately after exposure to product advertisements
measure: Abuse liability of flavored cigarillos products versus unflavored cigarillo as measured by Sensitivity (alpha)
timeFrame: One week after exposure to product advertisements
measure: Abuse liability of flavored cigarillos products versus unflavored cigarillo as measured by intensity (Q0)
timeFrame: One week after exposure to product advertisements
measure: Substitutability of flavored e-cigarettes versus unflavored e-cigarettes
timeFrame: One week after exposure to product advertisements
measure: Degree of substitutability of flavored e-cigarettes when compared to various cigarillo flavors
timeFrame: One week after exposure to product advertisements
measure: Future use intentions of flavored cigarillos products versus unflavored cigarillo advertisements
timeFrame: One week after exposure to product advertisements
measure: Perceptions of harm of flavored cigarillos products versus unflavored cigarillo advertisements
timeFrame: Immediately after exposure to product advertisements
measure: Perceptions of harm of flavored cigarillos products versus unflavored cigarillo advertisements
timeFrame: One week after exposure to product advertisements
measure: Product use intentions at the one- week follow-up survey
timeFrame: One week after exposure to product advertisements
measure: Appeal ratings of flavored cigarillos products versus unflavored cigarillo advertisements
timeFrame: One week after exposure to product advertisements
measure: Minnesota Tobacco Withdrawal Scale
timeFrame: At baseline and immediately after ETM
measure: Nicotine Dependence - Aim 1 survey
timeFrame: At baseline
measure: Nicotine Dependence - Aim 3/Supplemental Aim 3 group
timeFrame: At baseline and immediately after ETM
measure: Likelihood of flavor use - Aim 1 survey
timeFrame: At baseline
measure: Likelihood of flavor use - Aim 3/Supplemental Aim 3 group
timeFrame: At baseline and immediately after ETM
measure: Perceptions of flavors - Aim 1 survey
timeFrame: At baseline
measure: Perceptions of flavors - Aim 3/Supplemental Aim 3 group
timeFrame: At baseline and immediately after ETM
Secondary outcomes:
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Case Western Reserve University, Case Comprehensive Cancer Center
state: Ohio
Study officials:
affiliation: Case Western Reserve University, Case Comprehensive Cancer Center
name: Erika Trapl, PhD
role: PRINCIPAL_INVESTIGATOR
References: