Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 3:32 AM
Ignite Modification Date:
2025-12-25 @ 3:32 AM
NCT ID:
NCT04358705
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
16 Years
Maximum Age:
28 Years
Study:
NCT04358705
Study Brief:
Protocol Section:
NCT04358705