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:
2026-03-26 @ 3:17 PM
Ignite Modification Date:
2026-03-26 @ 3:17 PM
NCT ID:
NCT07322432
Eligibility Criteria:
Inclusion Criteria:
* Age: Adults aged 21 years and older
* Current Vaping Behavior: Daily or near-daily use (≥5 days/week or at least 20 days per month) of nicotine-containing e-cigarettes for at least the past 3 months.
* Motivation and desire to quit as determined by all of the following three assessment tools:
* Score of 4 or 5 on all 5-point Likert-type scale questions (see appendix)
* Score of 6 or 7 on Motivation To Stop Scale (MTSS) (see appendix)
* Participants must be classified in the Preparation stage of the Transtheoretical Model of behavior change (see appendix)
* Saliva Cotinine level ≥ 10 ng/ml
* Penn State Electronic Cigarette Dependence Index (PSECDI) of at least 4 and above
* Willingness to participate in the study and all study requirements
* Willingness to not use any other nicotine-containing products for the duration of the study
* Ability to attend visits and provide informed consent
Exclusion Criteria:
* Mental Health Concerns with a score above the following thresholds:
* PHQ-2 score ≥ 2 (see appendix)
* GAD-2 score ≥ 2 (see appendix)
* Use of Other Tobacco or Nicotine Products:
* Use of any nicotine products except for vaping, including combustible tobacco (e.g., cigarettes) or other non-e-cigarette nicotine delivery systems within the past 30-days
* Current Substance or alcohol Use Disorder:
* Self-reported or medically diagnosed substance use disorder (excluding nicotine), unless in sustained remission (\>12 months).
* Illicit drug use in the past 60 days
* Screening positive for alcohol use disorder in past year
* Medical Contraindications:
* Any serious medical condition or medication that would contraindicate participation in a behavioral cessation trial (to be defined and assessed by study physician or PI).
* Pregnant or breastfeeding
* Symptomatic cardiovascular disease
* Participation in another smoking/vaping cessation trial
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
21 Years
Study:
NCT07322432
Study Brief:
Protocol Section:
NCT07322432