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 @ 12:04 AM
Ignite Modification Date:
2025-12-25 @ 12:04 AM
NCT ID:
NCT06948058
Eligibility Criteria:
Inclusion Criteria:
* body mass index (BMI) ≥ 30 kg/m2 (i.e., obese)
* smoked ≥ 5 cigarettes/day during the past year
* 21 or older (due to minimum legal age EC restrictions)
* exhaled breath carbon monoxide (CO) level \> 6 ppm at Baseline (BL) (to confirm self-reported smoking)
* willing to use EC or NRT for 8 weeks
* access to a Bluetooth-enabled smartphone/tablet (to permit remote measurement of CO and other outcome variables)
Exclusion Criteria:
* received smoking cessation treatment of any kind in the past 30 days (actively quitting smoking),
* currently using EC or NRT more than 2 days/week (this may affect responses to study-supplied products)
* hospitalized for mental illness in past 30 days
* heart-related event (e.g., heart attack, severe angina) in past 30 days
* residing with another person currently enrolled in the study
* pregnant, nursing, or planning to become pregnant in the next 6 months
* medical contraindication for study or product use (e.g., allergy to adhesives)
* taken prescription weight loss medication in the last 30 days
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
21 Years
Study:
NCT06948058
Study Brief:
Protocol Section:
NCT06948058