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:
2025-12-24 @ 11:52 PM
Ignite Modification Date:
2025-12-24 @ 11:52 PM
NCT ID:
NCT05836051
Eligibility Criteria:
Inclusion Criteria:
1. 21 to 60 years old
2. Regular users of inhaled tobacco products (≥5 days out of the last 28)
3. Not planning to quit tobacco use within next month
4. Able to read and write in English
Exclusion Criteria:
1. Major neurological conditions or brain trauma
2. Current substance use impairing participation
3. Unstable or significant medical conditions (e.g., COPD, coronary heart disease)
4. Current use of smoking cessation medication (e.g., varenicline, patch)
5. Uncontrolled serious mental illness, suicidality, or inpatient psychiatric hospitalization in the past 6 months
6. Known allergic reaction to ENDS liquids ingredients propylene glycol or vegetable glycerin
7. Unable to use study provided ENDS ad-libitum for at least 3 hours per day
8. Pregnant or breastfeeding as indicated by self-report or urine pregnancy screen
MRI-specific exclusion criteria:
1. MRI safety contraindications (e.g., metal implants, claustrophobia)
2. Major neurological conditions or brain trauma
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
21 Years
Maximum Age:
60 Years
Study:
NCT05836051
Study Brief:
Protocol Section:
NCT05836051