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 @ 5:19 AM
Ignite Modification Date:
2025-12-25 @ 5:19 AM
NCT ID:
NCT04250727
Eligibility Criteria:
Inclusion Criteria:
1. 21-77 years old(in line with NIH guidelines for 18+ being the age of consent in adults) (2008 PHS Guideline Update Panel)
2. English literate
3. Smoke at least 1 cigarette per day
4. Expired breath carbon monoxide level ≥ 6ppm at baseline
5. Not currently actively pursuing smoking cessation services or planning to use evidence-based cessation tools to quit in the next month
6. Not interested in the use of existing FDA-approved tobacco pharmacotherapies (i.e., NRT, wellbutrin, varenicline).
Exclusion Criteria:
1. Currently using any stop smoking treatments (2008 PHS Guideline Update Panel)
2. History of serious psychiatric condition (i.e., bipolar disorder, schizophrenia)
3. Current uncontrolled medical condition
4. Cardiac conditions that required a hospitalization or intensive treatment on an outpatient basis in the past year including: myocardial infarction, coronary artery disease, unstable angina, congestive heart failure, or tachyarrhythmias (including rapid atrial fibrillation, ventricular tachycardia, or ventricular fibrillation)
5. Female participants of child-bearing age will be excluded if they are currently pregnant or breastfeeding or report an unwillingness to use effective birth control (i.e., abstinence, IUD, implant, sterilization, pill, patch, ring, or barrier method such as condoms) for the duration of the study
6. Severe lung disease that requires supplemental oxygen
7. Uncontrolled asthma (\<20 on the Asthma Control Test (ACT) or requiring steroids more than 1x per year)
8. Unstable COPD: defined as GOLD category C or D (more than 2 exacerbations or 1 exacerbation leading to hospitalization in the past year)
9. Planning to quit smoking with a set goal or time for quit attempt
10. Known hypersensitivity to propylene glycol
11. Patients with an FEV1 \< 40%
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
21 Years
Maximum Age:
77 Years
Study:
NCT04250727
Study Brief:
Protocol Section:
NCT04250727