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 @ 2:35 PM
Ignite Modification Date:
2025-12-24 @ 2:35 PM
NCT ID:
NCT03491059
Eligibility Criteria:
Inclusion Criteria:
* males and females greater than or equal to 18 years of age
* current regular user of e-cigarettes (use at least once daily for the past 30 days) with nicotine strength \> 6mg/ml
* health medical history
* abstinent from any tobacco/nicotine use for 4 hours prior to imaging
Exclusion Criteria:
* not a regular user of e-cigarettes
* pregnant or lactating (only excluded from imaging study)
* prisoner
* incapable of giving informed consent
* unable to lie flat on the scanner for extended periods of time
* unstable medical condition like heart disease, uncontrolled hypertension, thyroid disease, diabetes, renal or liver impairment, or glaucoma
* prostatic hypertrophy, stroke, or ulcer in past year
* psychiatric conditions such as schizophrenia, adult ADHD, or bipolar disorder
* current or regular use of psychiatric medications such as tranquilizers, antipsychotics, and/or antidepressants
* use of medications that are inducers of CYP2A6 (a nicotine metabolizing enzyme) such as rifampicin, dexamethasone, phenobarbital, and other anti-convulsant drugs
* unable to communicate in English
* current use of smokeless tobacco, tobacco cigarettes (5 and fewer a day)
* occasional use of pipes is permitted if subject abstains for the week prior to the study
* older than 80 years
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT03491059
Study Brief:
Protocol Section:
NCT03491059