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 @ 1:40 AM
Ignite Modification Date:
2025-12-25 @ 1:40 AM
NCT ID:
NCT04602494
Eligibility Criteria:
Inclusion Criteria:
* Ages 18-25 inclusive;
* Self report of daily or near daily nicotine vaping for the prior ≥ 3 months, screening semi-quantitative urine cotinine positive for recent nicotine use, exhaled CO \<10 ppm and score ≥4 on the 10-item E-cigarette Dependence Inventory (ECDI);
* Self-report of no combusted tobacco use in the past 2 months at enrollment;
* Total body weight at screening ≥35 kg (77 lbs) and Body Mass Index (BMI) ≤35 kg/m2;
* Report motivation to quit vaping in the next 30 days;
* Able to understand study procedures and read and write in English;
* Competent and willing to consent to participate in study procedures.
Exclusion Criteria:
* Use of a smoking cessation medication in the prior month (nicotine patch, gum, nasal spray, or inhaler, varenicline, bupropion);
* Unwillingness to abstain during the study from using smoking cessation aids other than those provided by the study;
* Unstable medical condition, epilepsy, severe renal impairment;
* Evidence of active problem substance use severe enough in the investigator's opinion to compromise ability to safely participate;
* Prior adverse drug reaction to varenicline;
* Unwilling to provide urine samples;
* Any condition or situation that would, in the investigator's opinion, make it unlikely that the participant could adhere safely to the study protocol.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
25 Years
Study:
NCT04602494
Study Brief:
Protocol Section:
NCT04602494