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 @ 3:15 PM
Ignite Modification Date:
2025-12-24 @ 3:15 PM
NCT ID:
NCT05367492
Eligibility Criteria:
Inclusion Criteria:
* Ages 16-25, inclusive;
* Self-report of daily or near daily nicotine vaping for the prior ≥ 3 months and semi-quantitative saliva screening for cotinine positive for recent nicotine use;
* Nicotine dependence as defined by a score ≥4 on the 10-item E-cigarette Dependence Inventory (ECDI), or report of persistent use despite negative consequences, or prior failed quit attempts;
* Self-report of no regular combusted tobacco use in the past 2 months at enrollment and exhaled CO \<10 ppm;
* Total body weight at enrollment ≥35 kg (77 lbs);
* Report willingness to try varenicline to stop vaping;
* Able to understand study procedures and read and write in English;
* Have a parent or legal guardian who is able and willing to provide written informed consent (if under the age of 18);
* Competent and willing to provide written informed consent (if age 18+) or assent (if under 18);
* For participants who could become pregnant: negative urine pregnancy test at enrollment and agree to use effective contraception (e.g., abstinence, hormonal contraception, intra-uterine device, sterilization, or double barrier contraception) during the study.
Exclusion Criteria:
* Use of a smoking cessation medication in the prior month (nicotine patch, gum, nasal spray, or inhaler, varenicline, bupropion);
* Unwilling to abstain during the study from using smoking cessation aids other than those provided by the study;
* Unstable medical condition, epilepsy, severe renal impairment;
* Inpatient psychiatric hospitalization in the prior 6 months, serious suicidal ideation or suicide attempt within 6 months of enrollment, recent active suicidal ideation or suicidal behavior identified at enrollment or baseline visits;
* Evidence of active problem substance use severe enough to compromise ability to safely participate, in the investigator's opinion;
* 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;
* Ward of the state.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
16 Years
Maximum Age:
25 Years
Study:
NCT05367492
Study Brief:
Protocol Section:
NCT05367492