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 @ 4:11 PM
Ignite Modification Date:
2025-12-24 @ 4:11 PM
NCT ID:
NCT07145866
Eligibility Criteria:
Inclusion Criteria:
* Age ≥ 18 and ≤65;
* The ability to give written, informed consent;
* Fluency in English;
* Reported interest in quitting nicotine vaping or smoking within the next month;
* Nicotine dependence, as defined by a score of ≥4 on the 10-question E-cigarette Dependence Inventory (ECDI) or Fagerström Test for Nicotine Dependence (FTND);
* Smoke or vape nicotine daily for at least the past 90 days, as confirmed by self-report and timeline follow-back methods;
* Saliva cotinine \>30ng/mL;
Exclusion Criteria:
* Pregnancy or breastfeeding;
* Use of smoking cessation pharmacotherapy in the past month;
* Unwilling to abstain during the study from using smoking cessation aids other than those provided by the study;
* Prior adverse drug reaction to varenicline;
* Receiving or planning to receive other TMS treatments or investigational drugs during course of participation
* Contraindications to TMS (including seizures, metallic implants, severe existing tinnitus, etc.);
* Contraindications to MRI (including presence of a cardiac pacemaker or pacemaker wires, metallic particles in the body, vascular clips in the head or previous neurosurgery, prosthetic heart valves, claustrophobia);
* Inpatient psychiatric hospitalization or suicide attempts in the past six months, or recent active suicidal ideation or suicidal behavior identified at enrollment or baseline visits;
* History of seizures and/or history of TBI subtypes associated with elevated seizure risk (e.g. penetrating injury and intraparenchymal hemorrhage)
* History of unstable neurological illness or major medical illness, such as epilepsy or renal impairment, in the past six months, unless clearly resolved;
* In the opinion of the investigators, evidence of active problem substance use severe enough to compromise ability to safely participate;
* In the opinion of the investigators, unable to safely participate in this study and/or provide reliable data (e.g., claustrophobia, unable to tolerate TMS or MRI procedures, etc.).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT07145866
Study Brief:
Protocol Section:
NCT07145866