Inclusion Criteria:

• 18 years of age or older at the time of consent.

• Currently smoking at least 10 cigarettes/day

• Motivated to stop smoking (on a scale of 0 to 10, motivation must be 3 or above);

• Ability to participate fully in all aspects of the study.

• Have the ability to provide informed consent.

• Have no contraindicating comorbid health conditions that would interfere with study participation, as determined by the clinical investigators.

Exclusion Criteria:

• Patients with a current moderate/severe depression as assessed by a score of ≥10 on the Patient Health Questionnaire-9 (PHQ-9).

• Patients who are or have used an investigational drug within the past 30 days.

• Patients who are currently using medication(s) known to interact with varenicline.

• Patients who have clinically significant acute/chronic progressive or unstable neurologic, hepatic, renal, cardiovascular, psychological, respiratory, or metabolic disease.

• Patients with a known allergy to nicotine patches or varenicline.

• Patients with a personal history of acute pancreatitis, hypoglycemia, acute kidney injury or impairment of renal function, type 1 diabetes or diabetic ketoacidosis, and/or severe gastrointestinal disease such as gastroparesis.

• Patients with an active implantable medical device, such as a pacemaker, hearing aid implant, or any implanted electronic device.

• Patients diagnosed with narrowing of the arteries (carotid atherosclerosis)

• Patients who have had surgery to cut the vagus nerve in the neck (cervical vagotomy)

• Patients with clinically significant hypertension, hypotension, bradycardia, or tachycardia

• Patients who have a metallic device such as a stent, bone plate, or bone screw implanted at or near your neck

• Patients who are using another device at the same time (e.g., TENS Unit, muscle stimulator) or any portable electronic device (e.g., mobile phone).

• Women who are pregnant or lactating, or who are of childbearing potential and are likely to become pregnant during the medication phase but are not willing to use a reliable form of contraception, will also be excluded.

  • Reliable forms of contraception include oral contraception, diaphragm or condom (with spermicide), injections, intrauterine devices, surgical sterilization, and abstinence. We are not including vulnerable populations in this research.

  • Specifically, we are not including fetuses, neonates, pregnant women, children (<18 years of age), prisoners, institutionalized individuals, or other vulnerable populations.

  • All female participants of childbearing potential must have a negative pregnancy test and must agree to use approved contraception during study participation.

Note: Other protocol defined Inclusion/Exclusion Criteria may apply.

Eligibility last updated 7/10/2025. Questions regarding updates should be directed to the study team contact.