VNS & NRTA Study Of Vagal Nerve Stimulation In Conjunction With NRT For Smoking Cessation

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.

1. Reliable forms of contraception include oral contraception, diaphragm or condom (with spermicide), injections, intrauterine devices, surgical sterilization, and abstinence. The study does not include vulnerable populations.
2. Specifically, the study does not include fetuses, neonates, pregnant women, children (<18 years of age), prisoners, institutionalized individuals, or other vulnerable populations.

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