A Study Of Vagal Nerve Stimulation In Conjunction With NRT For Smoking Cessation

This study will evaluate the role of vagal nerve stimulation as a potential adjunct to nicotine patches to help smokers stop smoking.

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. The study does not include vulnerable populations.
• 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.