Who is eligible for clinical trial NCT07487818?

Participants must meet protocol criteria for Smoking Cessation. Confirm exact inclusion and exclusion requirements with the study coordinator.

Does clinical trial NCT07487818 provide travel or cost reimbursement?

Check with the site coordinator at the participating facility for travel and lodging stipend availability, and for which routine-care costs are covered.

🏛️ Verified NIH Record • Updated 2026-08-17

A Study Of Vagal Nerve Stimulation In Conjunction With NRT For Smoking Cessation (NCT07487818)

🟢 Recruiting Phase2 / Phase3 💊 Investigational Drug / Biologic Sponsor: Mayo Clinic

🩺 Plain-English Summary (8th-Grade Level)

The purpose of this study is to provide preliminary evidence for the efficacy of 12 weeks of vagal nerve stimulation (VNS) and nicotine replacement therapy (NRT) for increasing smoking abstinence rates.

Who can join: To join this study, participants generally need to meet the listed inclusion criteria (6 items) and avoid the listed exclusions (16 items).

Location: Mayo Clinic in Rochester — Rochester, Minnesota

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

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.

Usually NOT eligible if any of the following apply:

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

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (1 Sites)

Mayo Clinic in Rochester — Rochester, Minnesota

💰 Cost, Insurance & Patient Rights

100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

🏛️ View Official NIH Record ↗