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A Study of Vagal Nerve Stimulation and Nicotine Patches for Smoking Cessation

This study is looking into whether combining a non-invasive vagus nerve stimulator (a handheld device that sends electrical signals to a nerve in your neck) with nicotine replacement patches can help people stop smoking. Researchers want to see if this combination increases the number of people who successfully quit smoking after 12 weeks. You might be able to join if you are 18 or older, smoke at least 10 cigarettes a day, and are motivated to quit. The study aims to enroll about 150 participants. The current recruitment status is unclear.

Study design
This interventional study plans to enroll 150 participants to evaluate two interventions: a non-invasive vagus nerve stimulator plus nicotine replacement patches, or nicotine replacement patches alone.
What's involved
You would use a non-invasive vagus nerve stimulator for 2 minutes at each treatment and a 21 mg nicotine patch daily for up to 12 weeks.
Compensation
Not stated in the trial record.
Follow-up
Smoking abstinence will be measured at week 12, indicating a follow-up period of at least 12 weeks.

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NCT07487818

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

Recruiting
PHASE2Ages 18+InterventionalTreatment
Mayo Clinic
~150 participants
Updated 2026-08-19 on ClinicalTrials.gov
What's tested:Non-invasive vagus nerve stimulator plus nicotine replacement patchesnicotine replacement patches

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Smoking Abstinence
Measured over week 12

Conditions

Smoking Cessation

Explore related trials

Nicotine Dependence

Where it's being run

1 sites across 1 states
Minnesota1

Study leadership

  • Ryan Hurt, MD, PhD · PRINCIPAL_INVESTIGATOR · Mayo Clinic
  • Ivana T Croghan, PhD · PRINCIPAL_INVESTIGATOR · Mayo Clinic

Who to contact

Shawn Fokken, CCRP
[email protected]
507-538-7820
Email the study team

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Eligibility criteria

Inclusion

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

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.

What this trial measures

  • Smoking Abstinenceweek 12

    reporting smoking abstinence and having it be biochemically confirmed (CO reading of \< 8 ppm)