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Can a zap to the neck help smokers quit? new trial tests nerve stimulator

NCT ID NCT07487818

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Aug 20, 2026 · Updated 3 times

Summary

This study tests whether a handheld device that gently stimulates the vagus nerve in the neck, combined with a nicotine patch, can help people stop smoking. Researchers at Mayo Clinic will enroll 150 motivated smokers who smoke at least 10 cigarettes a day. Participants use the device twice daily and wear a nicotine patch for 12 weeks, with quit rates checked by breath tests.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
non-invasive vagus nerve stimulator plus nicotine replacement patches
What this could lead to
If it works, this could offer a new, drug-free way to boost quit rates for smokers who struggle with cravings.
What could go wrong
This is an early-to-mid-stage trial with only 150 people, so results may not apply to everyone. The device is new for this use, and side effects or lack of benefit are possible.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2/3

Runs two stages together: whether the treatment works, then large-scale confirmation.

Participants

About 150 people

The number the study aims to enrol. It can still change while the study runs.

Started

Apr 2026

Expected to finish

May 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

nicotine dependence Smoking Smoking Cessation

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    1 site. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Study contacts

  • Contact

    Email: •••••@•••••

  • Contact

    Email: •••••@•••••

Locations

  • Mayo Clinic in Rochester

    RECRUITING

    Rochester, Minnesota, 55905, United States

    Contact Email: •••••@•••••

    Contact Email: •••••@•••••

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