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

March 18, 2026 updated by: Ryan T. Hurt, M.D., Ph.D., Mayo Clinic

Using Vagal Nerve Stimulation In Conjunction With NRT For Smoking Cessation

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Estimated)

150

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic in Rochester
        • Principal Investigator:
          • Ivana T Croghan, PhD
        • Principal Investigator:
          • Ryan T Hurt, MD, PhD
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Vagal Nerve Stimulator and Nicotine Replacement Patches
This arm will receive nicotine patches (21 mg) for 12 weeks and brief behavioral therapy (through the self-help manual Smoke Free and Living It), as well as the vagal nerve stimulator (VNS) device to use during these 12 weeks while trying to stop smoking. The VNS delivers up to 30 stimulations over 24 hours.
Combination product: Non-invasive vagus nerve stimulator plus nicotine replacement patches
VNS is a handheld, rechargeable, portable device that delivers electrical signals to the vagal nerve when positioned on the skin of the neck at the appropriate location to stimulate the vagal nerve for 2 minutes at each treatment. During these 12 weeks, participants will also use a 21 mg nicotine patch daily.
Other Names:
  • GammaCore Vagal Nerve Stimulator
Active Comparator: Nicotine Replacement Patches
This arm will receive nicotine patches (21 mg) for 12 weeks and brief behavioral therapy (through the self-help manual Smoke Free and Living It).
Drug: nicotine replacement patches
Use of a 21 mg nicotine patch daily for up to 12 weeks
Other Names:
  • NRT
  • nicotine patches

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Smoking Abstinence
Time Frame: week 12
reporting smoking abstinence and having it be biochemically confirmed (CO reading of < 8 ppm)
week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mayo Clinic

Collaborators

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Ryan Hurt, MD, PhD, Mayo Clinic
  • Principal Investigator: Ivana T Croghan, PhD, Mayo Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 15, 2026

Primary Completion (Estimated)

January 15, 2027

Study Completion (Estimated)

May 31, 2027

Study Registration Dates

First Submitted

March 16, 2026

First Submitted That Met QC Criteria

March 18, 2026

First Posted (Actual)

March 23, 2026

Study Record Updates

Last Update Posted (Actual)

March 23, 2026

Last Update Submitted That Met QC Criteria

March 18, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 25-005696
  • 1R21CA302802-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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