Smoking CessationPhase 2/3NCT07487818
A Study Of Vagal Nerve Stimulation In Conjunction With NRT For Smoking Cessation
A Phase 2/3 study testing Non-invasive vagus nerve stimulator plus nicotine replacement patches and nicotine replacement patches in people with Smoking Cessation, run by Mayo Clinic at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Smoking Cessation
- What is being tested?
- Non-invasive vagus nerve stimulator plus nicotine replacement patches and nicotine replacement patches
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Jun 2026to Jul 2028
- Phase
- Phase 2/3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years of age or older at the time of consent.
- Currently smoking cigarettes on a regular basis
- 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.
Who cannot join
- 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.
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- 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.
- All female participants of childbearing potential must have a negative pregnancy test and must agree to use approved contraception during study participation.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
Shawn Fokken, CCRP, 507-538-7820, RSTGIMRESStudies@mayo.edu
Sara Seegmiller, RN, 507-538-7820, RSTGIMRESStudies@mayo.edu
About this study
Official title: 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.
Read the detailed description
This study will evaluate the role of vagal nerve stimulation as a potential adjunct to nicotine patches to help smokers stop smoking.
- Conditions
- Smoking Cessation
- Being tested
- Non-invasive vagus nerve stimulator plus nicotine replacement patches, nicotine replacement patches
- Keywords
- nicotine dependence, smoking, vagal nerve stimulator, VNS, varenicline, nicotine replacement therapy, nicotine patches
- Medical subject headings
- Smoking Cessation, Tobacco Use Disorder, Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-invasive vagus nerve stimulator plus nicotine replacement patchesCombination product
Also called GammaCore Vagal Nerve Stimulator
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.
nicotine replacement patchesDrug
Also called NRT, nicotine patches
Use of a 21 mg nicotine patch daily for up to 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| Vagal Nerve Stimulator and Nicotine Replacement Patches | Experimental | 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. Receives: Combination Product: Non-invasive vagus nerve stimulator plus nicotine replacement patches |
| Nicotine Replacement Patches | Active comparator | 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). Receives: Drug: nicotine replacement patches |
What is being measured
The primary outcome is the main question the study is designed to answer.
Smoking Abstinence
reporting smoking abstinence and having it be biochemically confirmed (CO reading of < 8 ppm)
Measured: week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2026
- Study start4 Jun 2026
- Primary completionJan 2028 (estimated)
- Study completionJul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Smoking CessationStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This open-label study will randomize subjects to VNS plus nicotine patch or nicotine patch alone. In the second phase, those who are smoke-free at the end of phase one, will go into post-treatment follow-up (no med), and those who are continuing to smoke will go into a retreatment phase of 12 weeks of varenicline.
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Ryan T. Hurt, M.D., Ph.D., Mayo Clinic
- Investigators
- Ivana T Croghan, PhD, Principal investigator, Mayo ClinicRyan T Hurt, MD, PhD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07487818
- Sponsor's protocol ID
- 25-005696
- Other IDs
- 1R21CA302802-01
- Status last verified
- Sep 2026
- First submitted
- 16 Mar 2026
- Last updated
- 25 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Croghan IT, Hurt RT, Elrashidi MY, Milbrandt TJ, Ghosh AK, Fokken SC, Ebbert JO. Smoking Cessation in Primary Care: A Narrative Review of Evidence-Based Treatment, Emerging Technology, and Harm Reduction Approaches. J Prim Care Community Health. 2026 Jan-Dec;17:21501319261468510. doi: 10.1177/21501319261468510. Epub 2026 Jul 13.
PubMed 42439787
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using Vagal Nerve Stimulation In Conjunction With NRT For Smoking Cessation
- ClinicalTrials.gov ID
- NCT07487818
- Acronym / sponsor ID
- 25-005696
- Conditions
- Smoking Cessation
- Keywords
- nicotine dependence, smoking, vagal nerve stimulator, VNS, varenicline, nicotine replacement therapy, nicotine patches
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 4 Jun 2026 (actual)
- Primary completion
- Jan 2028 (estimated)
- Study completion
- Jul 2028 (estimated)
- First posted
- 23 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This open-label study will randomize subjects to VNS plus nicotine patch or nicotine patch alone. In the second phase, those who are smoke-free at the end of phase one, will go into post-treatment follow-up (no med), and those who are continuing to smoke will go into a retreatment phase of 12 weeks of varenicline.
| Arm | Type | Receives |
|---|---|---|
| Vagal Nerve Stimulator and Nicotine Replacement Patches | Experimental | Combination Product: Non-invasive vagus nerve stimulator plus nicotine replacement patchesThis 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. |
| Nicotine Replacement Patches | Active comparator | Drug: nicotine replacement patchesThis arm will receive nicotine patches (21 mg) for 12 weeks and brief behavioral therapy (through the self-help manual Smoke Free and Living It). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 18 years of age or older at the time of consent.
- Currently smoking cigarettes on a regular basis
- 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.
Key exclusion criteria (16 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Non-invasive vagus nerve stimulator plus nicotine replacement patchesAlso: GammaCore Vagal Nerve StimulatorVNS 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. | Combination product | Vagal Nerve Stimulator and Nicotine Replacement Patches |
| nicotine replacement patchesAlso: NRT, nicotine patchesUse of a 21 mg nicotine patch daily for up to 12 weeks | Drug | Nicotine Replacement Patches |
Primary outcome
Smoking Abstinence
Time frame: week 12
reporting smoking abstinence and having it be biochemically confirmed (CO reading of < 8 ppm)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2026.
- Background: PubMed 42439787Croghan IT, Hurt RT, Elrashidi MY, Milbrandt TJ, Ghosh AK, Fokken SC, Ebbert JO. Smoking Cessation in Primary Care: A Narrative Review of Evidence-Based Treatment, Emerging Technology, and Harm Reduction Approaches. J Prim Care Community Health. 2026 Jan-Dec;17:21501319261468510. doi: 10.1177/21501319261468510. Epub 2026 Jul 13.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ivana T Croghan, PhD principal investigator
Mayo Clinic
Ryan T Hurt, MD, PhD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Non-invasive vagus nerve stimulator plus nicotine replacement patches and nicotine replacement patches in people with Smoking Cessation, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sara Seegmiller, M.A.N, R.N (507-538-7820, NicotineRes@mayo.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Smoking Abstinence (time frame: week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07487818, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2026.