A Study Of Vagal Nerve Stimulation In Conjunction With NRT For Smoking Cessation
Using Vagal Nerve Stimulation In Conjunction With NRT For Smoking Cessation
2 other identifiers
interventional
150
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Apr 2026
Shorter than P25 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 16, 2026
CompletedFirst Posted
Study publicly available on registry
March 23, 2026
CompletedStudy Start
First participant enrolled
April 15, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 15, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
May 31, 2027
March 23, 2026
March 1, 2026
9 months
March 16, 2026
March 18, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Smoking Abstinence
reporting smoking abstinence and having it be biochemically confirmed (CO reading of \< 8 ppm)
week 12
Study Arms (2)
Vagal Nerve Stimulator and Nicotine Replacement Patches
EXPERIMENTALThis 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 COMPARATORThis arm will receive nicotine patches (21 mg) for 12 weeks and brief behavioral therapy (through the self-help manual Smoke Free and Living It).
Interventions
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.
Use of a 21 mg nicotine patch daily for up to 12 weeks
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
- 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.
- +1 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Mayo Cliniclead
- National Cancer Institute (NCI)collaborator
Study Sites (1)
Mayo Clinic in Rochester
Rochester, Minnesota, 55905, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ryan Hurt, MD, PhD
Mayo Clinic
- PRINCIPAL INVESTIGATOR
Ivana T Croghan, PhD
Mayo Clinic
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
March 16, 2026
First Posted
March 23, 2026
Study Start
April 15, 2026
Primary Completion (Estimated)
January 15, 2027
Study Completion (Estimated)
May 31, 2027
Last Updated
March 23, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will not share