Recruiting NCT07487818
A Study Of Vagal Nerve Stimulation In Conjunction With NRT For Smoking Cessation
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Non-invasive vagus nerve stimulator plus nicotine replacement patches, nicotine replacement patches.
- Who it may be relevant to
- Registry conditions: Smoking Cessation. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Using Vagal Nerve Stimulation In Conjunction With NRT For Smoking Cessation
Overview
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.
Interventions
- 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. - Drug nicotine replacement patches
Use of a 21 mg nicotine patch daily for up to 12 weeks
Primary outcome measures
- Smoking Abstinence [Time frame: week 12]
Eligibility criteria
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.
- 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.
i. All female participants of childbearing potential must have a negative pregnancy test and must agree to use approved contraception during study participation.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Mayo Clinic in Rochester — Rochester
Identifiers
NCT: NCT07487818 · 25-005696 · 1R21CA302802-01