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Clinical Trial NCT07487818 for Smoking Cessation is not yet recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here. | ||
Mayo ClinicA Study Of Vagal Nerve Stimulation In Conjunction With NRT For Smoking Cessation Phase 2, Phase 3 150
Using Vagal Nerve Stimulation In Conjunction With NRT For Smoking Cessation
Phase 3
smoking
vagal nerve stimulator
VNS
varenicline
nicotine replacement therapy
nicotine patches
| Participant Group/Arm | Intervention/Treatment |
|---|---|
ExperimentalVagal 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. | 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. |
Active ComparatorNicotine 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). | nicotine replacement patches Use of a 21 mg nicotine patch daily for up to 12 weeks |
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
Smoking Abstinence | reporting smoking abstinence and having it be biochemically confirmed (CO reading of \< 8 ppm) | week 12 |
- 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.
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.
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