Vagal nerve stimulation plus nicotine replacement for quitting smoking

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This interventional trial explores the use of a non-invasive vagus nerve stimulator in combination with nicotine replacement therapy to increase abstinence from smoking. It includes adults who smoke regularly and are motivated to quit, across Phase 2 and Phase 3. Participants will use the device alongside nicotine patches for 12 weeks, with outcomes focusing on smoking abstinence rates. The study excludes individuals with significant comorbid conditions or recent use of investigational drugs or varenicline-interacting medications. Mayo Clinic leads the study with collaboration from NCI at a single site in Rochester, Minnesota.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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.

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.

Where it's running

• Mayo Clinic in Rochester
  Rochester, Minnesota, United States Recruiting

Study contacts

• Principal investigator: Ivana T Croghan, PhD — Mayo Clinic
• Study coordinator: Sara Seegmiller, M.A.N, R.N
• Email: NicotineRes@mayo.edu
• Phone: 507-538-7820

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.