NCT07487818

A Study Of Vagal Nerve Stimulation In Conjunction With NRT For Smoking Cessation

Using Vagal Nerve Stimulation In Conjunction With NRT For Smoking Cessation

• Status: Not Yet Recruiting
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 150 (estimated)
• Sponsor: Mayo Clinic · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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

Interventions

Type	Name	Description
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

Timeline

• Start date: 2026-04-15
• Primary completion: 2027-01-15
• Completion: 2027-05-31
• First posted: 2026-03-23
• Last updated: 2026-03-23

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study