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

NCT07487818 · Status: NOT_YET_RECRUITING · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2026-03-23

No results posted yet for this study

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.

Conditions

  • Smoking Cessation

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

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • Mayo Clinic

    lead OTHER

Principal Investigators

  • Ryan Hurt, MD, PhD · Mayo Clinic

  • Ivana T Croghan, PhD · Mayo Clinic

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-04-15
Primary Completion
2027-01-15
Completion
2027-05-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07487818 on ClinicalTrials.gov