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

Part of paid clinical trials in Rochester, Minnesota.

Sponsor
Mayo Clinic
Study ID
NCT07487818
Phase
PHASE2/PHASE3
Status
Not Yet Recruiting

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Conditions

  • Smoking Cessation

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Non-invasive vagus nerve stimulator plus nicotine replacement patches — COMBINATION_PRODUCT
    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.
  • nicotine replacement patches — DRUG
    Use of a 21 mg nicotine patch daily for up to 12 weeks

Study Details

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.

Key Dates

Start date
Apr 15, 2026
Status verified
Mar 2026
Primary completion
Jan 15, 2027
Completion
May 31, 2027

Study Design

Enrollment
150 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Vagal 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.
  • Active Comparator: 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).

Primary Outcome Measure

Smoking Abstinence [ Time Frame: week 12 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Mayo Clinic in RochesterRochesterMinnesota55905
Shawn Fokken, CCRP
[email protected]
507-538-7820
Sara Seegmiller, RN
[email protected]
507-538-7820
Ryan T Hurt, MD, PhD (PRINCIPAL_INVESTIGATOR)
Ivana T Croghan, PhD (PRINCIPAL_INVESTIGATOR)

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