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

ConditionSmoking Cessation

Trial statusRecruiting

Trial phasePhase 2, Phase 3

Trial typeInterventional

Biological sexAll

Age18+

SponsorMayo Clinic

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

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

Treatment groups

150 Participants

are divided into 2 treatment groups

Group A: Vagal Nerve Stimulator and Nicotine Replacement PatchesExperimental treatment 1 intervention

Group B: Nicotine Replacement PatchesActive comparator 1 intervention

Trial outcomes

Primary outcomes

Smoking Abstinence

reporting smoking abstinence and having it be biochemically confirmed (CO reading of \< 8 ppm)

Time frame

week 12

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Mayo Clinic

Lead sponsor

National Cancer Institute (NCI)

Collaborator

Source ClinicalTrials.gov

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