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
Qualifiers
18 years of age or older at the time of consent.
Currently smoking at least 10 cigarettes/day
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
Treatments tested in this trial
- Non-invasive vagus nerve stimulator plus nicotine replacement patches
- nicotine replacement patches
Treatment groups
150 Participants
are divided into 2 treatment groupsSponsors and collaborators
Mayo Clinic
Lead sponsor
National Cancer Institute (NCI)
Collaborator
Source ClinicalTrials.gov