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New treatment option for Smoking Cessation
Official title A Study Of Vagal Nerve Stimulation In Conjunction With NRT For Smoking Cessation
ClinicalTrials.gov ID: NCT07487818
What this study is testing
What is Non-invasive vagus nerve stimulator plus nicotine replacement patches?
Non-invasive vagus nerve stimulator plus nicotine replacement patches is an investigational medicine, given as an once-daily, being studied as a potential treatment for smoking cessation.
Also referred to as GammaCore Vagal Nerve Stimulator.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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.
- Have the ability to provide informed consent.
You likely can't join if
- 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...
- Patients with a known allergy to nicotine patches or varenicline.
- Patients with a personal history of acute pancreatitis, hypoglycemia, acute kidney injury or impairment of renal function, type 1 diabetes or...
See the full eligibility criteria
- 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.
- Have the ability to provide informed consent.
- Have no contraindicating comorbid health conditions that would interfere with study participation, as determined by the clinical investigators.
- 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.
- Patients with a known allergy to nicotine patches or varenicline.
- Patients with a personal history of acute pancreatitis, hypoglycemia, acute kidney injury or impairment of renal function, type 1 diabetes or diabetic ketoacidosis, and/or severe gastrointestinal disease such as...
- Patients with an active implantable medical device, such as a pacemaker, hearing aid implant, or any implanted electronic device.
- Patients diagnosed with narrowing of the arteries (carotid atherosclerosis)
- Patients who have had surgery to cut the vagus nerve in the neck (cervical vagotomy)
- Patients with clinically significant hypertension, hypotension, bradycardia, or tachycardia
- Patients who have a metallic device such as a stent, bone plate, or bone screw implanted at or near your neck
- Patients who are using another device at the same time (e.g., TENS Unit, muscle stimulator) or any portable electronic device (e.g., mobile phone).
- Women who are pregnant or lactating, or who are of childbearing potential and are likely to become pregnant during the medication phase but are not willing to use a reliable form of contraception, will also be excluded.
- Reliable forms of contraception include oral contraception, diaphragm or condom (with spermicide), injections, intrauterine devices, surgical sterilization, and abstinence. The study does not include vulnerable...
- Specifically, the study does not include fetuses, neonates, pregnant women, children (\<18 years of age), prisoners, institutionalized individuals, or other vulnerable populations. i. All female participants of...
The study team makes the final eligibility decision.
Where it's taking place
- Rochester, Minnesota, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Rochester, Minnesota, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.