Using Vagal Nerve Stimulation In Conjunction With NRT For Smoking Cessation
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- Mayo Clinic
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Smoking Abstinence
研究概览
简要总结
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.
详细描述
This study will evaluate the role of vagal nerve stimulation as a potential adjunct to nicotine patches to help smokers stop smoking.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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 gastroparesis.
- •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 populations.
- •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 childbearing potential must have a negative pregnancy test and must agree to use approved contraception during study participation.
研究组 & 干预措施
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.
干预措施: Non-invasive vagus nerve stimulator plus nicotine replacement patches (Combination Product)
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).
干预措施: nicotine replacement patches (Drug)
结局指标
主要结局
Smoking Abstinence
时间窗: week 12
reporting smoking abstinence and having it be biochemically confirmed (CO reading of \< 8 ppm)
次要结局
未报告次要终点
研究者
Ryan T. Hurt, M.D., Ph.D.
Principal Investigator
Mayo Clinic