Auriculotherapy for Smoking Cessation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 125
- 试验地点
- 2
- 主要终点
- Percentage of Self-reported Abstinence at 6 Weeks.
研究概览
简要总结
Thirty three percent of our veterans currently smoke. Encouraging smoking cessation continues to be a top priority for the Veteran's Administration as smoking is the single most important preventable risk factor for mortality and morbidity. This study attempts to determine whether auriculotherapy may be used as an effective alternative to usual pharmacological interventions currently offered. Identifying an efficacious alternative method to nicotine patch or bupropion would be highly beneficial to veterans who want to quit smoking. This clinical trial took place at the Veterans Administration Medical Center, in conjunction with the smoking cessation clinic. One hundred twenty five veterans, male and female, age 19 or older, who smoked a minimum of 10 cigarettes per day, were evaluated for enrollment and randomized to two groups- true auriculotherapy and sham auriculotherapy in this 6 week trial.
详细描述
Methods: This randomized, double-blind, placebo-controlled clinical trial of 125 veterans was conducted to determine whether aural electrical stimulation (auriculotherapy) with the Stim Flex 400A TENS unit once a week for 5 consecutive weeks is associated with a higher rate of smoking abstinence are than observed with sham stimulation.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Do not meet any exclusion criteria; age 19 and above.
排除标准
- •Veterans will be excluded from the study if they:
- •have history or current evidence of pathological condition of the ear (e.g. infection, inflammation, or skin disruption of the auricle
- •are known to be pregnant (positive urine pregnancy test)
- •have an indwelling cardiac pacemaker or defibrillator
- •are actively psychotic (as evidenced by delusions, hallucinations, or disorganization), have a severe cognitive impairment, or current significant substance abuse disorder that might prevent full participation in this study. Also excluded are those who score greater than 20 on the PHQ-9 screening tool for depression
- •refuse to sign an informed consent form
- •have been on bupropion and/or nicotine patch in the past one month or intend to start bupropion and/or nicotine patch in the next 6 weeks.
- •Have a urine cotinine level less than 3.
结局指标
主要结局
Percentage of Self-reported Abstinence at 6 Weeks.
时间窗: 6 weeks
Percentage of study participants free from smoking at 6 weeks based on self-report (yes/no).
次要结局
未报告次要终点