NCT00931021终止早期 1 期
Smoking Cessation Treatment for Head and Neck Cancer Patients
适应症
干预措施
相关药物
试验速览
- 阶段
- 早期 1 期
- 状态
- 终止
- 入组人数
- 7
- 试验地点
- 1
- 主要终点
- To develop an effect size estimate for smoking cessation defined as continuous abstinence over the last 4 weeks of treatment for 2 mg varenicline compared to nicotine patch.
研究概览
简要总结
This is a pilot research study examining the use of varenicline (Chantix) and the nicotine patch. The study is designed to find out whether one of these medications is more effective for smoking cessation with head and neck cancer patients. The study has three parts: 1) two intake sessions; 2) an 8-week treatment phase, and 3) a 3-month follow-up.
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
- •age 18 or older
- •smoking 10 or more cigarettes per day
- •diagnosed with and completed an initial course of treatment for any type of head and neck cancer
- •life expectancy of 12 months or more
排除标准
- •history of allergic reactions to adhesives
- •unstable psychiatric/medical conditions such as suicidal ideation, acute psychosis, severe alcohol dependence, or dementia
- •females of childbearing potential who are pregnant, nursing, or not practicing effective contraception
研究组 & 干预措施
Varenicline (Chantix)
Active Comparator
干预措施: Varenicline (Chantix) (Drug)
Nicotine Patch
Active Comparator
干预措施: Nicotine Patch (Drug)
结局指标
主要结局
To develop an effect size estimate for smoking cessation defined as continuous abstinence over the last 4 weeks of treatment for 2 mg varenicline compared to nicotine patch.
时间窗: Eight weeks
次要结局
- To examine tolerability of 2 mg varenicline and the 21 mg nicotine patch in smokers who have been diagnosed with head and neck cancer.(Eight weeks)
- To examine the effects of smoking cessation, varenicline and nicotine patch on markers of inflammation.(Eight weeks)
- To examine the effect of varenicline and nicotine patch on alcohol consumption.(Eight weeks)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
不适用
Varenicline or Nicotine Patch in Promoting Smoking Cessation Among Current SmokersTobacco Use DisorderNCT01771627Roswell Park Cancer Institute300
进行中（未招募）
1 期
Smoking Cessation Treatment for Head & Neck Cancer PatientsHead and Neck CancerSmoking CessationNCT01098955M.D. Anderson Cancer Center51
已完成
3 期
Evaluation of Varenicline (Champix) in Smoking Cessation for Patients Post-Acute Coronary Syndrome (EVITA) TrialAcute Coronary SyndromeNCT00794573Mark Eisenberg302
已完成
4 期
Varenicline Treatment for Smoking Cessation in Patients With Bipolar DisorderSmoking CessationBipolar DisorderNCT01010204K.N. Roy Chengappa60
已完成
4 期
Varenicline Treatment in Alcohol and Nicotine Dependent Patients With SchizophreniaNicotine DependenceSchizophreniaSchizoaffective DisorderAlcohol DependenceNCT00727103State University of New York - Upstate Medical University10