Clinical Trial of Two Medications on Smoking Cessation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 594
- 试验地点
- 1
- 主要终点
- Smoking cessation rates (measured by self-report, saliva test, and exhaled carbon monoxide test)
研究概览
简要总结
Nicotine addiction is a serious health problem in the United States; 46 million people smoke cigarettes, and 70% of those are trying to quit. The nicotine patch and bupropion, a medication used to reduce nicotine cravings, are two commonly used smoking cessation aids. Both have been shown to reduce smoking rates, however, the effectiveness of combining the two treatments has not been widely examined. This study will evaluate the effectiveness of the nicotine patch combined with bupropion at reducing smoking rates among younger, low-income, and minority individuals.
详细描述
Cigarette smoking poses a serious but preventable health risk. The negative health effects of smoking are well-known, but the prevalence of cigarette smoking remains high in the United States, particularly among younger people, people of lower socioeconomic status, and minority groups. Nicotine replacement therapy, commonly known as the nicotine patch, has been proven to be an effective treatment for reducing nicotine use. The nicotine patch provides a measured dose of nicotine through the skin. By gradually lowering nicotine doses over a period of time, individuals experience fewer nicotine cravings; the ultimate goal is to stop using nicotine. Bupropion, a medication commonly used to treat depression, is also used as a smoking cessation tool. It helps to control nicotine cravings. The majority of studies on the nicotine patch and bupropion have been performed on older, white, middle-class individuals; more research is needed to confirm the benefit of these treatments in younger, low-income, and minority populations. While both the nicotine patch and bupropion appear to be individually effective as smoking cessation aids, little is known on the possible effectiveness of combining the two treatments. Because of the high relapse rates in low-income and minority individuals, the combination of the nicotine patch with bupropion may be particularly effective at reducing relapse rates in these individuals. The purpose of this study is to evaluate the effectiveness of the nicotine patch and bupropion at reducing smoking rates in younger, low-income, and minority individuals.
This 1-year study will enroll younger, low-income, and minority individuals who smoke. Participants will be randomly assigned to one of the following three groups: 1) nicotine patch plus placebo sustained-release bupropion; 2) placebo nicotine patch plus sustained-release bupropion; or 3) nicotine patch plus sustained-release bupropion. At study entry, participants will complete standardized psychological questionnaires to assess depression levels and will undergo a physical exam and blood testing. Study visits will take place at Weeks 5 and 11, Month 6, and Year 1. At each visit, questionnaires will be completed, and smoking cessation rates will be assessed by self-report and verified by saliva and exhaled carbon monoxide testing. In addition, all participants will take part in a standardized behavioral smoking cessation program.
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, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •In good health
- •In a lower socioeconomic group, defined as below median income in the study county
- •Smokes more than 5 cigarettes each day for at least 6 months prior to study entry, as determined by self-report
排除标准
- •History of a seizure disorder, brain tumor, or severe head trauma
- •History of substance abuse, including alcohol use in excess of 14 drinks a week
- •History of anorexia or bulimia
- •History of cerebral, coronary, or peripheral vascular disease
- •History of serious heart arrhythmia
- •Presence of an unstable psychiatric illness
- •Current use of a psychotropic medication, including antidepressant medications
- •History of peptic ulcer disease or currently taking an H2 blocker (e.g., cimetidine)
- •History of kidney disease, defined as creatinine levels greater than 1.5 times the upper limit of normal
- •History of liver disease, defined as serum glutamic oxaloacetic transaminase (SGOT) or serum glutamic-pyruvic transaminase(SGPT) levels greater than twice the upper limit of normal
- •History of uncontrolled hyperthyroidism or pheochromocytoma
- •History of atopic or eczematous dermatitis
- •Current use of a medication that cannot be discontinued and may interfere with study procedures or may increase the risk of side effects (e.g., nicotine gum, nicotine nasal spray, theophylline, systemic steroids, levodopa)
- •History of an allergic reaction to the nicotine patch or bupropion
- •History of diabetes treated with an oral agent or insulin
- •Uncontrolled high blood pressure, defined as blood pressure level greater than 140/90 mm Hg
- •Severe uncontrolled asthma, bronchitis, or emphysema
- •Pregnant or breastfeeding
研究组 & 干预措施
1
Nicotine patch plus placebo sustained-release bupropion
干预措施: Nicotine Patch (Drug)
2
Placebo nicotine patch plus sustained-release bupropion
干预措施: Sustained Release Bupropion (Drug)
3
Nicotine patch plus sustained-release bupropion
干预措施: Nicotine Patch (Drug)
3
Nicotine patch plus sustained-release bupropion
干预措施: Sustained Release Bupropion (Drug)
结局指标
主要结局
Smoking cessation rates (measured by self-report, saliva test, and exhaled carbon monoxide test)
时间窗: Measured at 1 year follow-up
次要结局
未报告次要终点