Pharmacotherapies: Efficacy, Mechanisms and Algorithms
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 1,504
- 试验地点
- 2
- 主要终点
- 7-day Point Prevalence of Smoking, Biochemically (Exhaled CO) Confirmed
研究概览
简要总结
The proposed work will advance the understanding and effectiveness of tobacco dependence treatment and result in more smokers quitting successfully.
详细描述
This research study will last for three years. The first year involves a comparison of smoking cessation medications (bupropion, nicotine patch, and nicotine lozenge), including medications used in combination. The results of this study may allow researchers and clinicians to decide which medications are best for helping people to quit smoking as well as what treatments work best for different people. In addition, the first year of this study may help to clarify how these medications work.The purpose of the second and third years of this research study will be to get long-term results on the physical health, mental health, lifestyle factors, and the overall quality of life of people attempting to quit smoking. The results of this study may help researchers and clinicians better understand the health improvements that come from quitting or not quitting smoking.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
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
- •Smoke at least 10 cigarettes per day for the previous 6 months - Expired CO > 9 ppm - Motivated to quit smoking - Able to read and write English - Willing to complete required study assessments
排除标准
- •Uncontrolled hypertension (systolic >180mm Hg or diastolic >110mm Hg) - History of bipolar disorder or psychosis - Myocardial infarction or other serious cardiac problem in the previous 4 weeks - History of diagnosed anorexia and/or bulimia - Diagnosis of Alcohol Dependence in the previous 6 months by participant self-report or drinking 6 or more drinks on six or more days a week - History of seizure and/or serious head injury involving loss of consciousness - Use of contraindicated medications (MAO inhibitors, bupropion, lithium, anticonvulsants, antipsychotics) - Currently pregnant or breast-feeding - Unwilling to use effective contraception during the treatment phase - More than one participant from the same household - Allergic reactions to 3 or more classes of drugs
研究组 & 干预措施
1
nicotine patch alone treatment
干预措施: nicotine patch (Drug)
2
nicotine lozenge alone treatment
干预措施: nicotine lozenge (Drug)
3
nicotine patch + lozenge combination treatment
干预措施: nicotine patch + nicotine lozenge (Drug)
4
bupropion alone treatment
干预措施: bupropion (Drug)
5
bupropion + nicotine lozenge combination treatment
干预措施: bupropion + lozenge (Drug)
6
placebo control (no active medication) treatment
干预措施: placebo (Drug)
结局指标
主要结局
7-day Point Prevalence of Smoking, Biochemically (Exhaled CO) Confirmed
时间窗: 6 months post quit date
Smoking status was assessed both as 7-day point-prevalence abstinence ("Have you smoked at all, even a puff, in the last 7 days?") and continuous abstinence (smoking at all since the target quit day), using a smoking calendar and the timeline follow-back method. All participants' self-reports of smoking status during study visits were confirmed by an expired carbon monoxide level of less than 10 ppm measured using a Micro-3 Smokerlyzer (Bedfont Scientific, Williamsburg, Virginia).
次要结局
未报告次要终点