Secondary Prevention of Tobacco Dependence in Alcohol-dependent Patients - a Randomized, Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 103
- 试验地点
- 2
- 主要终点
- Number of Smoke-free Patients
研究概览
简要总结
Most alcohol-dependent individuals are heavy smokers. The aim of this study is to evaluate whether a specific smoking cessation program (based on cognitive-behavioral therapy) for inpatient alcohol-dependent smokers is more effective than a control condition (treatment as usual).
详细描述
The study is designed as a randomised, controlled trial conducted in an inpatient alcohol treatment institution. Shortly after alcohol detoxification, smokers are offered to voluntarily participate in a smoking cessation program. Participation is possible if patients either want to stop smoking or to reduce their consumption for at least 50%. Patients are asked about their smoking behaviour at the following time points: at admission (T0), after finishing the smoking cessation program or the control condition (T1), one month later by phone (T2) and six months later in a closing meeting (T3). Urine samples and CO-breath controls are taken to check both nicotine and alcohol abstinence.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •alcohol-dependent
- •intend to stop or reduce smoking for at least 50%
排除标准
- •taking part in another smoking cessation program
- •being pregnant
- •not able to understand instruction due to cognitive impairment
结局指标
主要结局
Number of Smoke-free Patients
时间窗: 6 months
Smoke-free defined with following measures: * patients self-report about smoking in the last 7 days (yes/no) * CO-level (smoke-free \<10ppm) * urine sample (cotinine)
次要结局
- Drinking in the Last 7 Days (Patients Report + Urine Sample)(6 months)