Improving Smoking Cessation Outcomes in Heavy Drinkers
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 236
- 试验地点
- 2
- 主要终点
- Smoking Abstinence at 26 Weeks
研究概览
简要总结
To test the effectiveness of an smoking cessation treatment for smokers who also drink alcohol heavily.
详细描述
Heavy alcohol use frequently co-occurs with cigarette smoking and may impede smoking cessation. This clinical trial examined whether smoking cessation treatment that incorporates brief alcohol intervention can improve smoking cessation outcomes (7-day verified point prevalence abstinence) and reduce drinks consumed per week. Heavy drinkers seeking smoking cessation treatment were assigned by urn randomization to receive, along with 8-weeks of nicotine replacement therapy, either a 4-session standard smoking cessation treatment (ST, n = 119) or standard treatment of equal intensity that incorporated brief alcohol intervention (ST-BI, n = 117).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 95 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •be at least 18 years of age
- •have smoked cigarettes regularly for at least one year
- •currently smoke at least 10 cigarettes a day
- •currently be using no other tobacco products or nicotine replacement therapy
- •currently drink heavily according to self-report (>14 drinks per week or >5 drinks per occasion at least once per month over the last 12 months for men; >7 drinks per week or >4 drinks per occasion at least once per month over the past 12 months for women)
排除标准
- •meet full DSM-IV criteria for alcohol dependence in the past 12 months
- •meet criteria for other current psychoactive substance abuse or dependence (excluding nicotine dependence and alcohol abuse) in the past 12 months [this would also exclude individuals with lifetime substance dependence who continue to have some abuse/dependence symptoms in the past 12 months]
- •meet criteria for current dysthymia, major depression, or manic episode [past month]
- •are currently psychotic [past 12 months] or suicidal [suicidal ideation or intent in the past month]
- •have an unstable medical condition that would suggest caution in the use of the nicotine patch (e.g., unstable angina pectoris, arrhythmia, recent congestive heart failure)
- •are currently pregnant or lactating or intend to become pregnant. We also will exclude participants who are not alcohol dependent but who have characteristics that might make supervised alcohol detoxification necessary (e.g., morning drinking to avoid withdrawal, daily drinking of >12 drinks, recent withdrawal symptoms, history of severe withdrawal symptoms such as hallucinations, seizures, or delirium tremens).
结局指标
主要结局
Smoking Abstinence at 26 Weeks
时间窗: 26 weeks
7 days of smoking abstinence confirmed biochemically at 26 week post quit attempt
Smoking Abstinence at 16 Weeks
时间窗: 16 weeks
7 days of smoking abstinence confirmed biochemically at 16 weeks
Smoking Abstinence at 8 Weeks
时间窗: 8 weeks
7 days of smoking abstinence confirmed biochemically at 8 weeks
Smoking Abstinence at 2 Weeks
时间窗: 2 weeks
7 days of smoking abstinence confirmed biochemically at 2 weeks
次要结局
- Alcohol Drinks Consumed Per Week Over a 2-week Period(At 2, 8, 16, and 26-week follow-ups)
研究者
Christopher W. Kahler
Professor
Brown University