Advancing Tobacco & Cancer Control: Reducing Alcohol Use to Promote Smoking Cessa

描述（由申请人提供）：大量证据表明，戒烟电话咨询是有效的，并达到了大量有兴趣戒烟的吸烟者。例如，纽约戒烟热线去年收到了超过279，000个联系人（电话和在线请求）。此外，每日吸烟者被诊断为危险饮酒和酒精的风险更高。事实上，从过去一年的大量纽约戒烟热线电话（N = 30，667）的子样本中获得的试点数据显示，24.28%（7，389/30，438）符合NIAAA指南定义的危险饮酒标准。来自纽约戒烟热线和耶鲁临床试验的数据显示，危险饮酒与不良治疗结果相关，我们的顾问Kahler博士的数据显示，包括短暂酒精干预在内的戒烟治疗可以提高戒烟率。此外，《戒烟临床实践指南》建议吸烟者在戒烟时应考虑限制/戒断饮酒。然而，据我们所知，这是未经测试的背景下，人口为基础的戒烟热线，和戒烟的结果可能会得到加强，如果辅导员接受培训，建议来电者限制或放弃使用酒精在他们的戒烟尝试。因此，基于我们在耶鲁大学的研究小组与罗斯威尔公园癌症研究所/纽约戒烟热线的研究小组之间的现有关系，我们计划进行一项发展研究，以：1）创建并测试一个酒精咨询协议，有25个Quitline来电者，2）培训戒烟热线专家，使用至少100名试点戒烟热线呼叫者提供酒精干预，以确保酒精干预专家+标准护理条件提供咨询，以高水平酒精干预策略和技能解决危险饮酒问题。本阶段研究完成后，将对1，950名饮酒达到危险水平的纽约戒烟热线呼叫者进行一项发育随机临床试验，以比较实际咨询+标准护理（PC + SC条件）中添加的戒烟印刷材料与酒精干预咨询+标准护理（AI + SC条件）中添加的以酒精为重点的印刷材料。本试验的疗效数据将用于确定1周和6个月自我报告的点患病率戒烟率的效应量估计值。减少饮酒和饮酒作为戒烟结果的中介将是次要结果。酒精干预效应的其他介质和调节剂也将作为探索性结果进行检查。如果效应量估计值足够大，并且具有医学重要性，可以进行确定性试验，则这些数据将用于拟定一项全规模多中心大型研究。如果酒精干预在大规模研究中被证明可以提高治疗效果，那么戒酒咨询师的酒精干预可以被整个纽约州的戒酒热线和全国各地的其他戒酒热线所使用。这可能会提高戒烟干预措施的有效性，从而有可能接触到数百万吸烟者，从而支持美国各地的烟草和癌症控制工作。 公共卫生相关性：研究改善吸烟者电话戒烟热线咨询的方法，可以通过提高戒烟热线电话者的戒烟率来改善烟草控制干预措施。由于电话戒烟热线每年有可能接触到数百万吸烟者，更好的干预措施可以极大地影响美国的烟草和癌症控制工作。

DESCRIPTION (provided by applicant): substantial body of evidence shows that telephone counseling for smoking cessation is effective and reaches a large number of smokers interested in quitting smoking. For instance, the NY Quitline received over 279,000 contacts (calls & online requests) last year. In addition, daily smokers are at heightened risk for hazardous drinking and alcohol diagnoses. Indeed, pilot data from a large subsample of NY Quitline callers (N = 30,667) from this past year revealed that 24.28% (7,389/30,438) met criteria for hazardous drinking, as defined by NIAAA guidelines. Data from NY Quitline callers and from a Yale clinical trial revealed that risky drinking was associated with poor treatment outcomes, and data from our consultant, Dr. Kahler, showed that smoking cessation treatment including a brief alcohol intervention can increase smoking quit rates. Moreover, the Clinical Practice Guidelines for smoking cessation suggest that smokers should consider limiting/abstaining from alcohol use while quitting smoking. However, to our knowledge this is untested in the context of a population based quitline, and cessation outcomes might be enhanced if counselors were trained to advise callers to limit or abstain from alcohol use in the midst of their quit attempt. Thus, building on a pre-existing relationship between our research group at Yale and the research group at the Roswell Park Cancer Institute/NY Quitline, we plan to conduct a developmental study to: 1) create and beta test an alcohol counseling protocol with 25 Quitline callers and 2) train Quitline Specialists to provide an alcohol intervention using at least 100 pilot Quitline callers to ensure that Specialists in the alcohol intervention + standard care condition provide counseling that addresses hazardous drinking with a high level of alcohol intervention strategies and skill. After this phase of the study is complete, a developmental randomized clinical trial will be conducted with 1,950 NY Quitline callers who drink at hazardous levels to compare practical counseling + smoking cessation print materials added to standard care (PC + SC condition) to alcohol intervention counseling + alcohol-focused print materials added to standard care (AI + SC condition). Efficacy data from this trial will be used to determine effect size estimates for both 1-week and 6-month self-reported point prevalence abstinence rates. Reduction in alcohol consumption and reduced drinking as a mediator of smoking cessation outcome will be secondary outcomes. Other mediators and moderators of alcohol intervention effects will also be examined as an exploratory outcome. If the effect size estimates are sufficiently large and medically important to pursue a definitive trial, these data will be used to propose a full scale multi-site large study. If an alcohol intervention is shown to enhance treatment outcome in a large-scale study, alcohol interventions with quitline counselors could be translated for use by the entire NY state quitline and other quitlines across the country. This may increase the effectiveness of quitline interventions and thus has the potential to reach millions of smokers, thereby bolstering tobacco and cancer control efforts across the United States. PUBLIC HEALTH RELEVANCE: Studying ways to improve telephone quitline counseling for smokers may improve tobacco control interventions by enhancing quit rates of callers to quitlines. As telephone quitlines have the potential to reach millions of smokers annually, better interventions can greatly impact tobacco and cancer control efforts in the United States.