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，电话戒烟咨询是有效的，并覆盖了大量对戒烟感兴趣的吸烟者。例如，纽约戒烟热线去年收到了超过27.9万份联系（电话和在线请求）。此外，每天吸烟的人患有害饮酒和酒精诊断的风险更高。事实上，从去年纽约戒烟热线（N = 30,667）的大量子样本中获得的试点数据显示，24.28%（7,389/30,438）的人符合NIAAA指南定义的危险饮酒标准。来自纽约戒烟热线电话和耶鲁大学临床试验的数据显示，高风险饮酒与治疗效果不佳有关，我们的顾问卡勒博士的数据显示，戒烟治疗包括短暂的酒精干预可以提高戒烟率。此外，《戒烟临床实践指南》建议吸烟者在戒烟时应考虑限制/戒酒。然而，据我们所知，这还没有在以人群为基础的戒烟热线中进行过测试，如果咨询师接受过培训，建议来电者在戒烟过程中限制或戒酒，戒烟效果可能会得到提高。因此，基于我们在耶鲁大学的研究小组和罗斯威尔公园癌症研究所/纽约戒烟热线的研究小组之间已有的关系，我们计划进行一项发展研究，以：1)与25名戒断热线呼叫者一起创建并测试酒精咨询协议；2)培训戒断热线专家使用至少100名戒断热线试点呼叫者提供酒精干预，以确保在酒精干预+标准护理条件下的专家提供咨询，以高水平的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1950名纽约戒烟热线（NY Quitline）饮酒者进行一项发展随机临床试验，以比较标准治疗（PC + SC条件）中添加的实用咨询+戒烟打印材料与酒精干预咨询+标准治疗中添加的酒精打印材料（AI + SC条件）。该试验的疗效数据将用于确定1周和6个月自我报告的点流行戒断率的效应大小估计。减少酒精消费和减少饮酒作为戒烟结果的中介将是次要结果。酒精干预效果的其他中介和调节因子也将作为探索性结果进行研究。如果效应量估计足够大，并且在医学上具有重要意义，可以进行确定的试验，则这些数据将用于提出全尺度多地点大型研究。如果酒精干预在一项大规模研究中被证明可以提高治疗效果，那么戒断热线咨询师的酒精干预可以被翻译为整个纽约州戒断热线和全国其他戒断热线使用。这可能会提高戒烟干预措施的有效性，从而有可能惠及数百万吸烟者，从而加强美国各地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.