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

描述(申请人提供)：大量证据表明，电话戒烟咨询是有效的，并接触到大量有兴趣戒烟的吸烟者。例如，NY Quitline去年收到了超过27.9万个联系人(电话和在线请求)。此外，日常吸烟者被诊断为危险饮酒和酒精的风险更高。事实上，过去一年来自纽约Quitline呼叫者(N=30,667人)的试点数据显示，24.28%(7,389/30,438人)符合NIAAA指南定义的危险饮酒标准。来自纽约Quitline来电者和耶鲁大学临床试验的数据显示，高风险饮酒与糟糕的治疗结果相关，而我们的顾问卡勒博士的数据显示，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/戒酒。然而，据我们所知，这在以人群为基础的戒酒热线的背景下未经测试，如果辅导员接受培训，建议呼叫者在戒烟过程中限制或戒酒，戒酒结果可能会得到改善。因此，基于我们耶鲁大学的研究小组和罗斯威尔公园癌症研究所/纽约Quitline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)创建并对25名Quitline来电者进行酒精咨询方案的Beta测试，2)培训Quitline专家，使用至少100名Quitline试点来电者提供酒精干预，以确保酒精干预+标准护理条件下的专家提供具有高水平酒精干预策略和技能的针对危险饮酒的咨询。在这一阶段的研究完成后，将对1,950名饮酒水平达到危险水平的纽约Quitline呼叫者进行发展随机临床试验，以比较实际咨询+在标准护理中添加戒烟打印材料(PC+SC条件)与酒精干预咨询+在标准护理中添加酒精重点打印材料(AI+SC条件)。这项试验的疗效数据将被用来确定1周和6个月自我报告的点流行率戒断率的效果大小估计。减少饮酒和减少饮酒作为戒烟结果的中介将是次要的结果。酒精干预效果的其他调节剂和调节剂也将作为探索性结果进行检查。如果效应大小的估计足够大，并且在医学上具有重要意义，可以进行最终的试验，这些数据将被用来提出一项全面的多地点大型研究。如果在一项大规模研究中显示酒精干预可以改善治疗结果，戒酒咨询人员的酒精干预可能会被翻译成供整个纽约州戒酒热线和全国其他戒酒热线使用。这可能会增加戒烟干预的有效性，从而有可能接触到数百万吸烟者，从而加强美国各地的烟草和癌症控制努力。 公共卫生相关性：研究改善吸烟者电话戒烟咨询的方法可能会通过提高呼叫者戒烟率来改善烟草控制干预。由于戒烟电话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努力。

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.