Testing Relapse Recovery Intervention Components

吸烟是美国癌症死亡的主要可预防原因，因此改善吸烟治疗是一项重要的公共卫生目标。然而，大多数试图戒烟的吸烟者最终会复发，并且对如何治疗他们知之甚少。该项目旨在为最近复吸的吸烟者确定高度有效的干预成分，这些成分可以包含在吸烟的慢性护理治疗中，该治疗包括吸烟治疗每个阶段的有效干预成分，并且在医疗保健环境中使用是可行的。本POI申请项目3（停止RCT）中复发的受试者将过渡到本复发恢复项目（N~776）。将使用析因序贯多重分配随机试验（SMART）设计检验三个干预因素（每个因素将增强干预成分与标准干预成分进行比较）。所有参与者将被随机分配到一个准备因素，比较两种准备复吸者的策略。然而，只有选择进行新戒烟尝试的参与者将被随机分配到两个戒烟因素：1）个性化与常规戒烟药物，以及2）前负荷与常规戒烟咨询。增强的准备和戒烟干预组件旨在解决复吸者面临的主要挑战。增强的准备部分（减少吸烟咨询）旨在对抗士气低落和减少烟草依赖。个性化戒烟药物旨在增加药物依从性并减少戒烟尝试期间的戒断渴望，而前负荷戒烟咨询旨在通过在戒烟尝试早期提供支持和技能培训来减少早期失败。分析将确定两个戒烟因素对戒烟的主要影响和交互影响，并确定这些影响是否因准备因素而异。分析还将确定准备因素对有意义的戒烟尝试可能性的影响。这项研究将是第一项比较有效性的研究，以评估医疗机构中新颖但有前途的复发恢复干预成分，从而促进其快速转化为现实世界的使用。

Smoking is the leading preventable cause of cancer mortality in the US, making improved smoking treatment a vital public health goal. However, most smokers trying to quit ultimately relapse, and little is known about how to treat them. This project is designed to identify highly effective intervention components for recently relapsed smokers that can be included in a chronic care treatment for smoking that comprises effective intervention components for every phase of smoking treatment and that is feasible for use in healthcare settings. Participants from Project 3 of this POI application (the Cessation RCT) who relapse will transition to this Relapse Recovery project (N~776). Three intervention factors (each comparing an enhanced intervention component with a standard one) will be tested using a factorial Sequential Multiple Assignment Randomized Trial (SMART) design. All participants will be randomized to a Preparation factor comparing two strategies for preparing relapsers to requit. However, only participants choosing to make a new quit attempt will be randomized to the two Cessation factors: 1) Personalized vs. Regular Cessation Medication, and 2) Front-loaded vs. Regular Cessation Counseling. The enhanced Preparation and Cessation intervention components are designed to address the major challenges facing relapsers. The enhanced Preparation component (Smoking Reduction Counseling) is designed to counter demoralization and reduce tobacco dependence. Personalized Cessation Medication is designed to increase medication adherence and reduce withdrawal craving during a quit attempt, while Front-loaded Cessation Counseling is designed to reduce early lapsing by providing support and skills training early in the quit attempt. Analyses will determine the main and interactive effects of the two Cessation factors on smoking abstinence and determine whether these effects differ as a function of the Preparation factor. Analyses will also determine the effects of the Preparation factor on the likelihood of a meaningful quit attempt. The proposed research will be the first comparative effectiveness research to evaluate novel but promising Relapse Recovery intervention components in healthcare settings thus facilitating their rapid translation to real-world use.