Testing Relapse Recovery Intervention Components

在美国，吸烟是导致癌症死亡的主要可预防原因，因此改善吸烟治疗成为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都会复发，而人们对如何治疗却知之甚少。本项目旨在为新近复吸的吸烟者确定可纳入吸烟慢性护理治疗的高效干预成分，该慢性护理治疗包括吸烟治疗每个阶段的有效干预成分，并可在医疗机构中使用。该POI应用项目3（戒烟RCT）中复发的参与者将过渡到该复发恢复项目（N~776）。三个干预因素（每个因素比较增强干预成分与标准干预成分）将使用因子顺序多重分配随机试验（SMART）设计进行测试。所有参与者将被随机分配到一个准备因子，比较两种准备复吸者的策略。然而，只有选择进行新的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，2)预先加载与常规戒烟咨询。增强的准备和戒烟干预部分旨在解决复发者面临的主要挑战。加强准备部分（减少吸烟咨询）旨在打击士气低落和减少烟草依赖。个性化的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效。分析将确定两个戒烟因素对戒烟的主要影响和相互作用，并确定这些影响是否随准备因素而不同。分析还将确定准备因素对有意义的戒烟尝试的可能性的影响。拟议的研究将是第一个比较有效性的研究，以评估在医疗保健环境中新颖但有希望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.