Mathew Amanda R, Hatten Breeann Lynae, Esqueda-Medina Maritza, Gramajo Karisa, Yeh Chen, Avery Elizabeth F, Suzuki Sumihiro, Cropsey Karen, Carpenter Matthew J
Rush University Medical Center, Chicago, IL, United States of America.
Rush University Medical Center, Chicago, IL, United States of America.
Contemp Clin Trials. 2025 Apr;151:107832. doi: 10.1016/j.cct.2025.107832. Epub 2025 Feb 7.
Tobacco use disorder is a chronic, relapsing health condition that necessitates a chronic care approach. However, there are limited treatment strategies relevant to individuals who smoke across a continuum of motivation to quit. Further, there is no clear understanding of the mechanisms underlying treatment strategies to engage individuals who are not yet ready to quit smoking.
The current study will enroll 780 individuals who smoke and are unmotivated to quit within the next month through a nationwide remote clinical trial (NCT05513872). Participants are randomized to receive Practice Quitting or Motivational Interviewing counseling, with or without Nicotine Replacement Therapy product sampling. The primary outcome is incidence of an attempt to quit by 6 months post-treatment. The analytic strategy will examine treatment effects on quit attempts and smoking cessation, along with hypothesized treatment mediators to determine mechanisms of treatment outcomes.
Individuals who are not yet ready to quit smoking are a critical group to target in population health management efforts for smoking cessation. We discuss key methodological considerations relevant to the design of future remote and mechanistic clinical trials for smoking cessation.
烟草使用障碍是一种慢性复发性健康状况，需要采用长期护理方法。然而，对于不同戒烟动机阶段的吸烟者，相关的治疗策略有限。此外，对于促使尚未准备好戒烟的个体参与治疗策略的潜在机制，目前尚无清晰认识。
本研究将通过一项全国性远程临床试验（NCT05513872）招募780名吸烟者，他们在未来一个月内没有戒烟意愿。参与者被随机分配接受“练习戒烟”或动机性访谈咨询，并可选择是否接受尼古丁替代疗法产品抽样。主要结局是治疗后6个月内尝试戒烟的发生率。分析策略将考察治疗对戒烟尝试和戒烟的效果，以及假设的治疗中介因素，以确定治疗效果的机制。
尚未准备好戒烟的个体是戒烟人群健康管理工作中的关键目标群体。我们讨论了与未来戒烟远程和机制性临床试验设计相关的关键方法学考虑因素。
