Remote clinical trial to test mechanisms of ‘practice quitting’ treatment: Trial design and methodological report

IF 2 3区医学 Q3 MEDICINE, RESEARCH & EXPERIMENTAL

Contemporary clinical trials Pub Date : 2025-02-07 DOI:10.1016/j.cct.2025.107832

Amanda R. Mathew , Breeann Lynae Hatten , Maritza Esqueda-Medina , Karisa Gramajo , Chen Yeh , Elizabeth F. Avery , Sumihiro Suzuki , Karen Cropsey , Matthew J. Carpenter

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引用次数: 0

Abstract

Background

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.

Methods

The current study will enroll 780 individuals who smoke and are unmotivated to quit within the next month through a nationwide remote clinical trial (NCT 05513872). 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.

Conclusion

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.

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背景烟草使用障碍是一种慢性、复发性健康问题，需要采取慢性护理方法。然而，针对不同戒烟动机的吸烟者的治疗策略却很有限。此外，对于吸引尚未准备好戒烟的人参与戒烟的治疗策略的基本机制也没有清楚的认识：目前的研究将通过一项全国范围的远程临床试验（NCT05513872）招募 780 名在未来一个月内没有戒烟动机的吸烟者。参与者将随机接受 "实践戒烟 "或 "动机访谈 "咨询，同时接受或不接受尼古丁替代疗法产品采样。主要结果是治疗后 6 个月内尝试戒烟的发生率。分析策略将检查治疗对戒烟尝试和戒烟的影响，以及假设的治疗中介因素，以确定治疗结果的机制：结论：尚未准备好戒烟的人群是人群健康管理戒烟工作的一个关键目标群体。我们讨论了与未来戒烟远程和机理临床试验设计相关的主要方法学考虑因素。

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来源期刊

Contemporary clinical trials 医学-药学

CiteScore

3.70

自引率

4.50%

发文量

281

审稿时长

44 days

期刊介绍： Contemporary Clinical Trials is an international peer reviewed journal that publishes manuscripts pertaining to all aspects of clinical trials, including, but not limited to, design, conduct, analysis, regulation and ethics. Manuscripts submitted should appeal to a readership drawn from disciplines including medicine, biostatistics, epidemiology, computer science, management science, behavioural science, pharmaceutical science, and bioethics. Full-length papers and short communications not exceeding 1,500 words, as well as systemic reviews of clinical trials and methodologies will be published. Perspectives/commentaries on current issues and the impact of clinical trials on the practice of medicine and health policy are also welcome.