美国有1480万名符合肺癌筛查条件的成年人中，近一半吸烟。肺癌筛查环境下最佳的戒烟方案尚不清楚。本研究旨在评估在肺癌筛查资格者中，对吸烟者且未对早期吸烟治疗做出反应的患者，将处方药物疗法管理（MTM）转介添加到烟草纵向护理（TLC）计划中的效果，并评估对早期治疗有反应的参与者中，降低TLC强度的效果。本随机临床试验包括每日吸烟的符合肺癌筛查资格的患者。招募工作在美国的三个大型卫生系统的初级保健中心和肺癌筛查计划开始于2016年10月，随访18个月已于2021年4月完成。（1）TLC包括1年的深度电话辅导和每月至少一次的联合尼古丁替代疗法；（2）TLC加MTM，MTM提供药师转介用于处方药物；（3）季度TLC，减少TLC强度至季度联络。干预安排基于烟草治疗的早期反应（戒烟），在治疗开始后4周或8周进行评估。自报告的18个月6个月持续戒烟率。636名参与者中，228名（35.9%）为女性，564名（89.4%）为白种人，年龄的中位数（IQR）为64.3（59.6-68.8）岁。治疗开始后4周或8周，510名参与者（80.2%）继续吸烟（即早期治疗无反应者），126名参与者（19.8%）已戒烟（即早期治疗有反应者）。18个月的随访调查回应率为83.2%（636名中的529名）。在18个月的TLC组中，总体6个月持续戒烟率为24.4%（529中的129）。在416名早期治疗无反应者中，TLC加MTM和TLC的6个月持续戒烟率分别为17.8%和16.4%（调整后的比值比[aOR]1.13；95%置信区间[CI]，0.67-1.89）。在TLC加MTM组中，254名参与者中有98人（39%）至少进行了一次MTM访问。在113名早期治疗有反应者中，季度TLC和TLC的6个月持续戒烟率分别为55名中的24人（43.6%）和58名中的34人（58.6%）（aOR，0.54；95%CI，0.25-1.17）。在这项随机临床试验中，对于早期治疗无反应者，TLC中添加MTM转介并未改善戒烟效果。对于早期治疗有反应者，不建议降低至季度TLC。将长期的烟草戒烟护理与肺癌筛查相结合是可行的，并与临床意义上的戒烟率相关联。ClinicalTrials.gov识别号：NCT02597491。

Nearly half of the 14.8 million US adults eligible for lung cancer screening (LCS) smoke cigarettes. The optimal smoking cessation program components for the LCS setting are unclear.To assess the effect of adding a referral to prescription medication therapy management (MTM) to the tobacco longitudinal care (TLC) program among patients eligible for LCS who smoke and do not respond to early tobacco treatment and to assess the effect of decreasing the intensity of TLC among participants who do respond to early treatment.This randomized clinical trial included patients who currently smoked cigarettes daily and were eligible for LCS. Recruitment took place at primary care centers and LCS programs at 3 large health systems in the US and began in October 2016, and 18-month follow-up was completed April 2021.(1) TLC comprising intensive telephone coaching and combination nicotine replacement therapy for 1 year with at least monthly contact; (2) TLC with MTM, MTM offered pharmacist-referral for prescription medications; and (3) Quarterly TLC, intensity of TLC was decreased to quarterly contact. Intervention assignments were based on early response to tobacco treatment (abstinence) that was assessed either 4 weeks or 8 weeks after treatment initiation.Self-reported, 6-month prolonged abstinence at 18-month.Of 636 participants, 228 (35.9%) were female, 564 (89.4%) were White individuals, and the median (IQR) age was 64.3 (59.6-68.8) years. Four weeks or 8 weeks after treatment initiation, 510 participants (80.2%) continued to smoke (ie, early treatment nonresponders) and 126 participants (19.8%) had quit (ie, early treatment responders). The 18 month follow-up survey response rate was 83.2% (529 of 636). Across TLC groups at 18 months follow-up, the overall 6-month prolonged abstinence rate was 24.4% (129 of 529). Among the 416 early treatment nonresponders, 6-month prolonged abstinence for TLC with MTM vs TLC was 17.8% vs 16.4% (adjusted odds ratio [aOR] 1.13; 95% CI, 0.67-1.89). In TLC with MTM, 98 of 254 participants (39%) completed at least 1 MTM visit. Among 113 early treatment responders, 6-month prolonged abstinence for Quarterly TLC vs TLC was 24 of 55 (43.6%) vs 34 of 58 (58.6%) (aOR, 0.54; 95% CI, 0.25-1.17).In this randomized clinical trial, adding referral to MTM with TLC for participants who did not respond to early treatment did not improve smoking abstinence. Stepping down to Quarterly TLC among early treatment responders is not recommended. Integrating longitudinal tobacco cessation care with LCS is feasible and associated with clinically meaningful quit rates.ClinicalTrials.gov Identifier: NCT02597491.