A clinical trial of adaptive treatment for early smoking cessation relapse

早期戒烟复发适应性治疗的临床试验

• 批准号: 10752773
• 负责人: Matthew J Carpenter
• 金额: $ 62.21万
• 依托单位: MEDICAL UNIVERSITY OF SOUTH CAROLINA
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-07-01 至 2028-06-30
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10752773
• 关键词: Abstinence; Adult; Alabama; Biochemical; Centers for Disease Control and Prevention (U.S.); Cigarette; Cigarette Smoker; Clinical Trials; Communities; Coping Skills; Data; Decision Making; Dependence; Early treatment; Electronic cigarette; FDA approved; Failure; Frequencies; Frustration; Goals; Guidelines; Harm Reduction; Health Benefit; Health Personnel; Individual; Instruction; Intervention; Learning Skill; Measures; Methodology; Methods; Modality; Nicotine; Oral; Outcome; Participant; Pharmaceutical Preparations; Pharmacotherapy; Positioning Attribute; Prevalence; Randomized; Recommendation; Relapse; Research; Research Personnel; Seasons; Selection Bias; Selection for Treatments; Smoker; Smoking; Smoking Cessation Intervention; Smoking treatment; South Carolina; Testing; Time; Tobacco; behavior change; clinical decision-making; clinical practice; clinically relevant; design; evidence base; exhaust; experience; follow-up; innovation; interest; nicotine patch; nicotine replacement; non-smoking; pharmacologic; preempt; randomized, clinical trials; recruit; remote delivery; secondary outcome; skill acquisition; smoking abstinence; smoking cessation; success; tobacco products; treatment responders; treatment trial; varenicline

Abstract Most smokers want to quit smoking, and most smokers try to quit smoking each year. Yet, most attempts to quit smoking fail. FDA-approved pharmacotherapies can help, but non-response, either through relapse or through inability to initiate cessation, is still the most common outcome. Despite the frequency of treatment non-response, few trials have investigated the best path forward for treatment in these instances—should smokers try to quit again with the same pharmacotherapy, consistent with package guidelines to continue with treatment for 12 weeks, or should early failure be preempted and met with a change in pharmacotherapy? Further, for smokers who have tried to quit with pharmacotherapy multiple times and are still smoking, is it better to switch to a less harmful tobacco product rather than trying to quit repeatedly with FDA-approved pharmacotherapy? The proposed adaptive treatment trial will test whether 1) switching between pharmacotherapies following an initial failure better promotes abstinence than a repeated attempt with the same pharmacotherapy, and 2) whether switching to e-cigarettes following successive failures with multiple pharmacotherapies better promotes abstinence from cigarettes than a third attempt to quit with the same course of pharmacotherapy. Daily smokers across South Carolina and Alabama who are willing to set a quit date (N=544) will be provided with a 4-week supply of FDA approved smoking-cessation medication and provided with instructions to set a date and to quit smoking completely. First-course medication will be either combination nicotine replacement therapy (transdermal nicotine patch and oral nicotine lozenge) or varenicline, counterbalanced. After four weeks of treatment, those who have not responded to initial treatment (i.e., non-responders) will be assigned in a 2:1 fashion to either Adaptive Treatment (medication switch) or Non-Adaptive Treatment (medication continuance; Aim 1). After a second four weeks of treatment, non-responders will be assigned in a 2:1 fashion to either a Harm Reduction Approach (to switch to a less harmful tobacco product; e-cigarettes) or Non-Adaptive Treatment (medication continuance; Aim 2), again with instructions to switch or quit completely. Outcomes include biochemically-confirmed 7-day abstinence from smoking, smoking reduction, measures of dependence, duration of abstinence, and dual use, each measured at key intervention timepoints: after each course of treatment, with follow-up through six months. This innovative R01 application is led by two seasoned investigators with expertise in smoking cessation, harm reduction, and remote clinical trials. The research question is highly significant and is positioned to provide strong, data-driven guidance on treatment decision making for the most common problem facing even the best treatments for smoking: failure. Trial results provide a significant opportunity to optimize cessation outcomes for smokers who continue to struggle in quitting.

抽象的 大多数吸烟者都想戒烟，大多数吸烟者每年试图戒烟。但是，大多数辞职的尝试 吸烟失败。 FDA批准的药物治疗可以有所帮助，但通过继电器或通过 无法开始停止，仍然是最常见的结果。尽管治疗无响应的频率，但 在这些情况下，很少有试验调查了治疗的最佳途径 - 应该吸烟者试图退出 再次使用相同的药物治疗，与包装指南一致，以继续进行12 几周，还是应该先享受早期失败并遇到药物治疗的变化？此外，对于吸烟者 谁试图多次使用药物治疗戒烟，但仍在吸烟，最好切换到更少的 有害烟草产品，而不是试图通过FDA批准的药物疗法反复戒烟？这 拟议的自适应治疗试验将测试1）初始化后是否在药物治疗之间切换 与对同一药物治疗的反复尝试相比，失败更好地促进禁欲，以及2）是否是否 通过多个药物治疗成功促进成功故障后，切换到电子烟，更好地促进 戒烟比第三次尝试通过相同的药物治疗戒烟的尝试。每日吸烟者 整个愿意设定退出日期的南卡罗来纳州和阿拉巴马州将为4周提供4周 供应FDA批准的吸烟药物，并提供了设定日期并退出的说明 完全吸烟。第一道菜将是尼古丁替代疗法的组合 （透皮尼古丁补丁和口服尼古丁lozenge）或varinicline，平衡。四个星期后 治疗，那些未对初始治疗做出反应的人（即非反应者）将在2：1中分配 适应性治疗（药物转换）或非自适应治疗（药物持续性的时尚； 目标1）。经过第二个四个星期的治疗后，将以2：1的方式分配非反应者，以造成伤害 还原方法（切换到危害较小的烟草产品；电子烟）或非自适应治疗 （药物继续;目标2），再次带有指令以完全切换或戒烟。结果包括 生物化学确认的7天禁欲，减少吸烟，依赖度量，持续时间 禁欲和双重用途，每种都以关键干预时间点进行测量：每次治疗后， 随访至六个月。此创新的R01应用程序由两名经验丰富的调查员领导 在戒烟，减少伤害和远程临床试验中。研究问题非常重要， 定位为最常见问题提供有关治疗决策的强大，数据驱动的指南 面对吸烟的最佳治疗方法：失败。试验结果为优化提供了重要的机会 对于继续在安静而挣扎的吸烟者的戒烟结果。