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，而且大多数吸烟者每年都会尝试戒烟，但大多数人还是尝试戒烟。 FDA 批准的药物治疗可能会有所帮助，但会因复发或复发而无效。 尽管经常出现治疗无反应的情况，但无法开始戒烟仍然是最常见的结果。 很少有试验调查这些情况下的最佳治疗途径——吸烟者是否应该尝试戒烟 再次使用相同的药物治疗，符合包装指南，继续治疗 12 数周，还是应该预防早期失败并改变药物治疗？此外，对于吸烟者来说？ 多次尝试用药物戒烟但仍在吸烟的人，改用较少的药物是否更好？ 有害的烟草产品，而不是尝试通过 FDA 批准的药物疗法反复戒烟？ 拟议的适应性治疗试验将测试是否 1) 在初始治疗后切换药物疗法 失败比重复尝试相同的药物治疗更能促进戒断，2) 是否 在多种药物疗法连续失败后改用电子烟可以更好地促进 戒烟次数比每日吸烟者尝试相同疗程戒烟的次数要多。 南卡罗来纳州和阿拉巴马州愿意设定戒烟日期的人 (N=544) 将获得 4 周的戒烟期限 提供 FDA 批准的戒烟药物，并提供设定日期和戒烟的说明 完全戒烟的第一疗程将是联合尼古丁替代疗法。 （透皮尼古丁贴片和口服尼古丁含片）或伐尼克兰，平衡后四个星期。 治疗中，那些对初始治疗没有反应的人（即无反应者）将按照 2:1 的比例进行分配 流行适应性治疗（药物转换）或非适应性治疗（继续药物治疗； 目标 1) 在第二个 4 周的治疗后，无反应者将以 2:1 的方式分配到任一危害。 减少方法（改用危害较小的烟草产品；电子烟）或非适应性治疗 （继续用药；目标 2），再次说明如何转换或完全戒断。 生化证实的 7 天戒烟、吸烟减少、依赖性测量、持续时间 戒断和双重使用的情况，均在关键干预时间点进行测量：每个疗程后， 这项创新的 R01 应用程序由两名经验丰富且具有专业知识的研究人员领导。 该研究问题在戒烟、减少危害和远程临床试验中具有非常重要的意义。 旨在为最常见问题的治疗决策提供强有力的、数据驱动的指导 即使是最好的吸烟治疗方法：试验结果也提供了一个重要的优化机会。 继续努力戒烟的吸烟者的戒烟结果。