A Translational Randomized Clinical Trial of Varenicline Sampling to Promote Smoking Cessation and Scalable Treatment Dissemination

伐尼克兰取样促进戒烟和可扩展治疗传播的转化随机临床试验

• 批准号: 10669624
• 负责人: Matthew J Carpenter
• 金额: $ 33.85万
• 依托单位: MEDICAL UNIVERSITY OF SOUTH CAROLINA
• 依托单位国家: 美国
• 财政年份: 2020
• 资助国家: 美国
• 起止时间: 2020-07-08 至 2025-06-30
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10669624
• 关键词: Address; Agonist; Archives; Attitude; Behavior; Behavioral; Biochemical; Biological; Cancer Control; Clinic; Clinical; Cues; Data; Dose; Drug Prescriptions; Exercise; Face; Failure; Fatigue; Future; Goals; Guidelines; Hand; Happiness; Health Personnel; Health Technology; Incidence; Instruction; Internal Medicine; Intervention; Malignant Neoplasms; Measurable; Mediator; Medical; Methodology; Methods; Morbidity - disease rate; Motivation; Outcome; Participant; Penetrance; Pharmaceutical Preparations; Pharmacotherapy; Physicians; Population; Prevention Research; Procedures; Process; Public Health; Publications; Randomized; Reaction; Recommendation; Research; Resources; Risk Factors; Risk Reduction; Role; Safety; Sampling; Sampling Studies; Self Efficacy; Smoker; Smoking; Smoking Behavior; South Carolina; Testing; Therapy trial; Time; Tobacco; Work; antagonist; brief advice; cancer prevention; catalyst; clinically significant; comparison group; design; diaries; evidence base; follow-up; innovation; mHealth; mindfulness; mortality; nicotine replacement; optimism; pharmacologic; population based; pragmatic intervention; primary care setting; programs; psychologic; quitline; randomized, clinical trials; recruit; secondary outcome; side effect; smoking cessation; tobacco control; tool; uptake; varenicline

Abstract: Smoking is the leading risk factor for preventable morbidity and mortality, and smoking cessation remains the primary goal for population-based tobacco and cancer control. Many smokers lack resources to initiate and sustain a successful quit attempt. For the last decade we have been testing innovative approaches for delivery of pharmacotherapies that allow smokers to try evidence-based cessation medications and self- determine their goals and pace for cessation. Medication sampling is a brief, concrete, and easily understood exercise that often induces attitudinal shifts in favor of quitting smoking, and more importantly promotes quit attempts and actual cessation. Medication sampling is also favored by healthcare providers, augmenting their brief advice as per clinical guidelines. We have conducted three trials of nicotine replacement therapy (NRT) sampling (N=157, 849, 1245), all of which were remote, and some of which have been applied within medical settings. Each trial demonstrated increases in cessation behavior. Our prior work on NRT sampling creates a compelling question as to whether varenicline sampling would have similar, or potentially better, effects. Varenicline is inarguably the most effective single cessation medication available, superior to other monotherapy options. As a prescription medication, whether varenicline is suitable for sampling is unclear but worth testing empirically. On one hand, unstructured use, over a brief time, may not deliver sufficient pharmacologic benefit. Prescription delivery incurs its own barriers to widespread dissemination (which can be overcome). On the other hand, much like NRT sampling, it could provide a tangible cue to action that provides psychological engagement (motivation, confidence, autonomy) to sustain subsequent use and ultimately enhance cessation. A trial of varenicline sampling is not merely a routine extension of NRT trials, yet the significance is even more compelling given evidence of its unique benefits. We therefore propose a randomized clinical trial with primary aims to determine the 1) use, 2) consequences (on cessation), and 3) mechanisms of varenicline sampling. A demographically diverse sample of 648 smokers will be recruited across South Carolina and randomized (2:1:1) to receive I) a 4-week sample of varenicline, II) a 4-week supply of NRT, or III) nothing. Thus, our design is strengthened by both active and inactive comparison groups. Outcomes will be assessed through 6 months of follow-up. We employ innovations in mobile health technologies throughout to enhance methodological rigor, including remote biological verification of smoking behavior. If varenicline sampling were to show promise through this and future trials, this would offer great dissemination appeal to physicians, quitlines, etc in that, much like our NRT work, varenicline sampling could be a pragmatic strategy to engage more smokers in better treatments, sooner. Ultimately, the population impact of medication/varenicline sampling could be profound, offering a significant and measurable opportunity to lessen the impact of tobacco on public health and to reduce the risk, incidence and mortality of cancer.

摘要：吸烟是可预防的发病率和死亡率的主要危险因素，戒烟 仍然是基于人群的烟草和癌症控制的主要目标。许多吸烟者缺乏资源 发起并维持成功的戒烟尝试。在过去的十年中，我们一直在测试创新方法 提供药物治疗，允许吸烟者尝试基于证据的戒烟药物和自我戒烟 确定他们的目标和戒烟速度。药物抽样是一种简短、具体且易于理解的方法 经常引起有利于戒烟的态度转变，更重要的是促进戒烟的运动 尝试和实际停止。药物抽样也受到医疗保健提供者的青睐，增强了他们的能力 根据临床指南提供简短建议。我们进行了三项尼古丁替代疗法（NRT）试验 抽样（N=157、849、1245），所有这些都是远程的，其中一些已应用于医疗领域 设置。每项试验都表明戒烟行为有所增加。我们之前关于 NRT 采样的工作创造了 关于伐尼克兰取样是否会产生类似或可能更好的效果这一引人注目的问题。 伐尼克兰无疑是最有效的单次戒烟药物，优于其他药物 单一疗法选择。作为处方药，伐尼克兰是否适合取样尚不清楚，但 值得进行实证检验。一方面，在短时间内非结构化使用可能无法提供足够的 药理益处。处方交付在广泛传播方面存在其自身的障碍（这可能是 克服）。另一方面，就像 NRT 采样一样，它可以提供切实的行动提示，从而提供 心理参与（动机、信心、自主性）以维持后续使用并最终 加强戒断。伐尼克兰取样试验不仅仅是 NRT 试验的常规延伸，而且 鉴于其独特优势的证据，其重要性甚至更加引人注目。因此我们建议 随机临床试验，主要目的是确定 1) 使用、2) 后果（停止时）和 3) 伐尼克兰采样机制。将招募 648 名吸烟者组成的人口多样化样本 整个南卡罗来纳州并随机 (2:1:1) 接受 I) 4 周的伐尼克兰样本，II) 4 周的供应 NRT，或 III) 什么也没有。因此，我们的设计通过活跃和不活跃的比较组得到加强。 结果将通过 6 个月的随访进行评估。我们在移动健康领域采用创新 提高方法严谨性的技术，包括吸烟的远程生物验证 行为。如果伐尼克兰采样能够通过本次和未来的试验显示出希望，这将提供巨大的帮助 传播对医生、戒烟热线等的吸引力在于，就像我们的 NRT 工作一样，伐尼克兰采样可以 这是一项务实的策略，让更多吸烟者更快地接受更好的治疗。最终，人口 药物/伐尼克兰采样的影响可能是深远的，提供了重要且可衡量的机会 减少烟草对公共健康的影响并降低癌症的风险、发病率和死亡率。