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：吸烟是可预防发病率和死亡率和戒烟的主要危险因素 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 用于提供药物治疗，使吸烟者可以尝试循证戒烟药物和自我 确定他们的目标和停止步伐。药物采样是一种简短的，具体的，易于理解 通常诱导态度转变以戒烟的运动，更重要的是促进退出 尝试和实际停止。医疗保健提供者也支持药物抽样，增强其 根据临床准则的简短建议。我们已经进行了三项尼古丁替代疗法（NRT）的试验 采样（n = 157，849，1245），所有这些都是遥远的，其中一些已应用于医疗 设置。每个试验都表现出戒烟行为的增加。我们先前在NRT采样的工作创造了 关于varenicline采样的令人信服的问题是否会产生相似或可能更好的影响。 Varenicline无疑是最有效的单一戒烟药物，优于其他药物 单一疗法选择。作为处方药，是否适用于抽样尚不清楚，但 值得从经验上测试。一方面，在短时间内，非结构化的使用可能无法提供足够的时间 药理益处。处方交付会产生自己的广泛传播障碍（这可以是 克服）。另一方面，就像NRT采样一样，它可以为行动提供切实的提示 心理参与（动机，自信，自治），以维持随后的使用并最终 增强停止。 Varenicline采样试验不仅是NRT试验的常规扩展 鉴于其独特的好处的证据，意义更加令人信服。因此，我们建议 主要目的的随机临床试验确定1）使用，2）后果（停止）和3） Varenicline采样的机理。将招募有648名吸烟者的人口统计学样本 整个南卡罗来纳州和随机（2：1：1）接收i）4周的Varenicline样本，ii）4周的供应 NRT或III）什么都没有。因此，我们的设计通过主动和无效的比较组加强。 结果将在6个月的随访中进行评估。我们在移动健康方面采用创新 整个技术以增强方法论严格，包括吸烟的远程生物学验证 行为。如果Varenicline抽样通过此和将来的试验表现出希望，这将提供很棒的 传播对医师，戒烟等的吸引 早日成为一种务实的策略，使更多的吸烟者参与更好的治疗。最终，人口 药物/varenicline采样的影响可能是深远的，提供了一个很大且可衡量的机会 减少烟草对公共卫生的影响，并降低癌症的风险，发病率和死亡率。