Internet-based Medication Adherence Program for Nicotine Dependence Treatment

描述（由申请人提供）：每年尝试戒烟的吸烟者中有三分之一使用fda批准的三种药物治疗中的一种（相比之下，使用行为干预的吸烟者<9%），但对每种药物的依从性差是一个有充分记录的问题。例如，我们最近发现50%的吸烟者服用伐尼克兰的依从性不是最佳的。不依从性行为，如不一致的用药、剂量不足和早期停止治疗，大大破坏了治疗效果，这可能部分解释了为什么绝大多数接受治疗的吸烟者复发。提高现有药物治疗效果并帮助更多人戒烟的一种方法是提高治疗依从性。目前的试点研究将从吸烟者和临床医生（即系统用户）的角度评估基于互联网的药物依从性项目（iMAP）原型的可行性和可接受性。iMAP旨在促进患者和临床医生之间的持续沟通；加强不良事件监测；并提供全天候的个性化支持和鼓励，戒烟和服药依从性的行为技能培训，以及如何管理常见的、不严重的副作用和尼古丁戒断症状的个人定制反馈。iMAP可以通过个人电脑或智能手机互联网浏览器访问。考虑到varenicline的流行、高频率的麻烦、非严重的药物副作用以及对varenicline使用的监测需求增加，该试点原型旨在支持varenicline药物治疗，但如果提出的干预策略被证明是有希望的，iMAP将在未来扩展到支持尼古丁替代和安非他酮的使用。iMAP的设计和内容是根据之前与吸烟者和医学、临床心理学和药学临床专家团队的形成性工作得出的。该计划将在一项小型随机研究（n = 70）中进行测试，以评估使用者的反应，并评估该计划在5个月期间对药物依从性和戒烟结果的潜在影响。我们还将采访临床医生（n ~ 50），以评估他们对程序设计和功能的反应。临床医生定性访谈和试点试验的结果将与临床顾问委员会共享，临床顾问委员会将就进一步发展项目的可行性和必要的项目变更提供客观指导。如果结果证明是有希望的，我们将计划在必要时改进干预措施，并进行未来的随机有效性试验，以评估该计划对依从性、戒断性和治疗成本效益的影响。这项工作的发现将有助于提供增强药物依从性的最佳方法，如果有效，可以帮助减少美国的吸烟率，通过及时处理不良事件提高患者安全性，并提高治疗的成本效益。此外，如果有效，所提出的干预模式可以应用于其他药物的管理（如尼古丁替代品、安非他酮等）。

DESCRIPTION (provided by applicant): One third of all smokers who make an annual quit attempt use one of the three FDA-approved pharmacotherapies (in contrast, <9% use behavioral intervention), but poor adherence is a well-documented problem for each of these medications. For example, we recently found that 50% of smokers taking varenicline had sub-optimal adherence. Non-adherence behavior such as inconsistent medication use, under-dosing, and early treatment discontinuation significantly undermines treatment effectiveness, which may in part explain why the great majority of treated smokers relapse. One way to improve the effectiveness of existing pharmacotherapy and to help more people stop smoking is to enhance treatment adherence. The current pilot study will evaluate the feasibility and acceptability of a prototype Internet-based medication adherence program (iMAP) from the perspective of smokers and clinicians (i.e., system users). iMAP is designed to facilitate ongoing communication between patients and clinicians; enhance adverse event monitoring; and provide 24/7 access to personalized support and encouragement, behavioral skills training for smoking cessation and medication adherence, and individually-tailored feedback on how to manage common, non-serious side-effects and nicotine withdrawal symptoms. iMAP can be accessed via personal computer or smartphone Internet browser. Given the popularity, high frequency of bothersome, non-serious medication side-effects, and increased monitoring demands for varenicline use, the pilot prototype is designed to support varenicline pharmacotherapy, but if the proposed intervention strategy proves promising, iMAP will be expanded to support nicotine replacement and bupropion use in the future. iMAP's design and content were informed by prior formative work with smokers and a team of clinical experts in medicine, clinical psychology, and pharmacy. The program will be tested in a small randomized study (n = 70) to assess users' reactions and estimate the program's potential impact on medication adherence and smoking cessation outcomes assessed over a 5 month period. [We will also interview clinicians (n ~ 50) to assess their reaction to the program's design and functionality. Outcomes from the clinician qualitative interviews and pilot trial will be shared with a clinical advisory board who will provie objective guidance about the feasibility of further developing the program and necessary program changes.] If the results prove promising, we will plan to refine the intervention as necessary and conduct a future randomized effectiveness trial to assess the program's impact on adherence, abstinence, and treatment cost-effectiveness. Findings from this work will help inform optimal ways to enhance medication adherence and, if effective, could help reduce smoking prevalence in the US, increase patient safety by addressing adverse events in a timely way, and improve treatment cost-effectiveness. Moreover, if effective, the proposed intervention model could be applied to the management of other medications (e.g., nicotine replacement, bupropion, others).