Project 2 - Translational Clinic

项目-2的首要目标是完成一项观察性研究(n=3000)，旨在测试 P50-在“转化性戒烟计划”中开发的自适应药物治疗算法 (TSCP)。在过去四年的P50资助期间，我们开发了一种药物治疗“算法”， 使用对尼古丁“测试贴片”的反应，结合依赖测试，将吸烟者分配到特定的 药物疗法。目的1.这项研究将随机抽取30家杜克大学诊所参与 将戒烟计划(TSCP)转化为基于算法的药物治疗或Varenicline。之后 招募1500名受试者(50%)，诊所的随机状态将颠倒(交叉设计)， 允许控制临床效应和顺序效应。我们假设1)吸烟者在TSCP中接受治疗 在基于算法的药物治疗中，Varenicline与Varenicline相比，生化证实的结果明显更高 戒烟后12周连续戒烟30天(主要研究结果)；2)基于算法 与瓦伦克林相比，药物治疗在26岁和26岁时表现出显著更高的自我报告戒断率 戒烟后52周。目标2.我们假设1)药物不依从性将显著降低 算法与Varenicline治疗组，2)这些差异将在低收入人群中最大 受试者，以及3)在Patch Non Responder算法ARM中，禁酒率将在 受试者选择高强度行为干预与低强度行为干预。目标3.我们假设1)一个 算法与基于万乃馨的药物治疗的前瞻性经济分析将显示出重要的意义 从吸烟者、医疗保健系统、保险的角度改善成本效益结果 公司、雇主和2)TSCP的实施和运营将显示出有利的成本- 有利于长期运营的成果。

The overarching aim of Project-2 is the completion of an observational study (n = 3000) designed to test the P50-developed adaptive pharmacotherapy algorithm within the “Translational Smoking Cessation Program” (TSCP). During the past four years of P50 funding we have developed a pharmacotherapy “Algorithm” that uses response to nicotine “Test-Patch,” together with dependence testing, to allocate smokers to specific pharmacotherapies. Aim 1. The study will randomize 30 Duke University clinics participating in the Translational Smoking Cessation Program (TSCP) to Algorithm-based pharmacotherapy or Varenicline. After recruitment of 1500 (50%) subjects, the randomization status of clinics will be reversed (crossover design), allowing for control of both clinic effects and order effects. We hypothesize 1) that smokers treated in the TSCP with Algorithm-based pharmacotherapy vs. Varenicline will show significantly higher biochemically confirmed 12-week post-quit 30-day continuous abstinence (primary study outcome), and 2) that Algorithm-based pharmacotherapy compared to Varenicline will show significantly higher self-reported abstinence at 26- and 52-week post-quit. Aim 2. We hypothesize 1) that medication non-adherence will be significantly lower in Algorithm vs. Varenicline treatment group, 2) that these differences will be greatest among low-income subjects, and 3) that within the Patch Non-Responder Algorithm arms, abstinence rates will be higher among subjects opting for the High- vs. Low-Intensity Behavioral Intervention. Aim 3. We hypothesize 1) that a prospective economic analysis of Algorithm vs. Varenicline-based pharmacotherapy will show significant improvement in cost-benefit outcomes from the perspective of smokers, healthcare systems, insurance companies, and employers and 2) that of TSCP implementation and operations will show favorable cost- benefit outcomes for long-term operation.