Project 2 - Translational Clinic

项目2的总体目标是完成一项观察性研究（n = 3000），旨在测试 P50在“转化戒烟计划”中开发的适应性药物治疗算法 （TSCP）。在过去四年的P50资助中，我们开发了一种药物治疗“算法”， 使用响应尼古丁“测试补丁”，连同依赖性测试，分配吸烟者的具体 药物治疗目标1.这项研究将随机抽取30个杜克大学的诊所参加， 转化戒烟计划（TSCP）为基于顺铂的药物治疗或伐尼克兰。后 招募1500例（50%）受试者，将逆转诊所的随机化状态（交叉设计）， 允许控制临床效果和顺序效果。我们假设1）在TSCP中接受治疗的吸烟者 与伐尼克兰相比，基于替尼泊苷的药物治疗将显示出显著更高的生化证实 12-戒烟后30天连续戒烟一周（主要研究结果），和2）基于戒烟的 与伐尼克兰相比，药物治疗在26岁时显示出显著更高的自我报告的禁欲率， 52-辞职后的一周目标2.我们假设1）药物不依从性将显着降低 算法与伐尼克兰治疗组，2）这些差异在低收入人群中最大 受试者，以及3）在贴剂无应答算法组中， 选择高强度与低强度行为干预的受试者目标3.我们假设1）a Algorithm与基于伐尼克兰的药物治疗的前瞻性经济分析将显示出显著性差异， 从吸烟者、医疗保健系统、保险的角度来看， 公司，雇主和2）TSCP的实施和运营将显示出有利的成本- 有利于长期经营。

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.