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Project 2 - Translational Clinic

项目 2 - 转化诊所

基本信息

批准号：
9283516
负责人：
James M Davis
金额：
$ 37.6万
依托单位：
DUKE UNIVERSITY
依托单位国家：
美国
项目类别：
财政年份：
2010
资助国家：
美国
起止时间：
2010-09-15 至
项目状态：
未结题

来源：
https://reporter.nih.gov/project-details/9283516
关键词：
Abstinence Affect Algorithmic Analysis Algorithms Animals Behavior Therapy Biochemical Bupropion Cigarette Clinic Clinical Clinical Trials Comorbidity Costs and Benefits Crossover Design Cues Data Dependence Development Economics Electronic cigarette Elements Enrollment Funding Future Generations Health system Healthcare Systems Human Instruction Insurance Investigation Low income Medical Students Nicotine Nicotine Dependence Observational Study Outcome Outcome Study Patch Tests Patient Self-Report Patients Pharmaceutical Preparations Pharmacotherapy Phonation Positioning Attribute Postdoctoral Fellow Program Sustainability Randomized Recruitment Activity Research Research Infrastructure Site Smoker Smoking Telephone Testing Translating Translational Research Treatment Efficacy Universities Visit addiction arm base clinical practice comparative cost design disorder later incidence prevention distress tolerance doctoral student educational atmosphere follow-up graduate student medication compliance nicotine replacement operation programs prospective psychologic response smoking cessation treatment group treatment strategy varenicline

项目摘要

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.

项目2的总体目标是完成一项观察性研究（n = 3000），旨在测试