Balanced Placebo Design with Varenicline: Pharmacological and Expectancy Effects on Medication Adherence

伐尼克兰的平衡安慰剂设计：对药物依从性的药理学和预期影响

基本信息

批准号：
9753708
负责人：
Samantha P Yeager
金额：
$ 3.45万
依托单位：
UNIVERSITY OF ALABAMA AT BIRMINGHAM
依托单位国家：
美国
项目类别：
财政年份：
2018
资助国家：
美国
起止时间：
2018-07-09 至 2021-07-08
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/9753708
关键词：
Abstinence Accounting Adherence Adult Aftercare Agonist Behavior Therapy Bupropion Cellular Phone Cessation of life Chantix Cigarette Smoker Data Analyses Deception Disease Dose Double-Blind Method Ecological momentary assessment Effectiveness Evaluation Expectancy Gender Goals Headache Individual Instruction Intervention Link Mentorship Methodology Nausea Nicotine Withdrawal Outcome Pain Participant Patients Pharmaceutical Preparations Pharmacology Physiological Placebo Effect Placebos Race Randomized Relapse Reporting Research Sleeplessness Smoker Smoking Stomach Symptoms Testing Therapeutic Therapeutic Effect Time Training United States Withdrawal Symptom cigarette smoke cigarette smoking design effective therapy experience improved medication administration medication compliance medication nonadherence nicotine replacement preventable death research and development research data dissemination side effect smoking cessation symptom treatment varenicline

项目摘要

Smoking continues to be the leading cause of preventable death in the U.S., accounting for one in five deaths each year. Varenicline (Chantix) is a partial nicotinergic agonist and is the most efficacious monotherapy for successful smoking cessation; however, long-term abstinence with varenicline only ranges from 20% – 40%. One contributing factor to this low effectiveness may be poor medication adherence due to nonspecific side effects (i.e., side effects not explained by the pharmacology of the medication, but possibly due to negative medication expectancies or nicotine withdrawal symptoms that are mistakenly attributed to medication use). Nonspecific side effects have been linked to negative outcomes such as nonadherence, discontinuing effective treatment, and attempts to treat these symptoms with additional medications. The current proposal will utilize the double-blind balanced placebo design to differentiate expectancies versus pharmacologic mechanisms of varenicline administered for two weeks to smokers seeking treatment. The double- blind balanced placebo design includes a cross-balanced medication administration (active medication v. placebo) and instructional set (told truth v. deception) resulting in four groups of smokers seeking treatment: (1) told therapeutic dose (TD) medication + received TD medication; (2) told TD medication + received placebo; (3) told low dose (LD) medication+ received TD dose medication; (4) told LD medication + received placebo. Ecological momentary assessments (EMA) in the form of Daily Dairies delivered via smartphone will assess real-time side effects, withdrawal symptoms, cigarettes smoked, medication use, and reasons for medication non-adherence. The specific aims for this proposal will examine the main effects and interaction of instructional set and pharmacology on medication adherence (Aims 1 and 2) and evaluate moderators of pharmacology and expectancy effects on medication adherence (Exploratory Aim). Assessing expectancies and physiological barriers (i.e., non-specific side effects) to varenicline medication adherence will identify targets to improve medication adherence and to develop behavioral interventions that can modify and reframe negative expectancies and experiences. The specific aims of this project will be completed in conjunction with a formal training plan, sponsored by Dr. Karen Cropsey, Dr. Peter Hendricks, Dr. Michael Businelle, Dr. Richard Shelton, and Dr. Sylvie Mrug. This training plan includes: 1) pharmacological research development, 2) EMA methodology, 3) advanced longitudinal data analysis, and 4) research dissemination and mentorship.

吸烟仍然是美国可预防死亡的主要原因，其中一个是每年五人死亡。 Varenicline（Chantix）是一种部分烟碱能激动剂，是最多的有效的单一疗法成功戒烟；但是，长期禁欲 Varenicline的范围仅为20％至40％。导致这种低效率的一个因素可能是由于非特异性副作用而导致的药物依从性差（即，副作用未解释药物的药理学，但由于预期不良或尼古丁而可能错误归因于用药的戒断症状）。非特异性副作用具有与负面结果，例如不遵守，中断有效治疗以及尝试使用其他药物治疗这些符号。当前的建议将利用双盲平衡安慰剂设计以区分期望与药理学为寻求治疗的吸烟者提供了两周的varenicline机制。双 - 盲目平衡的安慰剂设计包括跨平衡的药物管理药物诉安慰剂）和教学集（告诉真相诉欺骗），导致四组寻求治疗的吸烟者：（1）告诉治疗剂量（TD）药物 +接受TD药物；（2）告诉TD药物 +接受安慰剂；（3）告诉低剂量（LD）药物 +收到的TD剂量药物; （4）告诉LD药物 +接受了安慰剂。生态瞬时评估（EMA）通过智能手机交付的每日乳制品的形式将评估实时副作用，提取症状，抽烟，使用药物以及药物不遵守的原因。这该提案的具体目的将检查教学集的主要影响和相互作用，药物依从性的药理学（目标1和2）并评估药理学的主持人对药物依从性的预期影响（探索目的）。评估期望和依从性的物理障碍（即非特异性副作用）将确定改善药物依从性并制定行为干预措施的目标，以修改和重新构建负面期望和经验。该项目的具体目的将在由Karen Cropsey博士，Peter Hendricks博士，Dr. Michael Businelle，Richard Shelton博士和Sylvie Mrug博士。该培训计划包括：1）药理学研究开发，2）EMA方法论，3）高级纵向数据分析，以及4）研究传播和心态。