EVarQuit: Extinguishing cigarette smoking via extended pre-quit varenicline

EVarQuit：通过延长戒烟前伐尼克兰来戒烟

• 批准号: 9236849
• 负责人: LARRY W HAWK
• 金额: $ 76.14万
• 依托单位: STATE UNIVERSITY OF NEW YORK AT BUFFALO
• 依托单位国家: 美国
• 财政年份: 2016
• 资助国家: 美国
• 起止时间: 2016-12-01 至 2021-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9236849
• 关键词: Abstinence; Adult; Agonist; Animal Experimentation; Behavioral; Binding; Biochemical; Biological; Cause of Death; Cessation of life; Cigarette; Clinical; Clinical Data; Cotinine; Counseling; Data; Development; Dopamine; Ecological momentary assessment; Exhibits; Expectancy; Extinction (Psychology); Female; Frequencies; Gender; Goals; Hawks; Human; Individual; Label; Laboratories; Learning; Life; Link; Malignant Neoplasms; Measures; Mediating; Mediation; Methods; Morbidity - disease rate; Nausea; Nicotine; Nicotinic Receptors; Outcome; Outcome Measure; Participant; Patient Self-Report; Patients; Pharmaceutical Preparations; Phase; Physicians; Physiological; Placebos; Process; Psychological reinforcement; Public Health; Randomized; Randomized Clinical Trials; Rattus; Relapse; Research; Research Support; Running; Self Administration; Smoke; Smoker; Smoking; Smoking Behavior; Testing; Time; Withdrawal; Woman; Work; base; cancer prevention; cigarette smoking; clinical efficacy; clinical practice; cost; craving; efficacy testing; follow-up; improved; mortality; next generation; novel therapeutics; pre-clinical; predictive modeling; primary outcome; smoking cessation; success; theories; varenicline

PROJECT SUMMARY/ABSTRACT Varenicline is the most effective smoking cessation therapy available. Nevertheless, most smokers using varenicline relapse within the first few months after quitting. Varenicline is hypothesized to help smokers to quit in part by reducing the reinforcing effects of smoking during the standard 1-week pre-quitting treatment phase. Learning theory and previous human and animal research support the hypothesis that a longer duration of varenicline treatment prior to the target quit date (TQD) will yield greater decreases in the number of cigarettes smoked per day before quitting, and higher long-term cessation rates, compared to standard varenicline treatment. Building on our promising preliminary clinical data, we propose to test these hypotheses with a full-scale randomized clinical trial (RCT). Four hundred treatment-seeking smokers (200 female) will be randomized to a standard run-in group (3 weeks of placebo, followed by the standard 1 week of pre-TQD varenicline) or an extended run-in group (4 weeks of pre-TQD varenicline). Both groups will receive brief individual cessation counseling and 11 weeks of post-TQD varenicline. The primary outcome measure will be bio-verified continuous abstinence at end-of-treatment (weeks 8-11 post-quit) and at long-term follow-up (weeks 8-26 and 8-52 post-quit). Hypothesized mediating mechanisms (e.g., smoking reinforcement) will be evaluated by converging behavioral, physiological, and subjective measures assessed both in the lab and using real-world, real-time electronic momentary assessments (EMA). We predict that long-term, bio-verified smoking cessation will be improved among the extended run-in group compared to the standard run-in group. We further predict the improved clinical outcomes with extended run-in varenicline will be explained (or mediated) by greater pre-quit reductions in smoking reinforcement among the extended run-in group compared to the standard run-in group. The significance of this work is clear: We aim to make best available treatment for smoking cessation even better, using a method that is ripe for dissemination and an approach that will elucidate critical mechanisms to target in the next generation of treatment enhancement.

项目总结/摘要 伐尼克兰是最有效的戒烟疗法。然而，大多数 使用伐尼克兰的吸烟者在戒烟后的最初几个月内复发。伐尼克兰是 假设通过减少吸烟的强化作用来帮助吸烟者戒烟 在标准的1周戒烟前治疗阶段。学习理论与人类 动物研究支持这一假设，即较长时间的伐尼克兰治疗之前， 到目标戒烟日期（TQD）的吸烟量将产生更大的减少， 与标准伐尼克兰相比， 治疗基于我们有希望的初步临床数据，我们建议测试这些 一个完整的随机临床试验（RCT）的假设。400名寻求治疗的 吸烟者（200名女性）将被随机分配到标准导入组（3周安慰剂， 随后是标准的1周TQD前伐尼克兰）或延长导入组（4周 的TQD前伐尼克兰）。两组都将接受简短的个人戒烟咨询， 服用伐尼克兰后的几周主要结局指标将是连续生物验证 治疗结束时（戒烟后第8-11周）和长期随访时（第8-26周）的戒烟率 8-52后退出）。假设的中介机制（例如，吸烟加固）将是 通过聚合行为，生理和主观测量评估， 实验室和使用真实世界，实时电子瞬时评估（EMA）。我们预测 延长磨合组的长期、生物验证的戒烟效果将得到改善 与标准导入组相比。我们进一步预测， 延长的导入期伐尼克兰将被解释为（或介导） 与标准磨合组相比，延长磨合组的吸烟强化 组这项工作的重要性是显而易见的：我们的目标是提供最好的治疗方法， 戒烟甚至更好，使用一种成熟的传播方法和方法， 这将阐明下一代治疗的关键机制 增强