Mechanisms of behavior change in a genetics-informed smoking cessation intervention

遗传学指导的戒烟干预中行为改变的机制

• 批准号: 10360607
• 负责人: Alex Taylor Ramsey
• 金额: $ 23.63万
• 依托单位: WASHINGTON UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-03-01 至 2024-01-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10360607
• 关键词: Adherence; Advanced Development; Behavior Therapy; Behavioral Mechanisms; Biochemical; Cigarette; Cognition; Communication Tools; Community Health; Comprehension; Consent; Control Groups; Development; Enrollment; Environmental Risk Factor; Focus Groups; Genes; Genetic; Genetic Risk; Genetic Variation; Genomics; Goals; Health; Individual; Intervention; Life Expectancy; Lung diseases; Meta-Analysis; Metabolism; Modeling; National Institute of Drug Abuse; Nicotine; Nicotinic Receptors; Outcome; Participant; Persons; Pharmaceutical Preparations; Pharmacotherapy; Process; Professional counselor; Protocols documentation; Randomized; Randomized Controlled Trials; Readiness; Receptor Gene; Research; Risk; Self Efficacy; Smoke; Smoker; Smoking; Smoking Behavior; Smoking Cessation Intervention; Strategic Planning; Substance Use Disorder; Substance abuse problem; Testing; Tobacco use; Translating; Validation; Variant; Withholding Treatment; acceptability and feasibility; behavior change; cigarette smoke; cigarette smoking; community setting; design; disorder risk; efficacy trial; genetic information; genetic testing; genome-wide; genome-wide analysis; innovation; novel; personalized medicine; pilot test; post intervention; precision genetics; preventable death; primary outcome; prognostic; recruit; secondary outcome; smoking abstinence; smoking cessation; smoking intervention; smoking-related disease; substance use treatment; therapy design; therapy development; tool; uptake

PROJECT SUMMARY/ABSTRACT Cigarette smoking remains the leading cause of preventable death. Several effective medications for smoking cessation exist, but uptake of these treatments is low, making it difficult to quit smoking. Difficulty quitting smoking is also driven in part by genetic factors, which have not been incorporated into cessation interventions, marking a major scientific gap. Large genome-wide studies have shown that variation in nicotinic receptor genes impacts the risk of smoking-related diseases and difficulty with quitting smoking. Incorporating genetic information within a risk communication tool may engage current smokers in new quit attempts and motivate treatment use. Genetically-informed interventions may promote cessation by changing health-related cognitions (e.g., personalized benefits of treatment and cessation) and engagement (e.g., personal relevance of the intervention). The overarching goal of this study is to advance the development of a genetically-informed smoking cessation intervention—the RiskProfile—to lay the groundwork for a full-scale efficacy trial. This trial will aim to test preliminary effects of the RiskProfile on medication use and smoking outcomes to estimate effect sizes for a larger trial (Aim 1a), determine effects of the RiskProfile on potential change mechanisms leading to smoking cessation (Aim 1b), and adapt the RiskProfile and evaluate feasibility and acceptability for use in real-world community settings (Aim 2). For Aim 1, we will enroll 128 current smokers to receive genetic testing, randomize participants to either the intervention (genetically-informed RiskProfile) or control (brief cessation advice) group, and assess outcomes up to 6 months post-intervention. In this pilot, parallel-group, randomized controlled trial (RCT), we will test effects of the RiskProfile on primary outcomes of use of smoking cessation pharmacotherapy and average cigarettes smoked per day, and secondary outcomes of readiness to quit smoking and biochemically-verified smoking abstinence. We will then test the effects on health-related cognitions (perceived risk, benefits of treatment use and cessation, self-efficacy) and engagement (personal relevance, comprehension, sharing results). In Aim 2, to explore the potential for transporting the RiskProfile from research to community settings, we will conduct focus groups with individuals who smoke (n=20) and substance abuse counselors (n=10) to adapt the tool for use in a partnering community health agency. Current smokers and counselors (n=20 dyads) will then pilot test the RiskProfile protocol, and quantitative metrics will be used to determine intervention acceptability and feasibility to proceed to a large-scale “real-world” efficacy trial. If successful, this study will (1) incorporate novel genetic information in the development of a behavioral intervention to promote medication use and smoking cessation, (2) reveal potential mechanisms of behavior change to guide intervention adaptation, and (3) demonstrate the potential for translating precision discoveries into efficacious tools to enhance the treatment of tobacco and substance use disorders more broadly.

项目总结/摘要 吸烟仍然是可预防死亡的主要原因。几种有效的戒烟药物 戒烟是存在的，但这些治疗的吸收率很低，使戒烟变得困难。戒烟困难 吸烟也部分受到遗传因素的驱动，这些因素尚未纳入戒烟计划 干预措施，标志着一个重大的科学差距。大规模的全基因组研究表明， 受体基因影响吸烟相关疾病的风险和戒烟的困难。结合 风险沟通工具中的遗传信息可能会使当前吸烟者参与新的戒烟尝试， 鼓励治疗使用。遗传信息干预可以通过改变健康相关的 认知（例如，治疗和戒烟的个性化益处）和参与（例如，个人关联性 的干预）。这项研究的总体目标是促进遗传信息的发展， 戒烟干预-风险概况-为全面的疗效试验奠定基础。本试验 将旨在测试RiskProfile对药物使用和吸烟结果的初步影响， 大型试验的效应量（目标1a），确定风险概况对潜在变化机制的影响 导致戒烟（目标1b），调整风险概况，并评估以下方面的可行性和可接受性： 在现实世界的社区环境中使用（目标2）。对于目标1，我们将招募128名当前吸烟者接受遗传学治疗， 测试，将参与者随机分配到干预组（遗传学告知的RiskProfile）或对照组（简要 戒烟建议）组，并评估干预后6个月的结果。在这个试点中，平行组， 随机对照试验（RCT），我们将测试RiskProfile对吸烟的主要结局的影响 戒烟药物治疗和平均每天吸烟量，以及准备好 戒烟和经生化验证的戒烟。然后我们将测试对健康相关的影响 认知（感知的风险，治疗使用和停止的益处，自我效能）和参与（个人 相关性、理解性、共享结果）。在目标2中，探索风险简介的传输潜力 从研究到社区环境，我们将与吸烟者（n=20）进行焦点小组讨论， 药物滥用顾问（n=10），以适应在合作的社区卫生机构使用的工具。电流 吸烟者和咨询师（n=20对）将对RiskProfile协议进行试点测试，定量指标将 用于确定干预的可接受性和可行性，以实现大规模的“真实世界”疗效 审判如果成功的话，这项研究将（1）将新的遗传信息纳入行为的发展， 促进药物使用和戒烟的干预，（2）揭示潜在的行为机制 指导干预适应的变化，以及（3）展示转化精确发现的潜力 转化为有效的工具，以更广泛地加强对烟草和物质使用障碍的治疗。