Research Supplement to Promote Diversity in Health-Related Research: Randomized controlled trial of varenicline for cessation of nicotine vaping in adolescent non-smokers

促进健康相关研究多样性的研究补充：伐尼克兰对青少年非吸烟者戒烟尼古丁的随机对照试验

• 批准号: 10878366
• 负责人: A EDEN EVINS
• 金额: $ 6.25万
• 依托单位: MASSACHUSETTS GENERAL HOSPITAL
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-09-01 至 2024-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10878366
• 关键词: Address; Adolescent; Adolescent and Young Adult; Affective; Behavioral; Bisexual; Caring; Clinical Research; Clinical Trials Design; Cognitive; Complement; Complex; Counseling; Data; Dedications; Dimensions; Ensure; Epidemic; Face; Funding; Generations; Goals; Health; Individual; Inhalation; Intervention; Investigation; Knowledge; Low income; Medicine; Mental Health; Mentors; Methodology; Minority Groups; Mission; Modeling; Nicotine Dependence; Patient-Focused Outcomes; Patients; Persons; Pharmacotherapy; Provider; Randomized, Controlled Trials; Research; Scientist; Services; Students; Substance Use Disorder; Supervision; Talents; Time; Tobacco Use Cessation; Training; Training Support; Underrepresented Populations; United States National Institutes of Health; Update; Work; Youth; addiction; aged; behavioral health; career; career development; combustible cigarette; design; disadvantaged background; disparity reduction; electronic cigarette use; ethnic minority population; experience; global health; graduate school; improved; indexing; innovation; minority children; nicotine cessation; nicotine use; nicotine vapor; non-smoker; parent project; patient population; peer; racial minority population; randomized placebo-controlled clinical trial; responsible research conduct; skills; substance use; tobacco cessation intervention; vaping; vaping nicotine; varenicline; women of color; young adult

PROJECT SUMMARY/ABSTRACT The behavioral health field faces an unprecedented mental health crisis and clinician shortage. One in five young people in the U.S. experience a mental health condition each year, but only 40% receive services, and merely 6% of individuals aged 12 and older with a substance use disorder receive treatment. Peer counseling is an emerging strategy that may help address this significant mental health and workforce shortage. One behavioral health concern requiring urgent innovation in treatment approaches and may benefit from peer-led interventions is vaping cessation. The rapid rise in popularity of electronic cigarettes used to inhale vaporized nicotine solutions has effectively reversed five decades of denormalization of nicotine use among youth. While the desire to quit is high, tobacco cessation efforts for young people often yield low engagement rates, and few effective strategies have been identified to date. Peer-delivered interventions show promise for youth combustible cigarette cessation; however, these have yet to be applied for vaping cessation, and little is known about what promotes engagement in these types of intervention approaches. The current diversity supplement proposal seeks to investigate the environmental-, patient, and provider-level constructs that influence multi- dimensional indices of vaping cessation peer-led behavioral and pharmacotherapy treatment engagement (physical, affective, and cognitive engagement). This supplement request aims to support the primary aims of the parent project (R01DA052583), a randomized, placebo-controlled clinical trial of varenicline added to peer- led behavioral counseling (QuitVaping) among adolescents and young adults with daily vaping and nicotine dependence. This diversity supplement aims to support the training and career development of Vanessa Iroegbulem, a talented junior clinician-scientist who has demonstrated herself to be among the top 1% of clinical research coordinators to work at the MGH Center for Addiction Medicine. Vanessa is a first-generation, low-income student and identifies as a bisexual woman of color. Her long-term career goal is to pursue a career as a clinician-scientist dedicated to reducing disparities in substance use and improving patient outcomes among minority youth and young adults. The research plan complements the mentoring goals by providing Vanessa with protected time to increase her knowledge in 1) clinical trial design and methodology, 2) basics of R programming and analysis, and 3) responsible conduct of research, particularly pertaining to diverse patient populations. Under the primary supervision of Drs. Eden Evins and Randi Schuster, this supplement will enhance Vanessa’s ability to develop her research skills, solidify her trajectory to graduate school and establish a path to independence as a clinician-scientist. This will increase the number of underrepresented persons of ethnic/racial minority groups and disadvantaged backgrounds in health-related research careers and further NIH’s mission to ensure the nation has a pool of highly talented scientists from diverse backgrounds capable of addressing complex global health issues with innovative solutions.

项目摘要/摘要 行为健康领域面临着前所未有的心理健康危机和临床医生短缺。每五个人中就有一个 美国的年轻人每年都会经历心理健康问题，但只有40%的人接受了服务，而且 在12岁及以上患有药物使用障碍的人中，只有6%接受了治疗。同伴咨询 是一项新兴的战略，可能有助于解决这一严重的心理健康和劳动力短缺问题。一 行为健康问题迫切需要治疗方法的创新，并可能受益于同行领导 干预措施是停止蒸发。用于吸入汽化的电子烟的迅速流行 尼古丁解决方案有效地扭转了50年来青年中尼古丁使用的非正常化。而当 戒烟的愿望很高，年轻人戒烟的努力往往会产生很低的参与率，而且很少 迄今为止，已经确定了有效的战略。同行提供的干预措施为年轻人带来了希望 可燃香烟的戒断；然而，它们还没有被应用于汽化戒烟，而且知之甚少。 关于是什么促进了对这些类型的干预方法的参与。当前的多样性补充 该提案旨在调查环境、患者和提供者级别的结构，这些结构影响多个 戒烟同伴主导的行为和药物治疗参与度维度指数 (身体、情感和认知投入)。本补充申请旨在支持以下主要目标 母项目(R01DA052583)，一项随机、安慰剂对照的瓦伦克林临床试验，添加到PEER- 对青少年和年轻人进行日常吸食和尼古丁的行为咨询(QuitVaping) 依赖。这一多样性补充旨在支持Vanessa的培训和职业发展 IroegBulem，一位才华横溢的初级临床医生兼科学家，她已经证明自己是 临床研究协调员在MGH成瘾医学中心工作。瓦内萨是第一代， 低收入学生，并认为自己是有色人种的双性恋女性。她的长期职业目标是追求一种 作为临床医生和科学家的职业生涯，致力于减少物质使用的差异和改善患者 在少数群体青年和青年中取得的成果。研究计划通过以下方式补充指导目标 为Vanessa提供有保护的时间，以增加她在1)临床试验设计和方法学方面的知识，2) R规划和分析的基础知识，以及3)负责任的研究行为，特别是与 不同的患者群体。在伊登·埃文斯博士和兰迪·舒斯特博士的主要监督下， 补充剂将增强Vanessa发展她的研究技能的能力，巩固她的毕业轨迹 在学校学习，并建立一条作为临床医生兼科学家的独立之路。这将增加 少数民族/种族少数群体代表性不足的人和健康相关领域的弱势背景 NIH的研究生涯和进一步的使命，以确保国家拥有一批来自 不同的背景，能够用创新的解决方案解决复杂的全球卫生问题。