Switching Individuals in Treatment for Opioid Use Disorder Who Smoke Cigarettes to the SREC

摘要/项目摘要 对于接受阿片类药物治疗的人来说，吸烟是可预防死亡的主要原因 使用无序(Moud)。接受Moud的人吸烟流行率是其他人的五倍 戒烟率比普通人群低得多，即使使用现有的治疗方法，如FDA- 批准的药物疗法。电子烟(电子烟)，如取代燃烧香烟 吸烟，可能为接受Moud Who Smoke(Moud-TUD)的个人提供一种减少伤害的策略 还没有准备好戒烟。在Moud-TUD中测试这种方法的工作很少。解决这个问题 知识鸿沟有可能回答一个关键问题，即电子烟是否可以减少烟草使用 以及暴露在这一高度脆弱的吸烟者群体中。它还可以为临床实践和政策制定提供信息 决定。在这个为期3年的职业发展奖中，我建议进行随机等待名单控制的试点 评估替代NIDA标准的可行性、可接受性和初步效果的试验 研究电子烟(SREC)，用于Moud-TUD地区尚未准备戒烟的燃烧香烟。一个 使用混合方法序贯解释设计的等待名单对照随机对照试验将调查 SREC关于：1)烟草使用行为的规定(例如，每天吸烟[主要结果]，SREC使用)，2) 生物标志物(如一氧化碳、阿那巴辛)，3)香烟依赖和戒断，以及4)短期 对健康的影响和耐受性(例如，呼吸道症状、物质使用)。在建议的随机对照试验中，N=40名成年人 在Moud上使用丁丙诺啡的稳定者报告从MGH初级保健诊所招募的每日吸烟将 随机分配在8周内接收SREC，要么立即(ISREC)，要么延迟8周 (等待名单控制[WLC])。在SREC规定结束后，他们将再接受4周的跟踪(至12周 ISREC和20周的WLC)。每个科学目标对应于三个能力中的一个具体培训目标 领域：1)临床试验的设计和实施，2)纵向定量数据分析，3)定性 和混合方法研究。科学和培训目标将在博士的指导下执行。 Nancy Rigotti和Eden Evins(联合小学导师)，Elyse Park博士(联合导师)，以及一个专家团队 顾问。这一职业发展奖的培训计划利用了来自 国际公认的面向患者的烟草、电子烟和OUD研究领域的领导者，以及 由著名的哈佛大学教员讲授的严谨课程。我将获得技能集和可行性数据 需要支持完全支持R01提案，以进行随机对照试验测试吸烟干预以减少 吸烟者的吸烟负担。拟议的研究，除了完成我的培训目标外，还将 让我朝着我的长期目标--作为一名进行高影响力的独立调查员--前进 研究开发干预措施以减轻肥皂症患者的烟草使用负担。

ABSTRACT/PROJECT SUMMARY Tobacco use is a leading cause of preventable mortality for people receiving medication treatment for opioid use disorder (MOUD). Individuals receiving MOUD have a five-fold higher prevalence of tobacco smoking and substantially lower quit rates than the general population, even when using existing treatments such as FDA- approved pharmacotherapies. Electronic cigarettes (e-cigarettes), if substituted for combusted cigarette smoking, may offer a harm reduction strategy for individuals receiving MOUD who smoke (MOUD-TUD) who are not ready to quit smoking. Little work has been done to test this approach in MOUD-TUD. Addressing this knowledge gap has the potential to answer a critical question of whether e-cigarettes can reduce tobacco use and exposure in this highly vulnerable smoker population. It can also inform clinical practice and policymaking decisions. In this 3-year career development award, I propose to conduct a pilot randomized waitlist-controlled trial to assess the feasibility, acceptability, and preliminary effects of substituting the NIDA standardized research e-cigarette (SREC) for combusted cigarettes in MOUD-TUD who are not ready to quit smoking. A waitlist controlled RCT using a mixed-methods sequential explanatory design will investigate the impact of SREC provision on: 1) tobacco use behavior (e.g., cigarettes per day [primary outcome], SREC use), 2) biomarkers (e.g., carbon monoxide, anabasine), 3) cigarette dependence and withdrawal, and 4) short-term health effects and tolerability (e.g., respiratory symptoms, substance use). In the proposed RCT, N=40 adults stable on MOUD with buprenorphine who report daily smoking recruited from MGH primary care practices will be randomly assigned to receive the SREC for 8 weeks, either immediately (iSREC), or after an 8-week delay (waitlist control [WLC]). They will be followed an additional 4 weeks after SREC provision ends (to 12 weeks in iSREC and 20 weeks in WLC). Each scientific aim corresponds to a specific training goal in three competency domains: 1) design and conduct of clinical trials, 2) longitudinal quantitative data analysis and, 3) qualitative and mixed-methods research. The scientific and training aims will be executed with mentorship from Drs. Nancy Rigotti and Eden Evins (co-primary mentors), Dr. Elyse Park (co-mentor), and a team of expert advisors. The training plan for this career development award leverages mentorship from a team of internationally recognized leaders in patient-oriented tobacco, e-cigarette, and OUD research, as well as rigorous coursework taught by renowned Harvard faculty. I will acquire both the skillset and the feasibility data needed to support a fully powered R01 proposal to conduct a RCT testing a smoking intervention to reduce the burden of smoking in those with OUD. The proposed study, in addition to completion of my training goals, will launch me towards my long-term goal of a career as an independent investigator conducting high impact studies to develop interventions to reduce the burden of tobacco use in people with SUDs.