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

将接受阿片类药物使用障碍治疗且吸烟的个体转至 SREC

基本信息

批准号：
10661301
负责人：
Joanna Streck
金额：
$ 19.59万
依托单位：
MASSACHUSETTS GENERAL HOSPITAL
依托单位国家：
美国
项目类别：
财政年份：
2023
资助国家：
美国
起止时间：
2023-07-01 至 2026-06-30
项目状态：
未结题

来源：
https://reporter.nih.gov/project-details/10661301
关键词：
Acceleration Address Adult Adverse effects Aerosols Anabasine Applications Grants Area Behavior Biological Markers Buprenorphine Carbon Monoxide Categories Cigarette Clinical Trials Competence Conduct Clinical Trials Cotinine Cross-Sectional Studies Data Data Analyses Decision Making Dependence Development Devices Educational process of instructing Electronic cigarette Enrollment Environmental Risk Factor Epidemic Evaluation Exposure to FDA approved Faculty Foundations Future General Hospitals General Population Goals Harm Reduction Health High Prevalence Individual International Intervention Interview K-Series Research Career Programs Knowledge Marketing Massachusetts Mentored Patient-Oriented Research Career Development Award Mentors Mentorship Methods Motivation National Institute of Drug Abuse Nicotine Outcome Outcome Measure Participant Patients Persons Pharmaceutical Preparations Pharmacotherapy Pilot Projects Policy Making Population Prevalence Randomized Randomized, Controlled Trials Reporting Research Research Design Research Methodology Research Personnel Respiratory Signs and Symptoms Smoke Smoker Smoking Standardization Stimulus Testing Tobacco Tobacco smoke Tobacco smoking behavior Tobacco use Toxin Training Vulnerable Populations Waiting Lists Withdrawal Withdrawal Symptom Work behavior change buprenorphine treatment career cigarette smoke cigarette smoking clinical practice combustible cigarette comorbidity design e-cigarette cessation electronic cigarette use experience interest mortality non-smoker novel novel strategies opioid use disorder patient oriented pod mods polysubstance use preventable death primary care practice primary outcome prospective psychiatric symptom public policy on tobacco recruit reduce tobacco use reduced substance use retention rate skills smoking cessation smoking intervention social substance use success therapy development tobacco exposure tool

项目摘要

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.

摘要/项目摘要烟草使用是接受阿片类药物治疗的人可预防死亡的主要原因使用障碍（MOUD）。接受 MOUD 的个体吸烟率高出五倍，并且即使使用 FDA 等现有治疗方法，戒烟率也比一般人群低得多批准的药物疗法。电子烟（e-香烟），如果替代燃烧香烟吸烟，可能为接受 MOUD 吸烟 (MOUD-TUD) 的个人提供减少危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。解决这个问题知识差距有可能回答电子烟是否可以减少烟草使用的关键问题以及这一高度脆弱的吸烟者群体的暴露情况。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，我建议进行一项随机候补名单控制的试点评估替代NIDA标准化的可行性、可接受性和初步效果的试验研究电子烟（SREC），针对 MOUD-TUD 中尚未准备好戒烟的已燃烧香烟。一个使用混合方法序贯解释性设计的候补名单控制随机对照试验将调查以下因素的影响： SREC 规定：1) 烟草使用行为（例如，每天吸烟[主要结果]、SREC 使用），2) 生物标志物（例如一氧化碳、假木香），3) 香烟依赖和戒断，以及 4) 短期健康影响和耐受性（例如呼吸道症状、物质使用）。在拟议的 RCT 中，N=40 名成人接受丁丙诺啡 MOUD 治疗稳定且每日吸烟的患者将从 MGH 初级保健诊所招募被随机分配接受 8 周的 SREC，可以是立即 (iSREC)，也可以是在 8 周延迟后（候补名单控制 [WLC]）。 SREC 规定结束后，将对其进行额外 4 周的跟踪（至 12 周） iSREC 和 WLC 中的 20 周）。每个科学目标都对应于三种能力的具体培训目标领域：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（联合导师）、Elyse Park 博士（联合导师）以及专家团队顾问。该职业发展奖的培训计划利用了以下团队的指导国际公认的以患者为导向的烟草、电子烟和 OUD 研究领域的领导者，以及由哈佛大学著名教师教授的严格课程。我将获得技能和可行性数据需要支持一项全面的 R01 提案，以进行随机对照试验，测试吸烟干预措施，以减少 OUD 患者的吸烟负担。除了完成我的培训目标之外，拟议的研究还将让我朝着作为一名具有高影响力的独立调查员的职业生涯的长期目标迈进研究制定干预措施以减轻 SUD 患者的烟草使用负担。