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

• 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
• 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

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/项目总结 对于接受阿片类药物治疗的人来说，烟草使用是可预防死亡的主要原因 使用障碍（MOUD）。接受MOUD的个人吸烟率高出五倍， 戒烟率远低于一般人群，即使使用现有的治疗方法，如FDA- 批准的药物治疗。电子香烟（e-cigarettes），如果取代燃烧的香烟 吸烟，可以为接受MOUD的吸烟者（MOUD-TUD）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。解决这一 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 和暴露在这个非常脆弱的吸烟人群中。它还可以为临床实践和政策制定提供信息 决策在这次为期3年的职业发展奖励中，我建议进行一个随机候补名单对照的试点 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中尚未准备好戒烟的燃烧香烟。一 使用混合方法序贯解释性设计的等待列表对照RCT将研究 SREC规定：1）烟草使用行为（例如，每日吸烟[主要结局]，SREC使用），2） 生物标记（例如，一氧化碳，假木贼碱），3）香烟依赖和戒断，和4）短期 健康影响和耐受性（例如，呼吸道症状，物质使用）。在拟定的RCT中，N=40名成人 从MGH初级保健实践中招募的报告每日吸烟的丁丙诺啡MOUD稳定， 随机分配接受SREC治疗8周，立即（iSREC）或延迟8周后 （等待列表控制[WLC]）。他们将在SREC供应结束后额外随访4周（至12周）。 iSREC和20周WLC）。每个科学目标对应于三种能力中的特定培训目标 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（共同初级导师），Elyse Park博士（共同导师）和一个专家团队 顾问。该职业发展奖的培训计划利用了来自以下团队的指导： 国际公认的以患者为导向的烟草，电子烟和OUD研究的领导者，以及 由著名的哈佛教师教授的严格课程。我将获得技能和可行性数据 需要支持一个完全有力的R 01提案，进行一项RCT测试吸烟干预，以减少 吸烟对OUD患者的影响除了完成我的培训目标外，拟议的研究还将 让我朝着我的长期目标前进，成为一名独立的调查员， 研究制定干预措施，以减轻SUD患者的烟草使用负担。