Effectiveness and impact of counseling enhanced with electronic cigarettes for harm reduction in smokers with opioid use disorder

摘要 阿片类药物使用障碍（OUD）患者（包括OUD患者）中的可燃香烟（CC）使用情况 美沙酮和丁丙诺啡治疗方案（OUDTP），几乎是普遍的（75~95%）。有助于 过早死亡和生活质量差，CC也可能促进阿片类药物复发。OUDTP中的CC吸烟者 尤其是对尼古丁戒断不适的严重不耐受。即使有强大的，基于证据的 尼古丁替代疗法（NRT）和延长护理干预，没有研究发现，即使是适度的利率， OUDTP中CC吸烟者的持续CC戒断。电子香烟（EC）可能比传统香烟更上级。 通过成功地完全转换为EC，或通过显著地降低烟草危害的NRT方法 减少每天吸烟的数量（CPD）。 此R 01应用程序的目标是测试为期8周的远程健康咨询EC危害减少的有效性 OUDTP中成人（≥ 21岁）CC吸烟者CPD减少的干预。我们建议进行一项 随机对照试验（RCT; N=302）比较远程健康咨询+尼古丁EC（干预）与 远程健康咨询+NRT组合（对照）对CPD减少的影响。我们的干预方法是以 信息-动机-行为技能模型。我们将从纽约市的OUDTP招募样本， 电子健康记录，以及参与者和提供者发起的方法。主要结局为 干预结束（8周）是指达到100% CPD减少的CC吸烟者比例[即转换 完全达到EC（干预组）或达到CC戒断（对照组）]，通过呼出碳验证 一氧化碳次要结局包括第26周和第52周时CPD减少100%，CPD变化百分比 与基线相比，与健康结果相关的标志物（呼吸道症状， 与健康有关的生活质量），并减少吸烟有毒物质暴露，如NNAL（烟草- 特定致癌物质代谢物）。具体目的是：1）比较EC与NRT对 CPD减少结果，2）估计和比较EC与NRT对健康结果的影响， 评估干预效果的调节和中介因素。 在第一年，我们将完成干预方案、调查、雇用和培训工作人员，并创建研究数据库 积极主动的招聘。参与者的招募将在第2年开始，并将在24个月内推出。 因此，迫切需要高质量的RCT来评估EC作为减少烟草危害的策略。如果有效，EC 将为OUDTP中CC吸烟者减少烟草危害提供额外的工具。本研究 OUD治疗的影响，以及烟草使用治疗政策和欧盟法规。

ABSTRACT Combustible cigarettes (CC) use among persons with opioid use disorders (OUD), including those in OUD methadone and buprenorphine treatment programs (OUDTP), is nearly universal (75~95%). Contributing to premature mortality and poor quality of life, CC may also promote relapse to opioids. CC smokers in OUDTP particularly suffer from severe intolerance to nicotine withdrawal discomfort. Even with potent, evidence-based nicotine replacement therapy (NRT) and extended care interventions, no study has found even modest rates of sustained CC abstinence among CC smokers in OUDTP. Electronic cigarettes (EC) may be superior to traditional NRT approaches for tobacco harm reduction either by successful switching to EC completely, or by substantially reducing the number of cigarettes smoked per day (CPD). The goal of this R01 application is to test the effectiveness of an 8-week telehealth counseling EC harm reduction intervention on CPD reduction among adult (≥ 21 years) CC smokers in OUDTP. We propose conducting a randomized controlled trial (RCT; N=302) to compare telehealth counseling + nicotine EC (Intervention) vs. telehealth counseling + combination NRT (Control) on CPD reduction. Our intervention approach is guided by the Information-Motivation-Behavioral Skills model. We will recruit our sample from OUDTP in New York City using electronic health records, in addition to participant and provider-initiated approaches. The primary outcome at end-of-intervention (8 weeks) is the proportion of CC smokers achieving 100% CPD reduction [i.e. switching completely to EC (Intervention Arm) or achieving CC abstinence (Control Arm)], verified by exhaled carbon monoxide. Secondary outcomes include 100% CPD reduction at 26- and 52-weeks, percent change in CPD relative to baseline, improvement in markers associated with health outcomes (respiratory symptoms, and health-related quality of life), and reduction in smoking toxicant exposure as measured by NNAL (a tobacco- specific carcinogen metabolite) in urine. The specific aims are to: 1) Compare the effect of EC versus NRT on CPD reduction outcomes, 2) Estimate and compare the effect of EC versus NRT on health outcomes and CC smoking exposure, 3) Evaluate moderating and mediating factors of the intervention effectiveness. In Year 1, we will finalize the intervention protocols, surveys, hire and train staff, and create the study database for proactive recruitment. Recruitment of participants will begin in Year 2 and will roll out over 24 months. There is a vital need for high‐quality RCTs evaluating EC as a tobacco harm reduction strategy. If effective, EC would provide an additional tool for tobacco harm reduction among CC smokers in OUDTP. This research has implications for OUD treatment, as well as tobacco use treatment policy and EC regulations.