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

电子烟增强咨询对减少阿片类药物使用障碍吸烟者危害的有效性和影响

• 批准号: 10676757
• 负责人: Omar El-Shahawy
• 金额: $ 61.27万
• 依托单位: NEW YORK UNIVERSITY SCHOOL OF MEDICINE
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-08-15 至 2027-04-30
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10676757
• 关键词: 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanol; Abstinence; Address; Adherence; Adult; Behavior; Behavioral; Carbon Monoxide; Caring; Cigarette Smoker; Clinical; Counseling; Databases; Dependence; Ecological momentary assessment; Effectiveness; Effectiveness of Interventions; Electronic Health Record; Electronic cigarette; Exhalation; Goals; Harm Reduction; Health; Intervention; Long-Term Care; Measures; Mediating; Modeling; Motivation; National Institute of Drug Abuse; New York City; Nicotine; Nicotine Withdrawal; Opioid; Outcome; Participant; Patient Recruitments; Patient Self-Report; Pattern; Perception; Persons; Pharmaceutical Preparations; Policies; Premature Mortality; Protocols documentation; Provider; Quality of life; Randomized, Controlled Trials; Regulation; Relapse; Research; Respiratory Signs and Symptoms; Ritual compulsion; Sampling; Self Efficacy; Smoker; Smoking; Surveys; Target Populations; Time; Tobacco; Tobacco use; Tobacco-Associated Carcinogen; Toxicant exposure; Training; Urine; Variant; Vulnerable Populations; arm; buprenorphine treatment; cigarette smoke; cigarette smoking; combustible cigarette; effectiveness testing; electronic cigarette use; evidence base; experience; follow-up; health related quality of life; improved; interest; meetings; methadone treatment; nicotine replacement; novel; open label; opioid use disorder; preference; primary outcome; pulmonary function; recruit; secondary outcome; skills; smoking cessation; smoking exposure; success; telehealth; tool; treatment arm; treatment program

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.

摘要 可燃香烟(CC)在阿片类药物使用障碍(OUD)人群中的使用，包括OUD人群 美沙酮和丁丙诺啡治疗方案(OUDTP)几乎是普遍的(75%~95%)。贡献于 过早死亡和生活质量差，CC也可能促进阿片类药物的复发。OUDTP中的CC吸烟者 尤其是患有严重的尼古丁戒断不耐受不适。即使是强有力的、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 OUDTP中CC吸烟者的持续CC戒断。电子烟(EC)可能优于传统香烟 减少烟草危害的NRT方法，要么完全成功地改用EC，要么基本上 减少每天吸烟的数量(CPD)。 此R01应用程序的目标是测试为期8周的远程健康咨询EC减害的有效性 OUDTP中成年(≥，21岁)CC吸烟者降低慢性阻塞性肺疾病的干预。我们建议进行一次 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(对照)减少慢性阻塞性肺疾病。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招募我们的样本 电子健康记录，以及参与者和提供者发起的方法。主要结果是 干预结束(8周)是慢性阻塞性肺疾病吸烟者达到100%慢性阻塞性肺疾病减少的比例[即改变 完全到EC(干预臂)或实现CC戒断(控制臂)]，通过呼出的碳进行验证 一氧化碳。次要结果包括在26周和52周时CPD减少100%，CPD改变百分比 相对于基线，与健康结果相关的标志的改善(呼吸道症状和 与健康相关的生活质量)，以及由NNAL(一种烟草- 尿液中的特定致癌代谢物)。具体目的是：1)比较EC和NRT对 CPD减少结果，2)评估和比较EC和NRT对健康结果的影响 3)评价干预效果的调节和中介因素。 在第一年，我们将最终确定干预方案、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。招募参与者将在第二年开始，并将在24个月内展开。 迫切需要高质量的随机对照试验评估EC作为一项减少烟草危害的战略。如果有效，EC 将为OUDTP的CC吸烟者提供另一个减少烟草危害的工具。这项研究已经 对OUD处理的影响，以及烟草使用处理政策和欧共体法规。