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.

抽象的 阿片类药物使用障碍者（OUD）中使用可燃香烟（CC），包括OUD Metagadone和丁丙诺啡治疗计划（OUDTP）几乎是普遍的（75〜95％）。贡献 过早死亡率和生活质量差，CC也可能促进阿片类药物的缓解。 CC吸烟者在OUDTP中 特别是患有严重的摄入剂对尼古丁戒断不适。即使有潜在的，基于证据的 尼古丁替代疗法（NRT）和扩展护理干预措施，甚至没有研究发现 OUDTP中CC吸烟者中持续的CC禁欲。电子烟（EC）可能优于传统 NRT方法通过成功切换到EC或基本上是通过成功切换到烟草伤害的方法 减少每天抽烟的数量（CPD）。 此R01应用的目的是测试为期8周的远程医疗咨询ec降低损害的有效性 OUDTP中CC吸烟者（≥21岁）的CPD减少CPD的干预。我们建议进行一次 随机对照试验（RCT; n = 302）比较远程医疗咨询 +尼古丁EC（干预）与 远程医疗咨询 +组合NRT（对照）减少CPD。我们的干预方法由 信息动机行为技能模型。我们将使用纽约市的OUDTP招募样本 电子健康记录除了参与和提供者发起的方法外。主要结果 干预终止（8周）是CC吸烟者的比例，可减少100％CPD [即交换 完全到EC（干预臂）或实现CC禁欲（控制臂）]，通过呼出的碳验证 一氧化物。次要结果包括在26周和52周减少100％CPD，CPD的变化百分比 相对于基线，与健康结果相关的标记的改善（呼吸症状和 与健康相关的生活质量），以及通过Nnal测量的吸烟毒物暴露的降低（烟草 - 尿液中的特异性致癌代谢产物）。具体目的是：1）比较EC与NRT的影响 CPD减少结果，2）估计并比较EC与NRT对健康结果的影响 CC吸烟暴露，3）评估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协议，调查，雇用和培训员工，并创建研究数据库 主动招募。参与者的招募将在2年级开始，并将在24个月内推出。 将EC评估为减少烟草危害策略的高质量RCT的重要需求。如果有效，EC 将为OUDTP中CC吸烟者减少烟草危害的额外工具。这项研究有 对OUD治疗以及烟草使用治疗政策和EC法规的影响。