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 (OUD) 患者（包括 OUD 患者）使用可燃香烟 (CC) 美沙酮和丁丙诺啡治疗方案（OUDTP）几乎普及（75~95%）。 过早死亡和生活质量差，CC 也可能促进 OUDTP 吸烟者复吸阿片类药物。 特别是对尼古丁戒断不适的严重不耐受，即使有有效的、基于证据的。 尼古丁替代疗法（NRT）和延伸护理干预措施，没有研究发现即使是适度的发生率 OUDTP 中 CC 吸烟者的持续戒烟可能优于传统香烟。 NRT 方法可以通过成功地完全转向 EC 或大幅减少烟草危害 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 周的远程医疗咨询 EC 减少伤害的有效性 我们建议在 OUDTP 中对成人（≥ 21 岁）CC 吸烟者进行 CPD 减少干预。 比较远程医疗咨询 + 尼古丁 EC（干预）与非尼古丁 EC（干预）的随机对照试验（RCT；N=302） 远程医疗咨询 + 组合 NRT（对照）以减少 CPD 我们的干预方法以以下内容为指导。 我们将使用信息-动机-行为技能模型从纽约市的 OUDTP 招募样本。 除了参与者和提供者发起的方法之外，电子健康记录也是主要成果。 干预结束（8 周）是 CC 吸烟者实现 100% CPD 减少的比例 [即转换 完全达到 EC（干预臂）或实现 CC 戒断（控制臂）]，通过呼出的碳进行验证 次要结果包括 26 周和 52 周时 CPD 减少 100%、CPD 变化百分比。 相对于基线，与健康结果相关的标志物（呼吸系统症状和 健康相关的生活质量），以及通过 NNAL（一种烟草- 尿液中的特定致癌物代谢物）具体目标是： 1) 比较 EC 与 NRT 对尿液中的影响。 CPD 减少结果，2) 估计并比较 EC 与 NRT 对健康结果的影响，以及 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方案、调查、雇用和培训员工，并创建研究数据库 主动招募参与者将从第 2 年开始，并将持续 24 个月。 迫切需要高质量的随机对照试验来评估 EC 作为减少烟草危害的策略（如果 EC 有效的话）。 这项研究将为 OUDTP 中的 CC 吸烟者提供减少烟草危害的额外工具。 对 OUD 治疗以及烟草使用治疗政策和 EC 法规的影响。