Methadone-Maintained Smokers Switching to E-Cigarettes

吸食美沙酮的吸烟者转向电子烟

• 批准号: 10640206
• 负责人: Ana M Abrantes
• 金额: $ 34.22万
• 依托单位: BUTLER HOSPITAL (PROVIDENCE, RI)
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-09-30 至 2024-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10640206
• 关键词: Behavioral; Benefits and Risks; Biological Markers; Buprenorphine; Cessation of life; Cigarette; Clinical Research; Clinical Trials; Electronic cigarette; Enrollment; General Population; Generations; Harm Reduction; Health; Individual; Industry; Intake; JUUL; Methadone; Methods; Morbidity - disease rate; Nicotine; Nicotine Dependence; Opioid; Outcome; Participant; Patient Self-Report; Persons; Pharmacotherapy; Population; Populations at Risk; Premature Mortality; Psychological reinforcement; Randomized; Recommendation; Reporting; Respiratory Signs and Symptoms; Risk; Self Efficacy; Severities; Smoke; Smoker; Smoking; Smoking Status; Smoking and Health Research; Spirometry; Testing; Tobacco; Toxicant exposure; United States; Vulnerable Populations; associated symptom; cardiovascular risk factor; cigarette smoking; cigarette user; combustible cigarette; craving; electronic cigarette use; experience; follow-up; illicit drug use; improved; interest; methadone treatment; mortality; nicotine replacement; novel; opioid use disorder; opioid user; preclinical study; prospective; pulmonary function; randomized trial; randomized, clinical trials; smoking cessation; smoking prevalence; tobacco smokers; tobacco toxicant; week trial

Abstract Persons with opioid use disorder (OUD) enrolled in methadone maintenance programs continue to have smoking prevalence rates of 80-90% and high rates of tobacco-related morbidity and mortality. Multiple clinical trials of pharmacotherapy have documented that methadone-maintained smokers (MMS) have very low smoking cessation rates. These low rates of successful quitting and the significant health consequences of smoking combustible cigarettes (CC), it is critical to identify harm-reduction strategies in this at-risk population. Electronic cigarette (EC) use has grown rapidly and substituting combustible cigarettes with EC use may decrease health risks in MMS. We propose to take a first step in examining the risks and benefits associated with EC use among MMS. Of particular interest would be the health effects of ECs among MMS because of MMS’ difficulty with prolonged CC quitting, the severity of their nicotine dependence, greater tobacco demand, and the precedent of harm reduction wherein opioid users substitute a lower risk opioid (methadone) for illicit drug use. Thus, we are proposing to utilize a fourth generation EC (JUUL) to examine behavioral and health biomarker changes of MMS smokers interested in switching from combustible cigarettes to ECs. Given the continuing popularity of ECs, there is an urgent need to improve our understanding of both the potential benefits and risks of EC use in this vulnerable population. We propose to conduct a 4-year randomized clinical trial of 240 MMS who are interested in switching to another nicotine alternative. Participants will be randomly assigned (2:1) to either 6-weeks of EC (JUUL; n=160) or to 6-weeks of nicotine replacement therapy (NRT; in the form of nicotine lozenges; n=80). Participants in both conditions will attend weekly assessment sessions where smoking status is confirmed. At the end of 6 weeks, we will assess biomarkers of total nicotine intake and tobacco toxicant exposure, respiratory symptoms, and spirometry-determined lung functioning as well as rates of complete switching, EC, NRT, and CC use (including dual use), tobacco demand and self-efficacy for quitting CC. Continued use of EC, NRT, and CC will be examined at the 12- and 24-week follow-ups. This study will be the first to test the potential behavioral and health effects of ECs in smokers with opioid use disorder, a population that is highly dependent on nicotine, highly vulnerable to smoking-related morbidity and mortality, and searching for novel methods to lower smoking-related risks.

抽象的 参加美沙酮维持计划的阿片类药物使用障碍 (OUD) 患者继续患有 吸烟率达80-90%，与烟草相关的多种临床发病率和死亡率很高。 药物治疗试验已证明，以美沙酮维持治疗的吸烟者 (MMS) 的吸烟率非常低 戒烟率低，戒烟成功率低，而且对健康造成严重影响。 吸食可燃香烟（CC）时，针对这一高危人群确定减少危害的策略至关重要。 电子烟 (EC) 的使用增长迅速，用 EC 替代可燃香烟可能会 我们建议首先检查相关风险和收益。 由于 EC 在 MMS 中的使用，人们特别感兴趣的是 EC 在 MMS 中的健康影响，因为 MMS 长期戒烟的困难、尼古丁依赖的严重性、更大的烟草需求、 以及减少危害的先例阿片类药物使用者用风险较低的阿片类药物（美沙酮）替代非法药物 因此，我们建议利用第四代 EC (JUUL) 来检查行为和健康状况。 有兴趣从可燃卷烟转向 EC 的 MMS 吸烟者的生物标志物变化。 EC 的持续流行，迫切需要提高我们对这两种潜力的了解 我们建议进行一项为期 4 年的随机临床研究，以了解 EC 在这一弱势群体中使用的益处和风险。 对 240 名有兴趣改用另一种尼古丁替代品的 MMS 进行的试验将是随机的。 分配（2:1）至 6 周 EC（JUUL；n=160）或 6 周尼古丁替代疗法（NRT；在 尼古丁含片形式；n=80）。 在确认吸烟状况后，我们将在 6 周结束时评估总尼古丁摄入量的生物标志物。 和烟草毒物暴露、呼吸道症状、肺活量测定确定的肺功能以及 完全转换率、EC、NRT 和 CC 使用（包括双重使用）、烟草需求和自我效能 戒断 CC 后，将在 12 周和 24 周的随访中检查是否继续使用 EC、NRT 和 CC。 研究将是第一个测试 EC 对使用阿片类药物的吸烟者的潜在行为和健康影响的研究 疾病，高度依赖尼古丁的人群，极易罹患与吸烟相关的疾病， 死亡率，并寻找降低吸烟相关风险的新方法。