Methadone-Maintained Smokers Switching to E-Cigarettes

吸食美沙酮的吸烟者转向电子烟

基本信息

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
项目类别：
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

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

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项目摘要

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MetagadOne维护计划的绿核酸使用障碍（OUD）的人继续吸烟率为80-90％，烟草相关的发病率和死亡率高。多个临床药物治疗的试验已证明Methodadone维持吸烟者（MMS）的试验很低戒烟率。这些成功的安静率低的速度和重大的健康后果吸烟混合香烟（CC），在这种高危人群中识别减少损害策略至关重要。电子香烟（EC）的使用迅速增长，并用EC用代替混合香烟可能降低MMS的健康风险。我们建议在研究相关的风险和利益方面迈出第一步在MMS中使用EC。特别感兴趣的是MMS中EC的健康影响 MMS在延长CC安静的困难，其尼古丁依赖的严重程度，更大的烟草需求，以及减少伤害的先例，其中阿片类药物使用者代替较低的风险阿片类药物（美沙酮）吸毒。这，我们建议利用第四代EC（JUUL）检查行为和健康 MMS吸烟者的生物标志物变化有兴趣从混合香烟转换为ECS。鉴于 EC的持续普及，迫切需要提高我们对潜力的理解在这个脆弱人群中使用EC的好处和风险。我们建议进行4年的随机临床对240毫米的试验，他们有兴趣切换到另一种尼古丁替代方案。参与者将随机分配（2：1）为6周的EC（Juul; n = 160）或6周的尼古丁替代疗法（NRT; IN in NRT； in 尼古丁lozenges的形式； n = 80）。两种情况下的参与者将参加每周评估会议确认吸烟状况的地方。在6周结束时，我们将评估总尼古丁摄入量的生物标志物以及烟草暴露，呼吸道症状和肺活量法定的肺功能以及完整开关，EC，NRT和CC使用的速率（包括双重用途），烟草需求和自我有效退出CC。在12周和24周的随访中，将继续检查EC，NRT和CC的继续使用。这研究将是第一个测试EC在吸烟者中使用阿片类药物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，高度容易受吸烟相关的发病率和死亡率，并寻找新的方法来降低与吸烟有关的风险。