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.

摘要 参加美沙酮维持治疗计划的阿片类药物使用障碍（OUD）患者继续有 吸烟率高达80-90%，与烟草有关的发病率和死亡率很高。多项临床 药物治疗的试验已经证明，美沙酮维持吸烟者（MMS） 戒烟率。戒烟成功率低，戒烟对健康造成的重大影响， 吸烟可燃香烟（CC），这是至关重要的，以确定在这一风险人群的危害减少策略。 电子烟（EC）的使用增长迅速，用EC替代可燃香烟可能会 降低MMS的健康风险。我们建议首先研究有关的风险和利益 在MMS中使用EC。特别感兴趣的是MMS中EC的健康影响，因为 MMS长期戒烟的困难，尼古丁依赖的严重程度，更大的烟草需求， 以及减少危害的先例，其中阿片类药物使用者用较低风险的阿片类药物（美沙酮）代替非法药物 吸毒因此，我们建议利用第四代EC（JUUL）来检查行为和健康 有兴趣从可燃香烟转换到EC的MMS吸烟者的生物标志物变化。鉴于 由于EC的持续流行，迫切需要提高我们对潜在的 在这一弱势群体中使用EC的益处和风险。我们建议进行一项为期4年的随机临床研究， 240名有兴趣改用另一种尼古丁替代品的MMS试验。参与者将随机 分配（2：1）至6周EC（JUUL; n=160）或6周尼古丁替代治疗（NRT; 尼古丁锭剂形式; n=80）。这两种情况的参与者将参加每周的评估会议 确认吸烟状态。在6周结束时，我们将评估尼古丁总摄入量的生物标志物 和烟草毒物暴露，呼吸道症状和肺功能测定，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， 退出CC。将在12周和24周随访时检查EC、NRT和CC的持续使用情况。这 这项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，一个高度依赖尼古丁的人群，极易受到吸烟相关疾病的影响， 死亡率，并寻找新的方法来降低吸烟相关的风险。