Methadone-Maintained Smokers Switching to E-Cigarettes
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 183
- 试验地点
- 2
- 主要终点
- FVC Lung Functioning
研究概览
简要总结
Participants in this randomized clinical trial will be methadone-maintained smokers interested in switching to electronic cigarettes (ECs). There will be a total of 7 study visits over the course of 6 weeks; each visit includes psychometric assessment and biomarker measurements. After completion of the baseline visit, participants will be randomized to either: 1) 6 weeks of EC use (JUUL 5% nicotine pods) or 2) 6 weeks of nicotine replacement therapy (NRT) in the form of nicotine lozenges. EC and NRT use will begin the day after the baseline assessment.
详细描述
Participants in this randomized clinical trial will be methadone-maintained smokers interested in switching to electronic cigarettes (ECs). There will be a total of 7 study visits over the course of 6 weeks: baseline, 5 weekly check-in (CI) visits, and a 6-week assessment. Baseline assessments will include biomarker measurement, carbon monoxide (CO) readings, smoking history and current cigarette use, spirometry, respiratory symptoms, and tobacco demand. After completion of the baseline visit, participants will be randomized to either: 1) 6 weeks of EC use (JUUL 5% nicotine pods) or 2) 6 weeks of nicotine replacement therapy (NRT) in the form of nicotine lozenges. EC and NRT use will begin the day after the baseline assessment.
All participants will attend weekly brief assessment check-in visits where distribution of either EC or NRT will occur. Check-in assessments will include cigarette use, EC use, NRT use, CO readings, respiratory symptoms, and tobacco demand. At the 6-week assessment, baseline measurements will be repeated to determine changes in the health effects, biomarkers, and combustible cigarette use associated with 6 weeks of EC use, relative to NRT.
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •moderate to heavy cigarette smokers (10 cigarettes/day for > 1 yr; breath CO > 10 ppm)
- •have been receiving methadone for at least three months
- •attend at least weekly to receive methadone dose
- •speak English
- •have a telephone or access to a telephone
- •are available over the next 6 weeks
- •are interested in switching to either electronic cigarettes or nicotine replacement therapy
排除标准
- •use of ECs on > 2 of the past 30 days
- •currently use medications that may reduce smoking (e.g., bupropion, varenicline, NRT)
- •have unstable psychiatric conditions
- •have near-daily or daily use of marijuana
- •are pregnant
- •had a cardiovascular event in the last month
- •daily medication for asthma or COPD
研究组 & 干预措施
Nicotine Lozenges
Participants in this arm are randomized to receive nicotine lozenge for the 6-week study period.
干预措施: Nicotine Lozenge (Drug)
Electronic Cigarettes
Participants in this arm are randomized to receive electronic cigarettes for the 6-week study period.
干预措施: Electronic Cigarette (Drug)
结局指标
主要结局
FVC Lung Functioning
时间窗: 6 weeks
Changes in Forced Vital Capacity (FVC), as measured by spirometry at baseline and again at 6-weeks.
FEV1 Lung Functioning
时间窗: 6 weeks
Changes in Forced Expiratory Volume (FEV - during the first second), as measured by spirometry at baseline and again at 6-weeks.
FEV1 Lung Functioning for Complete Switchers
时间窗: 6 weeks
Changes in Forced Expiratory Volume (FEV - during the first second), as measured by spirometry at baseline and again at 6-weeks, among complete switchers, irrespective of condition, (i.e., exclusive EC/NRT users based on 7-day carbon monoxide (CO)-verified reports at the 6-week time point) relative to dual users and exclusive CC users.
Nicotine Exposure for Complete Switchers
时间窗: 6 weeks
Extent of Nicotine Exposure as measured by urine-based tobacco toxicology assessment at baseline and again at 6-week among complete switchers, irrespective of condition, (i.e., exclusive EC/NRT users based on 7-day carbon monoxide (CO)-verified reports at the 6-week time point) relative to dual users and exclusive CC users.
Smoking Behavior and Experiences for Complete Switchers
时间窗: 6 weeks
Changes in smoking behavior and experiences, as measured by self-report at baseline and again at 6-weeks, among complete switchers, irrespective of condition, (i.e., exclusive EC/NRT users based on 7-day carbon monoxide (CO)-verified reports at the 6-week time point) relative to dual users and exclusive CC users.
FEV1/FVC Ratio Lung Functioning for Complete Switchers
时间窗: 6 weeks
Changes in FEV1/FVC ratio, as measured by spirometry at baseline and again at 6-weeks, among complete switchers, irrespective of condition, (i.e., exclusive EC/NRT users based on 7-day carbon monoxide (CO)-verified reports at the 6-week time point) relative to dual users and exclusive CC users.
Nicotine Exposure
时间窗: 6 weeks
Extent of Nicotine Exposure as measured by urine-based tobacco toxicology assessment at baseline and again at 6-weeks.
FEV1/FVC Ratio Lung Functioning
时间窗: 6 weeks
Changes in FEV1/FVC ratio, as measured by spirometry at baseline and again at 6-weeks.
Smoking Behavior and Experiences
时间窗: 6 weeks
Changes in smoking behavior and experiences, as measured by self-report at baseline and again at 6-weeks.
FVC Lung Functioning for Complete Switchers
时间窗: 6 weeks
Changes in Forced Vital Capacity (FVC), as measured by spirometry at baseline and again at 6-weeks, among complete switchers, irrespective of condition, (i.e., exclusive EC/NRT users based on 7-day carbon monoxide (CO)-verified reports at the 6-week time point) relative to dual users and exclusive CC users.
NNAL
时间窗: 6 weeks
urinary measure of NNAL
NNN
时间窗: 6 weeks
Urinary measure of NNN
3-HPMA
时间窗: 6 weeks
Urinary measure of 3-HPMA
次要结局
- Cigarettes Per Day(6 weeks)