Randomized Controlled Trial Methods for Novel Tobacco Products Evaluation
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 520
- 试验地点
- 4
- 主要终点
- urine carcinogen biomarker of exposure, NNAL
研究概览
简要总结
The purpose of this study is to use Randomized Controlled Trial (RCT) methods to examine the influence of novel tobacco products on biomarkers of toxicant exposure and disease risk, reports of adverse events, and concurrent use of other tobacco products. In this case, the novel products are one type of electronic cigarette and an imitation cigarette or cigarette substitute.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Care Provider)
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
- 是
入选标准
- •Age 21-65
- •Smoke >9 cigarettes per day for at least 1 year
- •Smoke regular filtered cigarettes or machine-rolled cigarettes with a filter
- •CO measurement >9 ppm at baseline
- •No serious quit attempt in the prior 1 month. This includes use of any FDA approved smoking cessation medication (varenicline, bupropion [used specifically as a quitting aid], patch, gum, lozenge, inhaler, and nasal spray) in the past 1 month as an indication of treatment seeking.
- •Not planning to quit in the next 6 months
- •Interested in reducing cigarette consumption
- •Willing to attend visits weekly and monthly over a 9-month period (not planning to move, not planning extended vacation, no planned surgeries)
- •Read and write in English
- •Able to understand and consent
排除标准
- •Pregnant and/or nursing women
- •Unstable or significant medical condition in the past 12 months (Recent heart attack or some other heart conditions, stroke, severe angina including high blood pressure if systolic >159 or diastolic >99 observed during screening).
- •Immune system disorders, respiratory diseases (exacerbations of asthma or COPD, require oxygen, require oral prednisone), kidney (dialysis) or liver diseases (cirrhosis), or any medical disorder/medication that may affect participant safety or biomarker data.
- •Use of any non-cigarette nicotine delivery product (pipe, cigar, dip, chew, snus, hookah, ECIGs, strips, sticks) in the past 7 days
- •Uncontrolled mental illness or substance abuse or inpatient treatment for these in the past 6 months
- •History of difficulty providing or unwilling to provide blood samples (fainting, poor veins, anxiety)
- •No surgery requiring general anesthesia in the past 6 weeks
- •Use of an ECIG for 5 or more days in the past 28 days or any use in the past 7 days
- •Use of marijuana or any illicit drug/prescription drugs for non-medical use daily/almost daily, or weekly in the past 3 months per NIDA Quick Screen
- •Use of hand-rolled, roll your own cigarettes
- •Known allergy to propylene glycol or vegetable glycerin
- •Other member of household is currently participating/participated in the study
研究组 & 干预措施
cigarette substitute
The QuitSmart cigarette substitute is a plastic tube that looks like a real cigarette and is designed to provide the same draw resistance as a smoker's usual cigarette. There is no drug delivery with this product. Two cigarette substitutes and a product manual are provided to participants following randomization and replacement products are provided throughout the intervention period (24 weeks).
干预措施: cigarette substitute (Other)
e-cigarette (with 0 mg/ml nicotine)
The e-cigarette used will be the EGO e-cigarette (marketed by www.liquidexpress.com). Each participant randomized to an ECIG condition will receive 2 e-cigarette batteries, 1 wall adapter, 1 USB charger, and a user manual. Cartomizers containing 0 mg/ml nicotine will be provided throughout the intervention period (24 weeks).
干预措施: e-cigarette (Other)
e-cigarette (with 8 mg/ml nicotine)
The e-cigarette used will be the EGO e-cigarette (marketed by www.liquidexpress.com). Each participant randomized to an ECIG condition will receive 2 e-cigarette batteries, 1 wall adapter, 1 USB charger, and a user manual. Cartomizers containing 8 mg/ml nicotine will be provided throughout the intervention period (24 weeks).
干预措施: e-cigarette (Other)
e-cigarette (with 36 mg/ml nicotine)
The e-cigarette used will be the EGO e-cigarette (marketed by www.liquidexpress.com). Each participant randomized to an ECIG condition will receive 2 e-cigarette batteries, 1 wall adapter, 1 USB charger, and a user manual. Cartomizers containing 36 mg/ml nicotine will be provided throughout the intervention period (24 weeks).
干预措施: e-cigarette (Other)
结局指标
主要结局
urine carcinogen biomarker of exposure, NNAL
时间窗: week 24
changes in NNAL concentration measured at week 0, week 4, week 12, and week 24
次要结局
- blood, urine, and exhaled breath condensate biomarkers of oxidative stress, glutathione and 8 Isoprostanes(week 24)
- urine biomarker of nicotine exposure, cotinine(week 24)