Examination of Low Wattage and High Wattage E-Cigarettes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 372
- 试验地点
- 2
- 主要终点
- Complete Change From Conventional Cigarettes - Self Report
研究概览
简要总结
The overall aim of the proposed study is to evaluate the effect of switching from conventional cigarettes to either a LWe or HWe on smoking behavior, product use patterns and continued use, as well as biomarkers of toxicant exposure and effects.
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
- None
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •smoke ≥5 cigarettes per day for the past year;
- •no quit attempt in the prior 3 months and no plan to quit in the next 3 months;
- •read, write, and speak in English;
- •report at least minimal interest in switching to an alternative product (> "not at all" on a Likert scale);
- •never purchased or regularly used a tank system, mechanical mod, or advanced personal vaporizer EC, though previous use of cig-a-like devices will be allowed but not in the last 3 months;
- •plan to live in the local area for next year; and
- •have reliable means of transport. -
排除标准
- •<18 years old;
- •unstable or significant medical condition such as respiratory, kidney, or liver disease that could potentially affect biomarker data;
- •unstable or significant psychiatric conditions (past and stable conditions will be allowed);
- •history of cardiac event or distress within the past 3 months; and
- •currently pregnant, planning to become pregnant, or breastfeeding (n.b: pregnancy status will continue to be evaluated throughout the study at each visit).
研究组 & 干预措施
Low wattage E cigarette device
干预措施: Low wattage E cigarette device (Behavioral)
High wattage E cigarette device
干预措施: High wattage E cigarette device (Behavioral)
Usual brand cigarette
干预措施: Usual brand cigarette (Behavioral)
结局指标
主要结局
Complete Change From Conventional Cigarettes - Self Report
时间窗: Week 4, Week 8, Week 12, Week 26, and Week 52
Self-Reported 7-day Point Prevalence Abstinence from Cigarettes evaluated via the Timeline Follow Back Questionnaire. An intent-to-treat approach is taken where no participants are excluded and missing data is imputed as not abstinent from cigarettes.
Complete Change From Conventional Cigarettes - Biochemically Verified
时间窗: Week 4, Week 8, Week 12, Week 26, and Week 52
Intent to treat biochemically verified abstinence rates - participants reporting both 7-day point prevalence abstinence and an exhaled carbon monoxide reading less than or equal to 10. An intent-to-treat approach is taken where no participants are excluded and missing data is imputed as not abstinent from cigarettes.
次要结局
- Biomarker of Exposure - Total Nicotine Equivalents (TNE)(Baseline, Week 4, Week 12)
- Cigarette Dependence(Baseline, Week 1, Week 4, Week 8, Week 12, Week 26 and Week 52)
- EC Likeability/Preference(Week 4, Week 12)
- EC Abuse Liability(Week 4, Week 12, Week 26, and Week 52)
- Cigarette Likeability/Preference(Baseline, Week 4, Week 12, Week 26, and Week 52)
- Biomarker of Exposure - NNN(Baseline, Week 4, Week 12)
- Biomarker of Exposure - Nicotine Metabolite Ratio(Baseline, Week 4, Week 12)
- Biomarker of Exposure - Nickel and Other Relevant Metals(Baseline, Week 4, Week 12)
- Biomarker of Exposure - 8-iso-PGF2a(Baseline, Week 4, Week 12)
- Biomarker of Exposure - Lead and Other Relevant Metals(Baseline, Week 4, Week 12)
- Biomarker of Exposure - PGEM(Baseline, Week 4, Week 12)
- Biomarker of Exposure - Cadmium and Other Relevant Metals(Baseline, Week 4, Week 12)
- Biomarker of Effect - q-PADDA(Week 4, Week 12)
- Biomarker of Exposure - NNAL(Baseline, Week 4, Week 12)
- Biomarker of Exposure - Nickel(Baseline, Week 4, Week 12)
- Biomarker of Exposure - Cadmium(Baseline, Week 4, Week 12)
- Biomarker of Exposure - Lead(Baseline, Week 4, Week 12)
研究者
Theodore Wagener
Principal Investigator
Ohio State University Comprehensive Cancer Center