A Comprehensive Evaluation of Tobacco-Flavored vs. Non-Tobacco Flavored E-Cigarettes on Smoking Behavior
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 1,500
- 试验地点
- 1
- 主要终点
- 7-day point prevalence complete switching rate
研究概览
简要总结
This clinical trial compares the use of tobacco flavored electronic cigarettes (ECs) vs. non-tobacco flavored ECs vs. nicotine replacement therapy (patches and lozenges) on smoking behavior in current cigarette smokers. ECs may reduce cigarette craving and withdrawal symptoms, increase motivation and confidence to stop cigarette smoking, and decrease cigarette smoking and dependence. By comparing participants' preferred flavor ECs (PEC) to tobacco flavor ECs (TEC) to NRT, researchers hope to determine the effect of EC flavors on appeal and use and learn how ECs affect smoking behaviors and health.
详细描述
PRIMARY OBJECTIVES:
I. Determine PEC versus vs. TEC vs. nicotine replacement therapy (NRT) on tobacco use patterns including product switching, abstinence from cigarettes, and number of cigarettes smoked.
II. Examine PEC vs. TEC vs. NRT on cigarette craving, withdrawal symptoms, and perceived nicotine dependence.
III. Examine PEC vs. TEC on product appeal and uptake, including initial trial, days used during period of product provision, and purchase and continued use after 12 weeks.
OUTLINE: Participants are randomized to 1 of 3 arms.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •>= 21 years old
- •Smoke >= 5 cigarettes per day for the past year
- •Willing to use either an EC or NRT
- •Read and speak English
- •Have a smartphone
排除标准
- •Report currently using smoking cessation medications, NRT, or actively seeking treatment for smoking cessation
- •Current use of an EC > 4 days a month
- •Diagnosed medical conditions of lung disease, asthma, cystic fibrosis, heart disease or chronic obstructive pulmonary disease (COPD)
- •Unmanaged (unmedicated and/or without counseling) diagnosis of schizophrenia
- •History of cardiac event or distress within the past 3 months
- •Currently pregnant, planning to become pregnant within 6 months, or breastfeeding
- •High blood pressure not controlled by medications
- •Serious angina pectoris or chest pain
- •Stroke within the past three months
- •Known allergy to propylene glycol or vegetable glycerin
- •Serious underlying arrhythmias, irregular heartbeat or abnormal heart rhythm
- •Live in same household as another study participant
研究组 & 干预措施
Arm I (PEC)
Participants receive PEC for 14 weeks, including a 2-week pre-switch period to become familiar with usage. Participants in all arms participate in discussions throughout the trial.
干预措施: Questionnaire Administration (Other)
Arm II (TEC)
Participants receive TEC for 14 weeks, including a 2-week pre-switch period to become familiar with usage. Participants in all arms participate in discussions throughout the trial.
干预措施: Questionnaire Administration (Other)
Arm I (PEC)
Participants receive PEC for 14 weeks, including a 2-week pre-switch period to become familiar with usage. Participants in all arms participate in discussions throughout the trial.
干预措施: Vaping (Device)
Arm II (TEC)
Participants receive TEC for 14 weeks, including a 2-week pre-switch period to become familiar with usage. Participants in all arms participate in discussions throughout the trial.
干预措施: Vaping (Device)
Arm III (NRT)
Participants receive NRT (nicotine patches and lozenges) for 14 weeks, including a 2-week pre-switch period to become familiar with usage. Participants in all arms participate in discussions throughout the trial.
干预措施: Questionnaire Administration (Other)
Arm III (NRT)
Participants receive NRT (nicotine patches and lozenges) for 14 weeks, including a 2-week pre-switch period to become familiar with usage. Participants in all arms participate in discussions throughout the trial.
干预措施: Nicotine Replacement (Drug)
结局指标
主要结局
7-day point prevalence complete switching rate
时间窗: At week 14
Self-reported 7-day point prevalence abstinence (no cigarettes, not even a puff, in the previous 7 days), any reported use of ECs or NRT over the past 7 days, and an exhaled CO reading of ≤6ppm.
Biochemically verified 7-day point prevalence abstinence from cigarettes
时间窗: At week 14
Biochemical verification of abstinence from cigarettes (exhaled CO reading of ≤6ppm) combined with self-reported 7-day point prevalence abstinence (no cigarettes, not even a puff, in the previous 7 days).
Cigarettes smoked per day
时间窗: At week 14
Cigarettes smoked per day as evaluated with the timeline follow-back questionnaire.
次要结局
- Change in cigarettes smoked per day(From baseline to 26 weeks)
- Change in nicotine dependence(From baseline to 14 weeks)
- Changes in cigarette craving and nicotine withdrawal(At baseline, 2, 6, 14, and 26 weeks)
- Number of days used in past week(At 2, 6, and 14 weeks)
- Number of days used in past month(At 6 and 14 weeks)
- Product appeal(At 2, 6, 14, and 26 weeks)
- Continued use of ECs(From 14 to 26 weeks)
研究者
Theodore Wagener
Principal Investigator
Ohio State University Comprehensive Cancer Center