Evaluating E-Cigarette Nicotine Form, Concentration, and Flavors Among Youth
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 88
- 试验地点
- 1
- 主要终点
- Plasma Nicotine Concentration
研究概览
简要总结
This clinical trial examines the influence of nicotine form, concentration, and e-liquid flavor on youth vaping behavior, as well as the heart and lung effects associated with this behavior. Electronic cigarette (e-cig) "vaping", while being promoted as a safer alternative to conventional cigarettes, has disproportionately attracted adolescents and young adults ("youth"). This trial may help researchers understand how nicotine form, concentration, and flavor affects people's vaping behaviors and health.
详细描述
We will examine the influence of nicotine form and concentration, and e-liquid flavor on youth vaping behavior, nicotine uptake, abuse liability, toxicant exposure, and acute cardiovascular and pulmonary effects. Participants will complete 9 vaping sessions. Each vaping session will include a standardized, 5-minute, 10-puff vaping bout (30 seconds between each puff) followed by 30 minutes of ad libitum (as desired) vaping. During the first session, participants will use their own e-cig and e-liquid; for the following 8 sessions, participants will vape a study-provided e-cig and e-liquid.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 21 Years 至 25 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •A current exclusive e-cigarette user (>= 1 vaping bout per day) for at least the past 3 months (confirmed in lab by salivary cotinine)
- •21-25 years old
- •Willing to abstain from all tobacco and nicotine for at least 12 hours prior to lab sessions
- •Willing to complete five, 6 hour lab visits
- •Able to read and speak English
- •Willing to provide informed consent
排除标准
- •Self-reported diagnosis of lung disease including asthma, cystic fibrosis, or chronic obstructive pulmonary disease
- •Unstable or significant psychiatric conditions (past and stable conditions will be allowed)
- •History of cardiac event or distress within the past 3 months
- •Currently pregnant (determined using urine pregnancy test), planning to become pregnant, or breastfeeding
- •Use of other tobacco products > 5 days in the past month
- •Current marijuana use > 5 times per month
- •Currently engaging in a vaping cessation attempt
- •Ohio State University (OSU) verifies study project 2 current membership/past participation
研究组 & 干预措施
High concentration free-base nicotine (5%), Tobacco flavor
Participate in vaping session with e-liquid including a standardized, 5-minute, 10-puff vaping bout (30 seconds between each puff) followed by 30 minutes of ad libitum (as desired) vaping.
干预措施: ECIG lab session 1 (Other)
High concentration nicotine salt (5%), Tobacco flavor
Participate in vaping session with e-liquid including a standardized, 5-minute, 10-puff vaping bout (30 seconds between each puff) followed by 30 minutes of ad libitum (as desired) vaping.
干预措施: ECIG lab session 2 (Other)
High concentration free-base nicotine (5%), Menthol flavor
Participate in vaping session with e-liquid including a standardized, 5-minute, 10-puff vaping bout (30 seconds between each puff) followed by 30 minutes of ad libitum (as desired) vaping.
干预措施: ECIG lab session 3 (Other)
High concentration nicotine salt (5%), Menthol flavor
Participate in vaping session with e-liquid including a standardized, 5-minute, 10-puff vaping bout (30 seconds between each puff) followed by 30 minutes of ad libitum (as desired) vaping.
干预措施: ECIG lab session 4 (Other)
Low concentration free-base nicotine (1%), Tobacco flavor
Participate in vaping session with e-liquid including a standardized, 5-minute, 10-puff vaping bout (30 seconds between each puff) followed by 30 minutes of ad libitum (as desired) vaping.
干预措施: ECIG lab session 5 (Other)
Low concentration nicotine salt (1%), Tobacco flavor
Participate in vaping session with e-liquid including a standardized, 5-minute, 10-puff vaping bout (30 seconds between each puff) followed by 30 minutes of ad libitum (as desired) vaping.
干预措施: ECIG lab session 6 (Other)
Low concentration free-base nicotine (1%), Menthol flavor
Participate in vaping session with e-liquid including a standardized, 5-minute, 10-puff vaping bout (30 seconds between each puff) followed by 30 minutes of ad libitum (as desired) vaping.
干预措施: ECIG lab session 7 (Other)
Low concentration nicotine salt (1%), Menthol flavor
Participate in vaping session with e-liquid including a standardized, 5-minute, 10-puff vaping bout (30 seconds between each puff) followed by 30 minutes of ad libitum (as desired) vaping.
干预措施: ECIG lab session 8 (Other)
结局指标
主要结局
Plasma Nicotine Concentration
时间窗: 0, 5, 10, 35 min.
Plasma nicotine concentration from blood drawn (3mL) 4 times in each session at baseline (0 min), 5 min., 10 min., 35 min.
Puff Count
时间窗: 30 minutes
E-cig puff topography data collection for abuse liability. Number of puffs taken during the 30 minutes of ad libitum (as desired) vaping session.
Average Puff Duration
时间窗: 30 minutes
E-cig puff topography data collection for abuse liability. Average puff duration during the 30 minutes of ad libitum (as desired) vaping session, in seconds.
Average Puff Volume
时间窗: 30 minutes
E-cig puff topography data collection for abuse liability. The total volume of all puffs taken for each participant during the 30 minutes of ad libitum (as desired) vaping session, in ml.
Lung Function Assessment
时间窗: Baseline and 35 minutes
Lung function data will be collect using a handheld spirometry device. Physiological effects of pulmonary function collected from inhaled and exhaled breaths. Measures amount inhaled and how quickly exhaled. Change from baseline in forced expiratory volume (FEV) Change from baseline in forced vital capacity (FVC)
Airway Inflammation (NIOX VERO)
时间窗: 35 minutes
Physiological effects of pulmonary function collected from inhaled and exhaled breaths. Airway inflammation will be assessed using exhaled nitric oxide via the NIOX VERO.
次要结局
- Sensory E-Cigarette Expectancies Scale (SEES)(Baseline)
- Modified Cigarette Dependence Scale(Baseline)
- Drug Effects/Liking Questionnaire(35 minutes)
- Modified Cigarette Evaluation Questionnaire (mCEQ)(35 minutes)
- E-cigarette Purchase Task - Breakpoint(35 minutes)
- Tiffany-Drobes Questionnaire of Smoking Urges: Brief Form(0, 5, 10, 35 min.)
- Vascular Reactivity(Pre-Vaping Session at Visit 1)
研究者
Theodore Wagener
Principal Investigator
Ohio State University Comprehensive Cancer Center