Vaping High vs. Low Nicotine E-Liquid
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 4
- 主要终点
- Nicotine Exposure
研究概览
简要总结
This study will examine the effects of electronic cigarette e-liquid nicotine content in a randomized, crossover clinical and behavioral pharmacology study of experienced adult e-cigarette users (N=36). The specific aim is to determine the impact of nicotine content of e-liquid on nicotine pharmacology, systemic exposure to toxic volatile organic compounds, and short-term cardiovascular effects.
详细描述
This is a within-subjects, crossover design of advanced electronic cigarette users in which we will examine nicotine pharmacokinetics, subjective effects, daily nicotine intake and nicotine titration, short-term cardiovascular effects, and toxicant exposure when participants are using low vs. high nicotine e-liquids.
Hypothesis 1: E-cigarette users will titrate their intake of nicotine such that they will inhale fewer aerosol toxicants and suffer less harm to health when using higher vs. lower nicotine content e-liquids.
Hypothesis 2: Compared to low nicotine, high nicotine e-liquid use will have similar cardiovascular effects throughout the day (due to compensatory behavioral changes), with similar effects on heart rate, blood pressure, and catecholamine release.
Hypothesis 3: Exposure to volatile organic compounds (VOCs) will be lower when vaping high nicotine e-liquids compared to low nicotine e-liquids.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy on the basis of medical history and limited physical examination, as described below:
- •Heart rate < 105 beats per minute (BPM)*
- •Systolic Blood Pressure < 160 and > 90*
- •Diastolic Blood Pressure < 100 and > 50*
- •*Considered out of range if both machine and manual readings are above/below these thresholds.
- •Age: >= 21 years
- •Age: <= 70 years
- •Current regular user of open tank electronic cigarette (EC) (at least 20 times in the past 30 days) with e-liquid nicotine of 3-6 mg/mL.
- •Non-smoker or non-daily cigarette smokers agreeing to abstain from cigarettes for the duration of the study.
- •Saliva cotinine >50 ng/mL and/or NicAlert=6
- •Carbon monoxide >= 5 ppm or per discretion of Principal Investigator
排除标准
- •Heart disease
- •Thyroid disease (okay if controlled with medication)
- •Hepatitis B or C or Liver disease
- •Kidney disease or urinary retention
- •History of stroke
- •An ulcer in the past year
- •Active use of an inhaler for Asthma or Chronic obstructive pulmonary disease (COPD)
- •Psychiatric conditions
- •Current or past schizophrenia, and/or current or past bipolar disorder
- •Major depression, current or within the past year
- •Major personality disorder
- •Participants with current or past minor or moderate depression and/or anxiety disorders will be reviewed by the PI and considered for inclusion
- •History of psychiatric hospitalizations is not exclusionary, but study participation will be determined as per PI's approval
- •Drug/Alcohol Dependence
- •Alcohol or illicit drug dependence within the past 12 months with the exception of those who have recently completed an alcohol/drug treatment program
- •Positive toxicology test for illicit drugs at the screening visit (THC & prescribed medications okay)
- •Opioid replacement therapy (including methadone, buprenorphine, or other)
- •Psychiatric medications
- •Current regular use of any psychiatric medications with the exception of Selective Serotonin Reuptake Inhibitors (SSRIs) and serotonin-norepinephrine reuptake Inhibitors (SNRIs) and current evaluation by the PI that the participant is otherwise healthy, stable, and able to participate.
- •Medications
- •Use of medications that are inducers of nicotine metabolizing enzyme CYP2A6 (Example: rifampicin, carbamazepine, phenobarbital, and other anticonvulsant drugs).
- •Use of sympatholytic medications for cardiovascular conditions including hypertension (Example: beta and alpha-blockers)
- •Concurrent use of nicotine-containing medications
- •Any stimulant medications (example: Adderall) generally given for attention deficit hyperactivity disorder (ADHD) treatment
- •Other/Misc. Chronic Health Conditions
- •Oral thrush
- •Fainting (within the last 30 days)
- •Other "life threatening illnesses" as per PI's discretion
- •Pregnancy
- •Pregnancy (self-reported and urine pregnancy test)
- •Breastfeeding (determined by self-report)
- •Concurrent participation in another clinical trial
- •Inability to read and write in English
- •Planning to quit vaping within the next 60 days
- •Concurrent regular use of marijuana (occasional users of these products may be enrolled if they agree to abstain from their use during the period of the study)
- •Use of other tobacco products, smokeless tobacco, pipes, cigars/cigarillos, blunts/spliffs (no more than 10 times in the past month and must agree to abstain from their use during the period of the study)
结局指标
主要结局
Nicotine Exposure
时间窗: Day 1 of each Arm
Plasma nicotine area under curve (AUC) (ng/ml\*h)
Cardiovascular Effects: Heart Rate
时间窗: Days 1-3 of each Arm
Participant heart rate will be measured in beats per minute throughout the inpatient stay.
Cardiovascular Effects: Systolic Blood Pressure
时间窗: Day 2 of each Arm
Participant systolic blood pressure will be taken for 24 hours during ad-lib e-cigarette use.
Cardiovascular Effects: Diastolic Blood Pressure
时间窗: Day 2 of each Arm
Participant diastolic blood pressure will be taken for 24 hours during ad-lib e-cigarette use.
次要结局
- Vaping Topography: Puff Duration(Days 1-3 of each Arm)
- Vaping Topography: Puff Number(Days 1-3 of each Arm)
- Vaping Topography: Inter-Puff Interval(Days 1-3 of each Arm)