Nicotine Delivery From Novel Non-tobacco Electronic Systems (ENDS)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 2
- 主要终点
- Determine Levels of nicotine effectively delivered by various types and brands of ENDS to the bloodstream and compare them to levels delivered from conventional cigarettes
研究概览
简要总结
This randomized pilot clinical trial studies nicotine delivery from novel non-tobacco electronic system (ENDS) in smokers. Studying the levels of nicotine delivered by various types and brands of ENDS to the bloodstream, and comparing this to the levels delivered from conventional cigarettes (the participant's own brand) may help provide information about the use of nicotine-containing products that may help inform/reform current tobacco policy, practice, and harm reduction approaches.
详细描述
PRIMARY OBJECTIVES:
I. Determine the levels of nicotine effectively delivered by various types and brands of ENDS to the bloodstream and compare them to levels delivered from conventional cigarettes. (Study 1)
II. Explore the effect of flavorings added to nicotine solution on puffing topography and nicotine delivery and, assess and compare short-term "functional" nicotine effects of the different products by using subjective measures such as relief of craving and withdrawal symptoms. (Study 2)
SECONDARY OBJECTIVES:
I. Determine the amounts of nicotine present in various brands and types of ENDS. (Study 3)
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy on the basis of medical history
- •Current moderate-to-heavy smoker as determined by:
- •Has smoked >=10 cigarettes per day regularly for the past year (by history) and (>=5 cigarettes per day Study 2 ONLY)
- •Has an expired carbon monoxide (CO) at screening visit of 8 parts per million (ppm) or more (6 ppm or more Study 2 ONLY)
- •Nicotine dependence assessed as > 4 with the Fagerstrom Test for Nicotine Dependence
- •Willingness to abstain from smoking for 8 hours (overnight abstinence) prior to study visits
- •Participant or legal representative must understand the investigational nature of this study and sign an Independent Ethics Committee/Institutional Review Board approved written informed consent form prior to receiving any study related procedure
排除标准
- •Unstable medical conditions (such as unstable heart disease, uncontrolled hypertension, thyroid disease, diabetes, renal or liver impairment, glaucoma, or prostatic hypertrophy) or psychiatric condition (such as current major depression, history of schizophrenia or bipolar disorder, or current regular use of psychiatric medications such as major tranquilizers and antidepressants
- •Pregnancy or lactation (by history) or positive pregnancy test at screening visit
- •Positive urine drug test at screening visit
- •History of serious side effects from nicotine or from any nicotine replacement therapies
- •Alcohol or illicit drug dependence within the past 12 months (by history and urine tests)
- •Concurrent participation in another clinical trial
- •Unable to communicate in English
- •Unwilling or unable to follow protocol requirements
- •Any condition which in the Investigator's opinion deems the participant an unsuitable candidate to receive study intervention
结局指标
主要结局
Determine Levels of nicotine effectively delivered by various types and brands of ENDS to the bloodstream and compare them to levels delivered from conventional cigarettes
时间窗: Up to 1 year
The maximum concentration of nicotine in plasma (Cmax) will be determined for each product.
Changes in withdrawal symptoms
时间窗: up to 1 year
Will be measured with Minnesota Withdrawal Scale
Subjective nicotine effect will be analyzed
时间窗: up to 1 year
Will be measured with Drug Effect Questionnaire
Changes in feelings and emotions
时间窗: up to 1 year
Will be measured with The Positive Negative Affect Scale
Levels of nicotine effectively delivered by various types and brands of ENDS to the bloodstream and compare them to levels delivered from conventional cigarettes
时间窗: up to 1 year
Area under the plasma concentration versus time curve (AUC) will be determined for each product.
次要结局
- Amounts of nicotine present in various brands and types of ENDS (Study 3)(Up to 1 year)
- Nicotine yields in vapors from various types of ENDS under laboratory conditions (Study 4)(Up to 1 year)