Comparative Pharmacokinetics and Pharmacodynamics of Nicotine With Use of NIDA Standardized Research Electronic Cigarette (SREC) vs Usual Brand E-cigarette
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Mean Time of Peak Nicotine Concentration
研究概览
简要总结
This is a crossover study that will examine use behaviors, chemical exposures, and biological effects of Standardized Research Electronic Cigarette (SREC) compared to usual brand e-cigarette use in natural or synthetic nicotine users.
详细描述
OBJECTIVES:
I. To characterize nicotine delivery, systemic exposure and effects from SREC in comparison with usual to usual nicotine brand use.
II. To assess aspects of harm of SREC use compared to usual nicotine brand use.
OUTLINE:
Eligible participants will be assigned to one of two treatment conditions for the initial assessment which will take place in a hospital setting. The participant will then be assigned to the second condition within 2 weeks after the initial assessment which will also take place in a hospital setting to repeat the same procedures.
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-
- •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.
- •Body Mass Index <= 38.
- •Current regular user of electronic cigarettes (EC)
- •EC device use at least 15 or more days in the past 30 days (with e- liquid >= 3mg/ml)
- •No restriction on flavor or type of e-cigarette used
- •Saliva cotinine >= 50 ng/ml and/or NicAlert = 6
- •Age >= 21 years old <= 70 years old
- •Willingness to abstain from drug use for the duration of the study
排除标准
- •The following unstable medical conditions:
- •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)
- •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 (Example: nicotine patch, lozenge, gum).
- •Any stimulant medications (example: Adderall) generally given for attention deficit hyperactivity disorder (ADHD) treatment.
- •Other/Misc. Health Conditions
- •Oral thrush
- •Fainting (within the last 30 days)
- •Other "life threatening illnesses" as per principal investigator and/or study physician's discretion
- •Pregnancy
- •Pregnancy (self-reported and urine pregnancy test)
- •Breastfeeding (determined by self-report)
- •Women of childbearing potential must be using an acceptable method of contraception
- •Concurrent participation in another clinical trial.
- •Inability to read and write in English
- •Planning to quit smoking or vaping within the next 60 days
- •A known propylene glycol/vegetable glycerin allergy
- •Uncomfortable with getting blood drawn
- •Recent onset or change (worsening) in cough, fever and/or abdominal symptoms (vomiting or pain) in the past two weeks
研究组 & 干预措施
Usual Brand E-Cigarette (EC) then SREC
Participants will be admitted to hospital research ward within 32 hours of the orientation visit and begin a standardized session of product use using the usual brand of e-cigarette that participants utilize for nicotine use, and will provide expired carbon dioxide samples, pharmacokinetic (PK) blood samples, urine samples, and have cardiovascular and vital signs monitored. Participants will also be asked to complete nicotine-related questionnaires. Participants will then return within 2 weeks to repeat the procedures using the SREC.
干预措施: Standardized Research E-Cigarette (SREC) (Other)
Usual Brand E-Cigarette (EC) then SREC
Participants will be admitted to hospital research ward within 32 hours of the orientation visit and begin a standardized session of product use using the usual brand of e-cigarette that participants utilize for nicotine use, and will provide expired carbon dioxide samples, pharmacokinetic (PK) blood samples, urine samples, and have cardiovascular and vital signs monitored. Participants will also be asked to complete nicotine-related questionnaires. Participants will then return within 2 weeks to repeat the procedures using the SREC.
干预措施: Over the Counter E-Cigarette (EC) (Other)
Usual Brand E-Cigarette (EC) then SREC
Participants will be admitted to hospital research ward within 32 hours of the orientation visit and begin a standardized session of product use using the usual brand of e-cigarette that participants utilize for nicotine use, and will provide expired carbon dioxide samples, pharmacokinetic (PK) blood samples, urine samples, and have cardiovascular and vital signs monitored. Participants will also be asked to complete nicotine-related questionnaires. Participants will then return within 2 weeks to repeat the procedures using the SREC.
干预措施: Biological Samples (Behavioral)
Usual Brand E-Cigarette (EC) then SREC
Participants will be admitted to hospital research ward within 32 hours of the orientation visit and begin a standardized session of product use using the usual brand of e-cigarette that participants utilize for nicotine use, and will provide expired carbon dioxide samples, pharmacokinetic (PK) blood samples, urine samples, and have cardiovascular and vital signs monitored. Participants will also be asked to complete nicotine-related questionnaires. Participants will then return within 2 weeks to repeat the procedures using the SREC.
干预措施: Smoking-related Questionnaires (Other)
SREC then Usual Brand E-Cigarette (EC)
Participants will be admitted to hospital research ward within 32 hours of the orientation visit and begin a standardized session of product use using the SREC, and will provide expired carbon dioxide samples, pharmacokinetic (PK) blood samples, urine samples, and have cardiovascular and vital signs monitored. Participants will also be asked to complete nicotine-related questionnaires. Participants will then return within 2 weeks to repeat the procedures using the usual brand of e-cigarette that participants utilize for nicotine use.
干预措施: Standardized Research E-Cigarette (SREC) (Other)
SREC then Usual Brand E-Cigarette (EC)
Participants will be admitted to hospital research ward within 32 hours of the orientation visit and begin a standardized session of product use using the SREC, and will provide expired carbon dioxide samples, pharmacokinetic (PK) blood samples, urine samples, and have cardiovascular and vital signs monitored. Participants will also be asked to complete nicotine-related questionnaires. Participants will then return within 2 weeks to repeat the procedures using the usual brand of e-cigarette that participants utilize for nicotine use.
干预措施: Over the Counter E-Cigarette (EC) (Other)
SREC then Usual Brand E-Cigarette (EC)
Participants will be admitted to hospital research ward within 32 hours of the orientation visit and begin a standardized session of product use using the SREC, and will provide expired carbon dioxide samples, pharmacokinetic (PK) blood samples, urine samples, and have cardiovascular and vital signs monitored. Participants will also be asked to complete nicotine-related questionnaires. Participants will then return within 2 weeks to repeat the procedures using the usual brand of e-cigarette that participants utilize for nicotine use.
干预措施: Biological Samples (Behavioral)
SREC then Usual Brand E-Cigarette (EC)
Participants will be admitted to hospital research ward within 32 hours of the orientation visit and begin a standardized session of product use using the SREC, and will provide expired carbon dioxide samples, pharmacokinetic (PK) blood samples, urine samples, and have cardiovascular and vital signs monitored. Participants will also be asked to complete nicotine-related questionnaires. Participants will then return within 2 weeks to repeat the procedures using the usual brand of e-cigarette that participants utilize for nicotine use.
干预措施: Smoking-related Questionnaires (Other)
结局指标
主要结局
Mean Time of Peak Nicotine Concentration
时间窗: Collected 2, 5, 7, 10, 15, 30, 45, 60, 75, 90, and 120 minutes post end vaping session
Compare peak nicotine concentration between SREC vs. EC use.
Mean overall systemic nicotine exposure
时间窗: during the 3 hr of ad libitum use
Descriptive statistics will be used to examine systemic nicotine exposure from use of SREC and compare to EC
Mean Peak Nicotine Concentration
时间窗: Collected 2, 5, 7, 10, 15, 30, 45, 60, 75, 90, and 120 minutes post end vaping session
The investigators will compare peak nicotine concentrations between SREC vs. EC use
Area Under the plasma nicotine concentration-time Curve (AUC) at 120 minutes
时间窗: Collected 2, 5, 7, 10, 15, 30, 45, 60, 75, 90, and 120 minutes post end vaping session
Compare peak nicotine concentration between SREC vs. EC
Mean inter-puff interval
时间窗: during the 3 hr of ad libitum use
The patterns of SREC puffing and EC use will be examined looking at the average and variability (SD) of inter-puff interval during the 3 hr of ad libitum use.
Change in Mean score on the Questionnaire on Smoking Urges (QSU-Brief)
时间窗: Up to 1 month
The QSU-Brief consists of 10 statements about the respondent's feelings and thoughts about the participants desire to smoke cigarettes as the participant is completing the questionnaire (i.e., right now). Each response is scored a number ranging from 1 (strongly disagree) to 7 (strongly agree) and total scores are calculated by summing the item scores to compare craving between SREC and EC use
Change in Mean score on the Modified Cigarette Evaluation Questionnaire (mCEQ)
时间窗: Up to 1 month
The mCEQ use three multi-item domains (subscales) and two single items: "Smoking Satisfaction", "Psychological Reward", "Aversion", "Enjoyment of Respiratory Tract Sensations" and "Craving Reduction". Scores for each subscale are calculated as the average of its individual item responses of The items are rated on a seven-point scale ranging from 1 (not at all) to 7 (extremely). Higher scores indicate greater intensity of each smoking effect with, for example, greater satisfaction or psychological reward after smoking. Scores will be compared between SREC and EC use.
Change in Mean score on the Minnesota Tobacco Withdrawal Scale-Revised (MTWS-R)
时间窗: Up to 1 month
The MTWS-R features two separate measures for examining the severity of nicotine withdrawal symptoms in a participant: a self-report scale and an observer scale. The observer scale asks the scale-taker to rate the severity of four symptoms in someone the they know who is experiencing nicotine withdrawal: "angry/irritable/frustrated," "anxious/tense," "depressed," and "restless/impatient." The self-report version asks for rankings of the severity of those same four symptoms, plus eleven others that cannot be observed by outsiders (including such things as "desire or craving to smoke," "insomnia, sleep problems, awakening at night," or "dizziness). Both scales use a Likert-type scale for the severity ratings, ranging from 0 ("not at all") to 4 ("severe"). These scores are tallied to calculate an a total withdrawal discomfort score and will be compared between SREC and EC use
次要结局
- Median benzene levels within participants(Up to 1 month)
- Mean plasma epinephrine within participants(Up to 1 month)
- Mean propylene oxide levels within participants(Up to 1 month)
- Mean blood pressure (both systolic and diastolic) within participants(Up to 1 month)
- Mean acrolein levels within participants(Up to 1 month)
- Mean heart rate within participants(Up to 1 month)