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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
20
Standardized Research E-Cigarette (SREC) will be obtained through NJOY, LLC and provided at the hospital stay.
Usual brand e-cigarettes will be provided at the hospital stay.
Blood, urine, and expired carbon dioxide will be obtained during the course of the study.
University of California, San Francisco - Tobacco Research Center
San Francisco, California, United States
RECRUITINGMean Peak Nicotine Concentration
The investigators will compare peak nicotine concentrations between SREC vs. EC use
Time frame: Collected 2, 5, 7, 10, 15, 30, 45, 60, 75, 90, and 120 minutes post end vaping session
Mean Time of Peak Nicotine Concentration
Compare peak nicotine concentration between SREC vs. EC use.
Time frame: Collected 2, 5, 7, 10, 15, 30, 45, 60, 75, 90, and 120 minutes post end vaping session
Area Under the plasma nicotine concentration-time Curve (AUC) at 120 minutes
Compare peak nicotine concentration between SREC vs. EC
Time frame: Collected 2, 5, 7, 10, 15, 30, 45, 60, 75, 90, and 120 minutes post end vaping session
Mean overall systemic nicotine exposure
Descriptive statistics will be used to examine systemic nicotine exposure from use of SREC and compare to EC
Time frame: during the 3 hr of ad libitum use
Mean inter-puff interval
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.
Time frame: during the 3 hr of ad libitum use
Change in Mean score on the Modified Cigarette Evaluation Questionnaire (mCEQ)
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.
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Nicotine and Smoking behavior and dependence questionnaires will be administered at screening, before and during hospital stays.
Time frame: Up to 1 month
Change in Mean score on the Minnesota Tobacco Withdrawal Scale-Revised (MTWS-R)
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
Time frame: Up to 1 month
Change in Mean score on the Questionnaire on Smoking Urges (QSU-Brief)
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
Time frame: Up to 1 month
Mean acrolein levels within participants
Urine excretion of mercapturic acid metabolites of volatile organic compounds (VOCs), with a particular focus on acrolein will be measured and compared between SREC and EC use
Time frame: Up to 1 month
Mean propylene oxide levels within participants
Urine excretion of mercapturic acid metabolites of VOCs, with a particular focus on propylene oxide will be measured and compared between SREC and EC use
Time frame: Up to 1 month
Median benzene levels within participants
Urine excretion of mercapturic acid metabolites of VOCs, with a particular focus on benzene will be measured and compared between SREC and EC use
Time frame: Up to 1 month
Mean heart rate within participants
The cardiovascular effects of e-cigarette use as measured by heart rate will be compared between SREC and EC use
Time frame: Up to 1 month
Mean blood pressure (both systolic and diastolic) within participants
The cardiovascular effects of e-cigarette use as measured by blood pressure will be compared between SREC and EC use
Time frame: Up to 1 month
Mean plasma epinephrine within participants
The cardiovascular effects of e-cigarette use as measured by plasma epinephrine will be compared between SREC and EC use
Time frame: Up to 1 month