This study will examine the short-term cardiovascular (CV) effects of e-liquid pH in a randomized, crossover clinical and behavioral pharmacology study of experienced adult e-cigarette users (N=21). The specific aim is to determine the impact of e-cigarette pH levels on nicotine pharmacology, systemic exposure to toxic volatile organic compounds (VOCs), and short-term cardiovascular effects.
This is a single-site, randomized, crossover study of experienced adult e-cigarette users to assess nicotine exposure, toxicant exposure, and the short-term CV effects of e-liquid pH. Three e-liquid pH conditions will be assessed on all participants: 5, 7, and 9. Hypothesis 2a: The rate of systemic nicotine absorption is inversely related to e-liquid pH and results in lower peak blood nicotine levels at higher pH. Hypothesis 2b: Heart rate acceleration will decrease and subjective measures of sensation in the throat, reward, and satisfaction will increase with increasing e-liquid pH.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
14
E-cigarette Device: The delivery device will be a variable wattage all-in-one device with operating wattage of 7.0 - 75.0 W. The device will be set at 10 watts for the study visits.
Zuckerberg San Francisco General Hospital
San Francisco, California, United States
University of California, San Francisco
San Francisco, California, United States
Mean Blood Nicotine Level
Concentration of plasma nicotine (ng/ml) will be used to assess differences across the three e-liquid pH levels.
Time frame: Day 1 of each Arm
Mean Saliva pH
Participant saliva pH will be measured before and during outpatient stay.
Time frame: Day 1 of each Arm
Mean Heart Rate
Participant heart rate will be measured in beats per minute throughout the outpatient stay.
Time frame: Day 1 of each Arm
Mean Skin Blood Flow
Participant skin blood flow will be measured by product of average blood cell velocity and concentration in mL/min during outpatient stay.
Time frame: Day 1 of each Arm
Mean scores on the Minnesota Nicotine Withdrawal Scale (MNWS)
The investigators will compile a score for the subjective effect of withdrawal using the sum of points scored on the Minnesota Nicotine Withdrawal Scale (MNWS), where a higher score (score range from 0 points to 60 points) indicates a higher intensity of the indicated subjective effect.
Time frame: Day 1 of each Arm
Mean scores on the Questionnaire of Smoking Urges (QSU-Brief)
The investigators will compile a score for the subjective effect of craving using the sum of points scored in the two subscales (intention and desire to engage in smoking behavior that is anticipated as pleasant, and anticipation of relief from negative affect through smoking) of the Questionnaire of Smoking Urges (QSU-Brief), where a higher score (score range from 10 points to 70 points) indicates a higher intensity of the indicated subjective effect.
Time frame: Day 1 of each Arm
Mean scores on the Cigarette Evaluation Scale (mCES)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
The investigators will compile a score for the subjective effect of reward using the sum of points scored in the five subscales (Smoking Satisfaction - score range from 1 point to 7 points; Psychological Reward - score range from 5 points to 35 points; Aversion - score range from 2 points to 14 points; Enjoyment of Respiratory Tract Sensations - score range from 2 points to 14 points; and Craving Reduction - score range from 1 point to 7 points) of the modified Cigarette Evaluation Scale (mCES), where a higher score indicates a higher intensity of the indicated subjective effect.
Time frame: Day 1 of each Arm
Mean puffs per minute
Vaping topography measures will be obtained from frame by frame analysis of high definition videos during the ad libitum sessions and measured as puffs per minute.
Time frame: Day 1 of each Arm
Mean seconds per puff
Vaping topography measures will be obtained from frame by frame analysis of high definition videos during the ad libitum sessions and measured as seconds per puff.
Time frame: Day 1 of each Arm
Mean time between puffs
Vaping topography measures will be obtained from frame by frame analysis of high definition videos during the ad libitum sessions and measured as seconds/minutes between puffs.
Time frame: Day 1 of each Arm