Comparison of the pharmacokinetics and pharmacodynamics of two different nicotine salt concentrations and free-base nicotine using an open vape pod system
On each study day, one puff will be taken with the assigned product every 30 seconds (total of 10 puffs). Blood samples will be collected to measure nicotine 15 minutes before vaping and 2, 5, 15, 30, 60, 120, and 180 minutes after the last puff. Heart rate and blood pressure will be measured 15 minutes before and 2, 10, 15, 30, 60, 120, and 180 minutes after the last puff. Post-use withdrawal, craving, reward, and satisfaction will be assessed 10 minutes and 1 and 3 hours after the last puff using the modified Minnesota Nicotine Withdrawal Scale (MNWS), the Tiffany Questionnaire on Smoking Urges (QSU), and the Positive and Negative Affect Schedule (PANAS) questionnaires. Respiratory symptoms will be assessed at baseline and 5 minutes after the last puff. Ten minutes post-use, the direct effects of the assigned product (e.g. satisfying, calming, pleasant, vape another one right now) will also be assessed using visual analog scales.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
DOUBLE
Enrollment
20
The following questionnaires will first be completed: Modified Minnesota Nicotine Withdrawal Scale, Tiffany Questionnaire on Smoking Urges-Brief total (global) craving score, Positive and Negative Affect Schedule. The assigned product will then be given to the participant, and one puff will be taken every 30 seconds (total of 10 puffs). Blood samples will be collected 15 minutes before vaping and 2, 5, 15, 30, 60, 120, and 180 minutes after the last puff. Heart rate and blood pressure will be measured 15 minutes before and 2, 10, 15, 30, 60, 120, and 180 minutes after the last puff. Post-use withdrawal, craving, reward, and satisfaction will be assessed 10 minutes and 1 and 3 hours after the last puff. Respiratory Symptoms will be assessed at baseline and 5 minutes after the last puff. Ten minutes post-use, the direct effects will also be assessed.
Inselspital, University Hospital Bern
Bern, Canton of Bern, Switzerland
Nicotine Peak Plasma Concentration (Cmax)
Comparison of nicotine Cmax between groups
Time frame: Blood samples collection: 15 minutes before and 2, 5, 15, 30, 60, 120, and 180 minutes after the last puff
Area under the plasma concentration versus time curve (AUC)
Comparison of the nicotine AUC between groups
Time frame: Blood samples collection: 15 minutes before and 2, 5, 15, 30, 60, 120, and 180 minutes after the last puff
Time at which the Cmax is observed (Tmax)
Comparison of the nicotine Tmax between groups
Time frame: Blood samples collection: 15 minutes before and 2, 5, 15, 30, 60, 120, and 180 minutes after the last puff
Elimination half-life (t1/2)
Comparison of t1/2 between groups
Time frame: Blood samples collection: 15 minutes before and 2, 5, 15, 30, 60, 120, and 180 minutes after the last puff
Genotyping of the hepatic cytochrome P450 enzyme CYP2A6
CYP2A6 genotype (allele variants)
Time frame: Blood sample collection during first session
Nicotine metabolite ratio (NMR)
Nicotine clearance assessed using 3'-hydroxycotinine/cotinine ratios
Time frame: Assessed at screening visit
Modified Minnesota Nicotine Withdrawal Scale (MNWS)
Excluding items relating to sleep disturbance and constipation, including eight items (angry/irritable/frustrated, anxious/nervous, depressed mood/sad, desire or craving to smoke, difficulty concentrating, increased appetite/hungry, restless and impatient), rated on a 0=none to 4=severe scale
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: Baseline, 10 minutes and 1 and 3 hours after the last puff
Tiffany Questionnaire on Smoking Urges-Brief (QSU) total (global) craving score
Mean of ten items, rated on a 1=strongly disagree to 7=strongly agree scale
Time frame: Baseline, 10 minutes and 1 and 3 hours after the last puff
Positive and Negative Affect Schedule (PANAS)
Including items assigned as Positive or Negative Affect (each score is the sum of ten items, rated on a 1=very slightly/not at all to 5=extremely scale)
Time frame: Baseline, 10 minutes and 1 and 3 hours after the last puff
Respiratory symptoms
Yes/no: shortness of breath, wheezing, cough, phlegm
Time frame: At baseline and 5 minutes after the last puff
Direct effects
E.g. satisfying, calming, pleasant, vape another one right now, assessed using visual analog scales (0-100 mm) with a single word scored from left (not at all) to right (extremely)
Time frame: Ten minutes post-use
Heart rate
Heart rate measurements (bpm)
Time frame: 15 minutes before and 2, 10, 15, 30, 60, 120, and 180 minutes after the last puff
Systolic blood pressure
Systolic blood pressure measurements (mmHg)
Time frame: 15 minutes before and 2, 10, 15, 30, 60, 120, and 180 minutes after the last puff
Diastolic blood pressure
Diastolic blood pressure measurements (mmHg)
Time frame: 15 minutes before and 2, 10, 15, 30, 60, 120, and 180 minutes after the last puff