Pharmacokinetics and Pharmacodynamics of Different Nicotine Salt Concentration Vape System Pods and Free-base Nicotine
- Conditions
- Nicotine Dependence
- Interventions
- Other: standardized vaping protocol
- Registration Number
- NCT04170907
- Lead Sponsor
- Insel Gruppe AG, University Hospital Bern
- Brief Summary
Comparison of the pharmacokinetics and pharmacodynamics of two different nicotine salt concentrations and free-base nicotine using an open vape pod system
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 20
- Men or women, age 18 or older at screening, who have used electronic cigarettes and/or smoked at least 5 cigarettes per day in the past 30 days
- Saliva cotinine of > 50 ng/mL at screening
- No clinically significant findings on the physical examination at screening
- Ability to communicate well with the investigator and to understand and comply with the requirements of the study
- Women of child-bearing age: willingness of using a reliable contraception method during the study
- Signed informed consent
- Known hypersensitivity/allergy to a content of the e-liquid
- Pregnancy or breast feeding
- BMI < 18 or > 28 kg/m2 at screening
- History or clinical evidence of alcoholism or drug abuse within the 3-year period prior to screening
- Loss of ≥ 250 ml of blood within 3 months prior to screening, including blood donation
- Treatment with an investigational drug within 30 days prior to screening
- Treatment with prescribed or over-the-counter (OTC) medications with potential influence on CYP2A6 function within 1 week prior to screening (with the exception of contraception)
- History or clinical evidence of any disease (e.g. gastrointestinal tract-disease) and/or existence of any surgical or medical condition, which in the opinion of the investigator might interfere with the absorption, distribution, metabolism or excretion of the study drugs, or which might increase the risk for toxicity
- Legal incapacity or limited legal capacity at screening
- Any circumstances or conditions, which, in the opinion of the investigator, may affect full participation in the study or compliance with the protocol
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Nicotine salt 20 mg/mL standardized vaping protocol Vaping of nicotine salt e-liquids with a nicotine concentration of 20 mg/mL. Free-base nicotine 20 mg/mL standardized vaping protocol Vaping of free-base nicotine e-liquids with a nicotine concentration of 20 mg/mL. Nicotine salt 40 mg/mL standardized vaping protocol Vaping of nicotine salt e-liquids with a nicotine concentration of 40 mg/mL.
- Primary Outcome Measures
Name Time Method Nicotine Peak Plasma Concentration (Cmax) Blood samples collection: 15 minutes before and 2, 5, 15, 30, 60, 120, and 180 minutes after the last puff Comparison of nicotine Cmax between groups
- Secondary Outcome Measures
Name Time Method Area under the plasma concentration versus time curve (AUC) Blood samples collection: 15 minutes before and 2, 5, 15, 30, 60, 120, and 180 minutes after the last puff Comparison of the nicotine AUC between groups
Time at which the Cmax is observed (Tmax) Blood samples collection: 15 minutes before and 2, 5, 15, 30, 60, 120, and 180 minutes after the last puff Comparison of the nicotine Tmax between groups
Genotyping of the hepatic cytochrome P450 enzyme CYP2A6 Blood sample collection during first session CYP2A6 genotype (allele variants)
Positive and Negative Affect Schedule (PANAS) Baseline, 10 minutes and 1 and 3 hours after the last puff 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)
Respiratory symptoms At baseline and 5 minutes after the last puff Yes/no: shortness of breath, wheezing, cough, phlegm
Elimination half-life (t1/2) Blood samples collection: 15 minutes before and 2, 5, 15, 30, 60, 120, and 180 minutes after the last puff Comparison of t1/2 between groups
Nicotine metabolite ratio (NMR) Assessed at screening visit Nicotine clearance assessed using 3'-hydroxycotinine/cotinine ratios
Tiffany Questionnaire on Smoking Urges-Brief (QSU) total (global) craving score Baseline, 10 minutes and 1 and 3 hours after the last puff Mean of ten items, rated on a 1=strongly disagree to 7=strongly agree scale
Modified Minnesota Nicotine Withdrawal Scale (MNWS) Baseline, 10 minutes and 1 and 3 hours after the last puff 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
Direct effects Ten minutes post-use 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)
Heart rate 15 minutes before and 2, 10, 15, 30, 60, 120, and 180 minutes after the last puff Heart rate measurements (bpm)
Systolic blood pressure 15 minutes before and 2, 10, 15, 30, 60, 120, and 180 minutes after the last puff Systolic blood pressure measurements (mmHg)
Diastolic blood pressure 15 minutes before and 2, 10, 15, 30, 60, 120, and 180 minutes after the last puff Diastolic blood pressure measurements (mmHg)
Trial Locations
- Locations (1)
Inselspital, University Hospital Bern
🇨🇭Bern, BE, Switzerland