Pharmacokinetics and Pharmacodynamics of Synthetic Nicotine and Nicotine Analogues
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorInsel Gruppe AG, University Hospital Bern
About this trial
Electronic cigarettes are battery-operated devices that can produce an aerosol by heating a liquid which commonly contains nicotine. In recent years, products containing synthetically produced nicotine and nicotine analogues have entered the market. However, it remains unclear whether these types of nicotine have the same effects as conventional nicotine derived from the tobacco plant. The aim of this study is to investigate the effects of these nicotine types and to gain a better understanding of their respective mechanisms of action.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Men or women, age 18 or older at screening who have used EC with nicotine during at least 10 of the past 30 days
Saliva cotinine concentration of > 30 ng/mL 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 engaging in sexual activities which can lead to pregnancy: willingness of using a reliable/hormonal contraception method during the study (hormonal, e.g. pill, intrauterine devices, or mechanical method, e.g. condom, diaphragm)
Disqualifiers
Known hypersensitivity/allergy to a content of the e-liquids
Smoking of more than 5 cigarettes per day in the past 30 days
Pregnant or lactating women
Intention to become pregnant during the course of the study
Trial design
Design model
Crossover
Treatments tested in this trial
Vaping of synthetic S-nicotine
Other interventionVaping of e-liquids containing synthetic S-nicotine
Vaping of racemic nicotine (S-/R-nicotine)
Other interventionVaping of e-liquids containing synthetic racemic nicotine (S-/R-nicotine)
Vaping of 6-methylnicotine
Other interventionVaping of e-liquids containing the nicotine analogue 6-methylnicotine (6MN)
Treatment groups
24 Participants
are divided into 3 treatment groupsGroup A: Synthetic S-NicotineOther 1 intervention
Group B: Racemic nicotine (S-/R-nicotine)Other 1 intervention
Group C: 6-methylnicotineOther 1 intervention
Trial outcomes
Primary outcomes
1
Maximum total nicotine concentrations (Cmax)
Comparison of the maximum total nicotine (i.e. sum of both enantiomers) in blood concentrations (Cmax) between groups
Time frame
15 minutes before vaping and 2, 5, 15, 30, 60, 120, and 180 minutes after the last puffSecondary outcomes
1
Maximum concentration (Cmax) of 6-methylnicotine
Maximum concentration of 6-methylnicotine in blood
Time frame
15 minutes before vaping and 2, 5, 15, 30, 60, 120, and 180 minutes after the last puff2
Maximum concentration (Cmax) of 6-methylnicotine's metabolites
Maximum concentration of 6-methylnicotine's metabolites in blood
Time frame
15 minutes before vaping and 2, 5, 15, 30, 60, 120, and 180 minutes after the last puff3
AUC (area under the concentration-time curve) nicotine enantiomers
Area under the concentration-time curve (AUC) of nicotine enantiomers in blood
Time frame
15 minutes before vaping and 2, 5, 15, 30, 60, 120, and 180 minutes after the last puff4
AUC (area under the concentration-time curve) 6-methylnicotine
Area under the concentration-time curve (AUC) of 6-methylnicotine in blood
Time frame
15 minutes before vaping and 2, 5, 15, 30, 60, 120, and 180 minutes after the last puffOther outcomes
1
Reported adverse events
Classification and severity grading scale in accordance with the "Common Terminology Criteria for Adverse Events CTCAE Version 5.0" terminology.
Time frame
Throughout study completion, an average of 2.5-6.5 weeksSponsors and contacts
Click on the lead sponsor to view all of their trials.
Insel Gruppe AG, University Hospital Bern
Lead sponsor
Swiss Tobacco Prevention Funds
Collaborator
Source ClinicalTrials.gov