An interventional study of Vaping of synthetic S-nicotine and Vaping of racemic nicotine (S-/R-nicotine) in Nicotine, Vaping and Synthetic Nicotine, sponsored by Insel Gruppe AG, University Hospital Bern. Recruiting at 1 site in Switzerland. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-30.
Sponsored by Insel Gruppe AG, University Hospital Bern · Not applicable, Interventional, and Other
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.
In the first part of the study, participants will use electronic cigarettes containing synthetic nicotine or nicotine analogs at three sessions in the hospital, following a specific schedule. In the second part, each product will be used for four days outside the hospital. The study is double-blind, meaning neither the participants nor the study team will know which product is being used.
The study comprises a total of seven appointments at the hospital. During these appointments, participants will be asked questions about their electronic cigarette and tobacco use, and samples of saliva, urine, and blood will be collected.
402 studies on the registry are indexed under Vaping; 95 are open to participants now.
This study's planned enrollment of 24 is below the median of 79 across 322 interventional studies indexed under Vaping.
Browse Vaping studies →Insel Gruppe AG, University Hospital Bern is the lead sponsor of 741 studies on the registry; 180 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Vaping of e-liquids contanining synthetic S-nicotine
Other: Vaping of synthetic S-nicotine
Vaping of e-liquids contanining synthetic racemic nicotine (containing both the S- and R-nicotine enantiomers)
Other: Vaping of racemic nicotine (S-/R-nicotine)
Vaping of e-liquids contanining the nicotine analogue 6-methylnicotine (6MN)
Other: Vaping of 6-methylnicotine
Vaping of e-liquids containing synthetic S-nicotine
Vaping of e-liquids containing synthetic racemic nicotine (S-/R-nicotine)
Vaping of e-liquids containing the nicotine analogue 6-methylnicotine (6MN)
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 puff
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 puff
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 puff
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 puff
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 puff
AUC (area under the concentration-time curve) 6-methylnicotine's metabolites
Area under the concentration-time curve (AUC) 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 puff
Tmax (time of Cmax) nicotine enantiomers
Tmax of nicotine enantiomers in blood
Time frame: 15 minutes before vaping and 2, 5, 15, 30, 60, 120, and 180 minutes after the last puff
Tmax (time of Cmax) 6-methylnicotine
Tmax of 6-methylnicotine in blood
Time frame: 15 minutes before vaping and 2, 5, 15, 30, 60, 120, and 180 minutes after the last puff
Tmax (time of Cmax) 6-methylnicotine's metabolites
Tmax 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 puff
T1/2 (elimination half-life) nicotine enantiomers
Elimination half-life (T1/2) of nicotine enantiomers in blood
Time frame: 15 minutes before vaping and 2, 5, 15, 30, 60, 120, and 180 minutes after the last puff
T1/2 (elimination half-life) 6-methylnicotine
Elimination half-life (T1/2) of 6-methylnicotine in blood
Time frame: 15 minutes before vaping and 2, 5, 15, 30, 60, 120, and 180 minutes after the last puff
T1/2 (elimination half-life) 6-methylnicotine's metabolites
Elimination half-life (T1/2) 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 puff
Blood nicotine metabolite ratio (NMR)
Nicotine clearance assessed using the 3'-hydroxycotinine/cotinine ratio (i.e. nicotine metabolite ratio (NMR)
Time frame: 15 minutes before vaping
Saliva nicotine metabolite ratio (NMR)
Nicotine clearance assessed using the 3'-hydroxycotinine/cotinine ratio (i.e. nicotine metabolite ratio (NMR)
Time frame: At baseline
Heart rate
bpm
Time frame: Baseline, 15 minutes before vaping and 2, 5, 15, 30, 60, 120, and 180 minutes after the last puff, at study completion (2.5-6.5 weeks after screening)
Blood pressure
mmHg
Time frame: Baseline, 15 minutes before vaping and 2, 5, 15, 30, 60, 120, and 180 minutes after the last puff, at study completion (2.5-6.5 weeks after screening)
Modified Minnesota Nicotine Withdrawal Scale (MNWS)
Score/questionnaire asssessing withdrawal: The Modified Minnesota Nicotine Withdrawal Scale (MNWS) (excluding items related 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.
Time frame: Baseline, 10 minutes, 1 hour and 3 hours after last puff
Tiffany Questionnaire on Smoking Urges-Brief (QSU) total (global) craving score
Score/questionnaire asssessing craving: The Tiffany Questionnaire on Smoking Urges-Brief (QSU) total (global) craving score as the average of all responses (mean of ten items, rated on a 1=strongly disagree to 7=strongly agree scale).
Time frame: Baseline, 10 minutes, 1 hour and 3 hours after last puff
Positive and Negative Affect Schedule (PANAS)
Score/questionnaire asssessing satisfaction: The 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, 1 hour and 3 hours after last puff
Respiratory symptoms
Questions regarding shortness of breath, wheezing, cough, phlegm; posisble answers: yes/no
Time frame: Baseline and 5 minutes after last puff
Direct effects
Questions regarding e.g. satisfying, calming, pleasant, vape another one right now, using visual analog scales (0-100 mm) with a single word scored from left (not at all) to right (extremely).
Time frame: 10 minutes post-use
Modified e-cigarette evaluation questionnaire (mCEQ)
Questionnaire asssessing subjective effects
Time frame: Following 4 days ad libitum use of each product
Urinary total nicotine equivalents (TNE) concentrations
Molar sum of urinary total (parent and glucuronide) nicotine, cotinine and 3'-hydroxycotinine
Time frame: Following 4 days ad libitum use of each product
Urinary volatile organic compounds (VOC) concentrations
VOC in urine
Time frame: Following 4 days ad libitum use of each product
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 weeks
Plan to share: Undecided
No publications or documents are linked to this record.
Started Aug 2026 (actual). Primary completion is estimated for Dec 2026, 4 months after the start.
Of 184 non-industry interventional studies with no phase under Vaping, half reached primary completion within 20 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 35. This study's planned 4 months is below that.
Counting every sponsor, half of 208 studies reached it within 18 months; a quarter within 6 and three quarters within 31.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Insel Gruppe AG, University Hospital Bern →