Pharmacokinetics and Pharmacodynamics of Synthetic Nicotine and Nicotine Analogues
Trial statusNot yet recruiting
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
Qualifiers
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
Treatments tested in this trial
- Vaping of synthetic S-nicotine
- Vaping of racemic nicotine (S-/R-nicotine)
- Vaping of 6-methylnicotine
Treatment groups
24 Participants
are divided into 3 treatment groupsSponsors and collaborators
Insel Gruppe AG, University Hospital Bern
Lead sponsor
Swiss Tobacco Prevention Funds
Collaborator
Source ClinicalTrials.gov