NCT07348224

Pharmacokinetics and Pharmacodynamics of Synthetic Nicotine and Nicotine Analogues

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 24 (estimated)
• Sponsor: Insel Gruppe AG, University Hospital Bern · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• Nicotine
• Vaping
• Synthetic Nicotine
• Nicotine Analogues

Interventions

Type	Name	Description
OTHER	Vaping of synthetic S-nicotine	Vaping of e-liquids containing synthetic S-nicotine
OTHER	Vaping of racemic nicotine (S-/R-nicotine)	Vaping of e-liquids containing synthetic racemic nicotine (S-/R-nicotine)
OTHER	Vaping of 6-methylnicotine	Vaping of e-liquids containing the nicotine analogue 6-methylnicotine (6MN)

Timeline

• Start date: 2026-01-31
• Primary completion: 2026-12-31
• Completion: 2026-12-31
• First posted: 2026-01-16
• Last updated: 2026-01-16

Locations

1 site across 1 country: Switzerland