Pharmacokinetics and Pharmacodynamics of Synthetic Nicotine and Nicotine Analogues

NCT ID: NCT07348224

Last Updated: 2026-01-16

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-01-31
• Study Completion Date: 2026-12-31

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: OTHER
• Blinding Strategy: DOUBLE

Study Groups

Synthetic S-Nicotine

Vaping of e-liquids contanining synthetic S-nicotine

Group Type: OTHER

Vaping of synthetic S-nicotine

Intervention Type: OTHER

Vaping of e-liquids containing synthetic S-nicotine

Racemic nicotine (S-/R-nicotine)

Vaping of e-liquids contanining synthetic racemic nicotine (containing both the S- and R-nicotine enantiomers)

Group Type: OTHER

Vaping of racemic nicotine (S-/R-nicotine)

Intervention Type: OTHER

Vaping of e-liquids containing synthetic racemic nicotine (S-/R-nicotine)

6-methylnicotine

Vaping of e-liquids contanining the nicotine analogue 6-methylnicotine (6MN)

Group Type: OTHER

Vaping of 6-methylnicotine

Intervention Type: OTHER

Vaping of e-liquids containing the nicotine analogue 6-methylnicotine (6MN)

Interventions

Vaping of synthetic S-nicotine

Vaping of e-liquids containing synthetic S-nicotine

Intervention Type: OTHER

Vaping of racemic nicotine (S-/R-nicotine)

Vaping of e-liquids containing synthetic racemic nicotine (S-/R-nicotine)

Intervention Type: OTHER

Vaping of 6-methylnicotine

Vaping of e-liquids containing the nicotine analogue 6-methylnicotine (6MN)

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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)
• Signed informed consent form

Exclusion Criteria

• 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
• BMI < 18 or > 30 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 medications with known 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 of 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Swiss Tobacco Prevention Funds

UNKNOWN

Sponsor Role: collaborator

Insel Gruppe AG, University Hospital Bern

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Inselspital

Bern, , Switzerland

Countries

Switzerland

Central Contacts

Evangelia Liakoni, Prof.

Role: CONTACT

evangelia.liakoni@insel.ch

+41 31 632 54 61

Facility Contacts

Evangelia Liakoni, Prof.

Role: primary

evangelia.liakoni@insel.ch

+41 31 632 54 61

Other Identifiers

BASEC-ID 2025-01893

Identifier Type: -

Identifier Source: org_study_id