How synthetic nicotine and nicotine analogues behave in the body when vaped

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This interventional study examines the pharmacokinetics and pharmacodynamics of synthetic nicotine, racemic nicotine, and nicotine analogues delivered via electronic cigarettes. It uses a double-blind design with seven hospital visits, followed by a four-day home-use period for each product. Researchers collect saliva, urine, and blood samples and survey participants about their vaping and tobacco use to understand absorption, distribution, metabolism, and effects of the different nicotine forms. The study aims to clarify whether synthetic nicotine and analogues act differently from traditional tobacco-derived nicotine. Participants must have recent nicotine vaping experience and meet specified health criteria to participate.

Why it matters

Who can join: the full rules

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

Where it's running

• Inselspital
  Bern, Switzerland Recruiting

Study contacts

• Study coordinator: Evangelia Liakoni, Prof.
• Email: evangelia.liakoni@insel.ch
• Phone: +41 31 632 54 61

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.