Usage behavior and nicotine kinetics during ad libitum use of tobacco heating systems, e-cigarettes, and tobacco cigarettes

Usage behavior and nicotine kinetics during ad libitum use of tobacco heating systems, e-cigarettes, and tobacco cigarettes - Nicotide 2

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00024751

Enrollment

Registered

2022-01-04

Start date

2021-09-01

Completion date

Unknown

Last updated

2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

F17.2

Interventions

Group 1: Interventional group: IQOS 3 Duo users (n=15). Here, according to the study protocol, blood will be drawn via an indwelling peripheral venous cannula (Braunüle) at 9 fixed time points within

Eligibility

Sex/Gender

All

Age

18 Years to 55 Years

Inclusion criteria

Inclusion criteria: Other general inclusion criteria: - 12-hour abstinence. - CO 3 months, daily use - No daily use of conventional tobacco cigarettes for >3 months. Special inclusion criteria for IQOS users: - experienced IQOS user for > 3 months, daily consumption of at least 10 heets of tobacco sticks - no daily use of conventional tobacco cigarettes for > 3 months Special inclusion criteria for smokers: - smoker for > 5 years - consumption of > 10 cigarettes/day

Exclusion criteria

Exclusion criteria: Exclusion criteria - patients under 18 years of age or over 55 years of age - acute psychiatric illness according to ICD-10/DSM IV - other severe psychiatric illnesses - acute suicidal tendencies - existing pregnancy - drug, medication or alcohol abuse at the time of the study - current malignant cancer during the last 5 years - severe internal diseases, especially cardiovascular diseases, such as manifest arterial hypertension, severe heart disease (DCM, history of myocardial infarction), cardiac pacemaker - respiratory diseases (e.g. asthma, COPD) - severe active infectious diseases - CO >5 ppm in expirium - Nicotine plasma concentration at baseline >10 ng/ml - no capacity to agree to an informed consent - Other circumstances that, in the opinion of the responsible study physician, militate against the patient's participation in this study.

Design outcomes

Primary

Measure	Time frame
The aim of the study is to find out how nicotine levels differ between 4 selected nicotine products (IQOS, JUUL, Myblu, tobacco cigarette) during free use in the context of different usage behaviour. It is assumed that nicotine pharmacokinetics, use behaviour, craving and side effect profile differ between the products to be tested.	—

Secondary

Measure	Time frame
In particular, the difference between predetermined usage behaviour and free usage behaviour is to be tested and put in relation to other studies.	—

Countries

Germany

Contacts

Public ContactAndrea Rabenstein

LMU Klinikum München - Klinik für Psychiatrie und Psychotherapie

andrea.rabenstein@med.uni-muenchen.de089440055539

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026