Nicotine delivery in venous blood during the use of tobacco heating devices within the acute phase.

Nicotine delivery in venous blood during the use of tobacco heating devices within the acute phase. - Nicotide Heat

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00024596

Enrollment

Registered

2021-08-30

Start date

2021-04-21

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: ! Cross-over design: all 15 subjects will test all 3 products (IQOS, glo, tobacco cigarette), on different days, in an outpatient setting. Interventional group 1/2: tobacco heating system IQ

Eligibility

Sex/Gender

All

Age

18 Years to 55 Years

Inclusion criteria

Inclusion criteria: General inclusion criteria: - Subjects between 18 and 55 years of age - 12-hour abstinence (tobacco and nicotine use). - CO < 5ppm; measurement in expiratory air using micro-smokerlyzer (Bedfont Scientific Ltd). - Ability to state an informed consent Specific inclusion criteria - experienced user of a tobacco heating device (e.g., IQOS, glo™) for at least 3 months (at least 10 tobacco sticks per day) - Occasional use of conventional tobacco cigarettes for at least 3 months (max. 20 cigarettes per week)

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 insufficiency (e.g. asthma, COPD) - severe active infectious diseases - CO >5 ppm in the expirium - Other circumstances that, in the opinion of the study physician, militate against the patient's participation in this study.

Design outcomes

Primary

Measure	Time frame
Assessment of the speed and concentration of nicotine during the use of the tobacco heating systems IQOS and glo compared to conventional tobacco cigarettes within the acute phase to a total of 9 measurement points.	—

Secondary

Measure	Time frame
Assessment of addiction potential, as the rate of onset and the concentration of a drug strongly correlate with the addiction potential.	—

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