icotine delivery in venous blood during the use of tobacco heating devices within the acute phase.
- Conditions
- F17.2
- Registration Number
- DRKS00024596
- Lead Sponsor
- MU Klinikum München - Klinik für Psychiatrie und Psychotherapie
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 15
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)
- 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.
Study & Design
- Study Type
- observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method Assessment of addiction potential, as the rate of onset and the concentration of a drug strongly correlate with the addiction potential.