F17.2
Conditions
Interventions
Group 1: crossover design: all participants test all the four products (3 nicotine pouches, 1 cigarette) on different days.
nicotine pouch V&YOU Boost Intense Mint Boost Plus 15mg
Group 2: nicotine p
Sponsors
LMU Klinikum München - Klinik für Psychiatrie und Psychotherapie
Eligibility
Sex/Gender
All
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: smoker for at least five years consumption of at least 10 cigarettes per day twelve-hour nicotine abstinence prior to testing CO < 5ppm in the exhaled air using a micro-smokerlyzer nicotine plasma concentration at the beginning of the test < 10ng/ml ability to consent
Exclusion criteria
Exclusion criteria: use of other nicotine products (e.g. pouches, e-cigarettes, snus) more than once a week acute psychiatric illness according to ICD-10 other severe psychiatric illness acute suicidal tendencies pregnancy or breastfeeding drug, alcohol or medication abuse at the time of the study malignant cancer in the last five years severe internal illness, e.g. arterial hypertension, pacemaker, asthma, COPD severe active infectious disease CO > 4ppm in the exhaled air nicotine plasma concentration at the beginning of the test > 9ng/ml other circumstances that, in the opinion of the investigators, speak against the person's participation in the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| measurement of nicotine delivery and systemic inflammation markers after use of nicotine pouches with similar nicotine strength but different pH | — |
Secondary
| Measure | Time frame |
|---|---|
| analysis of the impact of pH on the effect of nicotine pouches and collect data regarding systemic inflammation markers | — |
Countries
Germany
Contacts
Public ContactAndrea Rabenstein
LMU Klinikum München - Klinik für Psychiatrie und Psychotherapie
Outcome results
None listed