Systemic nicotine uptake and side effect by all-white nicotine pouches

Systemic nicotine uptake and side effect by all-white nicotine pouches - Nicotide Pouches

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

DRKS

Registry ID

DRKS00026244

Enrollment

Registered

2022-08-05

Start date

2021-09-30

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 test all 4 products (3 nicotine pouches with 6/20/25-30mg each and tobacco cigarette) on different days in outpatient setting. Intervention group 1/3: ni

Eligibility

Sex/Gender

All

Age

18 Years to 55 Years

Inclusion criteria

Inclusion criteria: • smoker for >5 years, consumption of >10 cigarettes/day. • 12-hour abstinence (nicotine and tobacco). • CO <5 ppm; measured in expiratory air using micro-smokerlyzer (Bedfont Scientific Ltd). • nicotine plasma concentration at baseline <10 ng/ml. • capacity to consent

Exclusion criteria

Exclusion criteria: • subjects 55 years of age • use of other nicotine products >1x/week (e.g., nicotine pouches, snus, e-cigarette) • use of certain medications in the past 14 days that interact with nicotine via CYP enzymes • acute psychiatric illness or other serious psychiatric illnesses according to ICD-10/DSM IV • acute suicidal tendencies • existing pregnancy or current breastfeeding • drug, medication, or alcohol abuse at the time of the study • current or less than 5 years past malignant disease • severe internal diseases, especially cardiovascular diseases such as manifest arterial hypertension, severe heart disease (DCM, history of myocardial infarction), pacemaker or respiratory insufficiency (e.g. bronchial asthma, COPD) • severe active infectious diseases • CO >5ppm in expiratory air • other circumstances which, in the opinion of the investigator, militate against the subject's participation in this study

Design outcomes

Primary

Measure	Time frame
Assessment of systemic nicotine uptake including acute phase and side effect during the use of the three differently dosed nicotine pouches compared to conventional tobacco cigarettes at a total of 10 measurement points.	—

Secondary

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