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

Not Applicable

• Conditions: F17.2

• Registration Number: DRKS00026244
• Lead Sponsor: MU Klinikum München - Klinik für Psychiatrie und Psychotherapie

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Completion: 2022-05-22
• Study Start: 2022-08-05
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 26

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

• subjects <18 or >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

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Assessment of addiction potential, as the rate of onset and concentration of a drug strongly correlate with dependence potential.