A study investigating the uptake to the blood circulation of nicotine from tobacco free nicotine pods compared to tobacco-based Swedish snus and American moist snuff
- Conditions
- Tobacco useNot Applicable
- Registration Number
- ISRCTN77807609
- Lead Sponsor
- Swedish Match Europe Division
- Brief Summary
2020 Results article in https://pubmed.ncbi.nlm.nih.gov/32319528/ results (added 28/05/2020)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 36
1. Snus user who have used snus for =1 year, with a minimum weekly consumption of
two or more snus cans (brands with nicotine content =1%)
2. Willing and able to give written informed consent for participation in the study
3. Healthy
4. Aged 19 years or older
5. Willing and able to comply with study procedures
1. Smoker, defined as smoking during the last 24 hours according to self-report and CO in exhaled air >10 ppm at clinical visits
2. A history or presence of diagnosed hypertension or any cardiovascular disease
3. Surgery within 6 months of the screening visit that, in the opinion of the investigator, could negatively impact on the subject’s participation in the clinical study
4. Any surgical or medical condition, which, in the judgement of the clinical investigator, might interfere with the absorption, distribution, metabolism or excretion of the investigational product
5. History of any clinically significant disease or disorder which, in the opinion of the Investigator, may either put the subject at risk because of participation in the study, or influence the results or the subject’s ability to participate in the study
6. Breast feeding, pregnancy or planning to get pregnant during the study
7. Female use of systemic contraceptives (such as oral contraceptives, implants, injectable steroids, vaginal ring, transdermal patch)
8. Any positive result on screening for serum hepatitis B surface antigen, hepatitis C antibody and Human Immunodeficiency Virus (HIV)
9. Positive screen for drugs of abuse or alcohol at screening or on admission to the unit prior to administration of the IP
10. Current or history of alcohol abuse and/or use of anabolic steroids or drugs of abuse
11. Plasma donation within one month of screening or blood donation (or corresponding blood loss) during the three months prior to screening
12. Investigator considers the subject unlikely to comply with study procedures, restrictions and requirements
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method AUCinf (based on plasma concentrations of nicotine after administration of a single dose of ZYN® Smooth containing 6 mg of nicotine, to that of two doses of General PSWL Swedish snus pouches), calculated based on measurement of nicotine in blood samples with a liquid chromatography-mass spectrometry (LC-MS/MS) analytical method at the completion of the study
- Secondary Outcome Measures
Name Time Method