Tobacco use not otherwise specified (NOS) Not Applicable Tobacco use
Conditions
Interventions
The treatments are administered as single doses in a pre-determined computer-generated randomized order according to a four-sequence list. Participants are randomly allocated as to what order they rec
Sponsors
Swedish Match North Europe
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Snus user, with a minimum weekly consumption of three or more snus cans (brands with nicotine content 1%) since =1 year 2. Consent to participate voluntarily and sign Informed Consent Form prior to any study procedure 3. Healthy male/female, age =19. Female subjects should have a negative pregnancy test. 4. Willing and able to comply with study procedures 5. A heart rate increase = 10 beats/min with first use of snus in the morning after overnight abstinence from any nicotine exposure
Exclusion criteria
Exclusion criteria: 1. A history or presence of diagnosed hypertension or any cardiovascular disease 2. 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 3. Any surgical or medical condition, which, in the judgment of the clinical investigator, might interfere with the absorption, distribution, metabolism or excretion of the drug 4. Subjects who are pregnant
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Extracted dose of nicotine from each portion is measured by using GC-MS analysis and calculated by subtracting the residual amount after use from the mean of 10 unused portions. Used portions are freezed after dosing and analysis using GC-MS is performed at the end of the trial. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Pulse rate is measured using a pulsimeter at baseline, five, ten, 15, 30 and 60 minutes 2. Head buzz (head rush, “hit”, feeling alert, overall “product strength” is measured using a 100-mm visual analogue scale (VAS) at preset time points up to 30 and 60 minutes, respectively, after study product administration (as a proxy for systemic uptake) 3. The extracted dose of flavor components are measured using GC-MS analysis and calculated by subtracting the residual amount after use from the mean of 10 unused portions. Used portions are freezed after dosing and analysis using GC-MS is performed at the end of the trial. 4. Adverse events are measured using patient interviews at predose, five, ten, 15, 30 and 60 minutes | — |
Countries
Sweden
Outcome results
None listed