A study investigating the extraction of nicotine and flavors from tobacco free nicotine pods compared to tobacco based Swedish snus

Not Applicable

Completed

• Conditions: Tobacco use not otherwise specified (NOS); Not Applicable; Tobacco use

• Registration Number: ISRCTN44913332
• Lead Sponsor: Swedish Match North Europe

Brief Summary

2022 Results article in https://doi.org/10.3390/separations9020052 (added 15/02/2022)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2017-11-14
• Study Start: 2017-11-21
• Last Update Posted: 27 February 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

1. Snus user, with a minimum weekly consumption of three or more snus cans (brands with nicotine content <1%) or two or more 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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
1. Pulse rate is measured using a pulsimeter at baseline, five, ten, 15, 30 and 60 minutes<br>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)<br>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.<br>4. Adverse events are measured using patient interviews at predose, five, ten, 15, 30 and 60 minutes