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

• Register: ISRCTN
• Last refreshed on: 27 February 2024
• Main ID: ISRCTN44913332
• Date of registration: 21/11/2017
• Prospective Registration: No
• Primary sponsor: Swedish Match North Europe
• Public title: A study investigating the extraction of nicotine and flavors from tobacco free nicotine pods compared to tobacco based Swedish snus
• Scientific title: The in-vivo extraction of nicotine and flavor compounds from a single dose of a non-tobacco-based nicotine pouch (ZYN®) compared with conventional, tobacco-based Swedish snus among current, daily snus users
• Date of first enrolment: 14/09/2017
• Target sample size: 20
• Recruitment status: Completed
• URL: https://www.isrctn.com/ISRCTN44913332
• Study type: Interventional
• Study design: Single-centre open randomized fourteen-way cross-over single dose administration (Prevention)
• Phase: Not Applicable

Countries of recruitment

Sweden

Contacts

• Name: Mikael Staaf

Key inclusion & exclusion criteria

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

Age minimum:
Age maximum:
Gender: Both

Health Condition(s) or Problem(s) studied

Tobacco use not otherwise specified (NOS)
Not Applicable
Tobacco use

Intervention(s)

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 receive the following doses:

1. ZYN® Smooth containing 3 mg nicotine per portion - 15 min single dose administration
2. ZYN® Smooth containing 3 mg nicotine per portion - 60 min single dose administration
3. ZYN® Smooth containing 6 mg nicotine per portion - 15 min single dose administration
4. ZYN® Smooth containing 6 mg nicotine per portion - 60 min single dose administration
5. ZYN® Smooth containing 3 mg nicotine per portion (alternative manufacturing process) - 15 min single dose administration
6. ZYN® Smooth containing 3 mg nicotine per portion (alternative manufacturing process) - 60 min single dose administration
7. ZYN® Smooth containing 6 mg nicotine per portion (alternative manufacturing process) - 15 min single dose administration
8. ZYN® Smooth containing 6 mg nicotine per portion (alternative manufacturing process) - 60 min single dose administration
9. ZYN® Wintergreen containing 3 mg nicotine per portion (Nicotine analysis) - 60 min single dose administration
10. ZYN® Wintergreen containing 3 mg nicotine per portion (Flavor analysis) - 60 min single dose administration
11. ZYN® Peppermint containing 3 mg nicotine per portion (Nicotine and Flavor analysis) - single dose 60 min administration
12. ZYN® Spearmint containing 3 mg nicotine per portion (Nicotine and Flavor analysis) - 60 min single dose administration
13. Swedish portion snus PSWL 1.0 g (8 mg nicotine/g) - 15 min single dose administration
14. Swedish portion snus PSWL 1.0 g (8 mg nicotine/g) - 60 min single dose administration

The treatments are administered as single doses in

Primary Outcome(s)

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(s)

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

Secondary ID(s)

SM 17-01

Source(s) of Monetary Support

Swedish Match North Europe

Ethics review

Status:
Approval date:
Contact:

Old ethics approval format; EPN Uppsala, 13/09/2017, ref: Dnr 2017/318

Results

• Results available: Yes
• Date Completed: 14/11/2017