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Completed

NCT Number: NCT05452278

A Relative Bioavailability Study of Nicotine Delivery From Selected Oral Nicotine Products

This will be a randomised, cross-over, single-blind, confinement study conducted in 27 male or female snus or nicotine pouch users. The study will investigate 4 different nicotine containing products in a cross-over design, incorporating pharmacokinetic (PK) evaluation, nicotine extraction evaluation, subjective questionnaire assessments as well as safety and tolerability evaluation.

During the study participation, subjects will come for 2 visits to the clinic, including a screening visit and a 4-day confinement period. A final follow up end-of-study telephone call will be performed within a week of last product use.

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Key information

Conditions

Healthy Volunteers

Age range

19 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CTC Clinical Trial Consultants AB

Uppsala, SE-752 37, Sweden

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • BMI ≥ 18.0 and ≤ 30.0 kg/m2
  • Clinically normal medical history
  • User of snus or nicotine pouches for ≥1 year, with a minimum weekly use of 2 or more snus or nicotine pouch cans and who is willing and considered able to use brands with nicotine content in the range of 14 to 20 mg nicotine/pouch

Exclusion criteria

  • History of any clinically significant disease or disorder
  • Any clinically significant illness, medical/surgical procedure or trauma within 4 weeks of the first use of IP.
  • Any positive result on screening for serum hepatitis B surface antigen, hepatitis C antibody and HIV
  • Female subjects who are pregnant or breastfeeding
  • Presence or history of drug or alcohol abuse
  • Excessive caffeine consumption defined by a daily intake of >5 cups of caffeine containing beverages
  • Intend to change nicotine-use habit or make a quit attempt within the next 3 months from the screening visit.

Treatment and study plan

Product A

Other

Tobacco-free pouch, 14 mg nicotine/pouch, used for 20 minutes

Product B

Other

Tobacco-free pouch, 16 mg nicotine/pouch, used for 20 minutes

Product C

Other

Tobacco-free pouch, 20 mg nicotine/pouch, used for 20 minutes

Product D

Other

Tobacco pouch, 16.6 mg nicotine/pouch, used for 20 minutes

Primary outcomes

  1. Nicotine Cmax

    Time frame: 5 minutes prior to product use and 5, 10, 15, 20, 25, 30, 45, 60, 90 minutes, 2, 4, 6 and 8 hours post start of product use

    Maximum observed plasma nicotine concentration

  2. Nicotine AUCt

    Time frame: 5 minutes prior to product use and at 5, 10, 15, 20, 25, 30, 45, 60, 90 minutes, 2, 4, 6 and 8 hours post start of product use

    The area under the concentration-time curve for nicotine, from time 0 to the time of the last sampling timepoint

Secondary outcomes

  1. Percentage of Orally Extracted of Nicotine

    Time frame: 20 minutes

    The percentage of orally extracted nicotine from each pouch after 20 minutes of product use is calculated by subtracting the amount of nicotine left in the study pouches after use, to the amount of nicotine in unused reference pouches.

    Extracted dose of nicotine was assessed by the formula:

    (A*B)/C - D where A = Reference value of nicotine as assessed by the average of extracted nicotine in unused reference pouches B = Weight of the unused pouch C = Reference weight value as assessed by the average of weight for unused reference pouches D = Extracted nicotine of the used pouch

  2. Urge to Use Emax

    Time frame: 5 minutes prior to product use and at 5, 10, 15, 20, 25, 30, 45 minutes, and 1, 1.5, 2, 4, 6 and 8 hours post start of product use

    The subjects will self-assess their urge to use a nicotine pouch, pre-use and after use, by answering the question: "How strong is your urge to use a nicotine pouch right now?" on a 100 mm visual analogue scale (VAS), with the anchor points 0 mm (= not at all/no urge) and 100 mm (= extremely/extreme urge). Emax is the maximum change from baseline VAS score (VASpre-use - VASpost-use).

Sponsors and collaborators

Lead sponsor

Imperial Brands PLC

Industry

Registry information

Official study title

A Randomised, Cross-over, Single-blind, Relative Bioavailability Study of Nicotine Delivery From Selected Oral Nicotine Products

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Jul 11, 2022
Registry last updated
Mar 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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