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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Product sequence ABCD | Experimental | Subjects use Product A on Day 1, Product B on Day 2, Product C on Day 3 and Product D on Day 4 |
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| Product sequence BCDA | Experimental | Subjects use Product B on Day 1, Product C on Day 2, Product D on Day 3 and Product A on Day 4 |
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| Product sequence CDAB | Experimental | Subjects use Product C on Day 1, Product D on Day 2, Product A on Day 3 and Product B on Day 4 |
|
| Product sequence DABC | Experimental | Subjects use Product D on Day 1, Product A on Day 2, Product B on Day 3 and Product C on Day 4 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Product A | Other | Tobacco-free pouch, 14 mg nicotine/pouch, used for 20 minutes |
|
| Measure | Description | Time Frame |
|---|---|---|
| Nicotine Cmax | Maximum observed plasma nicotine concentration | 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 |
| Nicotine AUCt | The area under the concentration-time curve for nicotine, from time 0 to the time of the last sampling timepoint | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Orally Extracted of Nicotine | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CTC Clinical Trial Consultants AB | Uppsala | SE-752 37 | Sweden |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41044396 | Derived | Chapman F, Morrissey R, McDermott S, Cahours X, Verron T, Taverner V, Stevenson M, Nahde T. Evaluation of high-nicotine oral products shows potential to reduce tobacco-related harm by offering satisfying alternatives. Sci Rep. 2025 Oct 3;15(1):34636. doi: 10.1038/s41598-025-21812-x. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Product Sequence ABCD | Subjects use Product A on Day 1, Product B on Day 2, Product C on Day 3 and Product D on Day 4 Product A: Tobacco-free pouch, 14 mg nicotine/pouch, used for 20 minutes Product B: Tobacco-free pouch, 16 mg nicotine/pouch, used for 20 minutes Product C: Tobacco-free pouch, 20 mg nicotine/pouch, used for 20 minutes Product D: Tobacco pouch, 16.6 mg nicotine/pouch, used for 20 minutes |
| FG001 | Product Sequence BCDA | Subjects use Product B on Day 1, Product C on Day 2, Product D on Day 3 and Product A on Day 4 Product A: Tobacco-free pouch, 14 mg nicotine/pouch, used for 20 minutes Product B: Tobacco-free pouch, 16 mg nicotine/pouch, used for 20 minutes Product C: Tobacco-free pouch, 20 mg nicotine/pouch, used for 20 minutes Product D: Tobacco pouch, 16.6 mg nicotine/pouch, used for 20 minutes |
| FG002 | Product Sequence CDAB | Subjects use Product C on Day 1, Product D on Day 2, Product A on Day 3 and Product B on Day 4 Product A: Tobacco-free pouch, 14 mg nicotine/pouch, used for 20 minutes Product B: Tobacco-free pouch, 16 mg nicotine/pouch, used for 20 minutes Product C: Tobacco-free pouch, 20 mg nicotine/pouch, used for 20 minutes Product D: Tobacco pouch, 16.6 mg nicotine/pouch, used for 20 minutes |
| FG003 | Product Sequence DABC | Subjects use Product D on Day 1, Product A on Day 2, Product B on Day 3 and Product C on Day 4 Product A: Tobacco-free pouch, 14 mg nicotine/pouch, used for 20 minutes Product B: Tobacco-free pouch, 16 mg nicotine/pouch, used for 20 minutes Product C: Tobacco-free pouch, 20 mg nicotine/pouch, used for 20 minutes Product D: Tobacco pouch, 16.6 mg nicotine/pouch, used for 20 minutes |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Product Sequence ABCD | Subjects use Product A on Day 1, Product B on Day 2, Product C on Day 3 and Product D on Day 4 Product A: Tobacco-free pouch, 14 mg nicotine/pouch, used for 20 minutes Product B: Tobacco-free pouch, 16 mg nicotine/pouch, used for 20 minutes Product C: Tobacco-free pouch, 20 mg nicotine/pouch, used for 20 minutes Product D: Tobacco pouch, 16.6 mg nicotine/pouch, used for 20 minutes |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Nicotine Cmax | Maximum observed plasma nicotine concentration | The analysis population represents all subjects who used a specific product. The overall number of participants analyzed for each product is therefore different from the number of participants in each arm provided in the Participant Flow module. | Posted | Mean | Standard Deviation | ng/mL | 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 |
|
7 days
The number of participants at risk represents all subjects who used a specific product. The overall number of participants analyzed for each product is therefore different from the number of participants in each arm provided in the Participant Flow module.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Product A | All subjects further to use of Product A | 0 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Photophobia | Eye disorders | MedDRA (Unspecified) | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Libby Clarke | Imperial Brands PLC | +44 (0117) 3320221 | libby.clarke@impbrands.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jun 21, 2021 | Sep 8, 2025 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Nov 23, 2021 | Sep 8, 2025 | SAP_001.pdf |
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| ID | Term |
|---|---|
| C476054 | HTR3D protein, human |
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| 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 |
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| Product D | Other | Tobacco pouch, 16.6 mg nicotine/pouch, used for 20 minutes |
|
| 20 minutes |
| Urge to Use Emax | 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). | 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 |
| BG001 | Product Sequence BCDA | Subjects use Product B on Day 1, Product C on Day 2, Product D on Day 3 and Product A on Day 4 Product A: Tobacco-free pouch, 14 mg nicotine/pouch, used for 20 minutes Product B: Tobacco-free pouch, 16 mg nicotine/pouch, used for 20 minutes Product C: Tobacco-free pouch, 20 mg nicotine/pouch, used for 20 minutes Product D: Tobacco pouch, 16.6 mg nicotine/pouch, used for 20 minutes |
| BG002 | Product Sequence CDAB | Subjects use Product C on Day 1, Product D on Day 2, Product A on Day 3 and Product B on Day 4 Product A: Tobacco-free pouch, 14 mg nicotine/pouch, used for 20 minutes Product B: Tobacco-free pouch, 16 mg nicotine/pouch, used for 20 minutes Product C: Tobacco-free pouch, 20 mg nicotine/pouch, used for 20 minutes Product D: Tobacco pouch, 16.6 mg nicotine/pouch, used for 20 minutes |
| BG003 | Product Sequence DABC | Subjects use Product D on Day 1, Product A on Day 2, Product B on Day 3 and Product C on Day 4 Product A: Tobacco-free pouch, 14 mg nicotine/pouch, used for 20 minutes Product B: Tobacco-free pouch, 16 mg nicotine/pouch, used for 20 minutes Product C: Tobacco-free pouch, 20 mg nicotine/pouch, used for 20 minutes Product D: Tobacco pouch, 16.6 mg nicotine/pouch, used for 20 minutes |
| BG004 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| OG002 | Product C | All subjects further to use of Product C |
| OG003 | Product D | All subjects further to use of Product D |
|
|
| Primary | Nicotine AUCt | The area under the concentration-time curve for nicotine, from time 0 to the time of the last sampling timepoint | The analysis population represents all subjects who used a specific product. The overall number of participants analyzed for each product is therefore different from the number of participants in each arm provided in the Participant Flow module. | Posted | Mean | Standard Deviation | h*ng/mL | 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 |
|
|
|
| Secondary | Percentage of Orally Extracted of Nicotine | 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 | The analysis population represents all subjects who used a specific product. The overall number of participants analyzed for each product is therefore different from the number of participants in each arm provided in the Participant Flow module. | Posted | Mean | Standard Deviation | Percentage of nicotine | 20 minutes |
|
|
|
| Secondary | Urge to Use Emax | 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). | The analysis population represents all subjects who used a specific product. The overall number of participants analyzed for each product is therefore different from the number of participants in each arm provided in the Participant Flow module. | Posted | Mean | Standard Deviation | mm | 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 |
|
|
|
| 27 |
| 0 |
| 27 |
| 2 |
| 27 |
| EG001 | Product B | All subjects further to use of Product B | 0 | 27 | 0 | 27 | 6 | 27 |
| EG002 | Product C | All subjects further to use of Product C | 0 | 27 | 0 | 27 | 1 | 27 |
| EG003 | Product D | All subjects further to use of Product D | 0 | 27 | 0 | 27 | 3 | 27 |
| Musculoskeletal stiffness | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Non-systematic Assessment |
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| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
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| Fatigue | General disorders | MedDRA (Unspecified) | Non-systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA (Unspecified) | Non-systematic Assessment |
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| Pruritus | Skin and subcutaneous tissue disorders | MedDRA (Unspecified) | Non-systematic Assessment |
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| Rash | Skin and subcutaneous tissue disorders | MedDRA (Unspecified) | Non-systematic Assessment |
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| Constipation | Gastrointestinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
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| Flatulence | Gastrointestinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
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| Disturbance in attention | Nervous system disorders | MedDRA (Unspecified) | Non-systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA (Unspecified) | Non-systematic Assessment |
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| Headache | Nervous system disorders | MedDRA (Unspecified) | Non-systematic Assessment |
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