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This study is a randomised cross-over, open-label, confinement study conducted in 24 male or female snus and cigarette consumers. The study investigates 5 different nicotine containing products in a cross-over fashion. The study incorporates pharmacokinetics evaluation, nicotine extraction evaluation, subjective questionnaire assessments as well as safety evaluation.
During the study participation, subjects come for two visits to the clinic, including a 5-day confinement period.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ABCDE | Other | Subjects use product A (ZoneX #2, white tobacco-free nicotine pouch, 5.8 mg nicotine/pouch) for 20 minutes on Day 1, then switch to use product B (ZoneX #3, white tobacco-free nicotine pouch, 10.1 mg nicotine/pouch) for 20 min on Day 2, then product C (Skruf snus fresh slim white, 10.9 mg nicotine/pouch) for 20 min on Day 3, then D (nicotine pouch, 10.6 mg/pouch) on Day 4 and finally E (Marlboro Gold, conventional cigarette, 0.8 mg nicotine/cigarette), smoked in approximately 5 minutes with puffs taken at regular intervals approximately 30 seconds apart, on Day 5. Subjects can use their assigned product ad libitum on each study day, after all study assessments are performed, until 10pm. A washout period of product abstinence is observed between products, overnight. |
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| BCDEA | Other | Same as previous arm but in a different randomization order. |
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| CDEAB | Other | Same as previous arm but in a different randomization order. |
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| DEABC | Other | Same as previous arm but in a different randomization order. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| A | Other | Use of product A (ZoneX #2, white tobacco-free nicotine pouch, 5.8 mg nicotine/pouch) for 20 minutes |
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| Measure | Description | Time Frame |
|---|---|---|
| Nicotine Cmax | Maximum plasma concentration of nicotine (Cmax) | Pre-use and at 2, 5, 7, 15, 20, 30, 45, 60, 90 minutes, and 2, 4, 6 and 8 hours post use start |
| Nicotine AUCt | Area under the plasma nicotine concentration-time curve at the last timepoint measured (AUCt) | Pre-use and at 2, 5, 7, 15, 20, 30, 45, 60, 90 minutes, and 2, 4, 6 and 8 hours post use start |
| Measure | Description | Time Frame |
|---|---|---|
| Nicotine Extraction | Extraction fraction (%) of nicotine in used product pouches after 20 minutes of use. | 20 minutes |
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Inclusion Criteria:
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
Positive for HIV, hepatitis B or C
After 10 minutes supine rest at the time of screening, any vital signs values outside the following ranges:
Alcohol or drug abuse
Use, or history of use of anabolic steroids
Allergy/hypersensitivity to drugs with a similar chemical structure or class to nicotine
Excessive caffeine consumption (daily intake of >5 cups)
Female subjects who are pregnant or breastfeeding
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CTC Clinical Trial Consultants AB (CTC) | Uppsala | SE-752 37 | Sweden |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35732751 | Derived | Chapman F, McDermott S, Rudd K, Taverner V, Stevenson M, Chaudhary N, Reichmann K, Thompson J, Nahde T, O'Connell G. A randomised, open-label, cross-over clinical study to evaluate the pharmacokinetic, pharmacodynamic and safety and tolerability profiles of tobacco-free oral nicotine pouches relative to cigarettes. Psychopharmacology (Berl). 2022 Sep;239(9):2931-2943. doi: 10.1007/s00213-022-06178-6. Epub 2022 Jun 23. |
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| ID | Title | Description |
|---|---|---|
| FG000 | ABCDE | Subjects use product A (ZoneX #2, white tobacco-free nicotine pouch, 5.8 mg nicotine/pouch) for 20 minutes on Day 1, then switch to use product B (ZoneX #3, white tobacco-free nicotine pouch, 10.1 mg nicotine/pouch) for 20 min on Day 2, then product C (Skruf snus fresh slim white, 10.9 mg nicotine/pouch) for 20 min on Day 3, then D (nicotine pouch, 10.6 mg/pouch) on Day 4 and finally E (Marlboro Gold, conventional cigarette, 0.8 mg nicotine/cigarette), smoked in approximately 5 minutes with puffs taken at regular intervals approximately 30 seconds apart, on Day 5. Subjects can use their assigned product ad libitum on each study day, after all study assessments are performed, until 10pm. A washout period of product abstinence is observed between products, overnight. A: Use of product A (ZoneX #2, white tobacco-free nicotine pouch, 5.8 mg nicotine/pouch) for 20 minutes B: Use of product B (ZoneX #3, white tobacco-free nicotine pouch, 10.1 mg nicotine/pouch) for 20 minutes C: Use of product C (Skruf snus fresh slim white, 10.9 mg nicotine/pouch) for 20 minutes D: Use of product D (Nicotine pouch, 10.6 mg/pouch) for 20 minutes E: Use of product E (Marlboro Gold, conventional cigarette, 0.8 mg nicotine/cigarette) for approximately 5 minutes |
| FG001 | BCDEA | Same as previous arm but in a different randomization order. A: Use of product A (ZoneX #2, white tobacco-free nicotine pouch, 5.8 mg nicotine/pouch) for 20 minutes B: Use of product B (ZoneX #3, white tobacco-free nicotine pouch, 10.1 mg nicotine/pouch) for 20 minutes C: Use of product C (Skruf snus fresh slim white, 10.9 mg nicotine/pouch) for 20 minutes D: Use of product D (Nicotine pouch, 10.6 mg/pouch) for 20 minutes E: Use of product E (Marlboro Gold, conventional cigarette, 0.8 mg nicotine/cigarette) for approximately 5 minutes |
| FG002 | CDEAB | Same as previous arm but in a different randomization order. A: Use of product A (ZoneX #2, white tobacco-free nicotine pouch, 5.8 mg nicotine/pouch) for 20 minutes B: Use of product B (ZoneX #3, white tobacco-free nicotine pouch, 10.1 mg nicotine/pouch) for 20 minutes C: Use of product C (Skruf snus fresh slim white, 10.9 mg nicotine/pouch) for 20 minutes D: Use of product D (Nicotine pouch, 10.6 mg/pouch) for 20 minutes E: Use of product E (Marlboro Gold, conventional cigarette, 0.8 mg nicotine/cigarette) for approximately 5 minutes |
| FG003 | DEABC | Same as previous arm but in a different randomization order. A: Use of product A (ZoneX #2, white tobacco-free nicotine pouch, 5.8 mg nicotine/pouch) for 20 minutes B: Use of product B (ZoneX #3, white tobacco-free nicotine pouch, 10.1 mg nicotine/pouch) for 20 minutes C: Use of product C (Skruf snus fresh slim white, 10.9 mg nicotine/pouch) for 20 minutes D: Use of product D (Nicotine pouch, 10.6 mg/pouch) for 20 minutes E: Use of product E (Marlboro Gold, conventional cigarette, 0.8 mg nicotine/cigarette) for approximately 5 minutes |
| FG004 | EABCD | Same as previous arm but in a different randomization order. A: Use of product A (ZoneX #2, white tobacco-free nicotine pouch, 5.8 mg nicotine/pouch) for 20 minutes B: Use of product B (ZoneX #3, white tobacco-free nicotine pouch, 10.1 mg nicotine/pouch) for 20 minutes C: Use of product C (Skruf snus fresh slim white, 10.9 mg nicotine/pouch) for 20 minutes D: Use of product D (Nicotine pouch, 10.6 mg/pouch) for 20 minutes E: Use of product E (Marlboro Gold, conventional cigarette, 0.8 mg nicotine/cigarette) for approximately 5 minutes |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | ABCDE | Subjects use product A (ZoneX #2, white tobacco-free nicotine pouch, 5.8 mg nicotine/pouch) for 20 minutes on Day 1, then switch to use product B (ZoneX #3, white tobacco-free nicotine pouch, 10.1 mg nicotine/pouch) for 20 min on Day 2, then product C (Skruf snus fresh slim white, 10.9 mg nicotine/pouch) for 20 min on Day 3, then D (nicotine pouch, 10.6 mg/pouch) on Day 4 and finally E (Marlboro Gold, conventional cigarette, 0.8 mg nicotine/cigarette), smoked in approximately 5 minutes with puffs taken at regular intervals approximately 30 seconds apart, on Day 5. Subjects can use their assigned product ad libitum on each study day, after all study assessments are performed, until 10pm. A washout period of product abstinence is observed between products, overnight. A: Use of product A (ZoneX #2, white tobacco-free nicotine pouch, 5.8 mg nicotine/pouch) for 20 minutes B: Use of product B (ZoneX #3, white tobacco-free nicotine pouch, 10.1 mg nicotine/pouch) for 20 minutes C: Use of product C (Skruf snus fresh slim white, 10.9 mg nicotine/pouch) for 20 minutes D: Use of product D (Nicotine pouch, 10.6 mg/pouch) for 20 minutes E: Use of product E (Marlboro Gold, conventional cigarette, 0.8 mg nicotine/cigarette) for approximately 5 minutes |
| Units | Counts |
|---|---|
| Participants |
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| 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 plasma concentration of nicotine (Cmax) | 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 | Pre-use and at 2, 5, 7, 15, 20, 30, 45, 60, 90 minutes, and 2, 4, 6 and 8 hours post use start |
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Adverse events were collected from the start of the first Investigational Product use until the end-of-study visit (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 | Subjects who used product A (ZoneX #2, white tobacco-free nicotine pouch, 5.8 mg nicotine/pouch) for 20 minutes |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Aphthous ulcer | Gastrointestinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Simon McDermott | Imperial Tobacco Ltd | +44 (0)117 332 0225 | simon.mcdermott@uk.imptob.co |
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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 | Aug 26, 2020 | Jun 8, 2022 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Feb 2, 2021 | Jun 8, 2022 | SAP_001.pdf |
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| ID | Term |
|---|---|
| C007792 | Fumigant 93 |
| C476054 | HTR3D protein, human |
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| EABCD | Other | Same as previous arm but in a different randomization order. |
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| B | Other | Use of product B (ZoneX #3, white tobacco-free nicotine pouch, 10.1 mg nicotine/pouch) for 20 minutes |
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| C | Other | Use of product C (Skruf snus fresh slim white, 10.9 mg nicotine/pouch) for 20 minutes |
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| D | Other | Use of product D (Nicotine pouch, 10.6 mg/pouch) for 20 minutes |
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| E | Other | Use of product E (Marlboro Gold, conventional cigarette, 0.8 mg nicotine/cigarette) for approximately 5 minutes |
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|
| BG001 | BCDEA | Same as previous arm but in a different randomization order. A: Use of product A (ZoneX #2, white tobacco-free nicotine pouch, 5.8 mg nicotine/pouch) for 20 minutes B: Use of product B (ZoneX #3, white tobacco-free nicotine pouch, 10.1 mg nicotine/pouch) for 20 minutes C: Use of product C (Skruf snus fresh slim white, 10.9 mg nicotine/pouch) for 20 minutes D: Use of product D (Nicotine pouch, 10.6 mg/pouch) for 20 minutes E: Use of product E (Marlboro Gold, conventional cigarette, 0.8 mg nicotine/cigarette) for approximately 5 minutes |
| BG002 | CDEAB | Same as previous arm but in a different randomization order. A: Use of product A (ZoneX #2, white tobacco-free nicotine pouch, 5.8 mg nicotine/pouch) for 20 minutes B: Use of product B (ZoneX #3, white tobacco-free nicotine pouch, 10.1 mg nicotine/pouch) for 20 minutes C: Use of product C (Skruf snus fresh slim white, 10.9 mg nicotine/pouch) for 20 minutes D: Use of product D (Nicotine pouch, 10.6 mg/pouch) for 20 minutes E: Use of product E (Marlboro Gold, conventional cigarette, 0.8 mg nicotine/cigarette) for approximately 5 minutes |
| BG003 | DEABC | Same as previous arm but in a different randomization order. A: Use of product A (ZoneX #2, white tobacco-free nicotine pouch, 5.8 mg nicotine/pouch) for 20 minutes B: Use of product B (ZoneX #3, white tobacco-free nicotine pouch, 10.1 mg nicotine/pouch) for 20 minutes C: Use of product C (Skruf snus fresh slim white, 10.9 mg nicotine/pouch) for 20 minutes D: Use of product D (Nicotine pouch, 10.6 mg/pouch) for 20 minutes E: Use of product E (Marlboro Gold, conventional cigarette, 0.8 mg nicotine/cigarette) for approximately 5 minutes |
| BG004 | EABCD | Same as previous arm but in a different randomization order. A: Use of product A (ZoneX #2, white tobacco-free nicotine pouch, 5.8 mg nicotine/pouch) for 20 minutes B: Use of product B (ZoneX #3, white tobacco-free nicotine pouch, 10.1 mg nicotine/pouch) for 20 minutes C: Use of product C (Skruf snus fresh slim white, 10.9 mg nicotine/pouch) for 20 minutes D: Use of product D (Nicotine pouch, 10.6 mg/pouch) for 20 minutes E: Use of product E (Marlboro Gold, conventional cigarette, 0.8 mg nicotine/cigarette) for approximately 5 minutes |
| BG005 | 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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| Body Mass Index (BMI) | Mean | Standard Deviation | kg/m^2 |
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| OG002 | Product C | Subjects who used product C (Skruf snus fresh slim white, 10.9 mg nicotine/pouch) for 20 min |
| OG003 | Product D | Subjects who used Product D (nicotine pouch, 10.6 mg/pouch) for 20 min |
| OG004 | Product E | Subjects who used Product E (Marlboro Gold, conventional cigarette, 0.8 mg nicotine/cigarette), smoked in approximately 5 minutes |
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| Primary | Nicotine AUCt | Area under the plasma nicotine concentration-time curve at the last timepoint measured (AUCt) | 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 | Pre-use and at 2, 5, 7, 15, 20, 30, 45, 60, 90 minutes, and 2, 4, 6 and 8 hours post use start |
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| Secondary | Nicotine Extraction | Extraction fraction (%) of nicotine in used product pouches after 20 minutes of 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. Only analyzed for pouch products (A, B, C and D), not for Product E (conventional cigarette). | Posted | Mean | Standard Deviation | Percent of nicotine used | 20 minutes |
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| 0 |
| 22 |
| 0 |
| 22 |
| 3 |
| 22 |
| EG001 | Product B | Subjects who used product B (ZoneX #3, white tobacco-free nicotine pouch, 10.1 mg nicotine/pouch) for 20 min | 0 | 23 | 0 | 23 | 0 | 23 |
| EG002 | Product C | Subjects who used product C (Skruf snus fresh slim white, 10.9 mg nicotine/pouch) for 20 min | 0 | 22 | 0 | 22 | 1 | 22 |
| EG003 | Product D | Subjects who used Product D (nicotine pouch, 10.6 mg/pouch) for 20 min | 0 | 23 | 0 | 23 | 1 | 23 |
| EG004 | Product E | Subjects who used Product E (Marlboro Gold, conventional cigarette, 0.8 mg nicotine/cigarette), smoked in approximately 5 minutes | 0 | 22 | 0 | 22 | 3 | 22 |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA (Unspecified) | Non-systematic Assessment |
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| Thrombophlebitis | Vascular disorders | MedDRA (Unspecified) | Non-systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Non-systematic Assessment |
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| Headache | Nervous system 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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| Hiccups | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
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