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This study aims to provide initial insights into the impact of orally delivered nicotine on attentional performance in adult occasional users of nicotine pouches. Nicotine will be administered via a dissolvable tablet for approximately 10 minutes. The main objective of this exploratory study is to characterize the effect of nicotine on attentional performance, using metrics derived from Continuous Performance Test (CPT).
Additionally, a second CPT assessment will be conducted two hours after the first administration to explore the potential sustained effects of nicotine on attention as an exploratory objective.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Product Sequence 1 | Active Comparator | The list of possible sequences are: NT-0mg; NT-0.5mg; NT-1.0mg; NT-1.5mg; NT-2.0mg |
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| Product Sequence 2 | Active Comparator | The list of possible sequences are: NT-0mg; NT-0.5mg; NT-1.0mg; NT-1.5mg; NT-2.0mg |
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| Product Sequence 3 | Active Comparator | The list of possible sequences are: NT-0mg; NT-0.5mg; NT-1.0mg; NT-1.5mg; NT-2.0mg |
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| Product Sequence 4 | Active Comparator | The list of possible sequences are: NT-0mg; NT-0.5mg; NT-1.0mg; NT-1.5mg; NT-2.0mg |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NICOTINE TABLET-0mg | Other | NICOTINE TABLET (nicotine content 0mg; Mint flavor) |
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| Measure | Description | Time Frame |
|---|---|---|
| Change in attentional performance after 15 minutes | To evaluate the effect of nicotine on attentional performance following a 10-minute use of five NICOTINE TABLET variants containing 0 mg, 0.5 mg, 1.0 mg, 1.5 mg, or 2.0 mg nicotine. Attentional performance will be assessed 15 minutes after the start of product use using the Conners Continuous Performance Test (CPT). | 15 minutes after the start of product use |
| Measure | Description | Time Frame |
|---|---|---|
| Change in attentional performance after 2 hours | To evaluate the effect of nicotine on attentional performance following a 10-minute use of five NICOTINE TABLET variants containing 0 mg, 0.5 mg, 1.0 mg, 1.5 mg, or 2.0 mg nicotine. Attentional performance will be assessed 2 hours after the start of product use using the Conners Continuous Performance Test (CPT). | 2 hours after the start of product use |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Xavier Jaumont, MD | Philip Morris Products S.A. | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CTC Clinical Trial Consultants AB | Uppsala | 752 37 | Sweden |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30793982 | Background | Shaked D, Faulkner LMD, Tolle K, Wendell CR, Waldstein SR, Spencer RJ. Reliability and validity of the Conners' Continuous Performance Test. Appl Neuropsychol Adult. 2020 Sep-Oct;27(5):478-487. doi: 10.1080/23279095.2019.1570199. Epub 2019 Feb 22. |
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All subjects, the Sponsor, and CRO personnel will remain blinded to the product allocation (i.e., the nicotine content of the NICOTINE TABLET), the randomized sequence, and the live randomization scheme. This blinding will be maintained until the Statistical Analysis Plan (SAP) is finalized or the database is locked, whichever occurs later.
| Product Sequence 5 |
| Active Comparator |
The list of possible sequences are: NT-0mg; NT-0.5mg; NT-1.0mg; NT-1.5mg; NT-2.0mg |
|
| NICOTINE TABLET-0.5mg | Other | NICOTINE TABLET (nicotine content 0.5mg; Mint flavor) |
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| NICOTINE TABLET-1.0mg | Other | NICOTINE TABLET (nicotine content 1.0mg; Mint flavor) |
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| NICOTINE TABLET-1.5mg | Other | NICOTINE TABLET (nicotine content 1.5mg; Mint flavor) |
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| NICOTINE TABLET-2.0mg | Other | NICOTINE TABLET (nicotine content 2.0mg; Mint flavor) |
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| Change in self-reported craving for nicotine pouch use | Participants will rate their craving on a 100 mm unipolar scale (0 = no craving, 100 = strong craving) in response to the question: "How strong is your craving for using a nicotine pouch?" following a 10-minute use of five NICOTINE TABLET variants containing 0 mg, 0.5 mg, 1.0 mg, 1.5 mg, or 2.0 mg nicotine. | 10 minutes after the start of product use |