Exploratory Randomized, Controlled, Dose-response Study on the Impact of Nicotine From Five Variants of a Nicotine Tablet (NICOTINE TABLET) on Attention
Impact of Nicotine From Five Variants of a Nicotine Tablet on Attention in Adult Users of Nicotine Pouches: An Exploratory, Randomized, Controlled, Double-blind, Crossover Study
1 other identifier
interventional
40
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Oct 2025
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 28, 2025
CompletedFirst Submitted
Initial submission to the registry
February 5, 2026
CompletedFirst Posted
Study publicly available on registry
February 13, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 16, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
April 23, 2026
CompletedMay 5, 2026
May 1, 2026
5 months
February 5, 2026
May 4, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (2)
Change in attentional performance after 2 hours
2 hours after the start of product use
Change in self-reported craving for nicotine pouch use
10 minutes after the start of product use
Study Arms (5)
Product Sequence 1
ACTIVE COMPARATORThe list of possible sequences are: NT-0mg; NT-0.5mg; NT-1.0mg; NT-1.5mg; NT-2.0mg
Product Sequence 2
ACTIVE COMPARATORThe list of possible sequences are: NT-0mg; NT-0.5mg; NT-1.0mg; NT-1.5mg; NT-2.0mg
Product Sequence 3
ACTIVE COMPARATORThe list of possible sequences are: NT-0mg; NT-0.5mg; NT-1.0mg; NT-1.5mg; NT-2.0mg
Product Sequence 4
ACTIVE COMPARATORThe list of possible sequences are: NT-0mg; NT-0.5mg; NT-1.0mg; NT-1.5mg; NT-2.0mg
Product Sequence 5
ACTIVE COMPARATORThe list of possible sequences are: NT-0mg; NT-0.5mg; NT-1.0mg; NT-1.5mg; NT-2.0mg
Interventions
NICOTINE TABLET (nicotine content 1.5mg; Mint flavor)
NICOTINE TABLET (nicotine content 0mg; Mint flavor)
NICOTINE TABLET (nicotine content 0.5mg; Mint flavor)
NICOTINE TABLET (nicotine content 2.0mg; Mint flavor)
NICOTINE TABLET (nicotine content 1.0mg; Mint flavor)
Eligibility Criteria
You may qualify if:
- Subject is able to understand the information provided in the ICF and has signed the ICF.
- Subject is a current non-daily user of nicotine pouches (past 30-day use) based on self-reported tobacco/nicotine-containing product use history.
- Subject expresses no desire to quit consumer nicotine product use within the next 3 months from Screening visit.
You may not qualify if:
- Subject uses or intents to start using nicotine replacement therapy or any other medication for smoking cessation.
- Subject uses other consumer nicotine products besides nicotine pouches more frequently than once per 30 days.
- Subject with a urine cotinine test exceeding 500 ng/mL.
- Subject has exhaled CO reading ≥ 10 ppm.
- Subject has reasons other than medical (e.g., psychological, social reason) to not participate in the study, as determined by the Investigator.
- Subject has a clinically relevant disease which requires medication or any other medical condition including clinically significant safety laboratory parameters at Screening visit, as determined by the Investigator.
- Subject has a positive serology test for HIV 1/2, hepatitis B or C.
- Subject has a positive urine drug test.
- Subject has a positive urine alcohol test.
- Subject has a visual or motor impairment that would interfere with their ability to perform a computer-based attentional task.
- Subject has used any medication, drugs, or substances that could affect cognitive processing such as antidepressants, antipsychotics, sedatives, stimulants, and hallucinogens within the past six months prior to Screening visit.
- Subject or one of their family members is an employee of the investigational site or of any other parties involved in the study.
- Subject has participated in another clinical study within 30 days prior to the Screening visit or concomitantly participates in an investigational study involving no drug or device administration.
- For female subjects only: subject is pregnant (does not have negative pregnancy tests at Screening visit or Visit 2 or breastfeeds.
- For female subjects of childbearing potential only: subject does not agree to use an acceptable method of effective contraception.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
CTC Clinical Trial Consultants AB
Uppsala, 752 37, Sweden
Related Publications (1)
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.
PMID: 30793982BACKGROUND
Study Officials
- STUDY CHAIR
Xavier Jaumont, MD
Philip Morris Products S.A.
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- 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.
- Purpose
- OTHER
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 5, 2026
First Posted
February 13, 2026
Study Start
October 28, 2025
Primary Completion
March 16, 2026
Study Completion
April 23, 2026
Last Updated
May 5, 2026
Record last verified: 2026-05