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

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.

Study Overview

• Status: Completed
• Conditions: Attention
• Intervention / Treatment: Other: NICOTINE TABLET-0mg; Other: NICOTINE TABLET-0.5mg; Other: NICOTINE TABLET-1.0mg; Other: NICOTINE TABLET-1.5mg; Other: NICOTINE TABLET-2.0mg

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Sweden
  • Uppsala, Sweden, 752 37
    • CTC Clinical Trial Consultants AB

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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 a current prescription for medical use of cannabis, any use of cannabis products in the past month, or inability to refrain from cannabis use during the Screening and Testing visits. For clarification, use of non-psychoactive cannabis-derived products which contain only cannabidiol is not considered to be cause for exclusion.
• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Quadruple

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Product Sequence 1; The list of possible sequences are: NT-0mg; NT-0.5mg; NT-1.0mg; NT-1.5mg; NT-2.0mg	Other: NICOTINE TABLET-0mg; NICOTINE TABLET (nicotine content 0mg; Mint flavor); Other: NICOTINE TABLET-0.5mg; NICOTINE TABLET (nicotine content 0.5mg; Mint flavor); Other: NICOTINE TABLET-1.0mg; NICOTINE TABLET (nicotine content 1.0mg; Mint flavor); Other: NICOTINE TABLET-1.5mg; NICOTINE TABLET (nicotine content 1.5mg; Mint flavor); Other: NICOTINE TABLET-2.0mg; NICOTINE TABLET (nicotine content 2.0mg; Mint flavor)
Active Comparator: Product Sequence 2; The list of possible sequences are: NT-0mg; NT-0.5mg; NT-1.0mg; NT-1.5mg; NT-2.0mg	Other: NICOTINE TABLET-0mg; NICOTINE TABLET (nicotine content 0mg; Mint flavor); Other: NICOTINE TABLET-0.5mg; NICOTINE TABLET (nicotine content 0.5mg; Mint flavor); Other: NICOTINE TABLET-1.0mg; NICOTINE TABLET (nicotine content 1.0mg; Mint flavor); Other: NICOTINE TABLET-1.5mg; NICOTINE TABLET (nicotine content 1.5mg; Mint flavor); Other: NICOTINE TABLET-2.0mg; NICOTINE TABLET (nicotine content 2.0mg; Mint flavor)
Active Comparator: Product Sequence 3; The list of possible sequences are: NT-0mg; NT-0.5mg; NT-1.0mg; NT-1.5mg; NT-2.0mg	Other: NICOTINE TABLET-0mg; NICOTINE TABLET (nicotine content 0mg; Mint flavor); Other: NICOTINE TABLET-0.5mg; NICOTINE TABLET (nicotine content 0.5mg; Mint flavor); Other: NICOTINE TABLET-1.0mg; NICOTINE TABLET (nicotine content 1.0mg; Mint flavor); Other: NICOTINE TABLET-1.5mg; NICOTINE TABLET (nicotine content 1.5mg; Mint flavor); Other: NICOTINE TABLET-2.0mg; NICOTINE TABLET (nicotine content 2.0mg; Mint flavor)
Active Comparator: Product Sequence 4; The list of possible sequences are: NT-0mg; NT-0.5mg; NT-1.0mg; NT-1.5mg; NT-2.0mg	Other: NICOTINE TABLET-0mg; NICOTINE TABLET (nicotine content 0mg; Mint flavor); Other: NICOTINE TABLET-0.5mg; NICOTINE TABLET (nicotine content 0.5mg; Mint flavor); Other: NICOTINE TABLET-1.0mg; NICOTINE TABLET (nicotine content 1.0mg; Mint flavor); Other: NICOTINE TABLET-1.5mg; NICOTINE TABLET (nicotine content 1.5mg; Mint flavor); Other: NICOTINE TABLET-2.0mg; NICOTINE TABLET (nicotine content 2.0mg; Mint flavor)
Active Comparator: Product Sequence 5; The list of possible sequences are: NT-0mg; NT-0.5mg; NT-1.0mg; NT-1.5mg; NT-2.0mg	Other: NICOTINE TABLET-0mg; NICOTINE TABLET (nicotine content 0mg; Mint flavor); Other: NICOTINE TABLET-0.5mg; NICOTINE TABLET (nicotine content 0.5mg; Mint flavor); Other: NICOTINE TABLET-1.0mg; NICOTINE TABLET (nicotine content 1.0mg; Mint flavor); Other: NICOTINE TABLET-1.5mg; NICOTINE TABLET (nicotine content 1.5mg; Mint flavor); Other: NICOTINE TABLET-2.0mg; NICOTINE TABLET (nicotine content 2.0mg; Mint flavor)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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
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

Collaborators and Investigators

• Sponsor: Philip Morris Products S.A.
• Investigators: Study Chair: Xavier Jaumont, MD, Philip Morris Products S.A.

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): October 28, 2025
• Primary Completion (Actual): March 16, 2026
• Study Completion (Actual): April 23, 2026

Study Registration Dates

• First Submitted: February 5, 2026
• First Submitted That Met QC Criteria: February 5, 2026
• First Posted (Actual): February 13, 2026

Study Record Updates

• Last Update Posted (Actual): May 5, 2026
• Last Update Submitted That Met QC Criteria: May 4, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: NS-CAP-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No