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AttentionNCT07408180

Exploratory Randomized, Controlled, Dose-response Study on the Impact of Nicotine From Five Variants of a Nicotine Tablet (NICOTINE TABLET) on Attention

A study testing NICOTINE TABLET-0mg, NICOTINE TABLET-0.5mg and NICOTINE TABLET-1.0mg in people with Attention, run by Philip Morris Products S.A. at 1 site in Sweden.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 19 to 60 yearsHealthy volunteers can take part
Conditions the study is for
Attention
What is being tested?
NICOTINE TABLET-0mg, NICOTINE TABLET-0.5mg and NICOTINE TABLET-1.0mg
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
1 siteSweden
Study dates
28 Oct 2025to 23 Apr 2026
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 19 to 60 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 16Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country.

Sweden1 site

  • CTC Clinical Trial Consultants AB

    Uppsala, 752 37

Other trials in Sweden

About this study

Official title: 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.

Conditions
Attention
Being tested
NICOTINE TABLET-0mg, NICOTINE TABLET-0.5mg, NICOTINE TABLET-1.0mg, NICOTINE TABLET-1.5mg, NICOTINE TABLET-2.0mg

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • NICOTINE TABLET-0mgOther

    NICOTINE TABLET (nicotine content 0mg; Mint flavor)

  • NICOTINE TABLET-0.5mgOther

    NICOTINE TABLET (nicotine content 0.5mg; Mint flavor)

  • NICOTINE TABLET-1.0mgOther

    NICOTINE TABLET (nicotine content 1.0mg; Mint flavor)

  • NICOTINE TABLET-1.5mgOther

    NICOTINE TABLET (nicotine content 1.5mg; Mint flavor)

  • NICOTINE TABLET-2.0mgOther

    NICOTINE TABLET (nicotine content 2.0mg; Mint flavor)

Study groups in NCT07408180
Study groupRoleWhat they receive
Product Sequence 1Active comparatorThe list of possible sequences are: NT-0mg; NT-0.5mg; NT-1.0mg; NT-1.5mg; NT-2.0mg
Receives: Other: NICOTINE TABLET-0mg; Other: NICOTINE TABLET-0.5mg; Other: NICOTINE TABLET-1.0mg; Other: NICOTINE TABLET-1.5mg; Other: NICOTINE TABLET-2.0mg
Product Sequence 2Active comparatorThe list of possible sequences are: NT-0mg; NT-0.5mg; NT-1.0mg; NT-1.5mg; NT-2.0mg
Receives: Other: NICOTINE TABLET-0mg; Other: NICOTINE TABLET-0.5mg; Other: NICOTINE TABLET-1.0mg; Other: NICOTINE TABLET-1.5mg; Other: NICOTINE TABLET-2.0mg
Product Sequence 3Active comparatorThe list of possible sequences are: NT-0mg; NT-0.5mg; NT-1.0mg; NT-1.5mg; NT-2.0mg
Receives: Other: NICOTINE TABLET-0mg; Other: NICOTINE TABLET-0.5mg; Other: NICOTINE TABLET-1.0mg; Other: NICOTINE TABLET-1.5mg; Other: NICOTINE TABLET-2.0mg
Product Sequence 4Active comparatorThe list of possible sequences are: NT-0mg; NT-0.5mg; NT-1.0mg; NT-1.5mg; NT-2.0mg
Receives: Other: NICOTINE TABLET-0mg; Other: NICOTINE TABLET-0.5mg; Other: NICOTINE TABLET-1.0mg; Other: NICOTINE TABLET-1.5mg; Other: NICOTINE TABLET-2.0mg
Product Sequence 5Active comparatorThe list of possible sequences are: NT-0mg; NT-0.5mg; NT-1.0mg; NT-1.5mg; NT-2.0mg
Receives: Other: NICOTINE TABLET-0mg; Other: NICOTINE TABLET-0.5mg; Other: NICOTINE TABLET-1.0mg; Other: NICOTINE TABLET-1.5mg; Other: NICOTINE TABLET-2.0mg

What is being measured

The primary outcome is the main question the study is designed to answer.

  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).

    Measured: 15 minutes after the start of product use

Secondary outcomes (2)

  1. 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).

    Measured: 2 hours after the start of product use

  2. 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.

    Measured: 10 minutes after the start of product use

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Feb 2026
  2. Study start28 Oct 2025
  3. Primary completion16 Mar 2026
  4. Study completion23 Apr 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Crossover
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07408180
Sponsor's protocol ID
NS-CAP-01
Status last verified
May 2026
First submitted
5 Feb 2026
Last updated
5 May 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

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.

    PubMed 30793982

Questions about this trial

What is this clinical trial studying?

A study testing NICOTINE TABLET-0mg, NICOTINE TABLET-0.5mg and NICOTINE TABLET-1.0mg in people with Attention, run by Philip Morris Products S.A. at 1 site in Sweden.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in attentional performance after 15 minutes (time frame: 15 minutes after the start of product use). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07408180, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 May 2026.

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