Attention
Conditions
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.
Interventions
OTHERNICOTINE TABLET-0mg
NICOTINE TABLET (nicotine content 0mg; Mint flavor)
OTHERNICOTINE TABLET-0.5mg
NICOTINE TABLET (nicotine content 0.5mg; Mint flavor)
OTHERNICOTINE TABLET-1.0mg
NICOTINE TABLET (nicotine content 1.0mg; Mint flavor)
OTHERNICOTINE TABLET-1.5mg
NICOTINE TABLET (nicotine content 1.5mg; Mint flavor)
OTHERNICOTINE TABLET-2.0mg
NICOTINE TABLET (nicotine content 2.0mg; Mint flavor)
Sponsors
Philip Morris Products S.A.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
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.
Eligibility
Sex/Gender
ALL
Age
19 Years to 60 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in attentional performance after 15 minutes | 15 minutes after the start of product use | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in attentional performance after 2 hours | 2 hours after the start of product use | 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). |
| Change in self-reported craving for nicotine pouch use | 10 minutes after the start of product 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. |
Countries
Sweden
Contacts
STUDY_CHAIRXavier Jaumont, MD
Philip Morris Products S.A.
Outcome results
None listed