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

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.