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

Philip Morris Products S.A.1 个研究点分布在 1 个国家目标入组 40 人开始时间: 2025年10月28日最近更新: 2026年5月5日

干预措施

试验速览

阶段: 不适用
状态: 已完成
发起方: Philip Morris Products S.A.
入组人数: 40
试验地点: 1
主要终点: Change in attentional performance after 15 minutes

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

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.

研究设计

研究类型: Interventional
分配方式: Randomized
干预模型: Crossover
主要目的: Other
盲法: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

盲法说明

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.

入排标准

年龄范围: 19 Years 至 60 Years（Adult）
性别: All
接受健康志愿者: 是

入选标准

•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.

排除标准

•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.