Study to Evaluate Abuse Potential of Five Modern Oral Nicotine Products Compared to Cigarettes and Nicotine Gum in Adult Smokers

What this Trial Is About

Researchers are evaluating the abuse potential of five modern oral nicotine products compared to combustible cigarettes and nicotine gum in generally healthy adult smokers aged 21 to 60 years. This open-label, randomized, cross-over study aims to assess subjective effects, physiological responses, and nicotine levels in the blood during and after use of these products. The study includes smokers who primarily use filtered menthol or non-menthol cigarettes, including those who also use smokeless tobacco or modern oral products. Participants will be randomly assigned to one of two study arms and use four different investigational products in separate test sessions following a Williams Design. The products include various nicotine doses delivered orally and participants usual brand cigarettes or nicotine gum, depending on their arm. Each test session lasts about 4 hours and is preceded by a product acclimation period allowing ad libitum use of the next study product. Used products are collected and stored for laboratory analysis. Participants will stay confined at the clinical site for 6 days 5 nights during which safety and effects will be closely monitored through vital signs, physical and oral exams, adverse event tracking, laboratory tests, and questionnaires. The main outcomes measured include nicotine uptake and peak response from 5 to 240 minutes after product use. The study also includes screening, eligibility confirmation, and follow-up availability by the medical monitor, with careful monitoring throughout the trial period.

Abuse Liability for Five Modern Oral Nicotine Products