NCT06777784

Modern Nicotine Oral Product Abuse Liability

An In-Clinic Confinement Study to Assess Elements of Abuse Liability for Six Modern Nicotine Oral Products

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: RAI Services Company · Industry
• Sex: All
• Age: 21 Years – 60 Years
• Healthy volunteers: Accepted

Summary

This is a two-site, open-label, randomized, 8-way cross-over study designed to evaluate elements of abuse liability (AL) including subjective effects and physiological measures (pharmacodynamics \[PD\]) and plasma nicotine uptake (pharmacokinetics \[PK\]) during and following ad libitum use of the study investigational products (IPs) by generally healthy smokers.

Detailed description

Cigarette smokers naïve to smokeless tobacco products (ST) and smokers also using ST will be recruited into this AL study to evaluate elements of AL of six modern oral nicotine products compared to combustible cigarettes (CC) and nicotine polacrilex gum. An attempt will be made for at least one-third of the study population to include smokers using ST. Potential subjects will complete a pre-screening telephone interview. They will complete a Screening Visit to assess their eligibility within 45 days prior to check-in and enrollment. Starting on check in day (Day -1), subjects will check-in at the clinical site to complete procedures to confirm eligibility. Eligible subjects will be enrolled, randomized and confined for 10 days (9 nights). Prior to the first product acclimation period, subjects will conduct a product familiarization of three of the modern oral nicotine products. Subjects will be randomized to one of eight product use sequences (using a Williams Design) in which they will evaluate one IP in each of eight separate Test Sessions, such that each subject will evaluate eight IPs, including six modern oral nicotine products, and both a high-AL comparator (subject's usual brand \[UB\] cigarette) and a low-AL comparator (a commercially available nicotine replacement therapy \[NRT\] nicotine gum). On Day 2 and continuing through Day 9, subjects will participate in Test Sessions that will last approximately 4 hours. Each Test Session will include collection of both types of PD measures (subjective and physiological) and PK measures prior to, during, and following IP use. On the half day prior to each respective Test Session, a Product Acclimation Period will allow subjects ad libitum use of the subsequent IP (at least two trial uses) as per randomized sequence for product acclimation prior to use in the next day's Test Session. Subjects can also use their UB cigarettes ad libitum, until the 12-hour tobacco and nicotine abstinence period begins prior to each Test Session, as long as the minimum use requirement for randomized IP is met.

Conditions

• Smoking
• Tobacco Use

Interventions

Type	Name	Description
OTHER	Product A	Usual Brand (UB) filtered, menthol or non-menthol combustible cigarette
OTHER	Product B	Modern Nicotine Oral Product Cool Mint 6 mg Nicotine
OTHER	Product C	Modern Nicotine Oral Product Cool Mint 12 mg Nicotine
OTHER	Product D	Modern Nicotine Oral Product Cool Mint 15 mg Nicotine
OTHER	Product E	Modern Nicotine Oral Product Smooth 6 mg Nicotine
OTHER	Product F	Modern Nicotine Oral Product Wintergreen 6 mg Nicotine
OTHER	Product G	Modern Nicotine Oral Product Dragon Fruit 6 mg Nicotine
OTHER	Product N	Nicorette® White Ice Mint 4 mg nicotine gum

Timeline

• Start date: 2025-02-03
• Primary completion: 2025-03-05
• Completion: 2025-03-05
• First posted: 2025-01-16
• Last updated: 2025-12-23

Locations

2 sites across 1 country: United States