NCT07132814

Abuse Liability for Five Modern Oral Nicotine Products

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

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

Summary

This is a two-site, open-label, randomized, 4-way (2 arm) 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 of (only) filtered menthol and/or non-menthol cigarettes naïve to smokeless tobacco products (ST) and/or modern oral tobacco (MO) products and smokers also using ST and/or MO will be recruited into this AL study to evaluate elements of AL of five modern oral nicotine products (hereinafter, Study IPs) compared to combustible cigarettes (CC) only (Arm 1) and combustible and and nicotine polacrilex gum (Arm 2). An attempt will be made for at least one-third of the study population to include smokers using ST and/or MO for each arm. Potential participants 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), participants will check-in at the clinical site to complete procedures to confirm eligibility. Eligible participants will be enrolled, randomized and confined for 6 days (5 nights). Participants will be randomized to a product use sequences (using a Williams Design) in which they will evaluate one IP in each of four separate Test Sessions, such that each participant will evaluate four IPs; Arm 1: Product C (8 and 12 mg), Product D 4 mg, and a high-AL comparator (participant's usual brand \[UB\] cigarette) or (Arm 2): Product B 8 mg, Product C 8 mg, a high-AL comparator (participant's usual brand \[UB\] cigarette), and a low-AL comparator (a commercially available nicotine replacement therapy \[NRT\] nicotine gum). On Day 1 and continuing through Day 4 for both study arms, participants 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. Following each test session, used IP will be collected, stored at -20°C, and shipped to a laboratory of the sponsor's choosing. For both study arms, on the half day prior to each respective Test Session, a Product Acclimation Period will allow participants 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. Participants 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. Used IP from each of the Product Acclimation periods will be collected, stored at -20°C, and shipped to a laboratory of the sponsor's choosing. Safety will be monitored throughout the study by the Principal Investigator (PI) (or designee) by assessing adverse events (AEs), vital sign measurements, physical examinations (including an oral examination), and clinical laboratory tests. The Medical Monitor will be available for consultation during the duration of the study and for any follow-ups after study discharge.

Conditions

• Smoking
• Smoking Behaviors
• Tobacco Use
• Tobacco Smoking

Interventions

Type	Name	Description
OTHER	Product A	Usual Brand (UB) filtered, non-menthol or menthol combustible cigarette
OTHER	Product B	8 mg nicotine oral product
OTHER	Product C	12 mg nicotine oral product
OTHER	Product D	6 mg nicotine oral product
OTHER	Product E	8 mg nicotine oral product
OTHER	Product F	8 mg nicotine oral product
OTHER	Product N	Nicorette® White Ice Mint 4 mg nicotine polacrilex gum

Timeline

• Start date: 2025-12-15
• Primary completion: 2026-04-15
• Completion: 2026-08-31
• First posted: 2025-08-20
• Last updated: 2025-12-30

Locations

1 site across 1 country: United States