NCT05294497

CSD201301: Study to Assess Elements of Abuse Liability for Four P13 Nicotine Pouches

CSD201301: An In-Clinic Confinement Study to Assess Elements of Abuse Liability for Four P13 Nicotine Pouches

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 42 (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, 6-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 and smokers also using smokeless tobacco products (ST) will be recruited into this AL study to evaluate elements of AL of four nicotine pouches compared to combustible cigarettes (CC) and nicotine polacrilex gum. At least one-third of the study population will include smokers using ST. Potential subjects may 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 Day 1, subjects will check-in at the clinical site to complete procedures to confirm eligibility. Eligible subjects will be enrolled and confined for 7 days. Subjects will be randomized to one of 6 product sequences (using a Williams Design) in which they will evaluate one IP in each of six separate Test Sessions, such that each subject will evaluate six IPs, including four nicotine pouch IPs, 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 7, subjects will participate in Test Sessions that will last for approximately 4 hours. Each Test Session will include collection of both 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 randomized IP (at least two trial uses) for product familiarization prior to use in the next day's Test Session. Subjects can also use their UB cigarettes ad libitum, until the 12-hour tobacco abstinence begins prior to each Test Session, as long as the minimum use requirement for randomized IP is met.

Conditions

• Smoking
• Tobacco Use
• Tobacco Smoking

Interventions

Type	Name	Description
OTHER	Product A	Usual Brand (UB) filtered, non-menthol or menthol cigarette
OTHER	Product B	Flavor variant P1312914 of a nicotine pouch product with 4 mg of nicotine
OTHER	Product C	Flavor variant P1312915 of a nicotine pouch product with 8 mg of nicotine
OTHER	Product D	Flavor variant P1313014 of a nicotine pouch product with 4 mg of nicotine
OTHER	Product N	Nicorette® White Ice Mint 4 mg nicotine gum
OTHER	Product E	Flavor variant P1313015 of a nicotine pouch product with 8 mg of nicotine

Timeline

• Start date: 2022-05-01
• Primary completion: 2022-05-27
• Completion: 2022-05-27
• First posted: 2022-03-24
• Last updated: 2022-06-29

Locations

2 sites across 1 country: United States