NCT04372290

CSD190401: A Study to Assess Elements of Abuse Liability for Nicotine-containing Pouch Tobacco Products

CSD190401: An In-Clinic Confinement Study to Assess Elements of Abuse Liability for Nicotine-containing Pouch Tobacco Products

• 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 single site, open-label, randomized, 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 subjects.

Detailed description

Cigarette smokers (SMK) and smokers who also use smokeless tobacco (SST) \[e.g., snus, moist snuff\] will be recruited into the study. An attempt will be made to have approximately one third of the study population made up of SST. Potential subjects may complete a pre-Screening telephone interview and will complete a Screening Visit to assess their eligibility within 45 days prior to check-in and enrollment/randomization. Starting on Day -1, eligible subjects will begin confinement at the clinical site for 6 days. Subjects will be randomized to evaluate one investigational product (IP) in each of five separate Test Sessions, such that each subject will evaluate five IPs, including three strengths of the nicotine pouches, and both a high- and a low-AL comparator. Each Test Session will last for approximately 4 hours during and following IP use and will include collection of both PD measures (subjective and physiological) and PK measures. On Day -1, subjects will participate in an IP acclimation period where they will be instructed on how to use the nicotine pouch IP and the nicotine gum (low-AL comparator IP). At the end of the acclimation period, subjects will have access to their usual brand (UB) cigarettes for ad libitum use until the 12-hour tobacco abstinence begins prior to the Day 1 Test Session.

Conditions

• Smoking
• Smoking Behaviors
• Tobacco Use
• Tobacco Smoking

Interventions

Type	Name	Description
OTHER	Product A	Usual brand (UB) filtered, combustible cigarette
OTHER	Product B	Nicorette® White Ice Mint 2 mg nicotine gum
OTHER	Product C	CSD1904-01, a nicotine pouch, 2 mg nicotine
OTHER	Product D	CSD1904-02, a nicotine pouch, 4 mg nicotine
OTHER	Product E	CSD1904-02, a nicotine pouch, 8 mg nicotine (simultaneous use of two 4 mg nicotine pouches)

Timeline

• Start date: 2020-05-06
• Primary completion: 2020-06-04
• Completion: 2020-06-04
• First posted: 2020-05-04
• Last updated: 2020-09-25

Locations

1 site across 1 country: United States