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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
42
New Orleans Center for Clinical Research (NOCCR)
Knoxville, Tennessee, United States
AUECPL 5-240
area-under-the-effects curve (AUEC) for PL numeric rating scale (NRS) score-versus-time curve from 5 minutes to 240 minutes after the start of IP use.
Time frame: 5 minutes to 240 minutes
Emax PL
maximum product liking (PL) numeric rating scale (NRS) score after the start of IP use.
Time frame: 240 minutes
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CSD1904-02, a nicotine pouch, 4 mg nicotine
CSD1904-02, a nicotine pouch, 8 mg nicotine (simultaneous use of two 4 mg nicotine pouches)