Smoking Clinical Trial
Official title:
CSD190401: An In-Clinic Confinement Study to Assess Elements of Abuse Liability for Nicotine-containing Pouch Tobacco Products
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.
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