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Clinical Trial Summary

This is a randomized, open-label, 6-way crossover, multi-site study designed to evaluate elements of abuse liability (AL) including subjective effects and physiological measures (pharmacodynamics [PD]), and nicotine uptake (pharmacokinetics [PK]) during and following ad libitum use of the Electronic Nicotine Delivery Systems (ENDS) investigational products (IPs) in generally healthy combustible cigarette (CC) smokers and dual users of CC and ENDS.


Clinical Trial Description

The study will evaluate elements of AL of ENDS IPs against CC and nicotine polacrilex gum in generally healthy menthol CC smokers of and dual users of CC and ENDS in a confinement setting. Potential subjects will complete a pre-screening interview and a Screening Visit to assess eligibility within 45 days prior to enrollment, randomization and confinement. Starting on Study Day 1, eligible subjects will be randomized to 1 of 6 IP use sequences (based on a Williams Design) and will be confined at the clinical site for 8 days and 7 nights to complete the study. On Day 3 and continuing through Day 8, subjects in each arm will participate in six separate Test Sessions, one for each IP, that will last for approximately 4 hours following the start of IP use. During each Test Session, subjects will use one of the six IPs: four ENDS IPs, a high-AL comparator (subject's UB cigarette) and a low-AL comparator (a commercially available nicotine gum for nicotine replacement therapy), based on the assigned IP use sequences. ENDS IP cartridges will be weighed prior to and after product use in the Test Session. Each Test Session will include collection of both PD measures (subjective and physiological) and PK measures prior to, during, and following IP use. Subjects will acclimate to the assigned products prior to each Test Session. On Study Day 1 (Pre-study Product Acclimation Period), subjects will use each of five IPs (four ENDS IPs and one nicotine gum) at least once. In addition, on the half day prior to each respective Test Session (Starting on Day 2), subjects will participate in a Product Acclimation Period in which they will use the randomized IP (to be tested during the following day's Test Session, to include ENDS or nicotine gum) at least four times . Subjects will have access to UB cigarette for ad libitum use at any time during Pre-Study Product Acclimation period and Product Acclimation Periods as long as they meet the IP acclimation criteria. At the end of each Product Acclimation Period, there will be a required 12-hour abstinence period from use of tobacco/nicotine containing products prior to the Test Session the following day. The study will complete when all six IPs have been tested. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05210699
Study type Interventional
Source RAI Services Company
Contact
Status Completed
Phase N/A
Start date March 21, 2022
Completion date May 17, 2022

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