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Clinical Trial Summary

This is a single-center, open-label, randomized, 2-arm, within-arm 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.

Clinical Trial Description

Smokers of both non-menthol and menthol combustible cigarettes (CC) will be recruited into this AL study to evaluate elements of AL of four heated tobacco products (HTP) (hereinafter, HTP investigational products [IPs]) compared to combustible cigarette (CC) and nicotine polacrilex gum. 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 (inclusive of enrollment/randomization) and to determine their assignment to either Study Arm 1 (non-menthol smokers) or Study Arm 2 (menthol smokers). Enrollment and clinical conduct for each of the two Study Arms will occur sequentially. Starting on Day 1, subjects will check-in at the study site to complete procedures to confirm eligibility. Eligible subjects will be enrolled into the appropriate Study Arm and confined for either 11 days (Study Arm 1) or 13 days (Study Arm 2). Based on their Study Arm assignment, subjects will be randomized to a product use sequence (using a Williams Design) in which they will evaluate one IP in each Test Session, including 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). In addition to the AL-comparators, Study Arm 1 will evaluate three HTP IPs (i.e., 5 Test Sessions) and Study Arm 2 will evaluate four HTP IPs (i.e., 6 Test Sessions). On Day 1 and continuing through Day 11 (Study Arm 1) or Day 13 (Study Arm 2), 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. There will be a 1.5-day Product Acclimation Period prior to each Test Session. During the Product Acclimation Period, subjects will be permitted ad libitum use of randomized IP for familiarization prior to use in the next Test Session, as well as ad libitum smoking of their UB cigarettes. ;

Study Design

Related Conditions & MeSH terms

NCT number NCT05114863
Study type Interventional
Source RAI Services Company
Contact Kristen Prevette
Phone 336-741-1873
Email [email protected]
Status Not yet recruiting
Phase N/A
Start date November 29, 2021
Completion date February 28, 2022

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