NCT05363254

CSD200902: Assessment of Indoor Air Quality for a Heated Tobacco Product With Four Non-Combusted Cigarette Variants in an Environmental Testing Chamber

CSD200902: A Study to Assess Indoor Air Quality for a Heated Tobacco Product (20023145 and 20022187) With Four Non-Combusted Cigarette Variants (40007386, 42001399, 42001401, 42001402) in an Environmental Testing Chamber

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 120 (actual)
• Sponsor: RAI Services Company · Industry
• Sex: All
• Age: 21 Years
• Healthy volunteers: Accepted

Summary

This is a single-center, open-label, parallel-cohort study to measure and compare the levels of selected secondhand smoke (SHS) constituents of a heated tobacco product (HTP) against combustible cigarettes (CC) after ad libitum smoking sessions by generally healthy smokers in an environmental testing chamber (ETC). Evaluation of SHS constituents detected during non-smoking sessions will be performed as a control.

Detailed description

This study will recruit smokers of both non-menthol and menthol combustible cigarettes, and will allow users of non-menthol and menthol HTPs, and dual users of non-menthol and menthol CCs and HTPs. Safety will be monitored throughout the study by the Principal Investigator (PI) (or designee) by assessing adverse events (AEs), vital sign measurements, standard physical examinations (including oral examinations), electrocardiograms (ECGs), changes in clinical laboratory test results, and pregnancy testing. Potential subjects will complete a pre-screening telephone interview and a Screening Visit to assess their eligibility within 45 days prior to the Enrollment Visit. The Enrollment visit will occur at least 2 weeks prior to the start of the Chamber Visits. Subjects will be assigned to one of the ten study cohorts based on reported usual brand (UB) CCs and/or HTPs. Cohorts 1 and 2 will use UB CC, Marlboro Gold Box or Newport Box. Subjects in Cohorts 3 through 10 will be assigned to either a non-menthol or menthol HTP investigational products (IP) flavor cohort depending upon past flavor usage history. Subjects will either be assigned to the non-menthol HTP IP or to one of the three menthol HTP IPs after sampling or trying the three menthol HTP IPs and determining which menthol product they would like to use for the length of the study. Once a particular cohort has reached full enrollment, that flavor will no longer be available for sampling and selection. Subjects will be instructed not to use UB CC or HTP during the study. Subjects assigned to Cohorts 3 through 10 will participate in a 2-week HTP IP familiarization period (prior to Chamber Visit 1), during which subjects will be provided sufficient HTP IP for at-home ad libitum use. The HTP IP includes a battery-powered device, which electronically heats but does not burn tobacco, and requires a non-combusted cigarette, which is inserted into and heated by the HTP device during use. Once heated, the user can begin puffing in the same way as with a CC, on the filter end of the non-combusted cigarette.

Conditions

• Tobacco Use
• Smoking
• Tobacco Smoking

Interventions

Type	Name	Description
OTHER	Marlboro Gold Box	A combustible cigarette
OTHER	Newport Box	A combustible cigarette
OTHER	Non-combusted cigarette variant 42001401	A menthol flavor variant of a non-combusted cigarette (42001401)
OTHER	Non-combusted cigarette variant 42001399	A menthol flavor variant of a non-combusted cigarette (42001399)
OTHER	Non-combusted cigarette variant 40007386	A menthol flavor variant of a non-combusted cigarette (40007386)
OTHER	Non-combusted cigarette variant 42001402	A non-menthol flavor variant of a non-combusted cigarette (42001402)

Timeline

• Start date: 2022-05-23
• Primary completion: 2022-07-30
• Completion: 2022-07-30
• First posted: 2022-05-05
• Last updated: 2024-04-30

Locations

1 site across 1 country: United States