A Multi-Site Study to Assess Actual Use of a Heated Tobacco Product With Four Non-Combusted Cigarette Variants in Current Adult Smokers
Sponsor study identifier
observational
1,180
1 country
10
Study Start
October 26, 2021
Actual (reported)Primary Completion
March 8, 2022
Actual (reported)Study Completion
March 8, 2022
Actual (reported)This is a multi-site, open-label, 8-week, prospective observational study, conducted at multiple sites geographically dispersed within the U.S. The purpose of this Actual Use Study (AUS) is to investigate how U.S. adult tobacco consumers 21 to 60 years of age, inclusive, who typically smoke on average (≥5 cigarettes/day) on at least 20 out of the past 30 days will use a heated tobacco product comprising a heating device and four non-combusted cigarette variants (HTP Investigational Product \[IP\]) over a 6-week Actual Use Period (AUP) in their real-life/naturalistic environment and in the context of typical consumer marketing materials.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
March 8, 2022
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 20, 2021
Actual (reported)October 26, 2021
Actual (reported)November 2, 2021
Actual (reported)March 8, 2022
Actual (reported)March 8, 2022
Actual (reported)Number and Proportion of Established Users
Number and proportion of subjects who meet the definition of "established users" of the HTP IP
6 weeks
Number and Proportion of Established Users who reduce their CPD consumption
Number and proportion of subjects among "established users" of the HTP IP who reduce their CPD consumption by at least 50%
8 weeks
Descriptive weekly average CPD consumption
Descriptive weekly average CPD consumption per subject among all subjects who complete the study, including both established and non-established users of the HTP IP
8 weeks
A non-combusted cigarette used with heated tobacco device 20020064
A non-combusted cigarette used with heated tobacco device 20020064
The study sample will comprise generally healthy, U.S. adult tobacco consumers 21 to 60 years of age, inclusive, who are regular smokers (≥5 cigarettes/day) on at least 20 of 30 days, who are not currently quitting all Tobacco- and/or Nicotine-containing Product (TNP) use, and who have no intention of quitting all TNP use in the next three months (quitting CC use only is allowable). Once enrolled, subjects confirming an intent to quit all TNP use during the AUP will be discontinued. A recruiting target for younger smokers (21-30 years old) of approximately 15% will be established to ensure that they are sufficiently represented among the enrolled subjects.
Schlesinger Atlanta
Atlanta, Georgia, 30328, United States
Schlesinger Chicago
Chicago, Illinois, 60611, United States
Schlesinger Baltimore
Baltimore, Maryland, 21204, United States
Schlesinger Minneapolis
Edina, Minnesota, 55439, United States
Schlesinger Kansas City
Kansas City, Missouri, 64114, United States
Schlesinger St. Louis
St Louis, Missouri, 63131, United States
Schlesinger Charlotte
Charlotte, North Carolina, 28273, United States
Mandara Shetty
BAT/RAIS
1,180 participants (actual enrollment reported by the registry).
First Submitted
October 20, 2021
First Posted
November 2, 2021
Study Start
October 26, 2021
Actual (reported)A non-combusted cigarette used with heated tobacco device 20020064
A non-combusted cigarette used with heated tobacco device 20020064
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Schlesinger Nashville
Nashville, Tennessee, 37203, United States
Schlesinger Dallas
Dallas, Texas, 75254, United States
Schlesinger Houston
Houston, Texas, 77027, United States
Primary Completion
March 8, 2022
Actual (reported)Study Completion
March 8, 2022
Actual (reported)Last Updated
June 24, 2022
Record last verified: 2022-06
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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