NCT05184920|Completed
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Sponsor study identifier
observational
1,105
1 country
10
Study Start
January 19, 2022
Actual (reported)Primary Completion
April 29, 2022
Actual (reported)Study Completion
April 29, 2022
Actual (reported)The purpose of this Actual Use Study (AUS) is to investigate how U.S. adult tobacco consumers 21-60 years of age) who are regular smokers (≥5 cigarettes/day) on at least 20 days out of the past 30 days will use P10 and P13 nicotine pouches (Study 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. Subjects will self-report their ad libitum use of the Study IP as well as use of combustible cigarette (CC) and any other tobacco- or nicotine-containing product (TNP) on a daily basis using an electronic diary (eDiary). The study design is planned to address topics that FDA's Center for Tobacco Products (CTP) has identified as useful in evaluating new tobacco products.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
April 29, 2022
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
December 22, 2021
Actual (reported)January 11, 2022
Actual (reported)January 19, 2022
Actual (reported)April 29, 2022
Actual (reported)April 29, 2022
Actual (reported)Number and Proportion of Established Users
Number and proportion of subjects who meet the definition of "established users" of the Study IP
6 weeks
Number and Proportion of Established Users who reduce their CPD consumption
Number and proportion of subjects among "established users" 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 Study IP
8 weeks
P1012919, a nicotine pouch with 12 mg of nicotine
P1012915, a nicotine pouch with 8 mg of nicotine
The study sample will comprise approximately 1,200 generally healthy, U.S. adult tobacco consumer 21 to 60 years of age, inclusive, who are regular smokers (≥5 cigarettes/day) on at least 20 of the past 30 days, who are not currently quitting all TNP use, and who have no intention of quitting all TNP use in the next three months (intention of quitting CC use only is allowable). A recruiting target for younger smokers (21-30 years old) of approximately 15% will be established 15% to ensure that they are sufficiently represented among the enrolled subjects.
Schlesinger Phoenix
Phoenix, Arizona, 85016, United States
Schlesinger Atlanta
Atlanta, Georgia, 30328, United States
Schlesinger Chicago
Chicago, Illinois, 60611, United States
Schlesinger Kansas City
Kansas City, Missouri, 64114, United States
Schlesinger St. Louis
St Louis, Missouri, 63131, United States
Schlesinger New Jersey
Iselin, New Jersey, 08830, United States
Schlesinger Columbus
Columbus, Ohio, 43235, United States
Patrudu Makena, PhD
RAIS
1,105 participants (actual enrollment reported by the registry).
First Submitted
December 22, 2021
First Posted
January 11, 2022
Study Start
January 19, 2022
Actual (reported)P1313314, a nicotine pouch with 4 mg of nicotine
P1312815, a nicotine pouch with 8 mg of nicotine
P1012914, a nicotine pouch with 4 mg of nicotine
P1013315, a nicotine pouch with 8 mg of nicotine
P1013119, a nicotine pouch with 12 mg of nicotine
P1013218, a nicotine pouch with 10 mg of nicotine
P1012818, a nicotine pouch with 10 mg of nicotine
P1312915, a nicotine pouch with 8 mg of nicotine
P1312914, a nicotine pouch with 4 mg of nicotine
P1313015, a nicotine pouch with 8 mg of nicotine
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 Philadelphia
Philadelphia, Pennsylvania, 19103, United States
Schlesinger Dallas
Dallas, Texas, 75254, United States
Schlesinger Houston
Houston, Texas, 77027, United States
Primary Completion
April 29, 2022
Actual (reported)Study Completion
April 29, 2022
Actual (reported)Last Updated
June 27, 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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