CSD201004: An Actual Use Study of P10 and P13 Nicotine Pouches Among U.S. Adult Smokers

NCT05184920 | Completed

• 1 other identifier: CSD201004
• Study Type: observational
• Target: 1,105
• Locations: 1 country
• Sites: 10

Brief Summary

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.

Conditions

Smoking; Tobacco Use; Tobacco Smoking

Outcome Measures

Primary Outcomes (3)

• 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

Interventions

P1012919 nicotine pouch OTHER

P1012919, a nicotine pouch with 12 mg of nicotine

P1012915 nicotine pouch OTHER

P1012915, a nicotine pouch with 8 mg of nicotine

P1012914 nicotine pouch OTHER

P1012914, a nicotine pouch with 4 mg of nicotine

P1013315 nicotine pouch OTHER

P1013315, a nicotine pouch with 8 mg of nicotine

P1013119 nicotine pouch OTHER

P1013119, a nicotine pouch with 12 mg of nicotine

P1013218 nicotine pouch OTHER

P1013218, a nicotine pouch with 10 mg of nicotine

P1012818 nicotine pouch OTHER

P1012818, a nicotine pouch with 10 mg of nicotine

P1312915 nicotine pouch OTHER

P1312915, a nicotine pouch with 8 mg of nicotine

P1312914 nicotine pouch OTHER

P1312914, a nicotine pouch with 4 mg of nicotine

P1313015 nicotine pouch OTHER

P1313015, a nicotine pouch with 8 mg of nicotine

P1313314 nicotine pouch OTHER

P1313314, a nicotine pouch with 4 mg of nicotine

P1312815 nicotine pouch OTHER

P1312815, a nicotine pouch with 8 mg of nicotine

Eligibility Criteria

• Age: 21 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• Adult males or females, 21-60 years old, inclusive, verified with government-issued photo ID.
• Must be a current smoker of factory-made filtered menthol and/or non-menthol cigarettes, has smoked at least 100 cigarettes in their lifetime, and typically smokes on at least 20 days out of the past 30 days.
• Must indicate "an intention to use" Study IP after a brief review of product information and product demonstration at the SEV. Subjects will not try the product at the SEV.
• Available and interested in participating in an 8-week study about the Study IP.
• Able and willing to comply with all study requirements, including questionnaires, the eDiary reporting procedures, and provide valid contact information.
• Able to read, understand, and willing to sign Informed Consent Forms (ICFs) and complete questionnaires written in English.
• Has not participated in any tobacco-, vapor-, or nicotine-related research within 3 months of screening.
• Agrees that the IP received are for their own personal use and they will not share the product with others.
• Agrees to restrict use of Study IP to only the investigational products (specified flavors, nicotine levels, and pouch sizes) supplied by the study Sponsor free of charge and labeled as "For Investigational Use Only" and to not obtain/use any other nicotine pouch products from other commercial sources.

You may not qualify if:

• Self-reports as currently quitting or intending to quit within the next 3 months all tobacco or nicotine product use ("currently" is defined as within (≤) 30 days). Those who intend to quit CC only can be enrolled.
• Must not be an ever-user of any nicotine pouches prior to screening.
• Female subjects who are currently pregnant or breastfeeding or planning to become pregnant or start breastfeeding within the next 6 months based on self-report.
• Female subjects who self-report they are not using adequate methods to prevent pregnancy.
• Self-reports "poor" physical health (based on the five-category Population Assessment of Tobacco and Health (PATH) questionnaire): "In general, how would you rate your physical health?" (Response choices: Excellent, Very Good, Good, Fair, Poor).
• Self-reports "poor" mental health (based on the five-category PATH questionnaire): "In general, how would you rate your mental health?" (Response choices: Excellent, Very Good, Good, Fair, Poor).
• Employees of tobacco or vapor companies.

Sponsors & Collaborators

• RAI Services Company: lead

Study Sites (10)

Schlesinger Phoenix

Phoenix, Arizona, 85016, United States

Location

Schlesinger Atlanta

Atlanta, Georgia, 30328, United States

Location

Schlesinger Chicago

Chicago, Illinois, 60611, United States

Location

Schlesinger Kansas City

Kansas City, Missouri, 64114, United States

Location

Schlesinger St. Louis

St Louis, Missouri, 63131, United States

Location

Schlesinger New Jersey

Iselin, New Jersey, 08830, United States

Location

Schlesinger Columbus

Columbus, Ohio, 43235, United States

Location

Schlesinger Philadelphia

Philadelphia, Pennsylvania, 19103, United States

Location

Schlesinger Dallas

Dallas, Texas, 75254, United States

Location

Schlesinger Houston

Houston, Texas, 77027, United States

Location

MeSH Terms

Conditions

Smoking; Tobacco Use; Tobacco Smoking

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Patrudu Makena, PhD

  RAIS

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 22, 2021
• First Posted: January 11, 2022
• Study Start: January 19, 2022
• Primary Completion: April 29, 2022
• Study Completion: April 29, 2022
• Last Updated: June 27, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (10)