Status:
COMPLETED
CSD201004: An Actual Use Study of P10 and P13 Nicotine Pouches Among U.S. Adult Smokers
Lead Sponsor:
RAI Services Company
Conditions:
Smoking
Tobacco Use
Eligibility:
All Genders
21-60 years
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 day...
Detailed Description
The AUS is a multi-site, open-label, 8-week, prospective observational study, conducted at multiple sites geographically dispersed within the U.S. Adult smokers will be recruited, and candidate subje...
Eligibility Criteria
Inclusion
- 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.
- Smokes on average ≥ 5 combustible cigarettes per day (CPD) on days when cigarettes are smoked. (There are no other requirements or exclusions regarding other TNP use. Dual and poly-users may enroll if they fulfill the cigarette use requirements.)
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
January 19 2022
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
April 29 2022
Estimated Enrollment :
1105 Patients enrolled
Trial Details
Trial ID
NCT05184920
Start Date
January 19 2022
End Date
April 29 2022
Last Update
June 27 2022
Active Locations (10)
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1
Schlesinger Phoenix
Phoenix, Arizona, United States, 85016
2
Schlesinger Atlanta
Atlanta, Georgia, United States, 30328
3
Schlesinger Chicago
Chicago, Illinois, United States, 60611
4
Schlesinger Kansas City
Kansas City, Missouri, United States, 64114