CSD201204 An Actual Use Study of P12 Electronic Nicotine Delivery System Among U.S. Adult Smokers

Completed · Not applicable

Conditions studied: Smoking, Tobacco

In brief

The purpose of this Actual Use Study (AUS) is to investigate how United States (US) adult tobacco consumers 21 to 60 years of age, inclusive, who are regular smokers (≥5 cigarettes/day on at least 20 of the past 30 days) will use the Cartridge-based ENDS investigational products (Study IP) over a 6-week Actual Use Period (AUP) in their real-life/naturalistic environments. Subjects will be able to choose freely among the Study IP available in one of the three study arms to which they are randomly assigned. The three study arms are organized by Study IP flavor categories: tobacco, menthol, and non-tobacco-non-menthol (NTNM). Subjects will self-report their ad libitum use of the Study IP as well as use of Combustible Cigarettes (CC) and any other tobacco- and nicotine-containing product (TNP) on a daily basis using an electronic diary (eDiary).

Key facts

Study ID: NCT05960305
Run by: RAI Services Company
People needed: 1845
Starts: 2023-09-15
Expected to finish: 2024-01-28
Last updated by the study team: 2024-02-23

Who can join

Age: 21 and older, up to 60. Sex: any. Healthy volunteers: accepted.

You may qualify if…

1. Generally healthy adult males or females, 21-60 years old, inclusive, verified with government-issued photo ID.
Must be a current smoker of manufactured menthol and/or non-menthol cigarettes, has smoked at least 100 cigarettes in their lifetime, and smoked 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 (in the past 30 days).
Must indicate "an intention to use" (6 or higher on a 10-point Likert scale) for at least one Study IP flavor per arm across all three study arms after a brief review of the products and related information (i.e. User Guide and Handout MM) at the SEV.
Has not participated in any tobacco-, ENDS-, or nicotine-related research within 1 month of screening.
Must sign the Informed Consent Forms (ICFs) and thereby agree to participate in the 8-week study, comply with all study requirements, including eDiary reporting procedures and completion of questionnaires/eDiary in English, and agree that the Study IP received are for their own personal use and will not be shared with others.

You may not qualify if…

1. 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 prior to pre-screening).
Currently a regular ENDS user (using ENDS >3 days per week, in the past 30 days), based on self-report.
Female subjects who are pregnant or breastfeeding or planning to become pregnant or start breastfeeding within the next 6 months based on self-report.
Female subjects who state they are not using adequate methods to prevent pregnancy.
Female subjects (as assigned at birth) who do not have a definitive negative pregnancy test result at SEV.
Self-reports "poor" physical health
Self-reports "poor" mental health
Employees of a company that manufactures tobacco or ENDS products.

Where it is running

Sago Phoenix — Phoenix, Arizona, United States
Non Sago Ft Lauderdale — Fort Lauderdale, Florida, United States
SAGO Orlando — Orlando, Florida, United States
Non Sago Tampa — Tampa, Florida, United States
Sago Atlanta — Atlanta, Georgia, United States
Sago St. Louis — St Louis, Missouri, United States
Non-Sago Las Vegas — Las Vegas, Nevada, United States
Sago Philadelphia — Philadelphia, Pennsylvania, United States
Sago Nashville — Nashville, Tennessee, United States
Sago Dallas — Dallas, Texas, United States
Sago Houston — Houston, Texas, United States
Non Sago San Anotonio — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

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