CompletedNot Applicable

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

United States1,845 participantsStarted 2023-09-15

Plain-language summary

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).

Who can participate

Age range

21 Years – 60 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 1\. Generally healthy adult males or females, 21-60 years old, inclusive, verified with government-issued photo ID. 2\. 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. 3\. Smokes, on average, ≥ 5 Combustible cigarettes per day (CPD) on days when cigarettes are smoked (in the past 30 days). 4\. 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. 5\. Has not participated in any tobacco-, ENDS-, or nicotine-related research within 1 month of screening. 6\. 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. Exclusion Criteria: * 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). 2\. Currently a regular ENDS user (using ENDS \>3 days per week, in the past 30 days), based on self-report. 3…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Number and proportion of subjects who reduce their cigarettes per day (CPD).

Timeframe: 6 weeks

CPD mean percent reduction

Timeframe: 6 weeks

Trial details

NCT IDNCT05960305

SponsorRAI Services Company

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-01-22

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