CSD201204 An Actual Use Study of P12 Electronic Nicotine Delivery System Among U.S. Adult Smokers
Public ClinicalTrials.gov record NCT05960305. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Multi-Site Randomized Actual Use Study of Electronic Nicotine Delivery System (P12) Products Among Current U.S. Adult Smokers to Assess the Relative Impact of Availability and Use of Different E-liquid Flavors on Changes in Cigarette Consumption
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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).
Study identification
- NCT ID
- NCT05960305
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Not applicable
- Enrollment
- 1,845 participants
Conditions and interventions
Eligibility (public fields only)
- Age range
- 21 Years to 60 Years
- Sex
- All
- Healthy volunteers
- Accepts healthy volunteers
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Sep 14, 2023
- Primary completion
- Jan 21, 2024
- Completion
- Jan 27, 2024
- Last update posted
- Feb 22, 2024
2023 – 2024
United States locations
- U.S. sites
- 12
- U.S. states
- 8
- U.S. cities
- 12
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Sago Phoenix | Phoenix | Arizona | 85016 | — |
| Non Sago Ft Lauderdale | Fort Lauderdale | Florida | 33309 | — |
| SAGO Orlando | Orlando | Florida | 32751 | — |
| Non Sago Tampa | Tampa | Florida | 33634 | — |
| Sago Atlanta | Atlanta | Georgia | 30328 | — |
| Sago St. Louis | St Louis | Missouri | 63131 | — |
| Non-Sago Las Vegas | Las Vegas | Nevada | 89119 | — |
| Sago Philadelphia | Philadelphia | Pennsylvania | 19103 | — |
| Sago Nashville | Nashville | Tennessee | 37203 | — |
| Sago Dallas | Dallas | Texas | 75254 | — |
| Sago Houston | Houston | Texas | 77027 | — |
| Non Sago San Anotonio | San Antonio | Texas | 78229 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT05960305, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Feb 22, 2024 · Synced Sep 2, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT05960305 live on ClinicalTrials.gov.