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NCT05960305 · ClinicalTrials.gov registry record · NA
CSD201204 An Actual Use Study of P12 Electronic Nicotine Delivery System Among U.S. Adult Smokers
A NA study, sponsored by RAI Services Company.
- Completed
- Registry status
- NA
- Development phase
- 1,845
- Enrollment target
NCT05960305: Completed NA study, sponsored by RAI Services Company.
NCT05960305 is a NA study that has completed, run by RAI Services Company. The registered enrollment target is 1,845 participants, above the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (31% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05960305, a NA study, has completed, sponsored by RAI Services Company.
- COMPLETED
- Registry status
- NA
- Development phase
- 1,845 participants
- Enrollment target
Study 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).
Primary Outcome
Number and proportion of subjects who reduce their cigarettes per day (CPD) consumption by at least 50% at Week 6 compared to baseline among all subjects who complete the study.
Interventions
- OTHER P1213416
- OTHER P1213422
- OTHER P1213716
- OTHER P1213722
- OTHER P1211216
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,845 participants |
| Start Date | 2023-09-15 |
| Est. Completion | 2024-01-28 |
| Phase | NA |
What the finished NCT05960305 record still lists
NCT05960305 is an interventional study that assigns participants to a tested intervention. Its 1,845 participants enrollment target places it among the larger protocols in the corpus, above the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (31% higher).
The record links to 0 conditions, and to 5 interventions - of which P1213416 is the first listed.
NCT05960305 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05960305 about?
NCT05960305 is a clinical study titled "CSD201204 An Actual Use Study of P12 Electronic Nicotine Delivery System Among U.S. Adult Smokers". 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-...
What is the current status of trial NCT05960305?
This trial is currently completed. It is a NA study. The enrollment target is 1,845 participants. The study started on 2023-09-15. Estimated completion is 2024-01-28.
What interventions are being tested in trial NCT05960305?
The interventions under investigation include: P1213416 (OTHER), P1213422 (OTHER), P1213716 (OTHER), P1213722 (OTHER), P1211216 (OTHER).
Who is sponsoring clinical trial NCT05960305?
This trial is sponsored by RAI Services Company, which has 42 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05960305's enrollment target sits among peer trials
1,845 57th of 2000 higher than 1,944 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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