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NCT05184920 · ClinicalTrials.gov registry record
CSD201004: An Actual Use Study of P10 and P13 Nicotine Pouches Among U.S. Adult Smokers
A clinical trial, sponsored by RAI Services Company.
- Completed
- Registry status
- 1,105
- Enrollment target
NCT05184920: Completed study, sponsored by RAI Services Company.
NCT05184920 is a clinical trial that has completed, run by RAI Services Company. The registered enrollment target is 1,105 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05184920 has completed, sponsored by RAI Services Company.
- COMPLETED
- Registry status
- 1,105 participants
- Enrollment target
Study 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 days will use P10 and P13 nicotine pouches (Study Investigational Product \[IP\]) over a 6-week Actual Use Period (AUP) in their real-life/naturalistic environment and in the context of typical consumer marketing materials. Subjects will self-report their ad libitum use of the Study IP as well as use of combustible cigarette (CC) and any other tobacco- or nicotine-containing product (TNP) on a daily basis using an electronic diary (eDiary). The study design is planned to address topics that FDA's Center for Tobacco Products (CTP) has identified as useful in evaluating new tobacco products.
Primary Outcome
Number and proportion of subjects who meet the definition of "established users" of the Study IP
Interventions
- OTHER P1012919 nicotine pouch
- OTHER P1012915 nicotine pouch
- OTHER P1012914 nicotine pouch
- OTHER P1013315 nicotine pouch
- OTHER P1013119 nicotine pouch
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,105 participants |
| Start Date | 2022-01-19 |
| Est. Completion | 2022-04-29 |
What the finished NCT05184920 record still lists
NCT05184920 is an observational study that tracks outcomes without assigning an intervention. Its 1,105 participants enrollment target places it among the larger protocols in the corpus.
The record links to 0 conditions, and to 5 interventions - of which P1012919 nicotine pouch is the first listed.
NCT05184920 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05184920 about?
NCT05184920 is a clinical study titled "CSD201004: An Actual Use Study of P10 and P13 Nicotine Pouches Among U.S. Adult Smokers". 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 days will use P10 and P13 nicotine pouches (Study Investigational Product \[IP\]) over a 6-week Actual ...
What is the current status of trial NCT05184920?
This trial is currently completed. The enrollment target is 1,105 participants. The study started on 2022-01-19. Estimated completion is 2022-04-29.
What interventions are being tested in trial NCT05184920?
The interventions under investigation include: P1012919 nicotine pouch (OTHER), P1012915 nicotine pouch (OTHER), P1012914 nicotine pouch (OTHER), P1013315 nicotine pouch (OTHER), P1013119 nicotine pouch (OTHER).
Who is sponsoring clinical trial NCT05184920?
This trial is sponsored by RAI Services Company, which has 42 total clinical trials registered on ClinicalTrials.gov.
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