CSD201004: An Actual Use Study of P10 and P13 Nicotine Pouches Among U.S. Adult Smokers
Public ClinicalTrials.gov record NCT05184920. 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.
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 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.
Study identification
- NCT ID
- NCT05184920
- Recruitment status
- Completed
- Study type
- Observational
- Phase
- Not listed
- Enrollment
- 1,105 participants
Conditions and interventions
Conditions
Interventions
- P1012919 nicotine pouch Other
- P1012915 nicotine pouch Other
- P1012914 nicotine pouch Other
- P1013315 nicotine pouch Other
- P1013119 nicotine pouch Other
- P1013218 nicotine pouch Other
- P1012818 nicotine pouch Other
- P1312915 nicotine pouch Other
- P1312914 nicotine pouch Other
- P1313015 nicotine pouch Other
- P1313314 nicotine pouch Other
- P1312815 nicotine pouch Other
Other
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
- Jan 19, 2022 (Actual)
- Primary completion
- Apr 29, 2022 (Actual)
- Completion
- Apr 29, 2022 (Actual)
- Last update posted
- Jun 27, 2022
2022
United States locations
- U.S. sites
- 10
- U.S. states
- 8
- U.S. cities
- 10
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Schlesinger Phoenix | Phoenix | Arizona | 85016 | — |
| Schlesinger Atlanta | Atlanta | Georgia | 30328 | — |
| Schlesinger Chicago | Chicago | Illinois | 60611 | — |
| Schlesinger Kansas City | Kansas City | Missouri | 64114 | — |
| Schlesinger St. Louis | St Louis | Missouri | 63131 | — |
| Schlesinger New Jersey | Iselin | New Jersey | 08830 | — |
| Schlesinger Columbus | Columbus | Ohio | 43235 | — |
| Schlesinger Philadelphia | Philadelphia | Pennsylvania | 19103 | — |
| Schlesinger Dallas | Dallas | Texas | 75254 | — |
| Schlesinger Houston | Houston | Texas | 77027 | — |
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 NCT05184920, 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 Jun 27, 2022 · Synced Oct 26, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT05184920 live on ClinicalTrials.gov.