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NCT05294497 · ClinicalTrials.gov registry record · NA
CSD201301: Study to Assess Elements of Abuse Liability for Four P13 Nicotine Pouches
A NA study of Smoking and Tobacco Use, sponsored by RAI Services Company.
- Completed
- Registry status
- NA
- Development phase
- 42
- Enrollment target
- 2
- Study locations
NCT05294497: Completed NA study of Smoking and Tobacco Use, sponsored by RAI Services Company.
NCT05294497 is a NA study of Smoking and Tobacco Use that has completed, run by RAI Services Company. The registered enrollment target is 42 participants, below the 455-participant average among 123 other Smoking trials with a reported enrollment target (91% lower). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05294497, a NA study of Smoking and Tobacco Use, has completed, sponsored by RAI Services Company.
- COMPLETED
- Registry status
- NA
- Development phase
- 42 participants
- Enrollment target
- 2
- Study locations
Study Summary
This is a two-site, open-label, randomized, 6-way cross-over study designed to evaluate elements of abuse liability (AL) including subjective effects and physiological measures (pharmacodynamics \[PD\]) and plasma nicotine uptake (pharmacokinetics \[PK\]) during and following ad libitum use of the study investigational products (IPs) by generally healthy smokers.
Primary Outcome
area-under-the-effects curve (AUEC) for PL numeric rating scale (NRS) score-versus-time curve from 5 minutes to 240 minutes after the start of IP use. Product Liking is a numeric rating scale ranging from 0 to 10. A higher score indicates a higher liking of the product.
Conditions Studied
Interventions
- OTHER Product A
- OTHER Product B
- OTHER Product C
- OTHER Product D
- OTHER Product N
Study Locations (2)
Kentucky
- AMR Lexington - Lexington
Tennessee
- AMR Knoxville - Knoxville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 42 participants |
| Start Date | 2022-05-01 |
| Est. Completion | 2022-05-27 |
| Phase | NA |
What the finished NCT05294497 record still lists
NCT05294497 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 42 participants, a relatively small participant target, below the 455-participant average among 123 other Smoking trials with a reported enrollment target (91% lower).
The record links to 3 conditions, with Smoking appearing as the primary indexed condition, and to 5 interventions - of which Product A is the first listed.
NCT05294497 reports a single indexed study location in Kentucky, Tennessee.
Frequently Asked Questions
What is clinical trial NCT05294497 about?
NCT05294497 is a clinical study titled "CSD201301: Study to Assess Elements of Abuse Liability for Four P13 Nicotine Pouches". This is a two-site, open-label, randomized, 6-way cross-over study designed to evaluate elements of abuse liability (AL) including subjective effects and physiological measures (pharmacodynamics \[PD\]) and plasma nicotine uptake (pharmacokinetics \[PK\]) during and following ad libitum use of the s...
What is the current status of trial NCT05294497?
This trial is currently completed. It is a NA study. The enrollment target is 42 participants. The study started on 2022-05-01. Estimated completion is 2022-05-27.
What conditions does trial NCT05294497 study?
This clinical trial studies the following conditions: Smoking, Tobacco Use, Tobacco Smoking.
What interventions are being tested in trial NCT05294497?
The interventions under investigation include: Product A (OTHER), Product B (OTHER), Product C (OTHER), Product D (OTHER), Product N (OTHER).
Who is sponsoring clinical trial NCT05294497?
This trial is sponsored by RAI Services Company, which has 42 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05294497 being conducted?
This trial has 2 study locations across Kentucky, Tennessee. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Smoking
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05294497's enrollment target sits among peer trials
42 99th of 123 higher than 24 of 123 other Smoking trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Smoking 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.
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