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NCT04167384 · ClinicalTrials.gov registry record · NA
CSD190301: A Study to Assess Elements of Abuse Liability for Two Dissolvable Nicotine Lozenge Tobacco Products
A NA study, sponsored by RAI Services Company.
- Completed
- Registry status
- NA
- Development phase
- 69
- Enrollment target
NCT04167384: Completed NA study, sponsored by RAI Services Company.
NCT04167384 is a NA study that has completed, run by RAI Services Company. The registered enrollment target is 69 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (95% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04167384, a NA study, has completed, sponsored by RAI Services Company.
- COMPLETED
- Registry status
- NA
- Development phase
- 69 participants
- Enrollment target
Study Summary
This is a two-arm, single use, single-center, randomized, 10-sequence per arm, open-label, crossover pharmacokinetic/pharmacodynamic (PK/PD) study, designed to evaluate elements of abuse liability (AL) including subjective effects, plasma nicotine uptake, and physiological measures during and following ad libitum use of the study investigational products (IPs) by generally healthy subjects.
Primary Outcome
area under the effects curve (AUEC) for product liking (PL) Visual Analogue Scale (VAS) score-versus-time curve from 5 minutes to 360 minutes after the start of IP use. Data is collected from a 100 point VAS scale; Range from 0 = "Strongly dislike" to 100 = "Strongly Like"
Interventions
- OTHER Product A
- OTHER Product B
- OTHER Product C
- OTHER Product D
- OTHER Product E
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 69 participants |
| Start Date | 2019-12-02 |
| Est. Completion | 2020-02-28 |
| Phase | NA |
What the finished NCT04167384 record still lists
NCT04167384 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 69 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (95% lower).
The record links to 0 conditions, and to 5 interventions - of which Product A is the first listed.
NCT04167384 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04167384 about?
NCT04167384 is a clinical study titled "CSD190301: A Study to Assess Elements of Abuse Liability for Two Dissolvable Nicotine Lozenge Tobacco Products". This is a two-arm, single use, single-center, randomized, 10-sequence per arm, open-label, crossover pharmacokinetic/pharmacodynamic (PK/PD) study, designed to evaluate elements of abuse liability (AL) including subjective effects, plasma nicotine uptake, and physiological measures during and follow...
What is the current status of trial NCT04167384?
This trial is currently completed. It is a NA study. The enrollment target is 69 participants. The study started on 2019-12-02. Estimated completion is 2020-02-28.
What interventions are being tested in trial NCT04167384?
The interventions under investigation include: Product A (OTHER), Product B (OTHER), Product C (OTHER), Product D (OTHER), Product E (OTHER).
Who is sponsoring clinical trial NCT04167384?
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 NCT04167384's enrollment target sits among peer trials
69 1133rd of 2000 higher than 868 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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