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NCT05205382 · ClinicalTrials.gov registry record · NA
Assessing the Effect of Nicotine Reduction on ENDS User's Addiction and Exposures
A NA study, sponsored by Florida International University.
- Completed
- Registry status
- NA
- Development phase
- 116
- Enrollment target
NCT05205382: Completed NA study, sponsored by Florida International University.
NCT05205382 is a NA study that has completed, run by Florida International University. The registered enrollment target is 116 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (92% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05205382, a NA study, has completed, sponsored by Florida International University.
- COMPLETED
- Registry status
- NA
- Development phase
- 116 participants
- Enrollment target
Study Summary
The rapid increase of electronic nicotine delivery systems (ENDS) use by young people in the US and their potential to harm health, cause addiction, and serve as a risk for cigarette smoking or dual-use is alarming. The epidemic of ENDS use among young people in the US has been associated with the rise in popularity of ENDS products that are very efficient in delivering high doses of nicotine to users. Therefore, the investigators propose to study the effects of nicotine reduction (NR) on young ENDS users as a potential regulatory strategy to reduce the addictiveness and use of ENDS. The proposed studies are directly responsive to research priories identified by the FDA and specified in this RFA under Addiction; studying the "Impact of changes in tobacco product characteristics (e.g. nicotine formulation) on dependence". This project aims to provide an overview of this project's rationale significance divided into 1) scientific rationale and regulatory implications; 2) the need to respond to the rising trend of ENDS use among young people in the US; 3) the importance of reducing the addictiveness of ENDS; 4) the strength of our clinical and analytical lab approach for regulatory purposes; and 5) the strengths and weaknesses in the rigor of prior research about NR for ENDS.
Primary Outcome
Change in plasma nicotine level. The plasma nicotine boost was calculated by subtracting the preplasma nicotine value from the postplasma value.
Interventions
- OTHER 5% nicotine
- OTHER 3% nicotine
- OTHER 0% nicotine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 116 participants |
| Start Date | 2022-04-01 |
| Est. Completion | 2025-04-15 |
| Phase | NA |
What the finished NCT05205382 record still lists
NCT05205382 is an interventional study that assigns participants to a tested intervention. The registered 116 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (92% lower).
The record links to 0 conditions, and to 3 interventions - of which 5% nicotine is the first listed.
NCT05205382 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05205382 about?
NCT05205382 is a clinical study titled "Assessing the Effect of Nicotine Reduction on ENDS User's Addiction and Exposures". The rapid increase of electronic nicotine delivery systems (ENDS) use by young people in the US and their potential to harm health, cause addiction, and serve as a risk for cigarette smoking or dual-use is alarming. The epidemic of ENDS use among young people in the US has been associated with the r...
What is the current status of trial NCT05205382?
This trial is currently completed. It is a NA study. The enrollment target is 116 participants. The study started on 2022-04-01. Estimated completion is 2025-04-15.
What interventions are being tested in trial NCT05205382?
The interventions under investigation include: 5% nicotine (OTHER), 3% nicotine (OTHER), 0% nicotine (OTHER).
Who is sponsoring clinical trial NCT05205382?
This trial is sponsored by Florida International University, which has 89 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05205382's enrollment target sits among peer trials
116 808th of 2000 higher than 1,191 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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