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NCT05706701 · ClinicalTrials.gov registry record · NA
Nicotine Flux, a Potentially Powerful Tool for Regulating Nicotine Delivery From Electronic Cigarettes
A NA study of Nicotine Vaping, sponsored by Yale University.
- Completed
- Registry status
- NA
- Development phase
- 36
- Enrollment target
- 1
- Study location
NCT05706701: Completed NA study of Nicotine Vaping, sponsored by Yale University.
NCT05706701 is a NA study of Nicotine Vaping that has completed, run by Yale University. The registered enrollment target is 36 participants, below the 343-participant average among 5 other Nicotine Vaping trials with a reported enrollment target (90% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05706701, a NA study of Nicotine Vaping, has completed, sponsored by Yale University.
- COMPLETED
- Registry status
- NA
- Development phase
- 36 participants
- Enrollment target
- 1
- Study location
Study Summary
The investigators will examine the relationship between nicotine flux, nicotine form, and the rate and dose of nicotine delivery. Participants will puff on electronic nicotine delivery system (ENDS) devices under conditions that differ by flux and form, while arterial blood is sampled in high time resolution. The outcome will indicate the degree to which nicotine flux and form determine the speed and dose of ENDS nicotine delivery, and thus, abuse liability.
Primary Outcome
For arterial blood sampling, a radial arterial line will be placed on the non-dominant side to provide access to blood samples during vaping sessions. Blood will be sampled 30sec prior to the initial puff, 5, 15, and 25sec after each puff, and 60sec after the last puff of a bout (3 puffs per bout; 4 bouts per visit day; two visit days, separated by three weeks). The obtained data will be used to calculate pharmacokinetic parameters of nicotine delivery under each condition.
Conditions Studied
Interventions
- OTHER Nicotine vaping visit 1 (free-base nicotine)
- OTHER Nicotine vaping visit 1 (protonated nicotine)
- OTHER Nicotine vaping visit 2 (free-base nicotine)
- OTHER Nicotine vaping visit 2 (protonated nicotine)
Study Locations (1)
Connecticut
- Human Research Unit (HRU) - New Haven
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 36 participants |
| Start Date | 2023-02-01 |
| Est. Completion | 2024-05-17 |
| Phase | NA |
What the finished NCT05706701 record still lists
NCT05706701 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 36 participants, a relatively small participant target, below the 343-participant average among 5 other Nicotine Vaping trials with a reported enrollment target (90% lower).
The record links to 1 condition, with Nicotine Vaping appearing as the primary indexed condition, and to 4 interventions - of which Nicotine vaping visit 1 (free-base nicotine) is the first listed.
NCT05706701 reports a single indexed study location in Connecticut.
Frequently Asked Questions
What is clinical trial NCT05706701 about?
NCT05706701 is a clinical study titled "Nicotine Flux, a Potentially Powerful Tool for Regulating Nicotine Delivery From Electronic Cigarettes". The investigators will examine the relationship between nicotine flux, nicotine form, and the rate and dose of nicotine delivery. Participants will puff on electronic nicotine delivery system (ENDS) devices under conditions that differ by flux and form, while arterial blood is sampled in high time r...
What is the current status of trial NCT05706701?
This trial is currently completed. It is a NA study. The enrollment target is 36 participants. The study started on 2023-02-01. Estimated completion is 2024-05-17.
What conditions does trial NCT05706701 study?
This clinical trial studies the following conditions: Nicotine Vaping.
What interventions are being tested in trial NCT05706701?
The interventions under investigation include: Nicotine vaping visit 1 (free-base nicotine) (OTHER), Nicotine vaping visit 1 (protonated nicotine) (OTHER), Nicotine vaping visit 2 (free-base nicotine) (OTHER), Nicotine vaping visit 2 (protonated nicotine) (OTHER).
Who is sponsoring clinical trial NCT05706701?
This trial is sponsored by Yale University, which has 1,492 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05706701 being conducted?
This trial has 1 study location across Connecticut. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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