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NCT05159934 · ClinicalTrials.gov registry record · Phase 1
Nicotine Differences in Smokers
A Phase 1 study of Nicotine Dependence, sponsored by Yale University.
- Completed
- Registry status
- Phase 1
- Development phase
- 11
- Enrollment target
- 1
- Study location
NCT05159934 is a Phase 1 study of Nicotine Dependence that has completed, run by Yale University. The registered enrollment target is 11 participants, below the 187-participant average among 67 other Nicotine Dependence trials with a reported enrollment target (94% lower). The trial reports 1 study location across 1 state.
The verdict
NCT05159934, a Phase 1 study of Nicotine Dependence, has completed, sponsored by Yale University.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 11 participants
- Enrollment target
- 1
- Study location
Study Summary
The primary aim of this project is to determine the threshold dose of nicotine, which the smokers will be able to differentiate from placebo (saline). Will use IV pulsed-nicotine infusion that closely matches nicotine delivery by inhaled tobacco use (i.e., tobacco cigarette or electronic cigarette), allowing precise and reproducible nicotine delivery. Four nicotine doses (0.1, 0.05, 0.025, and 0.0125 mg nicotine/pulse) which are within the range of nicotine doses that are delivered by cigarettes with very low to regular nicotine content. These doses will be delivered as a cluster of 4 pulsed-nicotine infusions of 2 sec duration with a 28 sec interval between each dose.
Conditions Studied
Interventions
- DRUG Saline
- DRUG 0.05, 0.025, and 0.0125 mg nicotine/pulse of nicotine
Study Locations (1)
Connecticut
- Veterans Affairs Hospital - West Haven
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 11 participants |
| Start Date | 2022-02-16 |
| Est. Completion | 2023-08-01 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05159934
The ClinicalTrials.gov registry entry for NCT05159934 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 11 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 187-participant average among 67 other Nicotine Dependence trials with a reported enrollment target (94% lower). The listed sponsor is Yale University, which has 1,492 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Nicotine Dependence appearing as the primary indexed condition, and to 2 interventions - of which Saline is the first listed.
NCT05159934 reports 1 study location spanning 1 distinct geographic area - top geographies include Connecticut.
Frequently Asked Questions
What is clinical trial NCT05159934 about?
NCT05159934 is a clinical study titled "Nicotine Differences in Smokers". The primary aim of this project is to determine the threshold dose of nicotine, which the smokers will be able to differentiate from placebo (saline). Will use IV pulsed-nicotine infusion that closely matches nicotine delivery by inhaled tobacco use (i.e., tobacco cigarette or electronic cigarette),...
What is the current status of trial NCT05159934?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 11 participants. The study started on 2022-02-16. Estimated completion is 2023-08-01.
What conditions does trial NCT05159934 study?
This clinical trial studies the following conditions: Nicotine Dependence.
What interventions are being tested in trial NCT05159934?
The interventions under investigation include: Saline (DRUG), 0.05, 0.025, and 0.0125 mg nicotine/pulse of nicotine (DRUG).
Who is sponsoring clinical trial NCT05159934?
This trial is sponsored by Yale University, which has 1,492 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05159934 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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Read our methodology - how this data is sourced, computed, and verified.
Related
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