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NCT03580525 · ClinicalTrials.gov registry record · Early Phase 1
Nicotine Delivery Rate and Its Abuse Potential: Impact of Menthol
A Early Phase 1 study, sponsored by Yale University.
- Completed
- Registry status
- Early Phase 1
- Development phase
- 24
- Enrollment target
NCT03580525: Completed Early Phase 1 study, sponsored by Yale University.
NCT03580525 is a Early Phase 1 study that has completed, run by Yale University. The registered enrollment target is 24 participants, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (55% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03580525, a Early Phase 1 study, has completed, sponsored by Yale University.
- COMPLETED
- Registry status
- Early Phase 1
- Development phase
- 24 participants
- Enrollment target
Study Summary
A placebo-controlled study to enroll male and female tobacco smokers who will participate in five experimental sessions. subjects will be given an IV infusion of either saline or 1 mg nicotine at rapid, moderate or slow infusion rates (nicotine at 0.24,0.096, 0.048 and 0.024, mcg per kg body weight per sec).
Primary Outcome
The peak change in the intensity of subjective effects as measured by the DEQ: Drug stimulatory effects questionnaire; Eleven questions with a minimum score of 0 to a maximum score of 100. Presented is the DEQ score at which the peak change was strongest by treatment arm. Each session took approximately 60 minutes, however the measures were only collected up to 10 minutes post infusion. This correction to the outcome time frame was made when the results were entered. Data were collected at 1, 3,
Interventions
- DRUG Nicotine saline infusion 0.00mcg/kg/s
- DRUG Nicotine infusion 0.24mcg/kg/s
- DRUG Nicotine infusion 0.096mcg/kg/s
- DRUG Nicotine infusion 0.048 mcg/kg/s
- DRUG Nicotine infusion 0.024mcg/kg/s
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2019-02-14 |
| Est. Completion | 2020-11-19 |
| Phase | Early Phase 1 |
What the finished NCT03580525 record still lists
NCT03580525 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 24 participants, a relatively small participant target, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (55% lower).
The record links to 0 conditions, and to 5 interventions - of which Nicotine saline infusion 0.00mcg/kg/s is the first listed.
NCT03580525 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03580525 about?
NCT03580525 is a clinical study titled "Nicotine Delivery Rate and Its Abuse Potential: Impact of Menthol". A placebo-controlled study to enroll male and female tobacco smokers who will participate in five experimental sessions. subjects will be given an IV infusion of either saline or 1 mg nicotine at rapid, moderate or slow infusion rates (nicotine at 0.24,0.096, 0.048 and 0.024, mcg per kg body weight ...
What is the current status of trial NCT03580525?
This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 24 participants. The study started on 2019-02-14. Estimated completion is 2020-11-19.
What interventions are being tested in trial NCT03580525?
The interventions under investigation include: Nicotine saline infusion 0.00mcg/kg/s (DRUG), Nicotine infusion 0.24mcg/kg/s (DRUG), Nicotine infusion 0.096mcg/kg/s (DRUG), Nicotine infusion 0.048 mcg/kg/s (DRUG), Nicotine infusion 0.024mcg/kg/s (DRUG).
Who is sponsoring clinical trial NCT03580525?
This trial is sponsored by Yale University, which has 1,492 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03580525's enrollment target sits among peer trials
24 1037th of 2000 higher than 914 of 2,000 other Early Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Early Phase 1 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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